SUMMIT FOR CLINICAL OPS EXECUTIVES - Scope Summit · SUMMIT FOR CLINICAL OPS EXECUTIVES 9th Annual...

SUMMIT FOR CLINICAL OPS EXECUTIVES

9th Annual

SCOPEsummit.com

Final Weeks to Register

Event Features More than 1,500 participants projected for 2018

18 Conferences

3 Plenary Keynote Sessions

Clinical Informatics News Best Practices Awards

Participant Engagement Awards

Dedicated Exhibit Hall Hours & Networking Functions

#SCOPE2018

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February 12-15, 2018Hyatt Regency Orlando Orlando, Florida

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SIGNATURE SPONSOR

CoverEvent-at-a-Glance

Sponsor & Exhibit Opportunities

Hotel & Travel Information

Registration Information

Register Online!SCOPEsummit.com

Plenary Keynote Program

A Division of Cambridge Innovation Institute

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Protocol Development, Global Site Selection, Feasibility and Site Management

Enrollment Planning and Patient Recruitment

Clinical Trial Forecasting, Budgeting and Contracting

Mastering an Outsourcing Strategy

Implementing Risk-Based Monitoring-Part 1

Clinical Data Strategy and Analytics

Sensors, Wearables and Digital Biomarkers in Clinical Trials NEW

Late Stage Research and Observational Studies

Biospecimen, Central Lab and Technology for Precision Medicine Trials

Improving Site-Study Activation and Performance

Patient Engagement, Enrollment and Retention through Communities and Technology

Resource Management and Capacity Planning for Clinical Trials NEW

Managing Outsourced Clinical Trials


Artificial Intelligence in Clinical Research NEW

Clinical Technology and Innovation

Leveraging Real World Data for Clinical and Observational Research

Clinical Supply Management NEW

Interactive Breakout Discussions

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Event-at-a-Glance

Stay ConnectedJoin the Clinical Trials Ops Executives group

The Intro-Net offers you the opportunity to set up meetings with selected attendees before, during and after this conference, allowing you to connect to the key people that you want to meet. This online system was designed with your privacy in mind and is only available to registered session attendees of this event.

Monday, February 12 Tuesday, February 13 Wednesday, February 14 Thursday, February 15

SCOPE’s Kick-Off Networking Happy Hour on the Garden Terrace6:30 pm – 8:30 pm

Pre-Conference User Group Meetings & Hosted Workshops (Opportunities Available)2:30 pm – 5:00 pm

Pharma Intelligence Citeline Launch Celebration (see page 6 for details) 2:30 - 5:00 pm

PM PMAMAM & PM AM & PM

Monday Evening Pre-Conference Plenary Keynote Panel5:00 pm – 6:15 pm

SITE ACTIVATION

RECRUITMENT

BUDGETING & MGMT

OUTSOURCING

MONITORING

DATA

REAL WORLD EVIDENCE

BIOSPECIMEN & CLINICAL SUPPLY

Conference 1AProtocol Development, Global Site Selection, Feasibility and Site Management

Conference 2AEnrollment Planning and Patient Recruitment

Conference 3AClinical Trial Forecasting, Budgeting and Contracting

Conference 4AMastering an Outsourcing Strategy

Conference 5AImplementing Risk-Based Monitoring - Part 1

Conference 6AClinical Data Strategy and Analytics

Conference 8ALate Stage Research and Observational Studies

Conference 9ABiospecimen, Central Lab and Technology for Precision Medicine Trials

Conference 1BImproving Site-Study Activation and Performance

Conference 2BPatient Engagement, Enrollment and Retention through Communities and Technology

Conference 3B NEWResource Management and Capacity Planning for Clinical Trials

Conference 4BManaging Outsourced Clinical Trials

Conference 5BImplementing Risk-Based Monitoring - Part 2

Conference 6B NEWArtificial Intelligence in Clinical Research

Conference 8BLeveraging Real World Data for Clinical and Observational Research

Conference 9B NEWClinical Supply Management

TECHNOLOGYConference 7A NEWSensors, Wearables and Digital Biomarkers in Clinical Trials

Conference 7BClinical Technology and Innovation

Make Space for Innovation: Trifecta InvestigatorSpace® User Forum (Invitation only, see page 6 for details)12:00 pm – 5:00 pm

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Premier Sponsors

Corporate Sponsors

Corporate Support Sponsors

Signature Sponsor

*IBM and the IBM logo are trademarks of International Business Machines Corp., registered in many jurisdictions worldwide.








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Sponsorship, Exhibit and Lead Generation Opportunities

CRO42%

Pharma20%

Other 1%

Academic 2%

Services/Societies 10%

Healthcare/Hospital 10%

Biotech 15%

Company Type

Company Title

Executive/Director

53%

Sales & Marketing 24%

Manager 14%

Scientist/ Technologist 7%

Professor 1%

Other 1%

2017 ATTENDEE DEMOGRAPHICS For sponsorship and exhibitor information, please contact:

Ilana QuigleySr Business Development Manager781-972-5457 [email protected]

Comprehensive sponsorship packages allow you to achieve your objectives before, during, and long after the event. Signing on earlier will allow you to maximize exposure to hard-to-reach decision-makers.

Podium Presentations — Available within Main Agenda!Showcase your solutions to a guaranteed, targeted audience through a 15- or 25-minute presentation during a specific conference program, breakfast, lunch, or separate from the main agenda within a pre-conference workshop. Package includes exhibit space, on-site branding, and access to cooperative marketing efforts by CHI. For the luncheon option, lunches are delivered to attendees who are already seated in the main session room. Presentations will sell out quickly, so sign on early to secure your talk!

One-to-One Meetings / Hospitality SuiteSelect your top prospects from the pre-conference registration list. CHI will reach out to your prospects and arrange the meeting for you. A minimum number of meetings will be guaranteed, depending on your marketing objectives and needs. A very limited number of these packages will be sold.

EXHIBIT – Hall Over 90% Sold!Exhibitors will enjoy facilitated networking opportunities with qualified delegates. Speak face-to-face with prospective clients and showcase your latest product, service, or solution.

Additional branding & promotional opportunities include:• Track Reception• Footprint Trails• Aisle/Meterboard Signs• Exhibit Hall Reception• Focus Groups• User Group Meetings• Padfolios• Program Guide Advertisement

Looking for additional ways to drive leads to your sales team?CHI’s Lead Generation Programs will help you obtain more targeted, quality leads throughout the year. We will mine our database of 800,000+ life science professionals to your specific needs. We guarantee a minimum of 100 leads per program! Opportunities include:• Live Webinars• White Papers• Market Surveys• Podcasts and More!VIEW FLOORPLAN VIEW EXHIBIT HALL

SCHEDULE








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Conference Venue and Hotel: Hyatt Regency Orlando9801 International DriveOrlando, FL 32819T: 407.284.1234

Reservations: Go to the travel page of SCOPEsummit.com.

Discounted Room Rate: $249 s/dDiscounted Cut-off Date: January 9, 2018

Why Stay at the Hyatt Regency Orlando?The Hyatt Regency Orlando offers guests the very best of both worlds from business travel to tourism. Located on I-Drive in the Convention District, it is an upscale vacation resort with an unrivaled radius to top attractions for corporate travel or theme park adventures. Top scale, yet family (and pet) friendly, the Hyatt has mixing business with pleasure down to a “T”.

After conference sessions, our attendees may enjoy

• Complimentary internet in their guest room• Three different swimming pools, with waterfalls

and a water slide• 24-hour state-of-the-art fitness center and spa• First rate onsite restaurants, including upscale, pool

dining, family friendly and grab-and-go options








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Plenary Keynotes & Panels

MONDAY, FEBRUARY 12, 2018

Monday Evening: WHERE ARE CLINICAL TRIALS HEADED FOR 2018?

5:00 - 6:15 PANEL DISCUSSION: Where Are Clinical Trials Headed for 2018?Moderator: Christopher Rull, Principle Consultant, CR Consulting, LLC; former Vice President, Head of Business Development & Account Management, UBC

Ibraheem (Ibs) Mahmood, CEO, DrugDev

Nancy Mulligan, Executive Director, Patient & Physician Services, UBC

Janet Baldwin, Vice President, Real World & Late Phase, Syneos Health

Jeffrey Kasher, Ph.D., Founder, Patients Can’t Wait; former Vice President, Clinical Innovation and Implementation, Eli Lilly and Company

As the biopharmaceutical industry increasingly turns to CROs to stay competitive and improve its efficiency, hear from senior CRO leaders as they explore where clinical trials are headed in 2018. Start off SCOPE by hearing leading CROs forecast new trends, changes in process, and partnerships and continue the discussion at our Welcome Reception. Topics to be discussed:• What are the key trends on the horizon for clinical trials? Where will the next big

pay-off be for clinical trials?• As new technology and increasing volumes of data become more accessible to

the biopharmaceutical industry, how will industry make meaningful, data-driven decisions in 2018? How will pharma put these trends to action?

• What is in store for Sponsor-CRO partnerships as mergers and acquisitions increase across the CRO landscape?

Monday, February 12 | 5:00 - 8:30 PM

Cambridge

HEALTHTECHInstitute SUMMIT FOR CLINICAL OPS EXECUTIVES

6:30 - 8:30 SCOPE’s Kick-Off Networking Happy Hour on the Garden Terrace co-hosted by CHI, DrugDev, Exostar, and PraxisCome connect with old friends, and make new ones on the Garden Terrace of the Hyatt Regency at the Happy Hour co-hosted by CHI, DrugDev, Exostar, and Praxis. Running shoes, jeans, Aloha shirts are all appropriate attire for Happy Hour.

Kick-Off SCOPE at our Networking Happy Hour!

Pre-Conference User Group Meeting & Hosted Workshops

12:00 pm Make Space for Innovation: Trifecta InvestigatorSpace® User Forum*Please join Trifecta Clinical for a user forum event featuring Trifecta’s comprehensive investigator training, safety letter delivery and communication platform, InvestigatorSpace. During this user-focused event, participants will:• Share success stories and best practices using Trifecta’s

technology solutions• Explore ways to leverage InvestigatorSpace enterprise wide

for maximum value • Learn more about the latest innovations being developed by

Trifecta Clinical• Engage with the Trifecta leadership team and provide feedback on

future product innovation and enhancements*By invitation only. If interested, please contact Rick Ward at [email protected] or 610-724-9765

2:30 - 5:00 pm Afternoon Pre-Conference User Group Meetings & Hosted Workshops (opportunities available, contact Ilana Quigley)

2:30 - 5:00 pm Pharma Intelligence Citeline Launch CelebrationInforma Pharma Intelligence is pleased to announce the launch of the Next Generation of Citeline – a new way to access the industry’s most comprehensive, accurate and up-to-date clinical trial intelligence. Our launch celebration will include an afternoon of networking with peers and partners, as well as forward-thinking presentations on R&D trends and challenges.

Register at the BEST VALUE rate and receive access to the entire SCOPE

event and all the Keynotes.Does not include access to sponsored workshops

and/or user groups








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TUESDAY, FEBRUARY 13, 2018

Tuesday Morning: PATIENT-CENTRIC DRUG DEVELOPMENT AND TRIAL

OPERATIONS8:20 am Organizer’s WelcomeMicah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

8:25 Chairperson’s IntroductionJerome Chiaro, Vice President, Clinical Site Operations, StudyKIK

8:30 Keynote Kick-Off: Stop Trying to Be Innovative! Hack Your Way to Creative, Valuable SolutionsShwen Gwee, Head of Digital Strategy, Global Clinical Operations, Biogen

At a time of unprecedented innovation disrupting almost every other industry, the healthcare and pharmaceutical industries seem to be laggards and most resistant to this change. This talk will cover three easy steps that are used by MIT Hacking Medicine, a student organization that runs health hackathons around the world, to help hack innovative solutions for medicine and healthcare. The approach draws principles and learnings from Design Thinking, Lean Startup and other innovation processes, which when applied to your organization or corporate approach, can help you hack your way to creative, valuable solutions that can engender value and drive true innovation.

8:45 Operating on a Beating Heart: Evolving Patient-Centricity End to End in Pharmaceutical DevelopmentRoslyn Schneider, M.D., Global Patient Affairs Lead, Pfizer

People living with and trying to prevent illness expect more iterative involvement in decisions that affect their health including in development of therapies. They are no longer content with surrogates speaking for them even if they are learned, compassionate professionals. We in the pharmaceutical industry are working together with patients to understand and implement the most appropriate ways to involve patients without missing a beat in the rush to advance and support therapies that may benefit them. This keynote will address some of the experiences, opportunities and challenges in doing just that.

9:10 PANEL DISCUSSION: What Does Digital Patient Engagement Mean Today?

Moderator: Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono

Roslyn Schneider, M.D., Global Patient Affairs Lead, Pfizer

Terrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

Michelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline

Gilles Frydman, Patient Advocate; Co-Founder, Smart Patients and ACOR (Association of Cancer Online Resources)

The research community has embraced patient-centricity as a driving force to improve participant experience, trial design and outcomes, but the engagement piece has many components. This panel will discuss current digital patient projects, engagement pilots, experiences with new technologies, the role of patient communities, and lessons learned to date. Key questions to be discussed by the panel and with the audience:• What is a complete digital patient experience? What is required to make this

a reality for all trials?• What are we getting right and what are we getting wrong as we realign our

processes and our research organizations around the patient-centric model?• What technologies and capabilities do we already have in house and what

pieces of the puzzle are we missing, whether low- or hi-tech?

9:45 - 10:45 Grand Opening Coffee Break in the Exhibit Hall

Plenary Keynotes & Panels Tuesday, February 13 | 8:20 - 9:45 AM

Group and Company Discounts!Group Discounts are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts contact Melissa Dolen at 781-972-5418.

Melissa Dolen Account Manager Cambridge Healthtech Institute T: 781-972-5418 | E: [email protected]








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Plenary Keynotes & Panels Wednesday, February 14 | 1:30 - 3:00 PM

WEDNESDAY, FEBRUARY 14, 2018

Wednesday Afternoon: NEW TECH, INNOVATION AND COLLABORATION IN

CLINICAL TRIALS1:30 Organizer’s WelcomeMicah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)

1:35 Chairperson’s IntroductionGreg Skalicky, Executive Vice President and General Manager, Syneos Health

1:40 Clinical Informatics News Best Practices AwardsAllison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics NewsThe Clinical Informatics News Best Practices Awards recognizes

outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process. An expert panel of judges assesses entries looking for solutions that are innovative, and needed in the industry.Learn More & Submit an Entry for 2018 at: www.clinicalinformaticsnews.com/BestPracticeAwards/

1:50 Part 1: The Forgotten PatientJoe Kim, MBA, Senior Advisor, Clinical Innovation, Eli Lilly and Company

Typically, all patients who volunteer for clinical research come from two places – either they are known to the investigator, or they are not. But there is a third type of patient that has long been forgotten and considered beyond our reach. And it has been our collective inability to accommodate this patient group that certainly hasn’t helped our ability to quickly deliver new medicines to the world. What will it take to reach them where they are?

2:10 Part 2: Pharma-ACO Collaboration and New Delivery Systems: Facilitating the Linkage between Healthcare’s Triple Aim and Improved Clinical Trials

Jeff James, MBA, CEO, Wilmington HealthThe worlds of healthcare delivery, payment reform, medical technology and clinical research are all evolving in tandem. This presentation will share how we are facilitating a linkage between an ACO’s triple aim aspirations and the need for Pharma to initiate trials that are better, faster, more predictable, more reliable and less expensive. In addition, it will illustrate the roadblocks that still need to be overcome.

2:30 PANEL DISCUSSION: Clinical Trial Technology and Innovation: Collaboration as the Key to Industry Transformation

Moderator: Dalvir Gill, Ph.D., CEO, TransCelerate BioPharma, Inc.

Ken Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

Anthony Rowe PhD, Director, R&D IT Business Technology Leader, Immunology TA, Janssen

Susan Griffing, Vice President, Global Head Country Clinical Operations, Roche

Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline

Harnessing the power of collaboration can alter the healthcare landscape as we know it today. This thought-provoking session will bring together a diverse panel representing some of the industry’s most influential organizations for a candid and innovative conversation about what is needed to shake up the current ecosystem and truly transform patient health. This panel discussion will address:• What is working today, and how will the ‘next generation of collaborations’ be different?• Is collaborative R&D, pooling data and insights from academia, sponsors, and CROs in our near future?• What roles will FDA, consortiums, technology providers, and other stakeholders play?

3:00 - 4:00 Valentine’s Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing








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Interactive Breakout Discussions Tuesday, February 13 | 3:50 - 5:00 PM

BREAKOUT DISCUSSION GROUPS3:50 Find Your Table and Meet Your Moderator

4:00 Interactive Breakout Discussion GroupsConcurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

5:00 Welcome Reception in the Exhibit Hall

6:15 Close of Day

TABLE 1: What Is Holding Back the Adoption of eConsent?Moderators:Eric Delente, President, Patient Solutions, DrugDev (An IQVIA Company)Scott Askin, Digital Development Director, Lead for eSource and eICF, Digital Development, Portfolio, Strategy & Innovation (PS&I), Novartis Pharma Anthony Costello, Vice President, Mobile Health, MedidataRobann Cunningham, Senior Vice President, Business Development, Advarra• Is eConsent for every trial? Discuss when eConsent is or isn’t appropriate• Understand IRB and regulatory feedback on the eConsent process• Discuss how eConsent technology integrates with other systems• Review a typical implementation timeline and how it impacts all stakeholders

TABLE 2: Embracing Best Practices in Protocol Design to Reduce Protocol Amendments and Improve TrialsModerators:Stella Stergiopoulos, Senior Project Manager, Center for the Study of Drug Development, Tufts UniversityBina Rathod, Associate Director & Business Lead, MRL IT Global Clinical Development, Merck & Co.Mitzi Allred, Director, Clinical Research, Clinical Content Standards, Merck & Co.Julie Dietrich, Director, Development Design Center, Amgen, Inc.• What are the updated metrics on the prevalence and causes of protocol

amendments and what does this mean for us?• How can we as an industry improve our process of protocol development?• What are some community initiatives and individual company approaches to

finding success?

TABLE 3: Coordinating Contracting and Payments to Enhance EfficienciesModerators:Stu Thiede, President, Payments, DrugDev (An IQVIA Company)Débora Araujo, Associate Director, Site Budgets and Payments (US Group Head), Boehringer Ingelheim Pharmaceuticals, Inc.JoAnn Pfeiffer, DrSC., Director, Clinical Research Management, Arizona State University• Understand how contracting and Investigator payments are connected• Review standard terms to use on both ends of the contracting process• Discuss how to improve and implement a plan to streamline operations








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TABLE 4: Barriers and Opportunities in Site Adoption of Clinical Trial TechnologyModerators:Claire Sears, Director, Product Communications, DrugDev (An IQVIA Company)Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology AssociatesDoug Pierce, President & Co-Founder, Clinical Ink• What site facing technology is critical to improving clinical trials?• What is holding sites back from adopting this technology?• What can be done to minimize the burden of technology for sites?• What opportunities exist to streamline and integrate technology in clinical

trials?

TABLE 5: Strategies for Accelerating Recruitment in Complex Clinical Trials in a Resource Constrained EnvironmentModerators:Kevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly & CompanyJerome Chiaro, Vice President, Clinical Site Operations, StudyKIKKate Boneck, Associate Director, Global Trial Optimization, Merck & Co.Angela Radcliffe, Managing Director, Executive Vice President, FCBVIOMatt Miller, Vice President, Global Patient Recruitment & Feasibility, StudyKIKDaniel Brunwasser, Associate Director, Marketing Operations, Consumer Marketing, Acurian• Dealing with the Acute Patient where timing is critical• Do traditional/past tactics still work in current environment? What tactics

(new and old) work best today?• Ensuring success for procedure driven protocols (Non-conventional

administration, device and/or diagnostic intense)• Utilization of supportive field resources to accelerate recruitment (Medical

Science Liaisons & Clinical Trial Educators)

TABLE 6: Precision Feasibility in Precision Medicine-Driven TrialsModerators:Jill Loftiss, Head, Clinical Operations, Oncology, MedImmune/AstraZenecaKarina Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research Laboratories• The impact of precision medicine on today’s clinical trial feasibility

assessment and trial planning• The impact of competition, breakthrough FDA approval and change of

standard of care• Leverage the power of real world data and trial intelligence data to enable

evidence-based trial feasibility assessment

TABLE 7: Optimizing Country and Site Selection: Strategies for Positioning Trials for Success Using a Global FootprintModerators:Christopher Conklin, Director, Feasibility Center of Excellence, PfizerMark Springer, Project Lead, Clinical Innovation, Eli Lilly & CompanyShawn Tedman, MBA, Head of Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS• Optimizing the site feasibility process: Improving global site feasibility

assessment to identify sites that will recruit on time and within budget• Objective country feasibility and selection: Where are the patients?• Data-driven site selection: Understand the number of sites, their probability

of success, and the impact of site non-performance

TABLE 8: Improving Both Time and Quality in Site Activation and Study Start-UpModerators:Valérie Reynaert, Head, In-Country Clinical Operations for the Americas, R&D Projects Clinical Platform & Sciences, GlaxoSmithKlineChristina Brennan, M.D., Vice President, Clinical Research, Executive Research Administration, Northwell HealthMarina Malikova, Ph.D., Executive Director, Surgery, Boston University Medical Center• Identifying and consolidating site start up activities that are redundant,

inefficient and needlessly complex• What are key learnings and opportunities for different approaches, including

a centralized approach of study activation and site performance?• How can sponsors, CROs and site streamline site activation and

study start-up?

TABLE 9: Strategies for Patient-Centric Trial Design and Digital Patient EngagementModerators:Lynn Hagger, Ph.D., Patient Engagement Director, Respiratory, INA & CVMD, Global Medical Affairs, Astra ZenecaGilles Frydman, Patient Advocate; Co-Founder Smart Patients and ACOR (Association of Cancer Online Resources)Terrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), BiogenAmir Lahav, Digital Innovation, Rare Disease Research Unit, PfizerMari Maurer, Pharma Clinical Solutions Consulting; former Vice President, Clin Ops, REGENXBIO• What are current digital patient projects gaining traction, engagement pilots,

new technologies, the role of patient communities?• What is a complete digital patient experience? What is required to make this

a reality for all trials?• What are we getting right and what are we getting wrong as we re-align our

processes and our research organizations around the patient-centric model?








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TABLE 10: Balancing Budgets and Performance in Resource Management and Capacity PlanningModerators:Chris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.Heather Baldwin, MPH, Principal Consultant, Frogbottom Consulting, LLCRajyalakshmi Nimmagadda, Global Trial Forecast Development Unit Head, Trial Forecasting and Resource Management, Novartis• What are key factors that should be considered when developing a resource

plan?• What situations warrant a bigger focus on cost savings, and which on using

other resources?• How do training and retention programs fit into capacity planning and overall

resource management?

TABLE 11: RBM in a Finance and Resource Limited EnvironmentModerators:Yiwen Sun, Senior Clinical Research Associate, Samumed, LLCAndy Lawton, Director & Consultant, Risk Based Approach Ltd.• How can we adopt TransCelerate’s RACT model for a resource limited

company/org?• In terms of technology, what are nice to haves vs. need to haves for

implementing RBM?• Who is involved in putting RBM in action at smaller companies?

TABLE 12: Vendor Performance Metrics and KPIsModerators:Rick Morrison, Co-Founder and President, Comprehend SystemsDiane Miller, Director, Vendor Management, AbbVieAaron Fleishman, Head of Emerging Markets, BBK Worldwide• How effective are your KPIs for measuring vendor performance and quality?• What is your strategy for establishing KPIs and metrics?• What are the key areas that should be evaluated for vendor performance and

quality?

TABLE 13: Understanding and Implementing the New Reality of Diversity in Clinical TrialsModerators:David Sall, President & CEO, Patient Enrollment Advisors; Co-Creator of the SCOPE Participant Engagement AwardJeri Burtchell, Director, Patient Initiatives, HealthiVibe, LLCMarisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.• What are the regulatory changes from FDA and updated requirements for

ethnicity/race inclusion in trial populations?• How do you formalize into a clinical development plan at a company level

to make it part of corporate culture by educating and training teams so that they can embrace the ethnicity value?

• How do you then implement at project team level and operationalize the activities to support diversity in clinical trials?

TABLE 14: Selecting, Developing and Incorporating Novel Endpoints, Generated from Data Captured by Mobile Technologies, for Use in Clinical TrialsModerators:Jennifer Goldsack Senior Project Manager, Clinical Trials Transformation Initiative (CTTI)Rob DiCicco, Ph.D., Vice President, Clinical Innovation and Digital Platforms, GSKMichelle Crouthamel, Digital Platform Leader, GSKAmy Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor, Eli Lilly and CompanyChristian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development• Describe approaches to identifying mobile technology-derived outcome

measures that are most valuable and warrant development• Review approaches for optimizing the efficiency of technology-derived novel

endpoint development• Discuss how to include and position technology-derived novel endpoints to

be most impactful

TABLE 15: RWE in Clinical Trial Research and Patient RecruitmentModerators:Jane Fang, M.D., Head, Research & Development Information for Clinical Biologics, MedImmune Biologics Science Unit, AstraZenecaJyotsna Mehta, Director, Economics Value Evidence and Outcomes, Alkermes, Inc.Hui Cao, M.D., Ph.D., Executive Director, Real-World Evidence, COE for RWE, Global Medical Affairs, Novartis Pharmaceuticals Corporation• The impact of precision medicine on today’s clinical trial feasibility

assessment and trial planning• Leverage the power of real world data to enable evidence-based trial

feasibility assessment• RWE needs to go beyond analysis and clinical trial is calling new clinical-

health service to link healthcare and clinical trial research

TABLE 16: Visual Analytics in Clinical ResearchModerators:Charlie Romano, Vice President, Global Clinical Operations, Peachtree Bioresearch SolutionsSteven Sweeney, Vice President, Clinical Development Operations, Rodin Therapeutics• Data visualizations for clinical operations• Focus on decision making and value• Using the data properly








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TABLE 17: Addressing Chronic Site and CRA Turnover Issues through a Competency-Based Approach to Workforce DevelopmentModerators:Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)Divya Chadha Manek, Head, Business Development (Commercial), Clinical Research Network, National Institute of Health ResearchJeff Kingsley, CEO, IACT HealthLisa Hegg, Ph.D., Vice President, Head Project Planning and Management, Project Management and Business Performance, GSK• Discuss common sources and reasons for CRA turnover and why those

issues arise• Examine the role of workforce development and how a competency-based

system can address turnover issues• Discuss strategies for implementing a competency-based approach

TABLE 18: Biospecimen, Central Lab and TechnologyModerators:Michael Tanen, Director, Clinical Biomarker Specimen Management, MerckBrenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² SolutionsJonathan Reuter, Associate Director, Global Procurement R&D, Clinical Labs, Bristol-Myers Squibb• Biorepositories: in house vs. outsourcing• Advanced informatics for biospecimen management• Central and reference labs: building the relationship• Biospecimen and central lab considerations for risk-based monitoring

TABLE 19: Artificial Intelligence and Machine Learning: Extreme Case of Data Analytics?Moderators:Balazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers SquibbFrancis Kendall, Technology Evaluation and Implementation Leader, Product Development, Roche• With Machine Learning becoming needing Big data sets, how could the

industry share more data in a precompetitive framework?• As more Deep learning techniques are deployed - how can we gain

confidence in “Black Box” approaches?• In what ways, if any, will we have to change how we work with regulators?• Will clinicians use and have confidence in ML using clinical decision support

tools• Will a ML algorithm be part of the molecule package?

TABLE 20: Blurring the Division between Clinical and Observational StudiesModerators:Cathy Critchlow, Ph.D., Vice President, Center for Observational Research, AmgenChristopher Chinn, Head, Real World Investigations, SanofiMark Price, Senior Director, Surveys and Observational Studies, RTI Health Solutions• Similarities and differences in operationalizing observational studies vs.

clinical trials• Building a continuous program that includes post-approval studies• Integration of real world data into decision-making across the drug

development cycle

TABLE 21: Driving Fully eSource Clinical TrialModerators: Michelle Crouthamel, Digital Platform Leader, GSKJaydev Thakkar, IS Director, R&D Informatics, AmgenAman Thukral, Assistant Director, Data and Statistical Sciences, AbbVieJonathan Andrus, MS, CQA, CCDM, COO, Clinical Ink• What is the current state?• High and low of eSource adoption, what are the drivers and barriers• How to get to 100% eSource?








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Data-driven global site selection, an optimized protocol development and feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often, companies fail to learn from past mistakes and take the same approach to trial planning and execution. In order to overcome challenges in clinical trial planning, operations and site management, leaders should learn from the best practices of their peers, utilize data and technology to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. CHI’s 8th Annual Protocol Development, Global Site Selection, Feasibility and Site Management will cover the topics one should consider when planning and implementing a trial.

MONDAY, FEBRUARY 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 Pre-Conference Plenary Keynote Panel (click here for details)

6:30 – 8:30 SCOPE’s Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, Exostar, & Praxis

8:30 Close of Day

TUESDAY, FEBRUARY 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes (click here for details)

9:45 Grand Opening Coffee Break in the Exhibit Hall

RATIONAL PROTOCOL DESIGN AND IMPROVED FEASIBILITY PRACTICES TO IMPROVE TRIAL

PERFORMANCE10:45 Chairperson’s RemarksChristopher Conklin, Director, Feasibility Center of Excellence, Pfizer

10:50 Trends in Protocol Design Practice and Its Impact on PerformanceKen Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRPThe scientific and operating demands of protocol designs have increased rapidly during the past decade due to numerous factors. This talk characterizes trends in, and the forces driving, protocol design practices. The impact of these practices on clinical trial performance and economics will be discussed.

11:15 Maximizing Site Contributions in a Competitive LandscapeKelly White, Director, Global Operations Oncology, Global Trial Optimization, Merck & Co.Sites submit trial proposals for participation and are selected (or not selected) without much insight into the protocol or rationale for why they have been allocated a particular number of patients. Sponsors create competitive recruitment strategies that don’t allow sites to plan or manage their resources, so even when sites have the ability to enroll more patients, they often don’t have the resources. I will set forth some proposals for how we might “stop the insanity” of peppering the world with sites and focus on a collaborative model where sites and sponsors plan their recruitment and resources synergistically with the goal of making both of them successful.

11:40 Feasibility... Decisions, Decisions, Decisions: Early Planning and Internal-External ModelsJohn Oidtman, Senior Vice President, Head of Global Clinical Operations, EMD SeronoThis presentation will focus on the steps that sponsors must consider when planning clinical trial conduct. It will provide insights into approaches to optimize the early planning process and will also provide perspectives on the pros and cons of internal vs. external business models.

Sponsored by12:05 pm CO-PRESENTATION: Strengths and Limitations of Data in Clinical Trial Feasibility Martin Lee, M.D., Vice President, Scientific Services, Scientific Affairs, PRA Health SciencesJacqui Whiteway, Ph.D., Senior Director, Feasibility, Scientific Affairs, PRA Health SciencesThere is an increasing emphasis on the use of data in clinical trial planning, especially in projecting enrollment rates and in selecting countries and sites for participation. Our presenters will identify the strengths, limitations and optimal use of existing and emerging data sources; discuss the importance of direct site interactions in the planning process; and recommend a systematic approach to optimal clinical trial planning.

12:30 Session BreakSponsored by

12:40 Luncheon Presentation: Combining Patient Registries with Investigator Site Experience to Enhance Trial Design & Clinical Trial PerformanceDawie Wessels, M.D., CMO, Synexus Clinical Research

1:20 Coffee and Dessert Break in the Exhibit Hall








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Interactive Breakout DiscussionsProtocol Development, Global Site Selection, Feasibility and Site Management

8th Annual

Improving Outcomes through Strategy, Relationships, Data and Execution February 13-14, 2018




PROTOCOL OPTIMIZATION DESIGN STRATEGIES: AUTOMATION AND DATA TRACEABILITY TO

DOWNSTREAM PROCESSES2:00 Chairperson’s RemarksKelly White, Director, Global Operations Oncology, Global Trial Optimization, Merck & Co.

2:05 Accelerating Drug Development through Protocol Harmonization: TransCelerate’s Common Protocol TemplateRobert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKlineIncreasing complexity in protocols makes implementation and reporting difficult and the lack of consistency compounds the issue. A significant opportunity exists for an improvement in quality and simplification through protocol harmonization, as all protocols rely on the same health care and regulatory infrastructure for design, review and implementation. This session will explore the collaboration between TransCelerate, FDA, and NIH to achieve alignment on a common protocol structure. It will also describe how TransCelerate’s CPT enables use of clinical data standards, as well as next steps towards automation and data traceability from protocol through to downstream processes.

2:30 CASE STUDY CO-PRESENTATION: How the Business Embedded the Tech-Enabled CPT in Our Business Process and Extended It to Extract Data for Downstream ProcessesBina Rathod, Associate Director & Business Lead, MRL IT Global Clinical Development, Merck & Co.Mitzi Allred, Director, Clinical Research, Clinical Content Standards, Merck & Co.This presentation will cover how our business partners leverage the tech enabled CPT to make protocol data and metadata available to downstream clinical processes, tools and applications to optimize reusability with minimum manual intervention. We will cover from protocol creation and downstream process to clinical study report finalization.

Sponsored by2:55 New Data-Driven Methods to Score Protocols for Patient Burden and Optimize Trial DesignDenise Messer, Scientific Advisor, Evidence Driven Design, IQVIANew methods to objectively quantify and score patient burden of a protocol design. Optimize protocol design using impact of burden insights based on algorithms and quantifications. Reduce site and patient burden to improve recruitment & retention effectiveness.

3:20 PANEL DISCUSSION: Current and Emerging Protocol Optimization Design StrategiesChristopher Conklin, Director, Feasibility Center of Excellence, PfizerRobert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKlineJohn Oidtman, Senior Vice President, Head of Global Clinical Operations, EMD SeronoA number of protocol design optimization strategies have been introduced and implemented including protocol authoring tools, feasibility review mechanisms, patient advisory boards, and pre-planning simulations. This talk touches on optimization strategies and provides data on their impact to date where available. Several protocol design optimization strategies will also be discussed including the adoption and use of adaptive designs and patient centric approaches. This introductory talk will be followed by a panel discussion among pharmaceutical and biotechnology company professionals. Panel members will discuss:• Optimization strategies that most resonate with their respective organizations and why• Experience with various strategies and lessons learned• Adoption challenges and impact following implementation


4:00 Interactive Breakout Discussion GroupsConcurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Click here for details.


6:30 Close of Day








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WEDNESDAY, FEBRUARY 14

7:15 am Registration OpenSponsored by

7:45 Breakfast Presentation: The Next Generation of Site Payments: Technology Do’s and Don’tsStuart Thiede, President, Payments, DrugDev (An IQVIA Company)Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

DATA-DRIVEN FEASIBILITY, COUNTRY SELECTION, AND SITE IDENTIFICATION

8:25 Chairperson’s RemarksChairperson to be Announced, Bio-Optronics

8:30 An Integrated Approach to Feasibility: Driving Operational Strategy and Planning Using Historical Data and Local ExpertsKate Boneck, Associate Director, Global Trial Optimization, Merck & Co.Historical benchmarking, real time expert input, and data-driven global site selection are critical to improving clinical trial timelines and outcomes. This presentation will share an approach to the feasibility process that uses both data assets as well as expert input to support clinical trial teams in optimizing trial planning and execution.

8:55 Assessing New Data-Driven Approaches Informing Global Investigative Site SelectionStella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development, Tufts UniversityA 2016 Tufts CSDD study has demonstrated that current shifts in the investigative site landscape will increase the need for data-driven approaches to inform global investigative site selection, as the landscape remains highly fragmented, nascent, and unstable. In light of these findings, Tufts CSDD conducted two studies assessing current industry trends and strategies on end-to-end site identification through study start-up as well as assessing the types of data that can be gathered from BMIS and clinicaltrials.gov. Industry strategies around data-driven solutions will be discussed.

9:20 CASE STUDY: Does Use of Public Data at the Study Level Result in a Different Planning Strategy When Compared to Shared Site-Level Data?Christopher Conklin, Director, Feasibility Center of Excellence, PfizerThis case study will compare use of shared CTMS data at the site-level vs. publicly available data at the study level in support of study planning for a Phase III study of 1000 subjects with moderate to severe plaque psoriasis. The analysis focuses on two planning endpoints: number of sites required and expected number of patients enrolled per site. Publicly available data underestimates the number of sites required by 21%, and overestimates the enrolment rate by 53%. The session will conclude with a discussion of the potential impact on the need for rescue studies, projected trial enrolment duration, country/site selection, and the benefits of cross-company sharing of CTMS.

Sponsored by

9:45 Translating Registry & Health Informatics Data to Site Performance: Opportunities to Accelerate Feasibility & EnrollmentEarl Seltzer, Director, Global Feasibility, Syneos HealthIn the age of burgeoning data sources and data driven clinical trial planning, many questions remain about how these data, particularly at the patient level, are actually translated to a viable trial delivery solution. This session will cover the use of patient data to facilitate trial feasibility and site selection from a CRO perspective, including lessons learned, current gaps and progress to address them globally, with a focus on understudied indications and rare diseases.

10:10 Coffee Break in the Exhibit Hall

FEASIBILITY/SITE SELECTION IN COMPETITIVE IMMUNO-ONCOLOGY TRIALS & DATA SOURCES FOR

EVIDENCE-BASED PLANNING11:10 Chairperson’s RemarksChairperson to be Announced, Bio-Optronics

11:15 CO-PRESENTATION: Rolling Feasibility in Competitive Immuno-Oncology TrialsJane Fang, M.D., Head, R&D Information, Clinical Biologics, MedImmune/AstraZenecaJill Loftiss, Head, Clinical Operations, Oncology, MedImmune/AstraZenecaWith the rapid development of cancer immunotherapy drug development, competition in the immuno-oncology (IO) trials is fierce. The precision medicine behind trial design is driving rapid change in the way of traditional feasibility assessment. As a result, the innovative approach of Rolling Precision Feasibility has been developed to provide ongoing comprehensive analyses covering trial competitive landscape, patient population, disease epidemiology, precision recruitment rate, regulatory approval landscape, country and site selection strategy, impact of standard of care change, etc.








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11:40 PANEL DISCUSSION: Evidence for Success: Which Data Sources and Data Elements to Use in Study Planning and Site SelectionModerator: Elisa Cascade, President, Data Solutions, DrugDevPanelists:Julie Argento, Principal Data Scientist, Center for Design and Analysis, Amgen Inc.Shawn Tedman, MBA, Head, Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMSWhen it comes to data to plan clinical trials, drive country selection, predict enrollment, and find sites, more may be better, but each data source often adds cost, time, and complexity to the process. While the published literature cites 4 factors for predicting successful site performance: investigative site focus, experience, past performance, time to randomize first subject, actual best practice doesn’t necessarily match the theory published in the literature. In this session, industry experts will review in detail which specific data sources and data elements they use to support evidence-based planning, and the relative importance and sequence in which these sources/elements are used.• Understand data sources and elements available to support study planning

and site selection• Identify strategies for maximizing return while minimizing cost and burden• Gain insight into which data sources/elements are most powerful in an

evidence-based approach

12:05 pm Session Break

Sponsored by12:10 Bridging Luncheon Presentation: Approaches to Evidence Based Site Planning in Trial DesignGavin Coney, Head, Clinical, Clarivate AnalyticsWe will explore approaches to ensuring that your study planning is based on the broadest evidence base. We will demonstrate how additional manually curated intelligence can complement existing data sources to identify relevant insights based on similar studies and provide specific insights into critical trial design and planning decisions.


1:30 Close of Conference

Stay on and attend Part 2: Improving Site-Study Activation and Performance. Click here for details.


Mark your calendar for

October 16-17, 2018 Barcelona, Spain








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8th Annual





On point with making the patient experience the best it can be.- Clinical Development Liaison, Clinical neuroscience Solutions, Inc.

“ ”Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment, if not adequately planned for, can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings. In order to optimize both, you have to have a plan. CHI’s 11th Annual Enrollment Planning and Patient Recruitment will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a clinical development program.

MONDAY, FEBRUARY 12




8:30 Close of Day





INCORPORATING DATA AND PATIENT INSIGHTS INTO ENROLLMENT PLANNING AND TRIALS

10:45 Chairperson’s RemarksMarisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.

10:50 Leveraging Data and Analytics for Enrollment Planning and Trial ExecutionSusan Griffing, Vice President, Global Head Country Clinical Operations, RocheClinical trials are still taking longer than planned and costing companies more than predicted. Of the challenges faced in trial execution, enrollment is still a major bottleneck for research. This presentation will talk to industry trends in this area and specifically how we are leveraging data to make decisions around operations.

11:15 Patient Voice Plans in R&D: Improving the Patient Experience and Clinical Trial SuccessKatherine Capperella, Global Patient Engagement Leader, JanssenJanssen has employed a focused approach to incorporating patient insights into clinical trial design. Working together, commercial and R&D colleagues gather patient feedback and modify clinical trials to improve the patient experience, leading to better recruitment and retention. This presentation will include case studies and an example of how patient engagement is being measured.

11:40 Bringing the Patient Voice and Community into the Drug Development ProcessFrancis Kalush, Ph.D., Health Programs Coordinator, Professional Affairs and Stakeholder Engagement (PASE), CDER, FDAFDA’s Professional Affairs and Stakeholder Engagement at CDER has been working with all stakeholders: patients/patient advocates, health professionals and industry to bring the patient voice and perspective into the drug development and approval process. The goal would be to continue the support of novel therapies that directly address the need of patients living with diseases. Learn to effectively engage with FDA. Understand how to bring the voice of the patient into the drug approval process.

Sponsored by12:05 pm Learning from Other Industries Ivor Clarke, CEO, SubjectWellThis presentation focuses on the root causes of this industry’s challenges in patient outreach and engagement. Then we’ll take a look at how other industries have solved similar problems and what we can apply to patient recruitment.


12:40 Luncheon Co-Presentation: Navigating Clinical Research from the Perspective of the Patient: A Journey in HumilityRobert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLCT.J. Sharpe, Patient Advisor, Starfish Harbor LLCOur industry is dependent upon the good intentions of ordinary volunteers








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Interactive Breakout DiscussionsEnrollment Planning and Patient Recruitment11th Annual

Strategic Enrollment Planning, Data-Driven Recruitment and Forecasting, and Central Campaign Management February 13-14, 2018




subjecting themselves to protocols that regularly include extraordinary procedures. Patients must understand their diagnosis, acquaint themselves to available trial/treatment options, comprehend the medical impact of their decisions, and choose a therapy – typically without a background in healthcare. This interactive session will walk the audience through the patient journey, focusing on treatment/trial selection from a newly-diagnosed patient with a potentially life-threatening disease perspective.


EXPANDING THE REACH OF TRIALS AND RECRUITMENT BEYOND TRADITIONAL METHODS: TELEMED, EMRs & RWD2:00 Chairperson’s RemarksJill Johnston, President, Clinical Services Organization, WCG

2:05 Pharma Bands Together to Activate a New Audience: HealthCare ProvidersJoe Kim, MBA, Senior Advisor, Clinical Innovation, Eli Lilly and CompanyIt’s no secret that attempts to inspire and enable health care providers to refer their patients into clinical trials have often failed. Reasons for this have been documented in peer reviewed literature and felt first hand by study teams in real world campaigns. Come learn about a key component of TransCelerate’s Clinical Research Awareness and Access workstream where they look to go beyond incentive models and skill building. Learn about a unique photojournalism campaign that seeks to activate the hearts of HCPs in a way that will make them believe in the benefit of research for patients, tomorrow and today.

2:30 Data-Driven Patient Recruitment with Real World Data at Roche pREDLiping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche Innovation Center New YorkWith the increasing use of Real World Data (RWD) in the pharma industry, Data-Driven Recruitment (DDR) team at Roche Pharm Research & Early Development (pRED) would like to share our experience of integrating RWD (e.g. insurance claims, EMR) with trial metrics data to optimize study protocol design and target patient recruitment strategy. While the team has received positive feedback from our business partners (translational medicine, clinical program teams, and study leaders) we would like also to share the challenges to expanding the effort in broader US and international settings.

2:55 PANEL DISCUSSION: Innovation in Recruitment Is Not a 4-Letter WordKevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly and CompanyMark Springer, Project Lead, Clinical Innovation, Eli Lilly and CompanyTaylor Wong, LRL Procurement, Medical and Regulatory, Eli Lilly and CompanyRahlyn Gossen, Founder & Principal, Rebar Interactive

Patient recruitment methods and execution have become stale. In the typical full-service model, a sponsor chooses one full-service supplier, who may not have expertise in all aspects of digital patient recruitment. To innovate in this space, Lilly Clinical Innovation sought to determine if creating a new patient recruitment sourcing solution would benefit the digital patient recruitment ecosystem. By analyzing each aspect of the ecosystem, we looked to identify the best in class vendors for each aspect of digital patient recruitment (e.g., creative, outreach, microsites, etc.) using Lilly TrialGuide as the centerpiece. This panel will examine the innovation and will represent the voices of Clinical Innovation, Research Procurement, and a supplier involved in the process. Our process for determining selected suppliers will be explored including defining the “Pitch Match” method for determining final suppliers. Communication, processes, challenges, best practices, and insights from all sides of the table will be explored and audience participation is encouraged.

Sponsored by3:20 Real World Data Meets Real World Evidence in Patient Recruitment and EngagementBonnie Brescia, Founding Principal, BBK WorldwideToday we have access to multiple health databases containing myriad data points that can be integrated, correlated and mined. The expectation is that these data will help researchers to better define target patient populations, improve protocol design, and enhance site selection. But will these efforts advance patient recruitment and retention? Using data from multiple global trials, we explore RWE pointing to the decisive role of support and engagement programs in recruiting and retaining study participants.




6:30 Close of Day


7:15 am Registration Open








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Interactive Breakout DiscussionsEnrollment Planning and Patient Recruitment11th Annual





Enrollment Planning and Patient Recruitment11th Annual

Strategic Enrollment Planning, Data-Driven Recruitment and Forecasting, and Central Campaign Management

Sponsored by7:45 Breakfast Presentation: The Next Generation of Site Payments: Technology Do’s and Don’tsStuart Thiede, President, Payments, DrugDev (An IQVIA Company)Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

REACHING PATIENTS AND IMPROVING RECRUITMENT OPERATIONS USING EXISTING AND/OR INNOVATIVE TOOLS8:25 Chairperson’s RemarksKevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly and Company

8:30 Deploying Patient Recruitment Websites: Behind the Scenes in Big PharmaPaul Whitehead, Ph.D., Head, Early Development Workflows, RocheThis talk will focus on the efforts that go into getting a patient recruitment website progressed from a study team request to production deployment. There are many factors to consider when deploying a new trial recruitment website in a global organization, these will be discussed, and strategies to reduce the effort will be presented.

Sponsored by8:55 Increasing Enrollment While Reducing SitesDan Brunwasser, Associate Director, Marketing Operations, Consumer Marketing, AcurianAfter decades of delayed trials, sponsors still face slow site setup and poor patient enrollment completing clinical studies on-time and on-budget. The traditional site-based model suggests that the more sites activated, the more patients and faster completion time happen. These delays prove that model lacks the productivity to move the chains, threatening time-to-file and time-to-market. Sponsors are now following a new model of enrollment and budget certainty built on reducing sites/countries for faster patient enrollment.

9:20 Lessons Learned from Rare Disease Trials: Community, Engagement, Recruitment and RetentionMarisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.Although late-phase costs of conducting orphan drug development are smaller when compared to non-orphan drugs, rare disease clinical trials encounter many challenges in patient recruitment and retention. What lessons can experts in trial planning and operations learn, whether they are running rare or non-rare disease trials, and apply to improve engagement, recruitment and retention?

9:30 SCOPE’s 2018 Participant Engagement Award Designed to inspire innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials, this award embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. We welcome submissions from every aspect of the industry including, but not limited to, Sites, CROs, e-Patient Advisors, Agencies, Start-Ups, and Sponsors to submit their best work in the Patient Recruitment and Retention communications field.Learn More & Submit an Entry for 2018

Event Designers:Kelly McKee, Advisor, Clinical Innovation, Eli Lilly and Company; Co-Creator of the SCOPE Participant Engagement AwardDavid Sall, President & CEO, Patient Enrollment Advisors; Co-Creator of the SCOPE Participant Engagement AwardJeri Burtchell, Director, Patient Initiatives, HealthiVibe, LLCShwen Gwee, Head of Digital Strategy, Global Clinical Operations BiogenAngela Radcliffe, Managing Director, Executive Vice President, FCBVIOMicah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)


INSIGHTS FROM SPONSORS: PATIENT OPINION LEADER (POL) ADVISORY PANEL & ONCOLOGY PATIENT

RECRUITMENT11:10 Chairperson’s RemarksRick Ward, Vice President, Commercial Operations, Trifecta

11:15 CO-PRESENTATION: Creating a Successful Patient Opinion Leader Steering CommitteeLynn Hagger, Ph.D., Patient Engagement Director, Respiratory, INA & CVMD, Global Medical Affairs, AstraZenecaAbbe Steel, CEO, HealthiVibe, LLCAs pharma struggles to turn the concept of patient engagement into more than just a feel-good catchphrase, there is a growing trend to partner with patients in a more meaningful way to impact development throughout the drug life cycle. In response to this growing need, AstraZeneca developed a Patient Opinion Leader (POL) Advisory Panel – a collaborative group of patients and caregivers possessing not only the knowledge of living with their health condition, but also having expertise in a variety of subjects that intersect nicely with pharma to result in more valuable insights than the average patient could provide.

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http://www.scopesummit.com/Participant-Engagement-Award/



Enrollment Planning and Patient Recruitment11th Annual


11:40 Oncology Patient Recruitment: Sponsor InsightsArchana Sah, Therapeutic Area Leader, Oncology, Genentech, Inc.In today’s US landscape in oncology drug development, the competitive marketplace compels sponsors to be more predictive in their enrollment planning. About 80% of clinical trials do not recruit on time and about 30-40% of sites are low productive sites. This presentation will focus on recruitment planning in oncology studies with recommendations on tactics from landscaping through LPI for a more predictive recruitment planning.

12:05 pm Session BreakSponsored by12:10 Bridging Luncheon Presentation: Taking

Patient Recruitment into the Next Generation of Clinical DevelopmentKimberly Ray, Vice President, Site and Patient Networks, IQVIAUsing real-world insights to drive better Site identifications. Understanding Site and PI capabilities to drive ideal patients. The importance of communication and advocacy groups to drive engagement and retention.



Stay on and attend Part 2: Patient Engagement, Enrollment and Retention through Communities and Technology. Click here for details.

Group and Company Discounts!Group Discounts are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts contact Melissa Dolen at 781-972-5418.









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There are many reasons a clinical trial can be delayed, but many of these can be prevented through proper forecasting, budgeting, and contracting strategies. As clinical trials become more complex, with a number of CROs, third-party vendors, and sites getting involved, sponsors must evolve their strategies and take advantage of technology to streamline these processes and set clear expectations from the get-go. Cambridge Healthtech Institute’s 8th Annual Clinical Trial Forecasting, Budgeting and Contracting conference shares case studies and best practices on effective budgets and clear contracts, as well as metrics and key performance indicators of their success.

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STRATEGIES FOR FINANCIAL FORECASTING AND BUDGETING

10:45 Chairperson’s RemarksChris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.

10:50 Budget Forecasting and Tracking: Teamwork and TransparencyKenneth Olovich, Chief Financial and Procurement Officer, ChorusThis talk will discuss how the application of budgetary and invoicing models can lead to increased trust. What do sponsors really need to help them manage CRO and trial related expenses? Some budgetary models require more effort to set up than others; when is it worth the investment? The timing of spend and the accurate projection of the same is just as important as the total spend -- this talk will discuss finding the balance.

11:15 Cost, Time, and Quality Trade-Off in Clinical TrialsOzgur Ozkan, Decision Science Director, Biometrics and Information Sciences, AstraZeneca PharmaceuticalsThis presentation will report on a novel approach to estimate trial costs at the country level and how it is used within a simulation tool to visualize cost, time and quality trade-offs between alternative recruitment scenarios. We will give an overview of the analysis on the operational/financial data and demo the tool to show how it informs decision making in Clinical Operations.

11:40 CO-PRESENTATION: Clinical Trial Budgeting/Forecasting SMACK-DOWN: Investigator Sites vs. Sponsors – Budgeting Issues Chris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.Al Peters, President, Clinical Operations and Finance, BTC NetworkAlthough theoretically teammates with common goals, when Sponsors and Investigator Sites interact over budget and money issues, conflicts often arise in the form of miscommunications or even animosity that would make the Hatfields and McCoys blush. This session will explore some common conflicts as well as possible resolutions.

Sponsored by12:05 pm The RX for Your Clinical Financial ManagementNina Pruitt, Senior Director, Global Product Marketing Payments, MedidataUpfront study design, grant budgeting, and an investigator payment strategy are foundational for comprehensive clinical financial management. Technology and historical data enable effective scenario planning to ensure your study: achieves desired endpoints and optimal outcomes, results in appropriate, defendable site budgets and delivers tight financial management for all stakeholders. Excel simply cannot deliver for the financial management requirements for todays’ clinical research. Top pharma and CROs have moved away from excel – have you?


12:40 Luncheon Presentation: An Easy 4-Step Process That Will Make You a CTMS Evaluation HeroJens B. Thuesen, CTMS Business Development, BSI Business Systems Integration AGIs your CTMS evaluation process outdated? Using scorecards to evaluate solutions based on features alone can be frustrating. And knowing the right questions to ask that go beyond basic features can be daunting. You don’t have to be an IT expert to choose a CTMS that will serve you well for years to come. Learn how a concise 4-step process can get you on your way to a solution that fits your organization perfectly.









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Interactive Breakout DiscussionsClinical Trial Forecasting, Budgeting and Contracting8h Annual

Innovative Budgeting and Contracting for Cost-Efficient Trials February 13-14, 2018




WORKING WITH SITES: BUDGETING AND PAYMENTS2:00 Chairperson’s RemarksMarina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston University

2:05 Building a Per Patient Cost and, Ultimately, the Entire Investigator Grant BudgetKenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, PfizerIn this session, we will look at a practical approach for establish a preliminary site budget template, and how this rolls into establishing the entire investigator grant budget. Standard of Care plays an important role in the US, and some countries; this needs to be factored into the budget templates. When all is complete for the site level template, we will evaluate how this can be utilized to build a forecast for total investigator grants and what is factored into these calculations. We will also look at how this feeds into a typical full clinical trial budget and forecast.

2:30 CO-PRESENTATION: Merck’s Site Ready Team: Integrating Capabilities to Provide a Centralized Approach and User Experience for Investigators Budget and Payment ProcessCathy Carfagno, Associate Director, MRL IT, Merck & Co., Inc.Rochelle Redding, Associate Program Manager, MRL, Merck & Co., Inc.This talk will present an overview of the strategy that Merck would like to take in changing its global budget and payment process and our thoughts on enabling a more integrated collaboration and interaction with our investigative sites. In order to maintain strong and effective investigator relations and to enhance our site performance, while ensuring meeting FDA compliance rules, we have started to map out a simplified process for creating and negotiating our budgets as well as improving our payment controls, all while operating in a very budget-conscious environment.

2:55 PANEL DISCUSSION: Budgeting with Sites: Bottlenecks, Challenges, and OpportunitiesModerator: Kenneth Wilson, Director, Business Operations; Clinical Outsourcing Lead, PfizerPanelists: Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston UniversityKenneth Olovich, Chief Financial and Procurement Officer, ChorusRochelle Redding, Associate Program Manager, MRL, Merck & Co., Inc.During site budget negotiations, don’t you often want to just ask the other party “Are you crazy or just being stubborn?” We all have different end games during negotiations, and it’s important to understand the dynamics of the Sponsor, Site and CRO triad. As this triad continues to be dominant in our industry, it’s important that we learn to predict each other’s reactions in order to avoid “show-down” meetings where all are frustrated and ready to walk away. We all think we are right, but ultimately, it’s about the final negotiated budget, how we get there, and creating a win-win-win scenario for all.

Sponsored by3:20 Clinical Payments Case Studies: Improving Efficiency, Cash Management, and Compliance Meghan Harrington, Vice President, Operations, Financial Lifecycle Solutions, Bioclinica




6:30 Close of Day



7:45 Breakfast Presentation: The Next Generation of Site Payments: Technology Do’s and Don’tsStuart Thiede, President, Payments, DrugDev (An IQVIA Company)Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

STRATEGIES FOR EFFICIENT NEGOTIATION AND CONTRACTING

8:25 Chairperson’s RemarksChairperson to be Announced, Strategikon Pharma

8:30 Contracts and Budgeting for Studies Involving Special Populations and Adaptive Designs: Evolving Challenges with Precision Medicine Trials








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Marina Malikova, Ph.D., MA, Executive Director, Surgical Translational Research Operations and Compliance, Boston UniversityIn-human (FIH) studies now routinely contain several parts with multiple cohorts with increased dose flexibility and accelerated dose escalation paradigms, each of which might have been previously a separate clinical trial. Sponsors, CROs and investigators struggle to minimize risks and avoid serious consequences, and yet, there remains real risk in an FIH study. Understating challenges associated with the use of special populations is critical to ensure that the study design will allow for the timely and successful completion of the project, while minimizing individual exposure to the risks of participating subjects, planning and implementing budgets, forecasting, managing costs, and assessing safety profile.

8:55 Streamlining CTA Negotiations beyond the Legal LanguageDébora Araujo, Associate Director, Site Budgets and Payments (US Group Head), Boehringer Ingelheim Pharmaceuticals, Inc.It is widely known that legal language is one of the main pain points threatening the timely execution of CTAs. The issue has prompted much-needed industry focus and related initiatives in recent years in an effort to standardize legal language and thus streamline CTA negotiations. However, to effectively address the overall delays in CTA execution, some other aspects of the negotiation process must be dealt with as well. In this presentation, we will explore the top aspects of the negotiation process threatening an expeditious CTA execution and some practical ways to counter each of them.

9:20 Strategies to Reduce Time to Contract Approval: A Site PerspectiveJoAnn Pfeiffer, DrSC., Director, Clinical Research Management, Arizona State UniversityHow can sites accelerate the CTA review process for quicker approval of a fair and balanced contract? This session covers strategies and practical tips to speed up the CTA review and approval process. Topics include preparation, contract pitfalls, language, contract editing, common contract challenges between the site and sponsor, and leveraging site data and metrics.

Sponsored by9:45 Driver Based Forecasting – Improving Accuracy and Timeliness of Clinical Trial Financial ForecastsRamprasad Keshavamurthy, MBA, Senior Manager, Life Sciences Consulting, CognizantThe current tools available to Clinical Finance groups make it effort-intensive and reliant on past experience of associates to develop forecasts. Intricacy of study design, global spread of trials, and reliance on third parties add to the

complexity. Learn how driver-based forecasting provides a consistent approach to clinical budgeting and how digital technologies can report on updated protocols, vendor contracts, and trial progress to provide the actual financial position of R&D budgets in near-real time.


CONTRACTING AND RESOURCE ALLOCATION11:10 Chairperson’s RemarksChairperson to be Announced, Strategikon Pharma

11:15 PANEL DISCUSSION: Resource Allocation and Its Effect on Contracting between CROs and SponsorsGreg Skalicky, Executive Vice President and General Manager, Syneos HealthRatan Ratnesh, Director & Head, Clinical Outsourcing, OtsukaTara Dubois, MBA, Head, Clinical Trial Cost Management, Business Operations, PfizerRene A. Stephens, MSHS, Independent Industry ConsultantProcurement, contracting, and clinical operations teams need transparency with their CRO partners in order to properly understand a CRO’s allocation of resources and costs, especially when contracting key deliverables. This panel will address, from the Sponsor’s and CRO’s perspective, resource allocation considerations during the contracting process: potential challenges, what CROs wish pharma knew, and pitfalls to avoid.

12:05 pm Session BreakSponsored by

12:10 Bridging Luncheon Presentation: Data and Insights into Site Operations Allow for Better Forecasting and Budgeting of Trials Noelle Gaskill, MBA, Vice President, Research Operations, SignalPath, LLCBy leveraging site level tooling to surface nearly real-time operational metrics; sponsors and CROs are better equipped to plan for costs associated with individual sites, manage ongoing trial costs and project future budgets.



Stay on and attend Part 2: Resource Management and Capacity Planning for Clinical Trials. Click here for details.








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First time experience and came away with a head buzzing full of ideas for our team!- Vitaflo International Ltd.

“ ”Understanding outsourcing needs and optimizing the selection process of vendors lays the foundation for an efficient, cost-effective clinical trial. Cambridge Healthtech Institute’s 2nd Annual Mastering an Outsourcing Strategy conference provides a new perspective on the vendor selection process and challenges attendees and speakers to reimagine the standard vendor selection process for improved efficiency on both the Sponsor and Vendor side of the relationship. The 2018 program focuses on case studies and interactive discussion on outsourcing strategy, the RFP and bid defense process, vendor selection, as well as contracting with outsourced partners and vendors, including sites, CROs, suppliers, and other vendors.

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8:30 Close of Day





OUTSOURCING TRENDS & STRATEGY: WHERE ARE WE HEADED?

10:45 Chairperson’s RemarksCharlotte French, Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas

10:50 Why Outsourcing Site Payments Make SenseBrett Kleger, CCO, DrugDev

11:15 Sourcing Model ConsiderationsRatan Ratnesh, Director & Head, Clinical Outsourcing, OtsukaThis presentation will focus on an approach to assessing and developing which sourcing model is right for your organization. We will define what a Sourcing Model is and how companies come to arrive at their current state. Then we will review sourcing options, considerations, and implications both on a functional level and organizational level. We will review the importance of assessing core competencies as well as a thorough market analysis. Then conclude with how all the pieces fit together to form a sourcing model that best fits your organization.

Sponsored by12:05 pm Talk Title to be AnnouncedMark Lanfear, MS, CCRA, Vice President and Global Practice Lead, Life Sciences Solutions, Kelly Outsourcing and Consulting Group (KellyOCG)

12:30 Session BreakSponsored by12:40 LUNCHEON CO-PRESENTATION: Protocol

Complexity and Strategic OutsourcingTess Gilbert, Consultative Solutions, Clinical Trial Optimization Solutions (CTOS), IQVIAKyle Holen, Head, Drug Development Center, AbbVieThe most foundational element of expectation setting between Sponsor, CRO and Site, is many times the most uncertain. As protocols become more complex, the impact can be strain on sponsor/CRO relationships. A recent survey conducted with Sites, Sponsor and CROs tells a story of uncertainty, and lack of evidence to support complexity assessments. Join us for a panel discussion to review best practices in complexity assessment to generate fair and predictive expectations in strategic outsourcing.


MAKING MEANINGFUL CHANGE TO THE VENDOR SELECTION PROCESS FROM RFI TO BID DEFENSE

2:00 Chairperson’s RemarksCharlotte French, Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, Astellas








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Interactive Breakout DiscussionsMastering an Outsourcing Strategy 2nd Annual

Making Meaningful Changes to the Outsourcing Process February 13-14, 2018




2:05 A Nimble, Rapid Approach to the RFI to Bid Defense ProcessCraig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar TherapeuticsThe RFI to bid defense process is notoriously time consuming and resource intense. One biopharmaceutical company presents their streamlined strategy for efficiently moving through the RFI to bid defense process while involving key stakeholders at every step and remaining nimble without sacrificing quality.

2:30 PANEL DISCUSSION: Request for Information (RFI) to Bid Defense – How Do Pharma and CROs Obtain the Most Value during This Process?Moderator: Charlotte French, Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, AstellasPanelists:Christopher Rull, Principle Consultant, CR Consulting, LLC; Former Vice President, Head of Business Development & Account Management, UBCJeff Van Noy, Vice President, Global Proposal Development and Business Information, ICONToday this is a very time consuming and resource intense activity at both Pharma and CROs. This panel discussion will be focused on how we jointly become more innovative in approaching these activities. We will explore:• How to develop the most effective RFI to deliver the key information required

to determine which CROs are short-listed for the Bid Defense meeting• How Pharma/CRO determine the participants at the Bid Defense meeting• What are the key deliverables for a CRO at a Bid Defense meeting?




6:30 Close of Day


7:15 am Registration Open

Sponsored by7:45 Breakfast Presentation: The Next Generation of Site Payments: Technology Do’s and Don’tsStuart Thiede, President, Payments, DrugDev (An IQVIA Company)Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

UNDERSTANDING THE OUTSOURCING FUNCTION & YOUR CHOSEN SUPPLIERS

8:25 Chairperson’s RemarksMark Lanfear, MS, CCRA, Vice President and Global Practice Lead, Life Sciences Solutions, Kelly Outsourcing and Consulting Group (KellyOCG)

8:30 Outsourcing versus Procurement: Is There a Difference?Charlotte French, Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, AstellasToday it can be difficult to navigate the various functions within Pharma, in particular relating to the roles and responsibilities of Outsourcing functions versus Procurement functions. In some instances, these are combined, but are there differences? And, if so, what are these? We will explore the advantages and disadvantages of separating these two functions within Pharma and review differences in the skill set that they should offer to an organization. Additionally, we will review how these functions work together, or in some instances, incorporate the vendor oversight responsibilities that are required under ICH E6. We will also discuss CRO’s response to the ICH E6 guidelines when providing third party contracting and oversight for additional services.

8:55 Choosing & Maintaining the Best Suppliers/PartnersCarrie Lewis, MS, Associate Director, Clinical Operations, Lupin Research, Inc.This presentation will discuss how to select the best Supplier/Partner for your company needs. This will include a case study of how Lupin set-up their initial Governance with all CROs at the table. Discussion will also include when to select a niche supplier over preferred vendor and the process. Lastly, the talk will discuss how to maintain relationships with preferred vendors.

CONSTRUCTING YOUR CONTRACT FOR MAXIMUM BENEFIT

9:20 Contracting with CROs to Optimize Working Relationship and to Guarantee On-Time Study StartsRichard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals








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This presentation will focus on the best strategies to ensure a smooth study start from a contracting perspective. It will address agreement construction and helpful terms. Also addressed will be optimal lead times as well as governance and communication strategies.

Sponsored by9:45 Three Key Elements to Operationalizing CRO Oversight: A Sponsor’s StoryGreg Skalicky, Executive Vice President and General Manager, Syneos HealthLearn how a leading sponsor revolutionized its relationship with its CROs. Understand the best practices they put in place to continuously manage study quality and achieve milestones on-time and on-budget across their portfolio of trials. This, combined with real-time data delivery, enabled them to expand their portfolio of trials and build new relationships with more CROs, all at the same rapid pace of business.


CONSTRUCTING YOUR CONTRACT FOR MAXIMUM BENEFIT

11:10 Chairperson’s RemarksAnca Copaescu, CEO, Strategikon Pharma

11:15 PANEL DISCUSSION: Resource Allocation and Its Effect on Contracting between CROs and SponsorsGreg Skalicky, Executive Vice President and General Manager, Syneos HealthRatan Ratnesh, Director & Head, Clinical Outsourcing, OtsukaTara Dubois, MBA, Head, Clinical Trial Cost Management, Business Operations, Pfizer

Rene A. Stephens, MSHS, Independent Industry ConsultantProcurement, contracting, and clinical operations teams need transparency with their CRO partners in order to properly understand a CRO’s allocation of resources and costs, especially when contracting key deliverables. This panel will address, from the Sponsor’s and CRO’s perspective, resource allocation considerations during the contracting process: potential challenges, what CROs wish pharma knew, and pitfalls to avoid.


12:10 Bridging Luncheon Presentation: Data and Insights into Site Operations Allow for Better Forecasting and Budgeting of Trials Noelle Gaskill, MBA, Vice President, Research Operations, SignalPath, LLC

By leveraging site level tooling to surface nearly real-time operational metrics; sponsors and CROs are better equipped to plan for costs associated with individual sites, manage ongoing trial costs and project future budgets.



Stay on and attend Part 2: Managing Outsourced Clinical Trials. Click here for details.

Mastering an Outsourcing Strategy 2nd Annual

Febuary 13-14, 2018

Second Annual Participant Engagement AwardsCambridge Health Institute (CHI) and SCOPE’s 2018 Participant Engagement Award program is designed to inspire innovation and change in how we communicate to participants in the fields of Recruitment and Retention for clinical trials. Learn more here.

2018 SCOPE AwardsFifth Annual Clinical Informatics News Best Practices AwardsClinical Informatics News is seeking submissions to its Fifth Annual Clinical Informatics News Best Practices Awards. This awards program seeks to recognize outstanding examples of applied strategic innovation—partnerships, deployments, and collaborations that manifestly improve the clinical trial process. Learn more here.

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http://www.scopesummit.com/Participant-Engagement-Award

http://www.clinicalinformaticsnews.com/BestPracticeAwards/



This year’s SCOPE meeting was a great place to hear high quality industry updates and to touch base with old friends and decision makers.- Associate Director, ClinOps, Gilead Sciences

“”

Poor quality and risk management of clinical trials significantly impacts the success, timeliness and cost-effectiveness of clinical trials. Cambridge Healthtech Institute’s 4th Annual Implementing Risk-Based Monitoring – Part 1: Integrating Quality into Clinical Trials conference provides guidance on how to holistically and proactively build quality standards into clinical trials with emphasis on the latest quality standards and guidelines, including the recent ICH-E6 R2 addendum changes, thereby ensuring higher quality clinical trials and laying the foundation for successful risk-based monitoring.

MONDAY, FEBRUARY 12




8:30 Close of Day





THE TRUE COST OF CLINICAL TRIAL QUALITY10:45 Chairperson’s RemarksJanis Little, Vice President, Global R&D Quality, Allergan

10:50 PANEL DISCUSSION: The Total Cost of Quality: Finding the Balance between Investing in Quality and the Cost of Fixing Quality ProblemsModerator: Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLCPanelists:Armelde Pitre, MBA, Head, Quality Performance Analytics, Clinical Development Quality, Global Product Development, Pfizer, Inc.Janis Little, Vice President, Global R&D Quality, AllerganNicole Stansbury, Executive Director, Adaptive and Intelligent Monitoring, Clinical Development Services, PPDYusuf Ghadiali, Senior Director, Performance Operational Capability, Global Clinical Operations, Biogen

Few organizations have a complete understanding of the financial impact of poor clinical trial quality. With better understanding of poor quality on an organization’s bottom line, it can improve buy-in for proactively investing in quality to avoid costly quality problems. In this panel, representatives from across pharma will come together to discuss the sources of poor clinical trial quality (ex. protocol amendments, low/non-enrolling sites, subjects dropping out, data quality issues, etc.), the challenges of estimating poor quality costs, current quality cost estimate techniques including the Cost of Poor Quality Estimator Tool developed by the MCC Study Quality Trailblazer Group, and how improved access to data about the cost of poor quality is impacting risk management and quality investment decisions.

CLINICAL QUALITY IN ACTION11:40 Quality by Collaboration: Practical ApplicationsJolie Weintraub, Executive Director, TA Head Oncology, MRL Quality Assurance, MerckThis presentation will discuss how quality is implemented within Merck, including the importance of collaborating with various quality functions at all levels of the organization. It will provide a holistic approach to supporting and achieving quality proactively throughout the clinical trial process. In addition, case studies will be shared on how this principle has been put into practice and steps to take to foster the collaborations.

Sponsored by12:05 pm The Value of Centralized Monitoring on Monitoring Visits—Increasing Quality and Decreasing CostsNicole Stansbury, Executive Director, Adaptive and Intelligent Monitoring, Clinical Development Services, PPDAs regulatory authorities embrace change and the industry focuses on reducing costs, increasing data integrity and patient safety, the importance of centralized monitoring increases. PPD combines centralized monitoring with site health assessments to enhance site performance. Learn how our CRAs are moving from finding to fixing issues and becoming experts in process improvement to help sites become more engaged and efficient—ultimately reducing risk, increasing safety, ensuring quality and reducing the costs of drug development.

12:30 Session Break








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Interactive Breakout DiscussionsImplementing Risk-Based Monitoring – Part 1 4th Annual

Integrating Quality into Clinical Trials February 13-14, 2018




Sponsored by12:40 Luncheon Presentation: The Role of Innovation and New Age Analytics in RBM EvolutionRajneesh Patil, Senior Director, Clinical Operations Process Design and Analytics, IQVIAWhat problems are we looking to solve with innovation in RBM models. How do the new age analytics and advent of machine learning augment risk-based strategies. What results are we experiencing through implementation of statistical monitoring and analytics.


CLINICAL QUALITY IN ACTION (CONT.)2:00 Chairperson’s RemarksLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

2:05 TransCelerate’s Clinical QMSJanis Little, Vice President, Global R&D Quality, AllerganThe presentation will cover what a Clinical QMS is, and what the benefits are to sponsors in having a Clinical QMS defined and in place in alignment with ICH E6 (rev 2) requirements in Section 5. Audience will recognize and understand the flexibility of the TransCelerate Conceptual Framework for a Clinical QMS that will help sponsors design a customized CQMS for their specific needs. The presentation will dispel myths that exist on what a Clinical QMS “is” and what it is not, and it will cover what TransCelerate QMS publications and tools are currently available to industry. The presentation will also take a deep dive into a newly available tool for sponsors to assess a clinical quality management system (if they have implemented in alignment with the TransCelerate CQMS Conceptual Framework).

2:55 Envisioning a Quality Management System to Address the ICH E6 R2 ChangesAndy Lawton, Director and Consultant, Risk Based Approach Ltd.The changes in ICH E6 R2 impact the fundamental basis of how quality should be addressed by a sponsor. This presentation will take a holistic look at the Regulatory background, and the tools that can be used to address the critical issues of Quality Tolerance Limits, Quality by Design, and Continuous Quality Improvement.

Sponsored by3:20 Risk-Based Monitoring Strategies for Improved Clinical Trial PerformanceHenry Galio, Senior Director, Vault CTMS, Veeva SystemsA strategic, risk-based approach to clinical trial management can aid sponsors and CROs in early detection and mitigation of risks that could affect the quality and safety of a study and its subjects. However, risk mitigation strategies have little value unless they are executed, monitored, and analyzed continuously throughout the trial’s lifecycle. This session explores how cloud-enabled solutions can be leveraged to gain real-time insights and actionable analytics to improve clinical trial safety and performance.




6:30 Close of Day


7:15 am Registration OpenSponsored by7:45 Breakfast Presentation: The Next Generation of

Site Payments: Technology Do’s and Don’tsStuart Thiede, President, Payments, DrugDev (An IQVIA Company)Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

ICH E6 R2 & ITS IMPACT ON CLINICAL TRIAL QUALITY8:25 Chairperson’s RemarksNithiya Ananthakrishnan, Senior Vice President, Data Science, OmniComm Systems

Sponsored by8:30 CO-PRESENTATION: How an Ongoing Joint Risk-Based Monitoring Deployment Aligns with ICH E6 (R2)Mike Walega, Executive Director, Monitoring & Data Flow, CovanceJude Burger, MS, Manager, Eli LillyWe will provide an overview of how an ongoing RBM deployment aligns with the new ICH GCP E6 (R2) guidelines. We will review the history of the deployment and the relevant aspects of E6 (R2). We will then focus on describing how this approach aligns with E6 (R2), where gaps exist, and how we plan to fill the gaps. Through examples and recommendations, we will provide attendees with insights to their own evolving RBM deployments.








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9:20 How ICH E6 Updates Redefine How We Manage and Measure QualityLinda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

Sponsored by9:45 Risk-Based Monitoring: Looking Beyond RiskGeorge H. Johnson IV, SCPM, Product Manager & Senior Analyst, Clinical Analytics, PerkinElmerThere is mass concentration and growing need to adopt Risk-Based Monitoring given the obvious benefits to clinical trials. However, there is unspoken value beyond just KRIs and process changes. Join us as we discuss real-world cases of tangible benefits when looking beyond risk, including: RBM implementation best practices; what it means to look beyond the risk to implement QbD; quality improvements derived by rich RBM insights; driving CRO-Sponsor-Site relationships to the next level.


ICH E6 R2 & ITS IMPACT ON CLINICAL TRIAL QUALITY (CONT.)

11:10 Chairperson’s RemarksNithiya Ananthakrishnan, Senior Vice President, Data Science, OmniComm Systems

11:15 PANEL DISCUSSION: ICH E6 and How the Industry Is Tackling Things Head OnModerator: Andy Lawton, Director and Consultant, Risk Based Approach Ltd.Panelists:Jonathan Rowe, Ph.D., Executive Director & Head, Quality Performance and Risk Management, PfizerNithiya Ananthakrishnan, Senior Vice President, Data Science, OmniComm SystemsNicole Stansbury, Executive Director, Adaptive and Intelligent Monitoring, Clinical Development Services, PPDWith the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. This panel will cover how individual organizations are approaching ICH E6 R2 addendum changes, the struggles and challenges they faced or continue to face, and how they are working with other stakeholders (their CRO partners, stakeholders across different departments, etc.).

12:05 pm Session BreakSponsored by12:10 Bridging Luncheon Presentation: Extracting

Data from the EHR Dramatically Reduces the Need for Manual Monitoring - New Standards Make This PossibleKim Rejndrup, Senior Vice President, Product Development, OmniCommThe typical workflow at an investigate site is for the patient data to be entered into the Electronic Health Record, then for the study coordinator to re-type that data into the EDC system. A big component of the subsequent Source Data Verification is simply checking that the retyping was done accurately. If data could instead flow automatically from the EHR system, with the coordinator just verifying the data in transit, then both the data entry and the subsequent SDV can be automated. New standards and technologies being introduced under the “SMART on FHIR” umbrella now make this possible. This presentation will describe the state of the art in this exciting new field.



Stay on and attend Implementing Risk-Based Monitoring – Part 2. Click here for details.








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SCOPE: Some Conferences Offer Premium Engagement!- Clinical Operations Manager, Bolton Medical, Inc.“ ”E-clinical technology is changing the landscape of the clinical research

industry and healthcare IT in general. Digitalization of healthcare data, mobile data capture technologies, and cloud storage of data are a few of the main technological advances that influence clinical research informatics. The technological advances have been coupled with novel data visualization solutions, and this powerful duo is helping to develop a new paradigm of data-driven clinical trials. Cambridge Healthtech Institute’s 10th Annual Clinical Data Strategy and Analytics conference is designed to bring together clinical research informatics experts to discuss the challenges and find solutions necessary to navigate and thrive in this rapidly changing environment.

MONDAY, FEBRUARY 12




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INTEGRATED TECHNOLOGY PLATFORMS10:45 Chairperson’s RemarksJaydev Thakkar, IS Director, R&D Informatics, Amgen

10:50 SPECIAL OPENING PRESENTATION: Integrated Technology Platforms and the Implications to Our Clinical OrganizationsRehbar Tayyabkhan, Vice President, Global Data Strategies & Solutions, Global Clinical Operations, Bristol-Myers SquibbAs capabilities emerge with e-clinical technology platforms, esource, analytics, etc., clinical operations organizations have no choice but to adapt and realign our capabilities. This presentation will provide some context for some high-impact emerging changes and share some practical approaches taken to realize the value from these technological advancements.

11:15 CO-PRESENTATION: Technology Innovations Transforming Clinical Research, Are We There Yet?Jaydev Thakkar, IS Director, R&D Informatics, AmgenYan Chow, M.D., MBA, Medical Director, Digital Health, AmgenInnovative digital technologies are starting to disrupt the highly regulated and conservative biopharmaceutical industry. We will examine the clinical and business drivers of this revolution, as well as its impact on how and why we conduct research studies and clinical trials.

11:40 Implementing Large Change in a Large OrganizationChristine Buesnel, Director, Product Development, Biometrics, RocheThis talk will inform the audience of a large system, process and people change for management of the medical data that Roche/Genentech undertook over a 3-year timeframe. I will discuss the scope of the change, the impact on the organization, and the impact on the people. I will also address the lessons we learned and think are applicable to any large scale change in an organization.

Sponsored by12:05 pm CO-PRESENTATION: New Tufts Research: EDC Trends, Insights, and OpportunitiesBeth Harper, President, Clinical Performance Partners; Consultant, Tufts Center for the Study of Drug DevelopmentRichard Young, Vice President, Veeva Vault EDC, Veeva SystemsHear new research from Tufts Center for the Study of Drug Development on current and evolving EDC practices across the drug development enterprise. Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. We’ll also share where the industry is headed and ways to overcome key clinical data management challenges including protocol changes, source data verification, and more.

12:30 Session BreakSponsored by12:40 Luncheon Presentation to be Announced

John Fontenault, COO, Omnicomm


BIOMETRICS TO FACILITATE INNOVATION IN CLINICAL DEVELOPMENT

2:00 Chairperson’s RemarksChristine Buesnel, Director, Product Development, Biometrics, Roche








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Interactive Breakout DiscussionsClinical Data Strategy and Analytics10th Annual

Enabling Data Driven Clinical Trials February 13-14, 2018




2:05 Analytics to Drive Better Decisions in Clinical DevelopmentAngelique Hopkins, MPH, Associate Director, Clinical Trial Analytics, Business Insights and Analytics, Bristol-Myers Squibb CompanyIntegrated, predictive analytics can help drive R&D strategy and execution, with clear benefits to operational costs and long-term financial success. Analytics in trial planning and execution are often viewed as drivers of delay rather than acceleration and analytics is rarely used effectively to drive decisions in planning. This presentation will discuss how embedding analytics into clinical development process can alleviate challenges and build trust with stakeholders for faster, better decisions.

2:30 From the Trenches: Technical Strategies for Start-Up and Virtual Pharma/BioTech CompaniesSteven Sweeney, Vice President, Clinical Development Operations, Rodin TherapeuticsThis presentation will focus on the technology stack utilized for clinical development in the start-up and virtual pharma/biotech sector. It will include a review of popular start-up models and overlay considerations for the use of technology to improve efficiency and vendor oversight and obtain scientific and medical insights.

2:55 Clinical Data Integration from Translational Modeling Using Machine Learning ApproachRaj Bandaru, Senior Director, Data Sciences Strategy, Translational Medicine, SanofiUse of clinical data for translational modeling and trial simulation is key capability to transform the pharma industry to more data and model-driven drug development. At Sanofi, we have developed some elegant machine learning approaches to integrate clinical study data and make it available for clinical research. This approach reduces the manual effort and thus enabling real time analytics and simulation of trial results.

Sponsored by3:20 Visual Analytics for Medical Data Review: A Physician’s PerspectiveAnthony Everhart, MD, FACP, Vice President, Medical Informatics, CovanceThe acceptance and adoption of new technology systems by physicians can be slow and is often met with resistance. Recent examples of this in clinical medicine include the challenges experienced when implementing electronic medical records (EMR) and computerized physician order entry (CPOE). Perceived usefulness and perceived ease of use per Davis’ Technology Acceptance Model (1989) have an impact on physician acceptance or rejection of new technology.


4:00 Interactive Breakout Discussion GroupsConcurrent breakout discussion groups are interactive, guided discussions

hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Click here for details.


6:30 Close of Day




8:15 Session Break

DIGITALIZATION OF CLINICAL TRIALS8:25 Chairperson’s RemarksJulie Smiley, Director, Product Strategy, Oracle Health Sciences

8:30 Harnessing Digital Technology and Big Data in Clinical Trials and BeyondAnthony Rowe PhD, Director, R&D IT Business Technology Leader, Immunology TA, JanssenMeasuring physiological and activity-based parameters remotely and continuously via unobtrusive on/off-body sensors or smartphones has the potential to revolutionise our ability to monitor patients between clinic visits and develop objective markers that track disease trajectory. How can we harness such advances in digital technology and big data analytics to enable more informative and efficient clinical studies and develop patient-centric digital solutions that improve outcomes in the real world?

8:55 Digital Biomarker Implementation, Presentation and ComparabilityAmy Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor,








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Eli Lilly and CompanyOver the past few years, data generation is beginning to take a new form. It’s moving from subjective to more objective, from episodic to contemporaneous, and is being generated through connected digital tools that can be used to quantitatively explain or predict physiological, behavioral, and functional health measures and outcomes. These digital measures are known as digital biomarkers. This presentation utilizes learnings from pilot examples to examine the implementation, presentation and comparability of digital biomarkers.

9:20 Wearables and Sensors Are Changing the Clinical Trial Process, but What’s the Return on Investment for This Dramatic Change in People, Process and Technology?Deborah Profit, Ph.D., Vice President, Otsuka Information TechnologyThe advent of wearables and sensors in clinical trials is changing the paradigm of trial designs, clinical teams, outsourcing practices, and ultimately patient engagement. However, what value does sensor/wearable data and these new trial practices bring, and how quick is the return of investment to the various stakeholders? Otsuka Pharmaceutical Development and Commercialization, Inc. is on the cutting edge of the trial and technology reform, and will share some critical learnings from “the road less traveled”.

Sponsored by9:45 CO-PRESENTATION: Driving Clinical Strategy & Optimized Design with RWD and Clinical Patient-Level DataQin Ye, MD, Associate Principal, Global RWE Lead, ZSJane Fang, MD, PhD, Head, Biologics, Research & Development Informatics, AstraZeneca/MedImmuneHistorical clinical trial and real-world data hold immense potential in sharpening R&D strategy, optimizing trial design and streamlining operational planning. This data-driven approach has become common practice for many in the pharmaceutical industry, but there are still hurdles to overcome. For some, the lack of efficient and timeline approach as well as tangible use cases leads to poor adoption and impact. In this presentation we’ll share how MedImmune leveraged an integrated framework to enable seamless data-driven decision making and process transformation within clinical program planning.


FROM THE TRENCHES: THE CASE STUDIES11:10 Chairperson’s RemarksVenkat Sethuraman, Associate Principal, ZS

11:15 Data Integration Solutions: A Case Study of CSL Behring’s Evolution on Managing Clinical DataSteve Carr, Director, Data Management, Coding, CSL BehringCSL Behring had three new molecular entity approvals in the last two years for

rare diseases to treat factor eight and nine deficiencies in hemophilia, along with hereditary angioedema. How does a company go from running small rare disease studies to delivering a Phase III CV mega-trial? We will discuss how we have spent the last two years preparing to start this study in the first half of 2018.

11:40 CO-PRESENTATION: Randomization Authorization Flow (RAF): It’s Not Just about Meeting Eligibility CriteriaJody Goldstein, Senior Clinical Project Manager, Center for Human Experimental Therapeutics, University of RochesterSusan Bennett, Senior Clinical Data Manager, Center for Human Experimental Therapeutics, University of RochesterRAF is a review and approval process of predetermined key data points and eligibility criteria by a single point of contact (medical monitor) prior to randomization. The RAF process helps to ensure enrollment of the appropriate study-specific patient population. This gestalt review takes into account critical elements not necessarily covered by the eligibility criteria. Looking for subtle (subjective) differences between patients upfront ensures meeting the primary outcomes of the study.


12:10 BRIDGING LUNCHEON CO-PRESENTATION: Centralizing Data to Address Imperatives in Clinical DevelopmentKarim Damji, Senior Vice President, Products, Solutions & Marketing, Saama TechnologiesAmit Gulwadi, Executive Director, Analytics-Patient Engagement/Recruitment, CelgeneWith the deluge of structured, unstructured, and syndicated data, the use of varied data for targeted outcomes remains difficult, despite increased industry efforts to address the issue. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical development and drug commercialization. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.



Stay on and attend Part 2: Artificial Intelligence in Clinical Research. Click here for details.








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From the Clin Ops executives to the individual contributors, THIS is the place to spend your time and budget to learn and meet innovators! As a first time attendee, the value of this conference with topic offerings and participants is GOLDEN!- Consultant, BAFallen Consulting LLC

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The clinical research industry is moving toward end-to-end digital clinical trials. The data collection should stay in line with this inevitable change, and wearables and point-of-care sensors address this need. Furthermore, digital biomarkers translate new data sources into clinically actionable insights. The inaugural Sensors, Wearables and Digital Biomarkers in Clinical Trials: Novel Data Sources and Connectivity for Virtual and Remote Trials conference, part of the 9th Annual SCOPE Summit, is designed as a knowledge and experience exchange for clinical data and clinical operations executives. The conference will feature case studies of clinical trials that already employ sensors and wearables as well as discussions of the future steps needed for digitalization of clinical trials.

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8:30 Close of Day





WEARABLES AND SENSORS AS NEW DATA SOURCES10:45 Chairperson’s RemarksChristian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early Development

10:50 Digital Biomarker Development at Roche pRED: How Mobile Technology Can Innovate Clinical EndpointsChristian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early DevelopmentMerging the best of two worlds - clinical trials and real world - is now increasingly possible. Mobile sensors are rapidly becoming a part of everybody’s lives. They allow for objective, precise and continuous measurements. We share our first real world digital biomarker results based on active tests and passive monitoring data - provided by Parkinson’s disease and Multiple Sclerosis patients in clinical trials.

11:10 What Drives the Success (or Failure) in mHealth Platform: Share Learning from GSK PARADE StudyMichelle Crouthamel, Digital Platform Leader, GSKThe ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Although the emerging mHealth technologies have the potential to improve the conduct of clinical trials, the successful implementation requires careful study design and patient engagement. Data and experiences from GSK PARADE study will be summarized, highlighting the learning and opportunities in this new area of clinical development.

11:30 Matching Clinical Needs to Medical NeedsIeuan Clay, Ph.D., Group Lead Digital Endpoints, Translational Medicine, Novartis Institutes for Biomedical ResearchDue to advances in technology, our ability to capture data in clinical settings is better than ever. How we match the right technology to a medical need, and how we ensure that we are extracting the relevant information from that stream of data in a robust and sensitive way is the focus of our research. We will present examples and discuss how we are tackling these challenges across different demographics and disease areas.

11:50 Integrating Wearable Sensors in Clinical Trials for Monitoring Real-Life Activities at Home: Developing Clinically-Meaningful Endpoints and Gamification Strategies for ComplianceAmir Lahav, Sc.D., Rare Disease Research Unit, PfizerThis talk will provide a visionary approach to developing and validating digital biomarkers using remote health monitoring of daily activities. The core idea of this approach is to create a patient-centric monitoring system that can objectively quantify meaningful changes in disease progression that would otherwise not be captured by traditional functional assessment in the clinic. This will largely depend on developing data-driven digital tools as well as engagement and compliance strategies for integrating wearable technology into clinical trials in an efficiently productive fashion.








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Interactive Breakout DiscussionsSensors, Wearables and Digital Biomarkers in Clinical TrialsInaugural

Novel Data Sources and Connectivity for Virtual and Remote Trials February 13-14, 2018




12:10 pm Clinical Trial Pilots of Wearable Sensors in Diabetes and AsthmaMartin Karpefors, Ph.D., Informatics Science Director, CardioRenal, Autoimmune & Neuroscience TA Lead, AstraZenecaSensors offer a way to transform clinical trial results from snapshot measurements of physiological parameters to continuous remote monitoring, which will enable disease insight, increase patient engagement and control, as well as give cost savings and operational advantages. However, these promises do not come without challenges. Based on our pilot experiences from (multi-)sensor trials in diabetes and asthma, we present some scientific, analytical and operational perspectives.

12:30 Session BreakSponsored by12:40 Luncheon Presentation: StepWatch™ Accuracy

and Reliability Means Greater Probability to Detect Changes in WalkingTeri Chou, PhD, CEO, Modus HealthOver 100 products exist that measure walking. It is well known that the accuracy of these products varies widely from consumer products such as Fitbit™ to medical devices such as StepWatch™. Independent published studies of the most used walking monitors emphasize how monitor accuracy and reliability can affect number of study participants needed to detect walking improvements, or alternatively, how power to detect change can be maximized within a fixed sample size.


DIGITAL TECHNOLOGY ADOPTION AND IMPLEMENTATION

2:00 Chairperson’s RemarksGahan Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & Development

2:05 Novel Biomarkers for Use in ASD Drug Development: State of the ScienceGahan Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & DevelopmentAutism Spectrum Disorder is a heterogeneous, complex neurodevelopmental disorder affecting 1-2% of the global population. There are currently no medications indicated for the treatment of core symptoms. Recently, research focus has shifted to the development and potential use of biomarkers to stratify the ASD population, or to assist with measuring treatment outcome change. The presentation will review the current state of the science in development of ASD biomarkers.

2:30 Key Considerations in Integrating Wearables/Sensors Data in Sponsor’s Ecosystem (AbbVie)Aman Thukral, Assistant Director, Data and Statistical Sciences, AbbVie

In pursuit of patient-centric clinical research, sponsors are leveraging wearables and sensors devices in clinical trials. These devices shoot data at a larger volume and velocity compared to traditional systems and require different skills to collect, integrate, and manage patient data. This session will discuss key considerations in integrating wearables/sensors data in sponsor’s ecosystem.

Sponsored by2:55 Right-sizing Technology for Early Development Proof of Concept Clinical TrialsLorraine Rusch, PhD, President, High Point Clinical Trials CenterThis discussion focuses on technologies used in early POC studies from a drug development and clinical research facility perspective. 1) Technologies can be utilized to assess endpoints such as glucose, biomarkers and disease progression in the development of novel therapies for metabolic disorders. 2) Cognitive assessments are crucial tools for the clinical development of CNS-focused therapies. 3) The emerging field of electronic, tablet-based source will be the future means to maximize data quality and efficiency.

3:20 PANEL DISCUSSION: Digital Technology Adoption and ImplementationModerator: Christian Gossens, Ph.D., Global Head Early Development Workflows, pRED Informatics, Roche Pharmaceutical Research and Early DevelopmentPanelists: Gahan Pandina, Ph.D., Senior Director, Compound Development Team Leader, Neuroscience, Janssen Research & DevelopmentAman Thukral, Assistant Director, Data and Statistical Sciences, AbbVieIeuan Clay, Ph.D., Group Lead Digital Endpoints, Translational Medicine, Novartis Institutes for Biomedical ResearchMichelle Crouthamel, Digital Platform Leader, GSKThis panel will discuss: Wearable sensors’ impact on trials design and execution, Collecting, integrating, and analyzing wearable devices data, and Driving innovation in patient centricity and PROs.




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8:15 Session Break

DIGITALIZATION OF CLINICAL TRIALS8:25 Chairperson’s RemarksJulie Smiley, Director, Product Strategy, Oracle Health Sciences

8:30 Harnessing Digital Technology and Big Data in Clinical Trials and BeyondAnthony Rowe PhD, Director, R&D IT Business Technology Leader, Immunology TA, JanssenMeasuring physiological and activity-based parameters remotely and continuously via unobtrusive on/off-body sensors or smartphones has the potential to revolutionize our ability to monitor patients between clinic visits and develop objective markers that track disease trajectory. How can we harness such advances in digital technology and big data analytics to enable more informative and efficient clinical studies and develop patient centric digital solutions that improve outcomes in the real world?

8:55 Digital Biomarker Implementation, Presentation and ComparabilityAmy Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor, Eli Lilly and CompanyOver the past few years, data generation is beginning to take a new form. It’s moving from subjective to more objective, from episodic to contemporaneous, and is being generated through connected digital tools that can be used to quantitatively explain or predict physiological, behavioral, and functional health measures and outcomes. These digital measures are known as digital biomarkers. This presentation utilizes learnings from pilot examples to examine the implementation, presentation and comparability of digital biomarkers.

9:20 Wearables and Sensors Are Changing the Clinical Trial Process, but What’s the Return on Investment for Making This Dramatic Change in People, Process and Technology?Deborah Profit, Ph.D., Vice President, Otsuka Information Technology

The advent of wearables and sensors in clinical trials is changing the paradigm of trial designs, clinical teams, outsourcing practices, and ultimately patient engagement. However, what value does sensor/wearable data and these new trial practices bring, and how quick is the return of investment to the various stakeholders? Otsuka Pharmaceutical Development and Commercialization, Inc. is on the cutting edge of the trial and technology reform, and will share some critical learnings from “the road less traveled”.

Sponsored by9:45 CO-PRESENTATION: Driving Clinical Strategy & Optimized Design with RWD and Clinical Patient-Level DataQin Ye, MD, Associate Principal, Global RWE Lead, ZSJane Fang, MD, PhD, Head, Biologics, Research & Development Informatics, AstraZeneca/MedImmuneHistorical clinical trial and real-world data hold immense potential in sharpening R&D strategy, optimizing trial design and streamlining operational planning. This data-driven approach has become common practice for many in the pharmaceutical industry, but there are still hurdles to overcome. For some, the lack of efficient and timeline approach as well as tangible use cases leads to poor adoption and impact. In this presentation we’ll share how MedImmune leveraged an integrated framework to enable seamless data-driven decision making and process transformation within clinical program planning.


TECHNOLOGY-DERIVED ENDPOINTS AND CASE STUDIES11:10 Chairperson’s RemarksVenkat Sethuraman, Associate Principal, ZS

11:15 Identifying, Developing and Incorporating Technology-Derived Endpoints into Clinical Trials: A ‘How-To’ Guide on the AgendaRob DiCicco, Ph.D., Vice President, Clinical Innovation and Digital Platforms, GSKMobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. This presentation will describe recommendations and tools from the Clinical Trials Transformation Initiative (CTTI) that aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

11:40 Making Sense of Sensor Data: A Case Study in Data Quality EvaluationBhaskar Dutta, Principal Scientist, Advanced Analytics Center, AstraZenecaWearable sensor technology brings the promise of improving management of chronic diseases, identification of drug adverse effects, and use of new efficacy endpoints. Future adoption of wearable sensors in clinical studies will depend on the usability of the devices and quality of the data. Currently, several sensors are commercially available, hence, requiring a comprehensive review. We carried out a study to compare them in healthy volunteers and implemented a comprehensive data analysis strategy, which has paved the way for improved








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designs of future studies involving wearable sensors.

12:05 pm Session BreakSponsored by12:10 Bridging Luncheon Presentation:

Introducing Consent Engineering: The Simplest and Safest Way to Create, Manage and Automate Consent Solutions In-HouseEric Delente, President, Patient Consent, DrugDev (an IQVIA company)The benefits eConsent provides for patient satisfaction and internal efficiencies cannot be overstated, yet the time and expense involved can make it cost-prohibitive for some clinical trials. Consent Engineering is a new SaaS technology solution enabling sponsors to bring eConsent entirely in-house. Featuring an interface as familiar and intuitive as Microsoft Word, Consent Engineering will completely change the way the industry does consent. Join us for the world’s first look at this exciting new solution!



Stay on and attend Part 2: Clinical Technology and Innovation. Click here for details.

From the nitty-gritty operational level details to the high-level philosophical approaches – SCOPE is the conference to be at!- Leader, Business Support Group, Boehringer Ingelheim

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Non-interventional studies are an integral part of product development plans. Product safety profiles, comparative effectiveness data, as well as health economic evidence obtained from non-interventional studies, are essential for multiple stakeholders. These stakeholders include but are not limited to regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, healthcare professionals, and patients. Cambridge Healthtech Institute’s 7th Annual Late Stage Research and Observational Studies: Novel Approaches and Data Sources for Post-Approval Research conference is designed to facilitate knowledge exchange around all aspects of observational research from the designing and managing of post-approval studies, to applying the obtained data to pivotal business and medical decisions. Similarities and differences between clinical and observational studies will be addressed by the top industry experts.

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EVOLVING ROLE OF OBSERVATIONAL RESEARCH10:45 Chairperson’s RemarksCathy Critchlow, Ph.D., Vice President, Center for Observational Research, Amgen

10:50 Evolving Role for Real-World Evidence in Facilitating Regulatory, Payer and Provider Decision-MakingCathy Critchlow, Ph.D., Vice President, Center for Observational Research, AmgenIncreasing use of real world evidence (RWE) to tailor health care decision-making to patients in clinical practice complements evidence obtained from the carefully selected patients enrolled in randomized clinical trials. While growing data availability and sophistication of analytic tools have transformed evidence generation, challenges impeding full realization of benefit from RWE remain.

Collectively addressing these challenges and advancing suitable use cases will help guide and enable appropriate impact of RWE.

11:15 Non-Interventional Studies and Pragmatic Clinical Trials to Support Product ValueChristopher Chinn, Head of RWE Strategy for Market Access Health Economics and Value Assessment, SanofiReal World Evidence can be defined to include both non-interventional studies - aka observational studies or registry studies – and pragmatic clinical trials. These can provide evidence of interest to payers and inform clinical guidelines. The design and delivery of such studies draws on skills required for RCTs, but raise new challenges. Study teams should be prepared to find appropriate solutions.

11:40 Combining Safety, Efficacy and Pharmacoeconomics EndpointsDurgesh Bhandary, Senior Director, HEOR, AstraZenecaThis talk will discuss the strategy and logistics of designing and executing an observational study that would incorporate multiple end points to serve major stakeholders such as epidemiologists, drug safety researchers, sales and marketing, treating physicians.

Sponsored by12:05 pm Next Generation Real-World Evidence: Moving the Industry Standard Forwards Louise Parmenter, PhD, Vice President, Global Head, Scientific Affairs, Real-World Insight Solutions, IQVIANew Approaches to Generate RWE. Using Data and Insights to Improve Predictability of Delivery.

12:30 Session BreakSponsored by12:40 Luncheon Presentation: Value of Natural

History Studies Throughout the Product Life CycleHaley Kaplowitz, Ph.D., Executive Director, Safety, Epidemiology, Registries and Risk Management, UBC: An Express Scripts CompanyHaving an in-depth knowledge of the disease or condition for which is drug is being developed seems fundamental, yet the natural history of the disease may not be fully known prior to or during drug development. Further, once a new product enters the marketplace, it is important to characterize the impact on disease natural history. Successful product development and marketing are aided by the collection of natural history data.


FEASIBILITY ASSESSMENT; DATA PARTNERSHIPS2:00 Chairperson’s RemarksEmily Freeman, PhD, Director, Risk Management Sciences, Abbvie








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Interactive Breakout DiscussionsLate Stage Research and Observational Studies7th Annual

Novel Approaches and Data Sources for Post-Approval Research February 13-14, 2018




2:05 CO-PRESENTATION: Value of Conducting Feasibility Studies in Observational ResearchMark Price, Senior Director, Surveys and Observational Studies, RTI Health SolutionsDavid Richardson, Project Manager, Surveys and Observational Studies, RTI Health SolutionsThis presentation will provide justification and case study examples to demonstrate why it is important to spend time and resources up front to conduct feasibility assessments in noninterventional studies and the range of feasibility approaches that could be performed to get the most out of the implementation phase.

2:30 CO-PRESENTATION: Collaborative Approach to Real World Data CollectionGinger Spitzer, Executive Director, Foundation of Sarcoidosis ResearchWinnie Nelson, Pharm.D., MS, MBA, Senior Director HEOR, Mallinckrodt PharmaceuticalsThis presentation will focus on the valuable role of non-profit disease research foundations in securing and managing real world data and collaboration with industry to access the data. The two-part presentation will include review of methods such as patient registries, clinical site networks, collaboration, wearables, and other techniques, and will feature the perspective of industry partners as both collaborators and first-line collectors of data. The “neutral third party” status of the non-profit organizations can enable industry to navigate more easily the issues in logistics to get direct real world data.

Sponsored by2:55 A Crawl, Walk, Run Strategy towards Virtual Studies in Real World Research Adam Halbridge, Vice President, Business Development, Parallel6, a PRA Health Sciences CompanyThis presentation will address new and exciting developments in planning and executing real world research studies virtually. Attendees will learn about the reality of conducting virtual studies on a global scale and the role mobile technology can have to optimize recruitment, engagement and retention of patients, while driving better data, decisions and outcomes more efficiently, and at a significant reduction in costs.

3:20 PANEL DISCUSSION: Meeting the Evidentiary Needs of Multiple Stakeholders by Better Non-Interventional StudiesModerator: Cathy Critchlow, Ph.D., Vice President, Center for Observational Research, AmgenPanelists: Ginger Spitzer, Executive Director, Foundation of Sarcoidosis ResearchJuliane Mills, Scientific Affairs Director, Real World Solutions, PRA Health SciencesTopics to be discussed include but are not limited to the following:• What are key considerations and approaches to balance scientific and

commercial values of non-interventional studies?• What are common utilizations of non-interventional studies in supporting

clinical development program?• How can evidences generated from non-interventional studies be used in

discussions with regulatory agencies during product development and post marketing in support of establishing product benefit risk profile, continual safety monitoring, and risk management and mitigation activities, as well as fulfilling regulatory post marketing safety requirement (PMRs and FUMs)?




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8:15 Session Break

EMBEDDING STUDIES IN PATIENT CARE 8:25 Chairperson’s RemarksHaley Kaplowitz, Ph.D., Executive Director, Safety, Epidemiology, Registries and Risk Management, UBC: An Express Scripts Company








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8:30 Pragmatic Clinical Trials: Bridging the Gap between Research and CareSean Zhao, M.D., Head, US Patient Safety Surveillance, AstraZenecaClinical trial findings that lead widespread change in health care is relatively slow. Since many clinical trials are not relevant to clinical practice, it is difficult to translate results to the real world clinical practice. Tens of thousands clinical trials published each year, yet systematic reviews consistently find that we don’t have enough evidence to effectively inform the clinical decisions. Clinical research is more than just traditional RCTs. Pragmatic research is designed with input from health systems and produces evidence that can be readily used in improve care. By engaging health systems, providers, and patients as partners, pragmatic research accelerates the integration of research, policy, and practice.

8:55 CASE STUDY: Leveraging Real World Data in Observational Research to Address Safety RisksYounus Muhammad, Director, Epidemiology, Worldwide Safety and Regulatory, PfizerObservational data from real-world setting are increasingly being used to assess safety risks with pharmaceutical products. This presentation will describe how real world data from routine clinical practice were used to address a safety risk in a special patient population including details around feasibility assessment, regulatory agency interactions, study methods and results, and impact on the product label.

9:20 CO-PRESENTATION: The Use of Real-World Data and Evidence in Clinical Research and Post-Marketing Safety MonitoringMary Jo Lamberti, Ph.D., Senior Research Fellow, Tufts CSDD, Tufts UniversityJill Abell, MPH, Ph.D., Team Leader, Real World Evidence, JanssenTufts CSDD has recently conducted a study of 30 biopharmaceutical companies to examine insights on the industry’s response to this opportunity including current and planned uses of real-world data, operational issues and return on investment/performance areas impacted by real-world data use. Significant challenges are identified as well as strategies and practices that impact return on investment or performance.

Sponsored by9:45 Real World Evidence: Separating the Hype from the PromiseCharles Makin, Vice President & Global Head, Late Phase Research, Commercialisation & Outcomes, ICONIncreasing availability of RWE has created justifiable excitement, accompanied by confusion about its true meaning and implications for stakeholders. While RWE is neither the starting point nor the solution, it is a critical component of the value demonstration toolkit. It is not the data that counts, but the insights gained from it. Join us for best practices to ensure you are asking the right questions and using data to guide the pursuit of answers.


PATIENT CENTRICITY11:10 Chairperson’s RemarksMaria Harrison, Vice President, Real World Solutions, PRA Health Sciences

11:15 Incorporating the Patient Perspective into PharmacovigilanceEmily Freeman, Ph.D., Director, Risk Management Sciences, AbbviePatient engagement is a key aspect to improving health outcomes and effectiveness of risk management activities within the pharmaceutical industry. It is imperative to incorporating the patient perspective into pharmacovigilance and subsequent risk management strategies. This session strategizes how to incorporate the patient perspective to develop patient focused risk minimization activities utilizing concepts from the social/behavioral sciences that focuses on patient activation, patient measurement, and shared-treatment decision making.

11:40 CO-PRESENTATION: Using Exit Interviews with Participants in Randomized Controlled Trials to Collect “The Rest of the Story”Carla Romano, MS, Executive Director, Patient Centered Outcomes Assessment, RTI Health SolutionsSandy Lewis, BSN, Director, Patient Centered Outcomes Assessment, RTI Health SolutionsThis presentation will explore the benefits of conducting qualitative interviews with patients as they complete participation in RCTs. Important information can be collected on safety signals, clinically meaningful change on PRO measures, understanding reasons for drop out, and bringing the patient voice into clinical trials.


12:10 Bridging Luncheon Presentation: Achieving Evidentiary EquilibriumDavid Thompson, Ph.D., Senior Vice President, Real-World & Late Phase, Syneos HealthAchieving Evidentiary Equilibrium - Generating the Right Evidence for the Right Stakeholders at the Right Time throughout the Clinical/Commercial Continuum



Stay on and attend Part 2: Leveraging Real World Data for Clinical and Observational Research. Click here for details.








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Outstanding, informative and forward looking!- Chief Executive Officer, Miami Dade Medical Research Institute“ ”

The availability of high-quality biological specimens, laboratory access and diagnostics services are of utmost importance for biomarker-driven clinical trials and future research. The complexity and number of samples collected during studies has increased steadily over the years and we need to come up with best practices, operational models and IT systems to deal with this volume and complexity. The next step, the testing of the samples and various laboratory services, also requires significant managerial efforts whether they are outsourced or provided by an in-house laboratory. Cambridge Healthtech Institute’s 3rd Annual Biospecimen, Central Lab and Technology for Precision Medicine Trials conference brings together leading experts to discuss challenges and identify actions to improve infrastructure for biomarker-driven clinical trials.

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ENABLING PRECISION MEDICINE TRIALS10:45 Chairperson’s RemarksMichael Tanen, Director, Clinical Biomarker Specimen Management, Merck

10:50 Precision Medicine Trials, and How the Bio-Repository Can Support Biomarker and Diagnostic DevelopmentMichael Tanen, Director, Clinical Biomarker Specimen Management, MerckPersonalized medicine initiatives have led to a marked increase in biomarker-driven research objectives within clinical trials. This has re-defined traditional biospecimen management into a more comprehensive information management role requiring innovative technology and best practices. The ability to integrate disparate data sources into centralized systems and present the information in a way that can guide decision-making and biomarker development, will define the utility and success of the biorepository.

11:15 Clinical Biomarker Sample Management: Taking Time to Do It Right, Rather than Do It OverDmitri Mikhailov, Ph.D., Director, Head, Biomarker Study Coordination, NovartisThe emergence of global clinical trials with complex biomarker analyses performed at CROs pushes the industry to reconsider clinical sample management. How to mitigate risks of losing samples or compromising quality? How to maximize sample usage beyond clinical study objectives? This presentation discusses how Novartis approaches these challenges, starting with trial documentation setup, to systems used in biorepository for sample inventory and enabling additional research use of clinical samples.

11:40 Operationalizing Precision Medicine Trials in OncologyKarina Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research LaboratoriesThe immuno-oncology revolution has required many sponsors to rethink the infrastructure needed to support complex biomarker driven trials. This presentation will discuss challenges and solutions in operationalizing such trials, including governance committees, roles and responsibilities of functional areas, biomarker plan structures, and vendor alignment.

12:05 pm Sponsored Presentation (Opportunity Available)

12:30 Session BreakSponsored by12:40 Luncheon Presentation: Best Practices in

Clinical Trial Samples & Consent TrackingJian Wang, Ph.D., CEO, BioFortis, Inc.In biomarker-driven precision medicine clinical trials, patient samples (biospecimens) are as important as patients themselves. Sample assay results often determine patient segmentation, and support primary and key secondary objectives. The lack of proper sample tracking & management escalate risks of milestone delays and regulatory scrutiny. We illustrate best practices and technology solutions that address the rise in complexity and importance of biospecimen operations, with unique perspectives from risk-based monitoring approaches.









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Interactive Breakout DiscussionsBiospecimen, Central Lab and Technology for Precision Medicine Trials3rd Annual

Infrastructure to Support Biomarker-Driven Clinical Research February 13-14, 2018




SOURCING AND PROCUREMENT2:00 Chairperson’s RemarksJonathan Reuter, Associate Director Global Procurement R&D, Clinical Labs, Bristol-Myers Squibb

2:05 Use of Make vs. Buy Analyses and “Should-Cost” Modeling in Clinical Laboratory ProcurementJonathan Reuter, Associate Director, Global Procurement R&D, Clinical Labs, Bristol Meyers-SquibbElevating the role of procurement in company decision-making. Using comprehensive analysis to enable informed sourcing decisions. Partnering with external supply base to implement cost-controlled and sustainable models in support of the clinical development cycle.

2:30 Comprehensive Bio-Inventory System to Support Clinical Biomarker StrategySandra Hudgens, MT(ASCP), BS, MBA, Associate Principal Scientist, Clinical Specimen Management Operations, MerckPrecision medicine is a key component to drug development strategy. The management of clinical specimens to support genetic and biomarker testing is critical to realizing precision medicine. This includes having a biospecimen inventory management system which can seamlessly link specimens to informed consent and clinical data to appropriately select specimens for analysis. Based on established business criteria, the biospecimen inventory management system should be able to track the specimen life cycle to provide a cost-effective inventory for the organization.

Sponsored by2:55 Frozen Clinical Biospecimens – New Approach for Optimizing Quality, Compliance, and CostRobert Sever, PhD, Associate Director, Research & Development, Praxair, Inc.This seminar will review the challenges of today’s cold chain for clinical biospecimens from kit preparation and dry ice management to sample acquisition and shipment logistics. A new approach will be described that can improve sample preservation, process compliance, and productivity while reducing overall complexity, risk, and cost.

3:10 Sponsored Presentation (Opportunity Available)

3:25 PANEL DISCUSSION: Biospecimen and Core Lab Considerations for Risk-Based MonitoringModerator: Michael Tanen, Director, Clinical Biomarker Specimen Management, MerckPanelists: Jonathan Reuter, Associate Director Global Procurement R&D, Clinical Labs, Bristol-Myers SquibbJian Wang, Ph.D., CEO, BioFortis, Inc.Dmitri Mikhailov, Ph.D., Director, Head, Biomarker Study Coordination, Novartis

Karina Bienfait, Ph.D., Head, Global Genomics Policy, Process and Compliance, Principal Scientist, Clinical Pharmacogenomics and Operations, Genetics and Pharmacogenomics (GpGx), Translational Medicine, Merck Research Laboratories• Importance of Biospecimens in Precision Medicine trials• When patient samples are as important as the patient themselves• Specimen-centric RBM approaches• Inclusion of specimen KRIs (key risk indicators)• Working with RMB colleagues to improve quality




6:30 Close of Day


7:15 am Registration OpenSponsored by7:45 Breakfast Presentation: The Next Generation

of Site Payments: Technology Do’s and Don’tsStuart Thiede, President, Payments, DrugDev (An IQVIA Company)Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

TECHNOLOGY SOLUTIONS8:25 Chairperson’s RemarksLynn Wetherwax, Senior Manager, Biobank, Translational Sciences Operations, Amgen








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8:30 CO-PRESENTATION: Clinical Sample Tracking Project Implementation: A Case StudyRon Bourque, Associate Director, RDI, Clinical Biologics, MedImmune/AstraZenecaVenkatraman Raman, Senior Project Manager, R&D Information, Clinical Biologics, AstraZenecaWe have developed a new and innovative sample management model combining MedImmune Clinical Operations with close alliance/partnership to a Central Lab. Together the technology we are employing is Labmatrix. This initiative is focused on accepting standardized data from all lab vendors. Discrepant data will be corrected at the source lab and reflected back into the tool. Labmatrix is also receiving consent data from our EDC.

8:55 Enabling Scientific Discovery and Innovation Using Biomarker Specimens by Means of Advanced InformaticsLynn Wetherwax, Senior Manager, Biobank, Translational Sciences Operations, AmgenBiomarker specimens may be collected with a specific purpose in mind or they may be stored until that “a-ha” moment when scientific discovery hinges on biomarker investigation. This presentation will provide an overview of biomarker specimen management strategy using informatics to track, confirm consent and search clinical data attributes related to available specimens.

9:20 Leveraging Systems and Automation to Address the Challenges in GSK’s Sample Management Strategy ImplementationKimberly Bojczuk, Investigator, Discovery Supply - Global Biological Assets, RD Platform Technology & Science, GSKGSK is developing a cross-functional strategy working with IT and global teams, to increase the visibility and use of human biomaterials in Discovery and Clinical. This integrated approach will increase standardization, allow GSK to maximize investment in biological materials and ensure increased compliance. An IT platform to provide a single interface to both on-site and off-site storage, as well as rapid delivery of samples from an automated sample store will facilitate addressing challenges faced.

Sponsored by9:45 Bringing the Trial to the Patient: Sample Collection at Home for Clinical TrialsKevin Bateman, Distinguished Scientist, Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck & Co.Merck’s “Smart Trials” initiative evaluates and implements technologies bringing clinical trials to the patient. Enabling this is the ability to collect

samples for pharmacokinetic/biomarker analysis away from the clinic. Dried blood collection is being investigated and learnings will be shared on hurdles met and how they are being addressed.


BIOSPECIMEN MANAGEMENT AS AN INTEGRAL PART OF OVERALL OPERATIONAL STRATEGY

11:10 Chairperson’s RemarksBrenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² Solutions

11:15 Biospecimen Tracking as an Integral Part of Risk Based MonitoringMorten Pedersen, Senior Manager, Novo NordiskThis presentation will share strategy that allows to make risk-based monitoring more precise and also to mitigate some risks related to biospecimens, biorepository and central lab management.

11:40 PANEL DISCUSSION: Outsourcing Strategy: Working with Central Labs and BiorepositoriesModerator: Brenda Yanak, Global Head, Specimen Strategy & Innovation, End-to-End Specimen Management, Q² SolutionsPanelists: Morten Pedersen, Senior Manager, Novo NordiskKimberly Bojczuk, Investigator, Discovery Supply - Global Biological Assets, RD Platform Technology & Science, GSKSandra Hudgens, MT(ASCP), BS, MBA, Associate Principal Scientist, Clinical Specimen Management Operations, Merck• Key Areas of Interest from Sponsors• What Vendors Wish Sponsors Knew• Innovation Opportunities

12:05 pm Session Break

12:10 Enjoy Lunch on Your Own



Stay on and attend Part 2: Clinical Supply Management. Click here for details.








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Collaborate and learn, not just buzzwords, attendees really get knowledge and ideas from SCOPE.- Contract and Budget Analyst, NewLink Genetics

“ ”Clinical trial site activation and efficient study start-up are critical to drug development programs, in terms of time, cost and quality of data. To improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively in order to improve: the study feasibility process, contract and budget negotiations, standardization of source documents and other study-related materials, development of patient and staff educational materials, and development of patient recruitment and retention programs. CHI’s 5th Annual Improving Site-Study Activation and Performance will cover the topics one should consider when strategically implementing a process for rapid study start-up.

Arrive early and attend Part 1: Protocol Development, Global Site Selection, Feasibility and Site Management. Click here for details.


11:30 am Registration OpenSponsored by12:10 pm Bridging Luncheon Presentation:

Approaches to Evidence Based Site Planning in Trial DesignGavin Coney, Head, Clinical, Clarivate AnalyticsWe will explore approaches to ensuring that your study planning is based on the broadest evidence base. We will demonstrate how additional manually curated intelligence can complement existing data sources to identify relevant insights based on similar studies and provide specific insights into critical trial design and planning decisions.


1:30 Plenary Keynotes (click here for details)

3:00 Valentine’s Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing

ACHIEVING EFFICIENCY FOR THE SPONSOR, CRO, SITE AND PATIENT IN SITE ACTIVATION

4:00 Chairperson’s RemarksShawn Tedman, MBA, Head, Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS

4:05 Site Activation, a Balancing Act between Time and Quality: How to Avoid Paying the Price Later OnValérie Reynaert, Head, In-Country Clinical Operations for the Americas, R&D Projects Clinical Platform & Sciences, GlaxoSmithKlineThere are many processes in the site start up activitities that are redundant,

inefficient and needlessly complex. Our study start up timelines often slip as a result. This presentation will share learnings and opportunities on how simplification of our processes and reducing complexity can help in starting up sites on time without paying the price for it later.

4:30 Accelerating Study Start Up: A Centralized ApproachChristina Brennan, M.D., Vice President, Clinical Research, Executive Research Administration, Northwell HealthHospitals and health system consolidations continue to be on the rise and will continue to remake the delivery system landscape over the next 10 years. Clinical research participation will be more efficient if it is approached centrally as a systemwide approach in these settings. Currently, 57% of the US hospitals are part of a system and this will continue to rise. A centralized approach to site selection and site activation will streamline this process and accelerate study start up. This will lead to improved processes with study performance.

Sponsored by4:55 CO-PRESENTATION: Why Is Study Startup Still so Inefficient? Jae Chung, President & Founder, goBaltoKen Gatz, Director, Sponsored Research Programs, Associate Professor, Tufts Center for the Study of Drug DevelopmentAn in-depth study conducted by Tufts Center for the Study of Drug Development focused on the end-to-end process of site identification through site initiation grapples with this question, and sheds light on the challenges organizations are facing, and on new tools, technologies, and approaches being developed to overcome these hurdles.

Sponsored by5:10 Optimizing Client/Vendor Collaboration: An Efficient Approach to Site Selection and Start-UpEric Richardson, MS, COO, CPi Global CRO

5:25 PANEL DISCUSSION WITH PATIENT & SITE: Why Site Buy-In Is Crucial to Improving the Trial Participant ExperienceModerator: Abbe Steel, CEO, HealthiVibe, LLCPatient: Nicole MoorePI: Bruce Rankin, M.D., Avail Clinical (An Accel Research Site)Site: Chris Hoyle, MBA, Executive Director, Elite Research NetworkIndustry-wide adoption and benchmarking of trial participant insights has the potential to truly improve clinical trial design and execution and improve the patient experience in clinical trials. But the overall success of these surveys is largely dependent on site staff willingness to help implement them at their site. Leveraging








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Interactive Breakout DiscussionsImproving Site-Study Activation and Performance5th Annual

Strategically Implementing a Process and Systems for Rapid Study Start-up and Improved Site-CRO-Sponsor Interactions February 14-15, 2018




sites to implement participant surveys allows the data to quickly grow and reveal a deeper look into the drivers behind what keeps patients coming back. This panel will explore, with site representatives and a patient, the best model for implementation.• What are the true hurdles to participation – from the patient perspective?• How can pharma do a better job to include sites, and why is this critical?• What do site staff (PI, site networks) think about these surveys and the most

critical considerations for a successful implementation?

5:50 – 7:00 Reception Hosted by

THURSDAY, FEBRUARY 15


7:45 Breakfast Presentation: Clinical Trial Operations Insights Evolved via Accenture Life Sciences Cloud Chandi Kodthiwada, Product Manager, Accenture Life Sciences Cloud (ALSC), AccentureChances are you have spent a meaningful amount of time on one of the below questions: How do you assess your Clinical Trial operational efficiency? How do I stay on top of Site behavior? How do you maintain Vendor-Oversight? In the presentation, we will go through Accenture Life Sciences Cloud(ALSC) - Clinical Operations Insights Platform(COIP) and our work with Metrics Champion Consortium(MCC) to answer the above questions.

LEVERAGING SOUND BUSINESS PROCESSES, COLLABORATION AND TECHNOLOGY TO ACCELERATE

THE PROCESS OF INITIATING A STUDY8:30 Chairperson’s RemarksChairperson to be Announced, Bio-Optronics

8:35 A Systematic Approach to Study Start-Up: Identifying Risk Factors and KPIs to Ensure Faster Start-Up and Better Accrual RatesMarina Malikova, Ph.D., Executive Director, Surgery, Boston University Medical CenterThe success of a trial heavily relies on the strong bond between trial operations and project management throughout the life cycle of the trial. It is important to develop a specific knowledge of the strengths, weaknesses and pitfalls of assumed risks at the inception of the project in order to devise a solid strategy to mitigate them throughout implementation phase. Systematic assessment of risk factors and key performance indicators at a start-up phase can allow for more efficient execution of a clinical trial and ensure better accrual rates. This session will discuss best practices to expedite start-up phase.

8:55 How Reg Ops and Clin Ops Business Integration Can Accelerate Timelines to SubmissionSophia Kourliouros, Senior Manager, Global Regulatory Operations, Eisai, Inc.This presentation will be given from a Regulatory Operations perspective to provide best practices to the Clinical Operations team when submitting clinical documents. In order to make submissions faster and ensure the quality of the data, it’s important to include RegOps in your planning, business process strategy and operations. This talk will provide best practices to help colleagues in Clinical Operations work more efficiently with their RegOps team to improve business process and study start-up.

9:10 Optimizing Site Activation in Rare Diseases and Novel Therapy StudiesMari Maurer, Pharma Clinical Solutions Consulting LLC; former Vice President, Clin Ops, REGENXBIOSite activation for studies for rare diseases especially those involving novel therapeutic modalities may have additional challenges due to additional regulatory review and oversight, specialized technology, novel interventional procedures, and training. We will be discussing the challenges frequently encountered during site activation in rare diseases and novel therapies and potential solutions to address them.

9:25 CASE STUDY: Transforming the Site Monitoring and Management Model to Become a Sponsor of Choice for Sites and Improve QualityMark Ridge, Vice President, Clinical Development Operations, CSL BehringThis session will explore an innovative site management and oversight approach to transform site relationships, enhance site quality and strengthen the overall site monitoring approach that yields successful approval of new therapies for patients. The presentation will include site survey results and lessons learned.

Sponsored by9:50 CO-PRESENTATION: Partnering Shared Expertise and Technology to Optimize Study Planning Loni Branon, Director, Sitetrove/Chinatrove, Pharma Intelligence-InformaMichael Fites, Senior Feasibility Strategist, Bayer PharmaceuticalsOtis Johnson, PhD, Vice President, ICON Clinical ResearchWhile navigating the rough seas toward study activation, advanced planning is key to staying on course. Our presenters will share insights on streamlining the study start up journey, by addressing major components such as protocol development, competitive landscape assessment, evaluating patient demand and country/site selection. We’ll touch on how combining expertise with a trusted crew, along with a few simple tech tools, will ensure smooth sailing and a timely arrival at your final destination.

10:15 Networking Coffee Break








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E-CONSENT (EICF) IMPLEMENTATION LESSONS LEARNED BY STUDY EXPERTS

10:30 Chairperson’s RemarksChairperson to be Announced, Bio-Optronics

10:35 PANEL DISCUSSION: eConsent after the Pilot: Implementation Lessons Learned by Study ExpertsModerator: Eric Delente, President, Patient Solutions, DrugDevScott Askin, Digital Development Director, Lead for eSource and eICF, Digital Development, Portfolio, Strategy & Innovation (PS&I), Novartis PharmaeConsent (eICF) is a potential participant’s first real interaction as they consider participation in a clinical trial, and as such, it can be the keystone of a patient engagement strategy. Different sets of challenges and solutions appear at each stage as the implementation moves beyond early stages. In this panel-led discussion, we’ll hear perspectives from experts that start with using eICF in a pilot, then move into regulatory and quality considerations with perspectives, and finally the challenges of broader, global implementations. This discussion will also reveal some of the reasons why use of eConsent is not yet ubiquitous across the industry. The panel will include an interactive discussion, driven by questions from attendees with a goal of illuminating the path beyond pilot implementations, and attendees’ understanding of how an eConsent program can improve patient engagement.• Understand the benefits and potential role of eConsent in Patient

Engagement• Recognize challenges of eConsent adoption across various stages of

implementation from several perspectives• Discuss potential approaches to implementation

Sponsored by11:00 Maximizing Study Startup & Site Selection with Collaborative CTMSMary Pat Cottengim, User Experience Manager, Clinical Research Systems, Bio-OptronicsAttendees will learn best practices for reducing the time between accepting a study and when sites begin enrollment through the use of technology. Innovative process improvements will be discussed for site selection, site questionnaires, budget negotiation, milestone tracking and credential management. Attendees from CROs, SMOs and Sponsors will understand how to maximize critical efficiencies and communications through detailed tracking and reporting, ultimately to enhance quality, profitability and sponsor relations.

11:25 Transition to Shared Session

M-HEALTH’S POTENTIAL TO IMPROVE PATIENT CENTRICITY AND THE CONDUCT OF CLINICAL TRIALS

11:35 Digital Trends Impacting Recruitment, Engagement and RetentionShwen Gwee, Head of Digital Strategy, Global Clinical Operations, BiogenDigital technology is connecting more people to clinical trials than ever before, and at the same time, the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technologies and approaches are having the greatest impact on recruitment, engagement and retention?

12:00 pm CASE STUDY: The Art and Science of Patient Engagement in the Digital Era – Learning from GSK PARADE StudyMichelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKlineThe ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Although the emerging mHealth technologies have the potential to improve the conduct of clinical trials, the successful implementation requires careful study design and patient engagement. Data and experiences from GSK PARADE study will be summarized, highlighting the learning and opportunities in this new area of clinical development.

12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation InitiativeHassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim PharmaceuticalsThis presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?Moderator: Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology AssociatesBeth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually

Improving Site-Study Activation and Performance5th Annual









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Improving Site-Study Activation and Performance5th Annual


work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites’ needs?• Share sites’ perspective on the evolving clinical research landscape• Discuss the reasons sites struggle with new processes and technology tools• Determine ways to facilitate adoption

1:15 Closing Remarks

1:20 SCOPE Summit 2018 Adjourns








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This was a great gathering of key players in the clinical research enterprise. I learned a lot from the many conversations I had with speakers and attendees, and found everyone very eager to share and exchange ideas.- Executive Director, Informa/Citeline

“”

Enrollment planning and patient recruitment are critical to drug development programs and garner a lot of attention by study teams. However, once the hard work of identifying and recruiting a trial subject has been accomplished, they must be retained and remain in compliance. Retention of patients throughout the life of a clinical trial is essential in order to have complete data sets for your analysis and subsequent filings. There are strategies, tools and techniques such as social media platforms and mobile technology, empowered patient communities, and a more informed patient population that need to be understood and engaged. CHI’s 5th Annual Patient Engagement, Enrollment and Retention through Communities and Technology will cover the topics one should consider when planning and strategically implementing a patient retention plan in the digital age.

Arrive early and attend Part 1: Enrollment Planning and Patient Recruitment. Click here for details.


11:30 am Registration OpenSponsored by12:10 pm Bridging Luncheon Presentation: Taking

Patient Recruitment into the Next Generation of Clinical DevelopmentKimberly Ray, Vice President, Site and Patient Networks, IQVIAUsing real-world insights to drive better Site identifications. Understanding Site and PI capabilities to drive ideal patients. The importance of communication and advocacy groups to drive engagement and retention.




KEY CONSIDERATIONS WHEN ENGAGING PATIENTS PARTNERING IN THE DRUG DEVELOPMENT PROCESS:

SHARED STRATEGY, PRIVACY, CONSENT4:00 Chairperson’s RemarksTerrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

4:05 Top 10 Rules of Engagement to Incorporate the Voice of the Patient in Clinical DevelopmentPaulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono

The industry is making strides in its attempt to include the voice of the patient in clinical development, but much uncertainty on how to do it still exists. Successful engagement between pharma and patients requires that some basic tenets be observed. This presentation will enumerate and discuss the top 10 rules based on several years of engaging patients to seek their input into clinical trial design and protocol operational implementation.

4:30 Developing the Conversation around Guardrails for Patient Information Gathered in Patient Engagement ActivitiesTherese Johnsen, Clinical Trial Intelligence Manager, Global Drug Development, NovartisA little studied topic is how companies and vendors are protecting the patient information gathered during engagement activities. Data Privacy rules protect a certain type of data depending on the country, but contracts can give wide access to patient data which can be used in a myriad of ways and travel the world in global clinical trial teams. Sponsors spend a lot of effort on governance, compliance and quality, often more focused on protecting the company. What guardrails are needed across the industry to ensure that people that share their data during partnerships in drug development do not experience unintended outcomes.

Sponsored by4:55 CO-PRESENTATION: Easing the Rare Disease Patient’s Burden in Clinical Trials with Innovative TechnologyScott Schliebner, MPH, Vice President, Rare Diseases, Scientific Affairs, PRA Health SciencesDavid Turner, MS, CISA, CEO/Founder, Parallel6, a PRA Health Sciences CompanyA rare disease patient’s diagnostic journey can be overwhelmingly arduous and expensive, so participating in clinical trials may seem especially burdensome. Traditional clinical trial models for screening, enrollment and ongoing study requirements may not be desired, possible or practical. Join this presentation to learn how a patient-centric approach, that provides an end-to-end solution and seamlessly integrates into a patient’s mobile lifestyle, may increase patient recruitment, enrollment and engagement.

5:25 CASE STUDY: Plain Language ICF ProjectSuzann Johnson, Associate Director, Investigator and Patient Engagement Projects, Global Clinical Development Operations, Janssen R&D








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Interactive Breakout DiscussionsPatient Engagement, Enrollment and Retention through Communities and Technology

5th Annual

Patient Centric Approaches to Optimize Clinical Trials and Participant Engagement February 14-15, 2018




Informed Consent is one of the most important aspects of the clinical research process; it is also one of the areas that most sponsor companies struggle with, as the document is heavily regulated by the regulations and internal compliance/legal groups. Janssen R&D is undergoing a project to overhaul our ICF to make it a more effective and patient-centric document.

5:50 Close of Day





APPLYING INSIGHTS FROM PATIENT COMMUNITIES AND SOCIAL NETWORKS TO IMPROVE OUTCOMES

8:30 Chairperson’s RemarksDaniel Piekarz, Senior Vice President, Healthcare & Life Sciences Practice Leader, DataArt

8:35 CO-PRESENTATION CASE STUDY: How Bioverativ Identified Endpoints That Matter Most to PatientsBrieana Cox-Buckley, Pharm.D., Executive Director, US Field Medical and Value Based Outcomes, BioverativChristopher O’Brien, Vice President, Strategic Partnerships, myHealthTeamsMore and more patients have become reliant upon and trust online information and they have access to more information than ever before. What have we learned from the patient communities, and how can we apply those insights into better outcomes for our clinical trials? This co-presentation will share a case study with a specific example from a hemophilia patient population.

9:00 Inclusion of Patient Reported Outcomes (PROs) in Rare Disease Trial Design: How Social Networks Can Enhance Patient Engagement and Patient ExperienceTerrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), Biogen

This presentation is given from the perspective of someone who understands clinical research both as a member of industry, but also as a patient. It will cover: Developing meaningful patient reported outcomes by gathering information about their disease journey through an independent social network, whether PROs will be used to run 3b trials to produce further evidence to support approval, strategies and tools to enhance patient engagement and patient experience.

9:25 PANEL DISCUSSION: Understanding the Power of Social Networks to Facilitate Engagement, Education, Research and RecruitmentModerator: Pablo Graiver, Co-Founder & CEO, AntidoteEric Peacock, Co-Founder & CEO, myHealthTeamsGilles Frydman, Patient Advocate; Co-Founder Smart Patients and ACOR (Asssociation of Cancer Online Resources)Terrie Livingston, Pharm.D., Senior Director, Real World Outcomes, Innovative Partnerships & Insights (RI2), BiogenHelen Kellar-Wood, Ph.D., Lead, Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb• How can patient communities empower patients and enable research?• What do trial designers, patient recruitment experts, protocol writers,

and patient centricity groups need to better understand about both the technology and the relationships?

• What are the key challenges and opportunities of using social media tech and social networks to better engage patients?

Sponsored by9:50 Finding the “Center” Of Your Clinical TrialJonathan Andrus, MS, CQA, CCDM, COO, Clinical InkThis presentation will focus on ways that you can center your clinical trial on the needs of the patient and the site throughout your clinical trial. Considerations during the start up, conduct and closeout phase will be examined. Further, attendees will learn about ways to engage with clinical trial patients in ways that enable better retention and engaged involvement in the study.


INNOVATIVE SPONSOR APPROACHES TO PATIENT ENGAGEMENT

10:30 Chairperson’s RemarksHeather Hernandez, Director, Business Development, Seeker Health

10:35 CO-PRESENTATION: Inside Out: A New Approach to Patient EngagementMary Murray, Associate Director, Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers SquibbHelen Kellar-Wood, Ph.D., Lead, Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb








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5th Annual





Patient engagement does not always look and feel the same from internal and external perspectives. How can patient engagement strategies be developed to perpetuate an ongoing and robust conversation with patients as partners? The speakers will address this question, sharing examples and unexpected experiences from the past few years that have led to the development of a new approach.

Sponsored by11:00 Patient Engagement Strategies to Increase Clinical Study Awareness, Interest, and Referrals Across IndicationsBarbara Zupancic, Senior Director, Global Patient Recruitment and Retention, Worldwide Clinical TrialsWithin patient communities certain populations have become more willing to embrace clinical trial communications through digital channels including social media. However, others remain hesitant when it comes to receiving information about sensitive health issues on platforms such as Facebook. This session will examine the benefits and best practices of social media while addressing other “off-line” strategies that have shown practical results in reaching prospective participants who prefer traditional communication channels.

11:25 Transition to Shared Session


11:35 Digital Trends Impacting Recruitment, Engagement and RetentionShwen Gwee, Head of Digital Strategy, Global Clinical Operations, BiogenDigital technology is connecting more people to clinical trials than ever before, and at the same time the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technologies and approaches are having the greatest impact on recruitment, engagement and retention?


12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation InitiativeHassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim PharmaceuticalsThis presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?Moderator: Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology AssociatesBeth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites’ needs?• Share sites’ perspective on the evolving clinical research landscape• Discuss the reasons sites struggle with new processes and technology tools• Determine ways to facilitate adoption










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5th Annual





SCOPE sets the bar for what a conference should be. A great opportunity for Sponsors, Sites and suppliers to connect and discuss truly innovative ways to improve the clinical trial process. - Associate Director, BMS

“”

Resource management and capacity planning is an essential step in setting up clinical trials. As protocols become more complex and as more partners are being used to execute them, the need to properly manage staff, workload, and outsourced partners is more essential than ever to run efficient clinical trials and get programs executed on time and within budget with as little variance as possible. Resource managers and capacity planners must gather input from executives in finance and those at the portfolio level, as well as from those in clinical operations and at the project level in order to understand the scope of projects in the pipeline, the effect complex protocols have on planning and timelines, and where internal and external resources may fall short. Operations managers and the budget team must ultimately be able to find the balance between cost savings and high performance. Cambridge Healthtech Institute’s Inaugural Resource Management and Capacity Planning for Clinical Trials conference will share case studies and best practices on clinical trial finance and capacity planning, metrics for resource management algorithms, maximizing efficiency of internal-external resources, optimizing staff, and managing changes and delays.

Arrive early and attend Part 1: Clinical Trial Forecasting, Budgeting and Contracting. Click here for details.








ANALYTICAL STRATEGIES FOR RESOURCE PLANNING, FORECASTING, AND BUDGETING

4:00 Chairperson’s RemarksGrant Morgan, Ph.D., PMP, Senior Vice President & Head of Portfolio Planning, R&D Finance, Systems & Analytics, Portfolio & Project Management, BTG PLC

4:05 An Analytical Approach to Making Informed Decisions around Resource ManagementGeoff Kremer, Director, CMR Informatics, Strategy & Operational Effectiveness, Novo NordiskInnovative tools and analytics are a key tool in enabling informed decision-making around resource management. This talk will discuss various ways to optimize resource management operations with analytics and data visualization.

4:30 Quantitative and Qualitative Factors for Outsourcing versus Using Internal ResourcesChris Chan, Executive Director, R&D Finance, Finance, FibroGen, Inc.One very important decision that biopharmaceutical companies need to make is what outsourcing strategy to pursue. Given the enormous cost and inherent complexity of the drug development process, this decision may play a key role in determining whether a company ultimately achieves its goals. This presentation will explore both quantitative (money!) and qualitative (money isn’t everything!) factors that companies should consider when determining the right outsourcing strategy.

Sponsored by4:55 Fostering a Committed Organization for Clinical Operations Geert Vanhove, Partner, BluecruxBinocs is a resource planning cloud application that targets R&D, Regulatory Affairs, Clinical Operations and Labs. On top of the “standard” features of conventional resource planning, together with clients, we work on two innovations that drastically speed up the organizational maturity and performance of PPM and resource planning. Let’s Share.


5:25 Predictive Clinical Resource Planning: Overview of a Bespoke Solution (SPEAR) that Converts Planned Clinical Workload to Role-Based Resource RequirementsGrant Morgan, Ph.D. PMP, Senior Vice President & Head of Portfolio Planning, R&D Finance, Systems & Analytics, Portfolio & Project Management, BTG PLC








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Interactive Breakout DiscussionsResource Management and Capacity Planning for Clinical Trials Inaugural

Metrics and Strategies for Efficient Resource Forecasting and Management February 14-15, 2018




The SPEAR Tool is used to analyze simple study information inputs to accurately predict resource requirements, visualize workload constraints, and better manage the business. This talk will cover the source data required, rationale behind complex predictive algorithms that drive highly accurate clinical resource requirements across multiple roles and study types plus the outputs that help resource managers better plan for the future workload.

5:50 Close of Day

5:50 - 7:00 Track Reception (Sponsorship Opportunity Available)




CONSIDERATIONS FOR EFFECTIVE CAPACITY PLANNING AND RESOURCE MANAGEMENT FOR SITES

8:30 Chairperson’s Remarks

8:35 Resource Management in a Managed Network at a National Level: Lessons from the NIHR Clinical Research NetworkDivya Chadha Manek, Head of Business Development (Commercial), Clinical Research Network, National Institute of Health ResearchThe NIHR Clinical Research Network is a government-funded research network that faces unique challenges related to resource management at a national level. This talk will discuss how resources are moved throughout the business and across sites in order to properly support hundreds of clinical trials. We will also review how the finance model affects decision-making around resource planning and optimizing the efficiency of clinical trials across the UK.

9:00 CO-PRESENTATION: Workforce Resource Management: Managing Onboarding and Training for Key Functional Area RolesChristine Senn, PhD, CIO, IACT HealthLiz Wool, RN, BSN, CCRA, CMT, Principal Consultant and Trainer, Barnett International

In today’s fast paced clinical research industry with heightened expectations of quality and qualified staff, effective on-boarding (beyond company orientation) requires a systematic review and analysis of key functional roles in order to strategically align and allocate resources for the development of efficient-reproducible on-boarding practices across the enterprise. This session reviews methods and analysis practices for deployment of on-boarding and training to include re-alignment when necessary, based upon organizational needs.

9:25 PANEL DISCUSSION: What Sponsors and CROs Need to Know about Site Capacity PlanningModerator: Jim Kremidas, Executive Director, Association of Clinical Research ProfessionalsPanelists: Jeff Kingsley, CEO, IACT HealthDavid Morin, Director, Research, Holston Medical GroupSites have a unique set of challenges when developing a resource management plan for their clinical trials, a process that evades many sponsors and CROs. This panel discussion will address a number of ways sites do capacity planning, how it differs from a sponsor or CRO strategy, and what sites wish these partners knew in order to close the gap in understanding. This panel will provide strategies for sponsors and CROs to improve their own budgets and resource management based on this information.• Discuss methods sites use to estimate staffing requirements• Review tools to drive site efficiency• Discuss the implications on current site payments (fee for service) vs.

performance-based payment structures



ADDRESSING OPERATIONAL CHALLENGES IN RESOURCE MANAGEMENT

10:30 Chairperson’s RemarksCharles O’Donnell, Director, Early Clinical Development Portfolio, AstraZeneca

10:35 Project Level Resourcing: A Journey of Resource ManagementLisa Hegg, Ph.D., Vice President, Head Project Planning and Management, Project Management and Business Performance, GSKThe drug development process is complex and expensive, and the ability to accurately forecast project resource is critical to identifying and managing key touch points across a portfolio of projects. We will discuss how improving resource capacity forecasting and integrating with planning across projects will enable us to effectively move resources and enable effective decision-making across the business to support a dynamic portfolio of medicines.








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11:00 Driving Accountability for Resource Efficiencies in Clinical DevelopmentTara Dubois, MBA, Head, Clinical Trial Cost Management, Business Operations, PfizerTeams and business leaders often have great ideas about how to make clinical trial execution more efficient and reduce spend. As budgets get tighter, there is an increasing need to hold leaders accountable to delivering those efficiencies and ensuring they translate to the bottom line. This presentation will focus on how to connect the dots from idea to implementation and assess the impacts on contracts, budgets and resource algorithms in a large complex organization.

11:25 Brief Session Break

11:35 Achieving Agile Resource Management in Big Pharma in Early Clinical Trials: Challenges and Successes in AstraZeneca Early Clinical DevelopmentCharles O’Donnell, Director, Early Clinical Development Portfolio, AstraZenecaThe Early Clinical Development (ECD) group in AstraZeneca is novel and forming, with a need to be agile, pioneering and collaborative. I will describe the history, challenges and successes in managing capacity and resource in a large pharma. Specifically, approaches to building and using resource algorithms will be described and our evolving approach to different clinical trial delivery models which utilize resource that is both internal and external. In addition, the presentation will provide insight into some of the cultural challenges faced by a small clinical group that has hatched out of a big clinical organization.

12:00 pm Human-Centered Design in Clinical Trial Operations: Setting Your Team Up for SuccessHeather Baldwin, MPH, Principal Consultant, Frogbottom Consulting, LLCSolutions to challenges in clinical research operations must be Business Viable, Technology Feasible, and Human Desirable to create real and lasting impact. Using Human-Centered Design in clinical trial operations engages the team at the heart of operations to come up with a range of solutions to the challenges they face each day. Sponsors, CROs and sites that use HCD with their operations team would benefit by increasing job-ownership and satisfaction, decreasing turn-over and training costs, decreasing start-up and enrollment periods, and decreasing team performance redundancies.

12:25 PANEL DISCUSSION: Operational Challenges in Resource Management and How to Overcome ThemSession Speakers• How do financial, clinical, or project management criteria influence

operational success?• What are the most effective ways to address last minute changes or changes

during a trial?• What does the future of resource management look like as technology and

tools develop?













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Managing Outsourced Clinical Trials 4th Annual


The SCOPE conference is a great meeting to take in fresh ideas, new perspectives, meet new friends and breathe in cool, ocean air to refresh your work of bringing new therapies to patients!- Director, Parkland Health and Hospital System

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As more clinical trial activities are outsourced to contract research organizations (CROs) and other third-party vendors, sponsors and their partners must form effective and quality partnerships. Effective management of outsourced clinical trials requires realistic and explicit expectations from each partner in the outsourcing relationship as well as effective oversight and the ability to measure partnership and project performance and quality. Cambridge Healthtech Institute’s 4th Annual Managing Outsourced Clinical Trials conference features case studies and lessons learned from sponsors and CROs on vendor quality and performance in light of the new ICH E6 R2 changes, as well as the outsourcing partnership and working with third party suppliers to achieve more efficient clinical trials.

Arrive early and attend Part 1: Mastering an Outsourcing Strategy. Click here for details.








ENSURING SUCCESSFUL VENDOR PARTNERSHIPS AND QUALITY

4:00 Chairperson’s RemarksWalter Young, External Partner Engagement & Governance Lead, CSL Behring

4:05 Put Your Money Where Your Mouth Is: Negotiating Win-Win Contract Structures for a Successful CRO PartnershipSondra Smyrnios, Vice President, Clinical Operations, Alkermes

4:30 Talk Title to be AnnouncedMichael Breton, Independent Consultant

4:55 PANEL DISCUSSION: Vendor Quality and Oversight in Light of the New ICH E6 R2 ChangesDiane Miller, Director, Vendor Management, AbbVieRichard O’Hara, Associate Director, Clinical Outsourcing, Endo PharmaceuticalsCheryl Evans, Senior Vice President, Clinical & Medical Operations, CRO, Advanced ClinicalRene A. Stephens, MSHS, Independent Industry ConsultantWith increased pressure of the ICH E6 R2 addendum changes on quality and oversight in clinical trials, Sponsors and CROs are concerned with ensuring quality partnerships. This panel will discuss KPIs for vendor quality, quality metrics, and how Sponsors and CROs are approaching their relationships with quality in mind.

5:50 Close of Day












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Interactive Breakout Discussions Forming Effective and Quality Partnerships




Managing Outsourced Clinical Trials 4th Annual


BUILDING MORE EFFECTIVE PARTNERSHIPS8:30 Chairperson’s Remarks

8:35 Governance, Oversight and Quality Management with Key VendorsSagarika Bollini, Director, Head of Clinical Partner Management, Central Clinical Planning and Solutions, Global Clinical Operations, Bristol-Myers SquibbDiscuss key components to CRO/sponsor relationship management and building a framework of trust within the partnership. Can we create a culture of engagement, ownership that drives performance driven culture within the partnership? This talk will focus on governance best practices including diagnosing issues/risk and quality management frameworks for oversight.

9:00 Optimizing External Service Provider RelationshipsWalter Young, External Partner Engagement & Governance Lead, CSL Behring

MAKING MEANINGFUL SUPPLIER SEGMENTATION9:25 Supplier Segmentation and Classification: How to Make It MeaningfulMarija Nikolic, Associate Director, Vendor Management, Contracts & Outsourcing, Astellas Pharma Global DevelopmentThis presentation will focus on how to go about understanding the true business levers and drivers to make meaningful supplier segmentation. Careful consideration should be given to levers that encompass inherent business risk as well as those that drive value. The segmentation or classification process should be made distinct to clearly drive the message as to the oversight and management of the classification. Meaningful classification translates into recognizable benefits to internal stakeholders.

9:50 Talk Title to be AnnouncedRene A. Stephens, MSHS, Independent Industry Consultant



10:35 Creating Stronger Biopharma-CRO Relationships Through TechnologyAnca Copaescu, CEO, Strategikon Pharma

WORKING WITH THIRD PARTY SUPPLIERS11:00 Contracting Dilemmas - Should the Sponsor or CRO Contract with Third Parties?Lan Bandara, Director, Pharmaceutical Contract Management Group (PCMG); Director, Clinical Outsourcing, Medicines Development Centre, Coordination Department, Eisai Limited

The talk covers 1. Different contract models, 2. Pros and cons of each model with reference to new ICH E6 R2 guidelines, 3. Lessons learned from recent case studies.


11:35 PANEL DISCUSSION: Where Is the Industry Headed with 3rd Party Suppliers?Bella Sessoms, Director, Development Sourcing Management, AstellasCharlotte French, Executive Director, Portfolio Relationship & Sourcing Management, Medical and Development, AstellasCraig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar TherapeuticsLan Bandara, Director, Pharmaceutical Contract Management Group (PCMG); Director, Clinical Outsourcing, Medicines Development Centre, Coordination Department, Eisai LimitedAs CROs are tasked with outsourcing more services on behalf of Sponsor companies, where is the industry headed with this practice? This panel will address the following questions: Are CROs equipped to effectively outsource for additional service providers? When Sponsors outsource to CROs, is the CRO’s capability to outsource additional services a factor in deciding to partner with a particular CRO? How is oversight and accountability of deliverables being handled? What are some best practices and lessons learned when CROs are outsourcing multiple services?










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Interactive Breakout Discussions Forming Effective and Quality Partnerships




Implementing Risk-Based Monitoring – Part 24th Annual

Ensuring Effective and Efficient Monitoring and Data QualityFebruary 14-15, 2018

Cutting-edge topics and industry leading speakers. Very informative!- Clinical Project Manager, Boston Biomedical Associates

“ ”Risk-based monitoring (RBM) approaches promise to improve clinical trial efficiency while ensuring data quality. As industry adoption of RBM increases, it is clear that although RBM takes many forms – remote, centralized, and risk-based monitoring – successful risk-based monitoring implementation requires developing new roles, analytics and processes among the stakeholders in RBM. Cambridge Healthtech Institute’s 4th Annual Implementing Risk-Based Monitoring – Part 2: Ensuring Effective and Efficient Monitoring and Data Quality conference offers case studies and practical solutions from across pharma and TransCelerate member organizations on effectively implementing clinical quality and RBM as well as a prospective look into the future of RBM.

Arrive early and attend Implementing Risk-Based Monitoring – Part 1. Click here for details.


11:30 am Registration OpenSponsored by12:10 pm Bridging Luncheon Presentation:

Extracting Data from the EHR Dramatically Reduces the Need for Manual Monitoring - New Standards Make This PossibleKim Rejndrup, Senior Vice President, Product Development, OmniCommThe typical workflow at an investigate site is for the patient data to be entered into the Electronic Health Record, then for the study coordinator to re-type that data into the EDC system. A big component of the subsequent Source Data Verification is simply checking that the retyping was done accurately. If data could instead flow automatically from the EHR system, with the coordinator just verifying the data in transit, then both the data entry and the subsequent SDV can be automated. New standards and technologies being introduced under the “SMART on FHIR” umbrella now make this possible. This presentation will describe the state of the art in this exciting new field.




CASE STUDIES ON HOW PHARMA IS TACKLING THE CHALLENGES OF RISK-BASED MONITORING

4:00 Chairperson’s RemarksDavid Lacagnina, Technology Entrepreneur, The e-Clinical Agency

4:05 PANEL DISCUSSION: A Cross-Functional Look at RBM from Abbott Nutrition’s RBM Task Force

Moderator: Sonya Verrill, Manager, Clinical Projects, Clinical Operations, Abbott NutritionPanelists:Geraldine Baggs, Ph.D., Principal Research Statistician, Statistical Sciences, ANRD Scientific and Medical Affairs, Abbott NutritionDione Smart, Research Data Coordinator, Clinical Data Management, Abbott NutritionXiaosong (Sue) Zhang, MS, MAS, Staff Statistical Analyst, Clinical Program & System Support, Abbott NutritionAbbott Nutrition has established a cross-functional RBM task force to address changes brought about by implementing RBM. Members from the following groups: Stats, ClinOps, Programming, and CDM will discuss change management, their successes and challenges, refinements and tools in their journey to implementing RBM.

Sponsored by4:55 Think You’re ICH E6 Compliant? Show Me the Quality Tolerance Limits Dan O’Connell, Principal, RBM Platform Adoption, MedidataICH E6 Good-Clinical-Practice Guideline addendum directs sponsors to decide which risks to reduce and/or which to accept, predefining quality tolerance limits(QTLs), taking into consideration the medical/statistical characteristics of the variables and the statistical design of the trial, to identify systematic issues that can impact subject safety or reliability of trial. The presentation will cover history behind QTLs, difference between QTLs and KRIs and mechanisms to establish, track and report deviations of QTLs in the CSR.

5:25 RBM Journey: RBM 1.0 to RBM 2.0 with Case Study on a PilotNurcan Coskun, Ph.D., Global Risk Based Monitoring Program and Technology Solutions Manager, MedtronicThis presentation will discuss: 1. Harmonization of two organizations RBM methodology in Medical Device setting, 2. Future state process development with tools and transition to system and technology solutions, 3. Sharing a case study of RBM 2.0 pilot implementation, and 4. The challenges around change management and getting everyone aligned to the same direction in a multi-BU company like ours as part of the journey.

5:50 Close of Day









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Implementing Risk-Based Monitoring – Part 24th Annual

Ensuring Effective and Efficient Monitoring and Data QualityFebruary 14-15, 2018




RBM: WHERE ARE WE AND WHAT IS NEXT?8:30 Chairperson’s RemarksAndy Lawton, Director & Consultant, Risk Based Approach Ltd.

8:35 Best Practices and Observations from Implementing TransCelerate’s Risk-Based Monitoring Model FrameworkSuzanne Lukac, Director, Risk-Based Monitoring Implementation, MerckAlthough Regulators were urging companies to move to a risk-based approach, no model framework existed to enable organizations to successfully deploy and scale risk-based monitoring. To address this, a collaboration of 18+ Sponsor Companies worked in an unprecedented way to develop a model approach for risk-based monitoring. This session will share the latest work of this initiative, including new tools to assist implementation, best practices for adoption, and post-adoption metrics and observations.

9:00 Developing a Risk RepositoryAdrienne Strickler, Associate Director, Risk Management-Central Monitoring, JanssenWhat comes next after your Risk-Based Monitoring process is established? Process improvement! After 4 years of RBM at Janssen R&D, our portfolio has grown to include well over 150 trials and we are now able to gain efficiencies by applying lessons learned across similar studies. One key way to do so is through a central risk repository that can be used to streamline RBM set-up and implementation for new trials.

9:25 CO-PRESENTATION: The Quality Journey - A Small Companies Approach to the Implementation of ICH E6 and RBMYiwen Sun, Senior Clinical Research Associate, Samumed, LLCAndy Lawton, Director & Consultant, Risk Based Approach Ltd.This presentation will be in two parts, firstly examining the overall quality imperative within the clinical trial arena and the second part will focus on Samumed’s ICH E6 and RBM journey to current status and future direction. Key points: 1. Understand the quality requirement expected of sponsors, 2. What can be achieved by a small company, current status, and 3. Future direction.


RBM: WHERE ARE WE AND WHAT IS NEXT? (CONT.)10:30 Chairperson’s RemarksAndy Lawton, Director & Consultant, Risk Based Approach Ltd.

10:35 RBM: A Larger Sponsor’s ApproachTaras Carpiac, Director, Global Development Operations, AmgenAmgen began its RBM journey in 2012. In the years since, Amgen has continued to make investments in its RBM process and tools in order to align with regulations and in response to industry developments. This presentation will examine the principles of Amgen’s RBM model and highlight areas of new focus.

Sponsored by11:00 CO-PRESENTATION: The Right Ingredients for RBM SuccessDanilo Branco, RBM Lead, Senior Manager, Monitoring & Data Flow Optimization, CovanceAaron Mackey, PhD, Director, Data Sciences, CovanceChoosing a RBM implementation plan is like following a cooking recipe – step by step or via experience! Hear from two of our experts as they discuss the RBM landscape for today and tomorrow, and offer real word experiences of RBM. Together, they will provide you with a recipe for success from both a theoretical and operational aspect.

11:25 Brief Session BreakSponsored by11:35 The Past, Present and Future of RBM

Technology Kristin Mauri, Global Head, Risk Based Monitoring, Bioclinica

12:00 pm PANEL DISCUSSION: What Lies in the Future for RBM?Moderator: Andy Lawton, Director & Consultant, Risk Based Approach Ltd.Panelists:Yiwen Sun, Senior Clinical Research Associate, Samumed, LLCTaras Carpiac, Director, Global Development Operations, AmgenAndrew Chapman, Senior Director, Informatics & Digital Marketing, CovanceKristin Mauri, Global Head, Risk Based Monitoring, BioclinicaAs the biopharma industry perfects the process of RBM, we will discuss the possibilities that lie ahead for RBM and its resulting data: In what capacity will onsite monitoring continue? Can onsite monitoring ever be eliminated? What are some possible uses for the data generated from RBM? Are there data patterns and predictive markers seen in the data?










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Artificial Intelligence in Clinical ResearchInaugural

Machine Learning, Robotics, Advanced Analytics and MoreFebruary 14-15, 2018

Artificial intelligence (AI) and machine learning (ML) have propelled many industries toward a new highly functional and powerful state. Now they are starting to make their way into the clinical research realm. Many pharmaceutical companies and larger CROs are starting projects involving some elements of AI, ML and robotic process automation in clinical trials. To facilitate the discussion and to accelerate the adoption of these approaches in clinical trials, Cambridge Healthtech Institute presents the Inaugural Artificial Intelligence in Clinical Research conference, part of 9th Annual SCOPE Summit.

Arrive early and attend Part 1: Clinical Data Strategy and Analytics. Click here for details.



12:10 pm BRIDGING LUNCHEON CO-PRESENTATION: Centralizing Data to Address Imperatives in Clinical DevelopmentKarim Damji, Senior Vice President, Products, Solutions & Marketing, Saama TechnologiesAmit Gulwadi, Executive Director, Analytics-Patient Engagement/Recruitment, CelgeneWith the deluge of structured, unstructured, and syndicated data, the use of varied data for targeted outcomes remains difficult, despite increased industry efforts to address the issue. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical development and drug commercialization. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.




BLOCKCHAIN, ML, AI4:00 Chairperson’s RemarksBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

4:05 Blockchain Disruption: How Blockchain Will Change Our IndustryMunther Baara, Senior Director, Development Business Technology, PfizerImagine a solution that makes it easy to aggregate health data in a secure, trusted, automated, and error-free way, a solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart-

contract between patient and healthcare stakeholders. This enables patients to aggregate their data from diverse health sources and share what they choose to with their physicians and researchers. All this puts the patient in control of their health and well-being, rather than being along for the ride: How it works, key benefits, empowering the patients with control over their data.

4:30 Exploration of Where Machine Learning Will Help in the Product Development Process in the Pharmaceutical IndustryFrancis Kendall, Technology Evaluation and Implementation Leader, Product Development, RocheThe talk will explore how Machine Learning is and will change how Product Development is carried out in the industry from improving efficiencies, gaining more insights on products, improved surveillance of products, especially safety, and its use in IoT devices.

Sponsored by4:55 Leveraging Digital Transformation to Unify Data and Process and Boost Clinical OperationsEvi Cohen, Vice President, Global Pharma & Life Sciences, AppianConducting and managing a successful, safe clinical trial is complicated. With massive data and complex processes at the core, it’s no surprise innovation in Business Process Management (BPM) is behind many successful trials.

5:25 Intelligent Clinical Trial Design, Planning and ConductBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers SquibbAs technology evolves and AI solutions become more sophisticated, there is a natural demand to test and apply them in areas that were traditionally expert opinion-guided. This presentation is about early experiences and challenges of pharma companies - including BMS - that are starting to apply AI in the R&D space to promote precision oncology, identify targets, design and plan trials and translate strategy to efficient operational execution.

5:50 Close of Day




7:45 Breakfast Presentation: Clinical Trial Operations Insights Evolved via Accenture Life Sciences Cloud Chandi Kodthiwada, Product Manager, Accenture Life Sciences Cloud (ALSC), AccentureChances are you have spent a meaningful amount of time on one of the below questions: How do you assess your Clinical Trial operational efficiency? How do I stay on top of Site behavior? How do you maintain Vendor-Oversight? In the








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presentation, we will go through Accenture Life Sciences Cloud(ALSC) - Clinical Operations Insights Platform(COIP) and our work with Metrics Champion Consortium(MCC) to answer the above questions.

AI AND ML IN CLINICAL TRIALS8:30 Chairperson’s RemarksVikram Gupta, Technology Innovation Senior Manager, Amgen

8:35 CO-PRESENTATION: AI and Machine Learning for Clinical TrialsVikram Gupta, Technology Innovation Senior Manager, AmgenWilliam Wong, Technology Strategy, Innovation Senior Manager, AmgenWhile technology will probably never completely replace HCPs, machine intelligence (Machine Learning, Natural Language Processing (NLP), and Artificial Intelligence (AI)) is transforming healthcare by improving outcomes and changing the way healthcare professionals think about providing care and manage clinical trials.

Sponsored by9:35 AI Guided Patient Selection to Elevate the Clinical Trial Efficiency and Accelerate Positive Outcomes Slava Akmaev, PhD, Senior Vice President & Chief Analytics Officer, BERGDrug development is well positioned to benefit from data driven approaches integrating disparate data types and delivering actionable insight with a commercial impact. The BERG AI driven platform, Interrogative Biology® identifies novel biochemical markers in phase I/II clinical studies for patient selection in registrational trials increasing the likelihood of success.

Sponsored by9:55 Applying Machine Learning Frameworks to Improve Trial OutcomesHrishikesh (Rishi) Karvir, Senior Manager, MedidataData is the cornerstone of modern AI/machine learning technologies, yet data integration and standardization remains a problem--especially in clinical trials. Discover how access to the right data can transform all aspects of a clinical trial, such as using predictive modeling for site performance or anomaly detection for data errors.


NATURAL LANGUAGE PROCESSING AND SEMI AUTOMATED CSR NARRATIVES

10:30 Chairperson’s RemarksXia Wang, Director, Health Informatics, Global Medicines Development Unit, R&D, AstraZeneca

10:35 CO-PRESENTATION: The Application of Natural Language Processing (NLP) to Explore the Understanding of Patient Treatment Journey in DiabetesXia Wang, Director, Health Informatics, Global Medicines Development Unit, R&D, AstraZenecaGerry Petratos, CEO, Hiteks Solutions, Inc.This talk relates a pilot work at AstraZeneca in utilizing Natural Language Processing (NLP) technology to explore the understanding of treatment journeys of newly diagnosed type 2 diabetes patients, by retrieving structured data from Diabetes Practice Guidelines & clinical documentation to identify events of interest and compare cohorts. This pilot provided benchmarking understanding of NLP technology to retrieve meaningful information from unstructured Electrical Health Record (EHR) data sources. The outcomes of discreet treatment pathways from SoC guidelines revealed important insights of the complexity involved in treating diabetes patients.

11:00 CO-PRESENTATION: Semi Automated CSR NarrativesAvanti Karandikar, Senior Manager, Clinical Business & System Analysis RDIS, MedImmune (AstraZeneca Biologics)Dorian Zoumplis, M.S. Biotechnology, Senior Innovation Project Manager, Technology Innovation & Delivery Excellence, AstraZenecaThis presentation will include topics such as: Create quality CSR narratives that are consistent across a therapeutic area and/or compound, scope, save time and effort on behalf of the author, reduction in cost associated with (e.g. costs associated with service providers) writing narratives from scratch, create narratives based on a template with specifics to protocol and/or compound, allow for collected data points to be pre-populated to avoid mistakes in study day calculations, event onset/resolution dates, etc.


11:35 CO-PRESENTATION: AI - Machine Learning for Clinical Data Management, a Pilot Case StudyAbhay Jha, Principal, Business Technology Lead, R&D Excellence Practice, ZS AssociatesVenkat Sethuraman, MBA, Ph.D., Associate Principal, ZS AssociatesMachine Learning can aid Clinical Data Management with smart and early detection of anomalies in patient data from sites, thereby reducing the need to unlock databases frozen for submission. To explore this hypothesis, ZS used univariate and multivariate analytics and fraud detection techniques to identifying anomalies that slip through the standard data quality checks. In this session we will share our case study results including lessons learned and future plans








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Amazing conference providing practical, up-to-date industry knowledge for your toolbox!- Senior Manager, Clinical Finance, PTC Therapeutics

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12:00 pm PANEL DISCUSSION: How to Make All the Data Machine Learnable?Moderator: Munther Baara, Senior Director, Development Business Technology, PfizerPanelists: Vikram Gupta, Technology Innovation Senior Manager, AmgenWilliam Wong, Technology Strategy, Innovation Senior Manager, AmgenFrancis Kendall, Technology Evaluation and Implementation Leader, Product Development, RocheBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb• Leveraging data for machine learning projects • Implementing robust data standards • Analyzing big data using machine learning algorithms

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?Moderator: Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)Panelists: David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)Sean Walsh, MBA, CDO, Raleigh Neurology AssociatesBeth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or

from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption and how can the innovators better understand sites’ needs?• Share sites’ perspective on the evolving clinical research landscape• Discuss the reasons sites struggle with new processes and technology tools• Determine ways to facilitate adoption













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Clinical Technology and Innovation7th Annual

Disruptive Technologies for Data and Trial ManagementFebruary 14-15, 2018

SCOPE was the perfect conference to attend! The conference size was just right that allowed for great learning from a variety of organizations. The topics were relevant to the current issues being discussed today. And, majority of the attendees were in manage-ment level positions which allowed for even better interactions and discussions during the sessions due to the level of experience shared from everyone. It’s a conference you don’t want to miss!- Clinical Operations Consultant, Gilead Sciences, Inc.

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Digital technology, mobile solutions, novel data collection modalities and integrative systems are becoming game-changing features of modern clinical trials. However, the adoption of novel technology solutions to improve overall outcomes and garner operational efficiencies has been slower than expected. Cambridge Healthtech Institute’s 7th Annual Clinical Technology and Innovation conference will feature a broad array of topics such as blockchain technology, machine learning, digital trends, and their adoption and implementation in clinical research. We are looking forward to hosting a practical and productive knowledge and experience exchange.

Arrive early and attend Part 1: Sensors, Wearables and Digital Biomarkers in Clinical Trials. Click here for details.


11:30 am Registration OpenSponsored by12:10 Bridging Luncheon Presentation: Introducing

Consent Engineering: The Simplest and Safest Way to Create, Manage and Automate Consent Solutions In-HouseEric Delente, President, Patient Consent, DrugDev (an IQVIA company)The benefits eConsent provides for patient satisfaction and internal efficiencies cannot be overstated, yet the time and expense involved can make it cost-prohibitive for some clinical trials. Consent Engineering is a new SaaS technology solution enabling sponsors to bring eConsent entirely in-house. Featuring an interface as familiar and intuitive as Microsoft Word, Consent Engineering will completely change the way the industry does consent. Join us for the world’s first look at this exciting new solution!




BLOCKCHAIN, ML, AI4:00 Chairperson’s RemarksBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

4:05 Blockchain Disruption: How Blockchain Will Change Our IndustryMunther Baara, Senior Director, Development Business Technology, PfizerImagine a solution that makes it easy to aggregate health data in a secure, trusted, automated, and error-free way. A solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart-contract between patient and healthcare stakeholders. This enables patients to

aggregate their data from diverse health sources and share what they choose to with their physicians and researchers. All this puts the patient in control of their health and wellbeing, rather than being along for the ride: How it works; Key benefits; Empowering the patients with control over their data.

4:30 Exploration of Where Machine Learning Will Help in the Product Development Process in the Pharmaceutical IndustryFrancis Kendall, Technology Evaluation and Implementation Leader, Product Development, RocheThe talk will explore how Machine Learning is and will change how Product Development is carried out in the industry from improving efficiencies, gaining more insights on products, improved surveillance of products, especially safety and its use in IoT devices.

Sponsored by4:55 Leveraging Digital Transformation to Unify Data and Process and Boost Clinical OperationsEvi Cohen, Vice President, Global Pharma & Life Sciences, AppianConducting and managing a successful, safe clinical trial is complicated. With massive data and complex processes at the core, it’s no surprise innovation in Business Process Management (BPM) is behind many successful trials.

5:25 Intelligent Clinical Trial Design, Planning and ConductBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers SquibbAs technology evolves and AI solutions become more sophisticated, there is a natural demand to test and apply them in areas that were traditionally expert opinion-guided. This presentation is about early experiences and challenges








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of pharma companies - including BMS - that are starting to apply AI in the R&D space to promote precision oncology, identify targets, design and plan trials and translate strategy to efficient operational execution.

5:50 Close of Day





REMOTE TRIALS AND DIGITAL TECHNOLOGY8:30 Chairperson’s RemarksJulie Dietrich, MS, Director, Development Design Center, Amgen

8:35 Remote Data Monitoring: Ideal Model versus Current PracticesCharlie Romano, Vice President, Global Clinical Operations, Peachtree Bioresearch SolutionsThis presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints. Key findings from a survey of patients in four therapeutic areas will also be presented, focusing on factors important to the design and conduct of clinical trials involving mobile devices.

9:00 CO-PRESENTATION: How Technology Can Enable Patient-Centric Clinical ResearchJulie Dietrich, MS, Director, Development Design Center, Amgen

Sindhya Govind, Specialist Business Systems Analyst, AmgenPresentation highlights will include: Opportunities for technology to be part of a patient-centric strategy and improve patients’ experience with clinical research.

Sponsored by9:25 Talk Title to be Announced Theodora Sarver, Manager, Product Management, Almac Clinical Technologies

Sponsored by9:50 CO-PRESENTATION: Real World Innovation and Application in Pipeline Data ApproachesKate Dugan, Vice President, Client Operations and Scientific Data Strategy, Global Specimen Solutions, Inc.John “JJ” Spegele, Vice President, Business Solutions and Enterprise PMO, Covance Central Lab Services, Covance, Inc.Pharmaceutical companies have collected vast amounts of data during a clinical trial, yet only ~20% of the data is used. Disparate data sources, unaligned data, and incomplete data sets prevent in-life interventions, lead to delays in go to market, and can lead to non-compliance with regulations. In this presentation, we will discuss case studies that empowered translational medicine and clinical operations teams to make decisions that advanced drug development.


REMOTE TRIALS AND DIGITAL TECHNOLOGY (CONT.)10:30 Chairperson’s Remarks

10:35 CO-PRESENTATION: Incubating Digital Innovation Across the Clinical Trial ProcessLeyla Rich, IT Business Partner, Digital Health, Information Technology, Bristol-Myers SquibbErin Rossi, Category Manager, Clinical Core Technologies, Global Procurement, Bristol-Myers SquibbOur internal working group is executing a number of proof-of-concepts (POCs), pilots, and tests in 2017 to evolve the digital clinical trials landscape at Bristol-Myers Squibb aligned to our enterprise strategy and with a focus on patient and site experience. These POCs focus on telemedicine, Quality of Life (QoL) metrics via wearables and sensors, and the use of digital technologies for adverse event reporting in Clinical Trials. As part of the session we will also share the outcomes from these experiments.

Sponsored by11:00 BYOD: A Game-Changer for Sponsors, Sites and PatientsChris Watson, PhD, Director, Product Strategy, Digital Patient, ERTElectronic clinical outcomes assessments (eCOA) are no longer just about patient diaries. eCOA has become a valuable tool that helps sponsors gain greater insight into patients’ experiences during clinical development – especially in site-less trials. We’ll share Bring Your Own Device (BYOD) and flexible provisioning success stories, and demonstrate why sponsors need to incorporate this approach into study protocols and post-marketing evidence programs.

11:25 Transition to Shared Sessions








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11:35 Digital Trends Impacting Recruitment, Engagement and RetentionShwen Gwee, Head, Digital Strategy, Global Clinical Operations, BiogenDigital technology is connecting more people to clinical trials than ever before and at the same time the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technolgies and approaches are having the greatest impact on recruitment, engagement and retention?


12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation InitiativeHassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim Pharmaceuticals

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?Moderator: Jim Kremidas, Executive Director, Association of Clinical ResearchProfessionals (ACRP)David Vulcano, Assistant Vice President & Responsible Executive for ClinicalResearch, Hospital Corporation of America (HCA)Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology AssociatesBeth Harper, MBA, Workforce Innovation Officer, Association of ClinicalResearch Professionals (ACRP)Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites’ needs?• Share sites’ perspective on the evolving clinical research landscape• Discuss the reasons sites struggle with new processes and technology tools• Determine ways to facilitate adoption



Lead Sponsoring Publications:

Sponsoring Publications:

Lead Media Partners:

Media Partners:

Sponsoring Organizations:

CLINICALINFORMATICSNEWS

Media Partners








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3rd Annual

Integrating Evidence Generation with RWD and Pre-Existing Data February 14-15, 2018

I best express my experience with one word, ‘SCOPE’ - A satisfied communication of peoples’ experiences.- President, Advances In Health

“”

The abundance of data generated during routine health care is growing in significance and should be re-used for clinical and observational research. Patient electronic records, registries, data from pharmacy and social media, and wearable sensors have been increasingly used as eSources. This process requires strategizing, utilizing novel data technologies, as well as close collaboration between pharmaceutical companies and organizations that possess the data. CHI’s 3rd Annual Leveraging Real World Data for Clinical and Observational Research will discuss challenges and solutions with secondary use of existing healthcare data for assessing the effectiveness and safety of medical products.

Arrive early and attend Part 1: Late Stage Research and Observational Studies. Click here for details.



12:10 pm Bridging Luncheon Presentation: Achieving Evidentiary EquilibriumDavid Thompson, Ph.D., Senior Vice President, Real-World & Late Phase, Syneos HealthAchieving Evidentiary Equilibrium - Generating the Right Evidence for the Right Stakeholders at the Right Time Throughout the Clinical/Commercial Continuum




RWE TO INFORM STUDY DESIGN AND EXECUTION4:00 Chairperson’s RemarksSean Mooney, Ph.D., Chief Research Information Officer, UW Medicine

4:05 Systematic Approach to Use RWD to Inform Trial Design: Going beyond Simple FeasibilityHui Cao, M.D., Ph.D., Executive Director, Real-World Evidence, COE for RWE, Global Medical Affairs, Novartis Pharmaceuticals CorporationWe developed a structured framework to guide the use of RWD to inform clinical trial design. This framework consists of three dimensions: recruitability, efficacy endpoint impact and risk impact. Each major criterion in the trial inclusion/exclusion criteria can be assessed on how it would impact the size of patient pool, the efficacy endpoints and risks. This framework was validated via its application on pre-authorization pivotal trials.

4:30 RWE Analytics to Link Patient Journey with Trial Feasibility and Patient RecruitmentJane Fang, M.D., Head, Research & Development Information for Clinical Biologics, MedImmune Biologics Science Unit of AstraZenecaThe precision medicine behind trial design is driving rapid change in the way of traditional feasibility assessment and patient recruitment. Emerging market of healthcare information and records providers is bringing game-changing approaches to enable hypothesis generation of protocol design, deep dive analysis of patient journey and precision patient recruitment. The innovative approach of linking RWE analysis with clinical trial research and patient recruitment is critical for today and future precision trial conduct.

Sponsored by4:55 Leveraging Real World Data to Streamline Clinical TrialsManfred Stapff, M.D., Ph.D., CMO, TriNetX, Inc.Industry is encumbered with lengthy drug development timelines and high costs. These challenges are correlated with the difficulty to recruit appropriate patient populations for clinical trials. Join this session to learn how real world data is transforming the way biopharma, CROs and study sites navigate obstacles in drug development across protocol design, site selection and patient recruitment.

5:25 Current State of Real World Evidence to Support the Medicine LifecycleNicolle Gatto, Group Lead, Senior Director, Epidemiology, Worldwide Safety and Regulatory, PfizerObservational data from electronic health records, insurance claims and disease registries are often used for premarketing studies. This presentation will describe the uses of real-world, observational data across the drug development lifecycle with particular focus on more innovative uses such as serving as a source for embedded clinical trials, for active surveillance of rare events across multiple linked data sources where relevant, case studies will be briefly described.

5:50 Close of Day









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3rd Annual


Attention Pharma! 25 for 25 Special OfferIf you are an employee of the following TOP 25 Pharmaceuticalcompanies as cited by Pharmaceutical Executive*, you may attend this meeting at a 25% discount off the current rate. Enter Keycode TOP25 when registering for SCOPE on-line.


Get your team to Orlando at special company rates.

Group registrations are encouraged and we suggest calling:

*http://www.pharmexec.com/pharm-execs-top-50-companies-2017

1 Pfizer2 Novartis3 Roche4 Merck & Co.5 Sanofi6 Johnson & Johnson 7 Gilead Sciences8 GlaxoSmithKline9 AbbVie 10 Amgen11 AstraZeneca 12 Allergan 13 Teva Pharmaceutical Industries

14 Bristol-Myers Squibb15 Eli Lilly 16 Bayer 17 Novo Nordisk 18 Boehringer Ingelheim19 Takeda 20 Celgene21 Astellas Pharma 22 Shire 23 Mylan 24 Biogen 25 Daiichi Sankyo




INTEGRATING EHR THROUGHOUT THE LIFE CYCLE OF DRUG PRODUCTS

8:30 Chairperson’s RemarksKuno van der Post, MSc, PhD, Chief Commercial Officer, OmniComm

8:35 Optimize Your Clinical Trials Using Electronic Health Records: The Case of EHR4CRXia Wang, Ph.D., Director, Health Informatics, Global Medicines Development Unit, R&D, AstraZenecaThis talk presents the AZ coordinated IMI project EHR4CR (Electronic Health Records for Clinical Research). The objective of EHR4CR is to research and develop a trustworthy technical platform and services to allow re-use of EHR

data to support clinical research in Europe. We will also share our experiences to test and evaluate the EHR4CR InSite platform for protocol feasibility and recruitment services on a growing hospital network.

9:00 Platform-Based Approaches in RWE: Approaches, Methodologies and ExamplesJyotsna Mehta, MS, B.Pharm., Principal and Owner, KevaHealth

This presentation will provide an in-depth understanding of platform-based approaches in real world evidence and provide examples to show its usefulness and value in drug development throughout the life cycle of drug products. It will also provide a framework of how and when to consider these for your studies and explain pros and cons through the use of examples.

9:25 Building Credibility with the Audience: MethodologyElizabeth MacLean, Pharm.D., Director, Global Health and Value/Outcomes & Evidence, PfizerInterest in the use of real world evidence to inform decision making in healthcare is growing. Importantly, concerns have been raised in the scientific and decision making communities regarding the reproducibility of observational studies using large healthcare databases. This presentation will review the concepts of reproducibility and transparency and efforts to guide researchers in this regard.

Sponsored by9:50 Real World Evidence Based on Electronic Health Record (EHR) Data Requires Transparency in Key Operational Decisions Irene Cosmatos, Software Delivery Manager, Database Analytics Automation, UBCLack of transparency in research conducted using longitudinal healthcare








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http://www.pharmexec.com/pharm-execs-top-50-companies-2017




3rd Annual


databases has led to discrepancies in results and reduced confidence in evidence. Small differences in study definitions can impact study results and conclusions. This presentation examines the impact of using different database algorithms for defining a patient’s activity period and length of continuous exposure definitions for various study outcomes when identifying a cohort of heart failure patients to evaluate medication switching.


RWD IN EUROPE AND POC TRIALS IN US10:30 Chairperson’s RemarksKuno van der Post, MSc, PhD, Chief Commercial Officer, OmniComm

10:35 RWD from Europe to Optimize Clinical Research Processes: Creating Value for Patients, Hospitals and Sponsors/CROsTine Lewi, Ph.D., MBA, Scientific Director, Quantitative Sciences/Real World Evidence Partnerships, Janssen Global Research & DevelopmentThe European Real World Data (RWD) scene is developing at full speed. Multiple new approaches to RWD and Big Data emerge to optimize the clinical research process. An overview of the state of the art on RWD for clinical research in Europe will be provided, with a special focus on RWD from EHRs. Use cases demonstrate the value of RWD to optimize protocol design, accelerate feasibility for site selection and ultimately support the patient recruitment. These use cases will also demonstrate benefits to the patient, the hospital, the research sponsors and CROs.

Sponsored by11:00 CO-PRESENTATION: Online Health Communities: A New Frontier in Clinical Research Presentation to be Announced Olivier Chateau, CEO & Co-Founder, Health UnionLauren Lawhon, COO, Health UnionToday’s technology-equipped patient uses the Internet to communicate with their clinicians, connect with fellow patients, share their experiences, and track their own health. Millions of these engaged patients, sharing common ailments, make up the rising group of online health communities. Members connect over common experiences, frustrations, and questions - and a wealth of insights can be gleaned from these online interactions. Learn how online health communities provide valuable real-world evidence to advance clinical research.


11:35 Conducting and Translating Research in Real-Time at Point of Care: Designing a Clinical Research Enterprise InfrastructureUli Chettipally, M.D., MPH, CTO, CREST Network, Division of Research, Kaiser PermanenteImprovements in information technology have provided better tools to conduct research. Electronic health records and mobile technology are now ubiquitous in

care delivery environments. The design of a clinical research enterprise infrastructure should take into account these factors. This talk will discuss the design, development, and deployment of such a system at a large integrated health system.

12:00 pm Embedding Clinical Trials in the Electronic Medical Record: Challenges of Integrating Research into Clinical CareSarah Leatherman, Associate Director, Point of Care Program, Cooperative Studies Program Massachusetts Veterans Epidemiology Research & Information Center, Veterans Health AdministrationPoint-of-care clinical trials (POC-CT) are a pragmatic trial design intended to reduce the burden of research for both patient and provider and to support the learning healthcare system within the VA Healthcare System. Trials are fully embedded in the electronic medical record and use only data that can be found in the corresponding data warehouse, Medicare, and the National Death Index. With this innovative design come a number of challenges associated with regulation and implementation. We will discuss these challenges and their solutions in an active clinical trial.

12:25 Enhancing Clinical Research with Data and Technology at an Academic Health SystemSean Mooney, Ph.D., Chief Research Information Officer, UW MedicineAt the University of Washington, there are many clinical research touch points with our health system, UW Medicine. Not surprisingly, this is especially relevant in activities surrounding data and information technology. In this presentation, I will discuss our efforts to leverage data and IT platforms to support research activities throughout the enterprise.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?Moderator: Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)Panelists: David Vulcano, Assistant Vice President & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)Sean Walsh, MBA, CDO, Raleigh Neurology AssociatesBeth Harper, MBA, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption and how can the innovators better understand sites’ needs?• Share sites’ perspective on the evolving clinical research landscape• Discuss the reasons sites struggle with new processes and technology tools• Determine ways to facilitate adoption










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Clinical Supply Management Inaugural


Successful, patient-centric clinical trials depend upon streamlined clinical trial supply processes that ensure that the study drug is properly handled and delivered to the right patient whether at the trial site, pharmacy, or in their home. Cambridge Healthtech Institute’s Inaugural Clinical Supply Management conference offers case studies and practical solutions from across pharma focusing on effective clinical supply management from handling the study drug to direct-to-patient distribution.

Arrive early and attend Part 1: Biospecimen, Central Lab and Technology for Precision Medicine Trials. Click here for details.


11:30 am Registration OpenSponsored by12:10 pm Luncheon Presentation: Case Study: How to

Select and Deploy a Forecasting Solution and Measure its ROI Post-ImplementationOliver Cunningham, Director, Client Enablement, BracketThis presentation will discuss how a top 20 pharmaceutical company was able to save over $25M on a single clinical program within 12 months of implementing a new forecasting software that drives demand planning and supply chain optimization. Oliver will present the case-study, review the Forecasting tool’s specific features, and discuss how integrating IRT and forecasting creates a dynamic planning model feeding of actual data.




CLINICAL SUPPLY MANAGEMENT & STRATEGY4:00 Chairperson’s RemarksDoug Meyer, MBA, RPh, Associate Director, Clinical Drug Supply, Biogen, Inc.

4:05 Building an Effective End-to-End Cold Chain Supply Management ProcessDoug Meyer, MBA, RPh, Associate Director, Clinical Drug Supply, Biogen, Inc.This presentation will discuss: 1. What tools and technologies can you leverage to protect the product and avoid costly temp excursions? 2. How can you build efficient processes that ensure drug is always available for patient dosing? 3. What strategies should you adopt in your stability program to enable an efficient and scalable supply chain for temperature sensitive products?

4:30 Is It Time for the Industry to Develop Consensus-Based, Standardized Clinical Supply Performance Metrics?Linda Sullivan, Co-Founder & President, Metrics Champion Consortium LLC

Sponsored by4:55 Patient-Centric Services: Points to Consider for Your Trial and How to Avoid ChallengesMichael Macneir, Director, Commercial Operations, MarkenPatient-centric services are growing at incredible rates throughout the industry. Complexity within the supply chain is also growing as the sensitivity and value of products grows. Explore critical points to consider to protect your drug products when setting up a DTP trial.

Sponsored by5:10 Managing Complex Supply Challenges in Oncology StudiesPhil Woodson, Senior Software Engineer, 4G Clinical

5:25 Achieving Accurate Forecasts and Minimizing Delays in Clinical TrialsPaul Larochelle, PharmD, RPh, Senior Manager, Clinical Asset Planning, Specialty Therapeutic Area, Clinical Drug Supply, BiogenThis presentation will 1. Discuss the importance of accurate forecasting in clinical trials and associated challenges, 2. Review how accuracy is driven by the strength of data points/information provided to supply professionals, 3. Determine ways to enhance relationships with partners to manage unanticipated variations and minimize delays, 4. Examine how tools can help us better manage our studies and supplies

5:50 Close of Day





TECH TOOLS FOR TRACKING AND TRACING CLINICAL SUPPLIES


Building an Effective End-to-End Clinical Supply Strategy








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Clinical Supply Management Inaugural


8:35 Supply Chain Integrity; Technology Tools for Tracking and Tracing Clinical SuppliesTom Skiendzielewski, Associate Director, Clinical Supply, ShireThis presentation will discuss: 1. Benefits of ERP system application in Clinical Supply Management (in-source vs. out-source), 2. Scoping your IRT to optimize benefit, reduce risk, and increase compliance, 3. Comprehensive Technology-Based Time Out of Environment (TOE) Management, 4. Analyzing RFID utilization in the Clinical Supply Chain, and 5. The Last Link of the Clinical Supply Chain – Site Level Management

9:00 IRT Considerations for Managing Clinical SuppliesCarol Lee, Associate Director, Clinical Drug Supply, Logistics, & IRT, RegeneronThis presentation will discuss: 1. Exploring methods through which IRT technology can improve clinical supply logistics, 2. Pinpointing how IRT technology can be set up to improve your logistical planning, 3. Exploring the benefits of creating your own in-house IRT system versus using a base-line vendor model, 4. Recognizing the value of IRT in clinical supply ordering and distribution, and 5. Emphasizing ways through which IRT systems can become more effective for your different trials.

9:25 IRT Data Integration Provides Big BenefitsAaron Harlett, Director, Supply Chain Systems and Related Services, Eli Lilly and CompanyIt’s obvious an IRT makes conducting a clinical trial more efficient and secure; from study drug forecasting and distribution to treatment group assignment and blinding. But using an IRT can provide benefits in many other aspects of trial execution. IRT allows near real-time data capture that can seamlessly integrate with multiple systems and functions while safeguarding sensitive data through automation. And combining data from an IRT with patient data from other systems can allow information alignment and facilitate reconciliation. And sharing a consistent data flow from an IRT can reduce vendor cost and play a critical role in bringing an asset to market in less time.

Sponsored by9:50 Eliminating Peepholes into Blinded Clinical TrialsGayle Flynn, MA, Director, Cognizant Life Sciences Consulting, Interactive Response Technology Practice, CognizantAs Clinical Ops professionals, we consider conducting blinded clinical trials a core competency. Then one day unexpectedly, we receive an email that someone believes they can tell the treatment allocation of patients in a trial that seemingly was not at risk for unblinding. This session will review the points to consider when setting up studies to ensure the blind is adequately maintained throughout the clinical supply chain.


PATIENT CENTRICITY AND CLINICAL SUPPLY10:30 Chairperson’s Remarks

10:35 FEATURED PRESENTATION: Patient Centered Clinical Trial Material Design and DeliveryJanelle Sabo, Pharm.D., RPh, MBA, Senior Group Director, Product Delivery, Eli Lilly and CompanyWe will explore areas for patient-centered design and delivery in CT material, including formulation/drug product, kitting, delivery and technology. Practical current examples and inspirational goals will both be discussed to frame where we are today but where the future opportunities lies within clinical supplies.

Sponsored by11:00 Research Reveals: RTSM Frustrations, Expectations, and Future Predictions Greg Jones, Enterprise Strategy Architect, Product Strategy, Oracle Health SciencesA recent survey of more than 250 clinical operations professionals conducting randomized trials reveals frustrations with current systems, must-have technology innovations and future predictions for Randomization and Trial Supply Management In this session: 1) Hear what 92% of clinical study teams must do more than once in a randomized trial 2) Understand the current state and future direction of RTSM technology 3) Discover how the new capability platform approach will provide huge benefits for RTSM.


11:35 The Near-Term Viability and Benefits of eLabels for Clinical, Sites and PatientsJodi Smith-Gick, RPh, Senior Advisor, Product Delivery and Supply, Eli Lilly and CompanyThis session will speak to the options and benefits of utilizing eLabeling to enhance site efficiency and enhance patient centricity. Specifically discussed will be approaches, considerations when planning a study, and potential add-on technologies which can further improve productivity at sites. Specific feedback received from patients and sites on these concepts will be shared. In addition, this session will de-bunk some of the misconceptions around the near-term viability for an eLabel solution.

12:00 pm PANEL DISCUSSION: Direct-to-Patient Distribution: Meeting the Patient’s NeedsModerator: Sascha Sonnenberg, MBA, Vice President, Commercial Operations Americas & EMEA, MarkenPanelists: Gerald Finken, CSO/Founder and Innovator, Clinical Supplies ManagementJanelle Sabo, Pharm.D., RPh, MBA, Senior Group Director, Product Delivery, Eli Lilly and CompanyAs the pharma industry moves towards more patient-centric initiatives for clinical trials, direct-to-patient distribution is growing in popularity, but many challenges still remain. Topics discussed in this panel include: 1. Investigator and site buy-in and support for direct-to-patient initiatives, 2. Logistical, cost and regulatory considerations; and 3. Challenges with patient handling of IMPs.



Building an Effective End-to-End Clinical Supply Strategy








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Pricing and Registration InformationCONFERENCE PRICING

Commercial Academic, Government, Hospital-affiliated

BEST VALUE! - Includes access to the entire 3-day SCOPE program, plus Monday Evening’s Pre-Conference Plenary Keynote Panel and Networking Happy Hour on the Garden Terrace

Registration after January 12, 2018, and on-site $2,849 $1,349

BASIC CONFERENCE PRICING - Includes access to ONE conference

Registration after January 12, 2018, and on-site $1,899 $1,025

Tuesday-Wednesday (February 13-14) Wednesday-Thursday (February 14-15)1A: Protocol Development, Global Site Selection, Feasibility and Site Management 1B: Improving Site-Study Activation and Performance

2A: Enrollment Planning and Patient Recruitment 2B: Patient Engagement, Enrollment and Retention through Communities and Technology

3A: Clinical Trial Forecasting, Budgeting and Contracting 3B: Resource Management and Capacity Planning for Clinical Trials NEW

4A: Mastering an Outsourcing Strategy 4B: Managing Outsourced Clinical Trials

5A: Implementing Risk-Based Monitoring-Part 1 5B: Implementing Risk-Based Monitoring-Part 2

6A: Clinical Data Strategy and Analytics 6B: Artificial Intelligence in Clinical Research NEW

7A: Sensors, Wearables and Digital Biomarkers in Clinical Trials NEW 7B: Clinical Technology and Innovation

8A: Late Stage Research and Observational Studies 8B: Leveraging Real World Data for Clinical and Observational Research

9A: Biospecimen, Central Lab and Technology for Precision Medicine Trials 9B: Clinical Supply Management NEW

CONFERENCE DISCOUNTSAlumni Discount - SAVE 20%: CHI appreciates your past participation at Summit for Clinical Ops Executives (SCOPE). As a result of the great loyalty you have shown us, we are pleased to extend to you the exclusive opportunity to save an additional 20% off the registration rate. Alumni Discount* 20% Off 20% OffREGISTER 3 - 4th IS FREE: Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply.Group Discounts: Discounts are available for multiple attendees from the same organization. For more information on group rates contact Melissa Dolen at 781-972-5418.*Alumni, Twitter, LinkedIn, Facebook or any other promotional discounts cannot be combined.

If you are unable to attend but would like to purchase the Summit for Clinical Ops Executives (SCOPE) CD for $750 (plus shipping), please visit SCOPEsummit.com. Massachusetts delivery will include sales tax.

How to Register: [email protected] • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288Please use keycode SCOPE F when registering

ADDITIONAL REGISTRATION DETAILSEach registration includes all conference sessions, posters and exhibits, food functions, and access to the conference proceedings link.Handicapped Equal Access: In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting.To view our Substitutions/Cancellations Policy, go to healthtech.com/regdetailsVideo and or audio recording of any kind is prohibited onsite at all CHI events.

Reports designed to keep life science professionals informed of the salient trends in pharma technology, business, clinical development, and therapeutic disease markets InsightPharmaReports.com Contact Adriana Randall, [email protected], +1-781-972-5402.

Barnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit BarnettInternational.com.

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