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Crafting a global development strategy5th Annual
Global Clinical TrialsSEPTEMBER 10, 2014 FAIRMONT COPLEY PLAZA, BOSTON, MAGC
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REGISTER AT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
Lori AbramsBristol-Myers Squibb
Debra Barker, MDNovartis
Phil BirchAptiv Solutions
Shannon CookeTransPerfect
Alice DonnellyBristol-Myers Squibb
Roberta DuncanTrevi Therapeutics
Christopher Gallen, MD, PhDSK biopharmaceuticals
Jeremy GilbertPatientsLikeMe
Abraham GutmanAG Mednet
Thomas HaagNovartis
Donna Jarlenski, PMPVertex Pharmaceuticals
Annalisa Jenkins, MBBS, MRCPTransCelerate Biopharma
Mitchell Katz, PhDPurdue Pharma
Carol Lewis-CullinanFORUM Pharmaceuticals
Rebecca Li, PhDMulti-Regional Clinical Trials Center at Harvard
Simon Li, MD, PhDLuye America Pharmaceuticals
Thomas Lonngren, PhD (hc), MRPharmS, FRCPEMA
Veronica LudenskyMillennium: the Takeda Oncology Company
Richard Margolin, MDCereSpir, Inc.
Christine PierreSociety for Clinical Research Sites (SCRS)
Susan RombergChiltern
Adrian Senderowicz, MDSanofi
Badhri SrinivasanQuintiles
Kate WilliamsBayer Healthcare
REGISTER AT WWW.THECONFERENCEFORUM.ORG OR CALL 646-350-2580
OVERVIEW
The Conference Forum is pleased to present the 5th Annual Executing Global Clinical Trials conference. The 2014 program is being offered as a one-day intensive followed by the option to attend the DPharm: Disruptive Innovations to Advance Clinical Trials on September 11-12 in the same venue.
The purpose of the 2014 conference is to help:
1. Make global clinical trials easier for patients and for sites
2. Craft a global development strategy
The conference offers concrete topics impacting management of clinical studies globally by finding the right balance between recruitment, cost savings, future regulatory obligations, and managing relationships with global service providers.
• Lessons Learned from Unsuccessful Global Clinical Trials
• Overview on the Current EU Regulatory Landscape
• Regulatory Barriers in Emerging Markets
• The effect of Remote-Based Monitoring on Regulatory Approval in other countries
• CRO Case Study on Remote-Based Monitoring in Global Clinical Trials
• Reducing Global Protocol Complexities for the Patient and Sites
• Working with Patient Advocacy Groups in Global Clinical Trials
• Driving Faster Global Patient Enrollment Rates
• Communication Strategies for Global CRO/Sponsor Partnerships
• Partnering with Global Investigative Sites
• Understanding the Use of Adaptive Trials and Adaptive Design in Multi-National Trials
• Best Practices and Lessons Learned from Conducting Trials in Asia
• Technologies Driving Efficiencies in Global Clinical Trials
- 5th Annual Regional Roundtables -
One of the best-rated sections of the conference is the regional roundtable session for one-on-one discussions with an expert in the following areas:
EU • Latin America • India • JapanEastern Europe • Middle East/North Africa • Korea
The conference includes breakfast, networking breaks, and a luncheon. For any questions, contact us at [email protected].
We look forward to welcoming you on September 10 in Boston. For those of you planning on attending DPharm: Disruptive Innovations to Advance Clinical Trials, take advantage of the combined discount.
Sincerely,
Valerie BowlingExecutive DirectorGCT
Kristen PisanelliConference ProducerGCT
Jessica RothenbergMarketing DirectorGCT
5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS OVERVIEW
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SPEAKING FACULTY
Lori AbramsDirector, Patient AdvocacyBristol-Myers Squibb
Debra Barker, MDGlobal Program Head, Oncology BiosimilarsNovartis
Phil BirchSVP, Global Strategic MarketingAptiv Solutions, an ICON plc Company
Shannon CookeProject ManagerTransPerfect
Alice DonnellyDirector, Recruitment Strategy & Operations, GR&ABristol-Myers Squibb
Roberta DuncanSenior Director, Clinical OperationsTrevi Therapeutics
Christopher Gallen, MD, PhDCEOSK biopharmaceuticals
Jeremy GilbertVP, Product & StrategyPatientsLikeMe
Abraham GutmanPresident & CEOAG Mednet
Thomas HaagData Integrity Process ExpertNovartis
Donna Jarlenski, PMPSenior Director, Clinical Development Execution & Global Medicines Development & AffairsVertex Pharmaceuticals
Annalisa Jenkins, MBBS, MRCPChair of the Board of DirectorsTransCelerate Biopharma
Mitchell Katz, PhDExecutive Director, Medical Research OperationsPurdue Pharma
Carol Lewis-CullinanSenior Director, Clinical OperationsFORUM Pharmaceutical
Rebecca Li, PhDExecutive DirectorMulti-Regional Clinical Trials Center at Harvard
Simon Li, MD, PhDVP, Global Clinical DevelopmentLuye America Pharmaceuticals
Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer HeadEMA
Veronica LudenskySenior Manager, Clinical OutsourcingMillennium: the Takeda Oncology Company
Richard Margolin, MDVP, Clinical DevelopmentCereSpir, Inc.
Christine PierrePresidentSociety for Clinical Research Sites (SCRS)
Susan RombergVP, Global Clinical Development, NAChiltern
Adrian Senderowicz, MDVP, Sanofi Oncology & Global Regulatory AffairsSanofi
Badhri SrinivasanSVP & Global Head, Data & Safety MonitoringQuintiles
Kate WilliamsSenior Feasibility ExpertBayer Healthcare
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SPEAKING FACULTY 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS
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AGENDA - WEDNESDAY, SEPTEMBER 10, 2014
8:00 amRegistration & Breakfast
8:45 amConference Chair Opening Remarks
Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals
9:00 amGlobal trends in generating clinical evidence for Regulatory approval and Market Access
• Drivers for change in the way clinical evidence is generated
• Trends in what regulators are looking for?
• Trends in what the payers are looking for?
• Interventional vs non interventional clinical studies
• Consequences for the pharmaceutical and the CRO industry
Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer Head, EMA
9:20 amGlobal Regulatory Update
• Overview on regulatory changes
• Regulatory barriers when conducting trials in emerging markets
• Remote-based monitoring considerations for small, medium and large companies and their affect on global approval
• Progress for accelerated approval: Breakthrough Designation and Adaptive Licensing
Moderator:Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer Head, EMA
Panelists:Debra Barker, MDGlobal Program Head, Oncology Biosimilars, Novartis
Thomas HaagData Integrity Process Expert, Novartis
Adrian Senderowicz, MDVP, Sanofi Oncology & Global Regulatory Affairs, Sanofi
10:00 amDeveloping Global Protocols that are Easier to Execute for Patients and Sites
• Strategies for upfront planning
• Making protocols less complex and more patient-centric
• Incorporating investigator and patient feedback in study design
• Tapping into patient insights during the design process
• Working with patient advocacy groups
Moderator:Annalisa Jenkins, MBBS, MRCPChair of the Board of Directors, TransCelerate Biopharma
Panelists:Lori AbramsDirector, Patient Advocacy, Bristol-Myers Squibb
Jeremy GilbertVP, Product & Strategy, PatientsLikeMe
Rebecca Li, PhDExecutive Director, Multi-Regional Clinical Trials Center at Harvard
Kate WilliamsSenior Feasibility Strategist, Bayer Healthcare
10:40 amAdaptive Trials and its Uses Globally
• Communicating the value proposition for adaptive trials
• Understanding the use of adaptive trials in both exploratory and late phase development
• Increased use of adaptive design software by regulatory agencies
• Strategic partnerships to drive portfolio-wide adoption
Phil BirchSVP Global Strategic Marketing, Aptiv Solutions, an ICON plc Company
11:00 amNetworking Break
5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA
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11:30 amOptimizing Patient Enrollment in Global Clinical Trials
• Overcoming enrollment issues due to changes in country requirements
• How to create less burdensome global protocols with the patient in mind
• How to decrease the cost of medicines and care
• How to incorporate local assessments/reduce travel
• Mobile technologies used in global enrollment procedures
• The potential of registries to enhance recruitment
Moderator:Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals
Panelists:Alice DonnellyDirector, Recruitment Strategy & Operations, GR&A, Bristol-Myers Squibb
Donna Jarlenski, PMPSenior Director, Clinical Development Execution & Global Medicines Development & Affairs, Vertex Pharmaceuticals
Richard Margolin, MDVP, Clinical Development, CereSpire, Inc.
12:05 pmRethinking Communication Strategies to Ensure Optimal CRO/Sponsor Global Partnerships
• Establishing communication norms to ensure a positive CRO/Sponsor relationship
• Empowering CRO/sponsor teams to communicate up to management effectively
• How to develop the infrastructure collaboratively to quickly and easily share data
• Global CRO approaches on remote-based monitoring and the impact on the trial
Moderator:Christopher Gallen, MD, PhDCEO, SK Biopharmaceuticals
Panelists:Carol Lewis-CullinanSenior Director, Clinical Operations, FORUM Pharmaceutical
Veronica LudenskySenior Manager, Clinical Outsourcing, Millennium: the Takeda Oncology Company
Susan RombergVP, Global Clinical Development, NA, Chiltern
12:35 pmLuncheon
1:45 pm5th Annual Country-Specific RoundtablesIn this very popular section of the conference, global clinical trial leaders with experience on the ground and expertise in different countries will address:
• Regulatory environments
• How to work globally with different regulatory agencies
• Market access
• Patient recruitment, enrollment and engagement
• Site selection
• Government protection of intellectual property
• Cultural differences and idiosyncrasies
• Key questions for CROs
• What does it mean to “have a presence?”
Attendees may choose one country-specific roundtable in this section. In addition to the discussion points outlined above, you are welcome to bring any additional issues or questions to the table.
EU • Latin America • India • JapanEastern Europe • Middle East/North Africa • Korea
Roundtable leaders include:
Debra Barker, MDGlobal Program Head, Oncology Biosimilars, Novartis
Christopher Gallen, MD, PhDCEO, SK Biopharmaceuticals
Annalisa Jenkins, MBBS, MRCPChair of the Board of Directors, TransCelerate Biopharma
Mitchell Katz, PhDExecutive Director, Medical Research Operations, Purdue Pharma
Simon Li, MD, PhDVP of Global Clinical Development, Luye America Pharmaceuticals, Ltd
Thomas Lonngren, PhD (hc), MRPharmS, FRCPFormer Head, EMA
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AGENDA 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS
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2:20 pmRethinking How We Partner with Global Investigational Sites
• How to best target new centers globally
• Identifying investigator challenges in order to improve training standards
• Advancements in technology for patients
• Advancements in technology and training for global sites
• Non-traditional ways of collecting data globally
• The emergence of virtual clinical trials
• Update on TransCelerate’s work to collaborate and optimize site partnerships
Moderator:Annalisa Jenkins, MBBS, MRCPChair of the Board of Directors, TransCelerate Biopharma
Panelists:Roberta DuncanSenior Director, Clinical Operations, Trevi Therapeutics
Abraham GutmanPresident & CEO, AG Mednet
Mitchell Katz, PhDExecutive Director, Medical Research Operations, Purdue Pharma
Christine PierrePresident, Society for Clinical Research Sites (SCRS)
3:00 pmRemote-Based Monitoring Case Study on a Global Clinical Trial
• A model for centralized monitoring and clinical data management: successful use of data-driven trial execution
• Identifying the difficulties
• The process of executing RBM
• Data quality, submission and FDA response
• Comparing expectations with realities
Badhri SrinivasanSVP & Global Head, Data & Safety Monitoring, Quintiles
3:30 pmSoapbox Presentations: Innovative Technologies and Services that Drive Efficiencies in Global Clinical TrialsQuick fire presentations. This soapbox session gives a spotlight on key technologies/services in the global clinical space.
• How to use technologies to better plan and design global clinical trials
• How you can change your business model and manage clinical trials with “e-source”
• The use of mobile technologies, i.e. remote ECGs and home monitoring
• Quality data capture and management
• The use of digital and social media technologies for patient recruitment and engagement
Led by:Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals
4:00 pmNetworking Break
4:20 pmGlobal R&D Guest InterviewIn this section of the program, we introduce the head of R&D of Luye America Pharmaceuticals who shares best practices and lessons learned in conducting trials in Asia.
Simon Li, MD, PhDVP of Global Clinical Development, Luye America Pharmaceuticals, Ltd
with
Christopher Gallen, MD, PhDCEO, SK biopharmaceuticals
5:00 pmConference Concludes
HOTEL INFORMATION
The Fairmont Copley Plaza Hotel138 St. James AvenueBoston, MA 02116617-267-5300www.fairmont.com/copley-plaza-boston/
For reservations, call 800-441-1414 or 617-267-5300 and ask for the Global Clinical Trials group rate.
Centrally located in Boston’s historic Back Bay, The Fairmont Copley Plaza sits steps away from the Boston Public Library, Beacon Hill, and the Freedom Trail. The hotel is only a few blocks from Copley Place Mall and the boutiques of Newbury Street. The hotel recently went through a $20 million restoration project.
5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS AGENDA
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REGISTRATION & PRICING
1st Early Bird - before June 27, 2014 $895
2nd Early Bird - before August 8, 2014 $995
Standard - after August 8, 2014 $1,095
The conference fee includes the program, morning coffee/tea, reception, luncheons, and conference documentation.
To register, visit our website at: www.theconferenceforum.org/events/global-clinical-trials/
Discount ProgramsGroup Registration – Receive a 10% discount off each registration when two or more colleagues from the same company register online.
Large group discounts available.
Please contact [email protected] or call 646-350-2580 for any questions on discount rates.
Payment PolicyPayment must be received in full by the event date. All discounts will be applied to the Conference-Only fee (excluding add-ons)‚ cannot be combined with any other offer‚ and must be paid in full at the time of conference.
Substitution and Cancellation PolicyIf you are unable to attend and would like to register a substitute, please email [email protected]. Please ask your substitute to provide identification on-site.
If you need to cancel your registration, please note the following policies based on the start date of the event:
Ten or more business days prior: A full refund less the administration fee of $295, or a pass to another event valid for two years from the date of issue.
Less than ten business days prior: A pass to a future event for either yourself or a colleague from the same company valid for two years from the date of issue.
To cancel and receive a refund or pass, please email [email protected] or call 646-350-2580.
EXECUTIVE SPONSORS
ASSOCIATE SPONSORS
MEDIA PARTNERS
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AGENDA 5TH ANNUAL EXECUTING GLOBAL CLINICAL TRIALS
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