Discover & Validate Novel Predictive Biomarkers Improve...

Discover & Validate Novel Predictive Biomarkers Improve Your Selection of Patient Responders Effectively Commercialize Diagnostic-Enabled Therapies to Market

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Tel: +1 212 537 5898 Email: [email protected] World CDx Companion Diagnostics

Expert speakers include:

Emmanuelle di TomasoVice President & Head of Translational MedicineSyros Pharmaceuticals

Hakan SakulVice President & Head of DiagnosticsPfizer

Roman YelenskyExecutive Vice President & Chief Technology OfficerGritstone Oncology

Jason ChristiansenVice President, DiagnosticsIgnyta

Sarah HerseyCompanion Diagnostics & Precision Medicine HeadCelgene

Phillip LernerVice President & National Medical Director Aetna

Nicholas DracopoliVice President, Oncology DiagnosticsJanssen R&D

Kenneth EmancipatorExecutive Medical Director & Head of Companion DiagnosticsMerck

Jakob DupontVice President &Global Head, Breast& Gynecologic CancerDevelopmentGenentech

www.world-cdx.com

October, 17-19 Boston/Woburn, MA

Adopt, implement and deploy a CDx strategy to ensure regulatory compliance, achieve market penetration and gain market share for your precision medicine candidates

World CDx October, 17-19 | Boston/Woburn, MA


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Welcome to World CDx The forum dedicated to helping large pharma and biotech drug developers turn predictive biomarkers into clinically validated companion diagnostic assays for safe, effective and targeted therapeutics.Back for the 8th year, World CDx will bring together thought leaders and pioneers in the biomarker, CDx and precision medicine fields to provide the platform for candid conversations on how to define, adopt and implement a CDx strategy to ensure your drug candidates are regulatory compliant, achieve reimbursement and gain market share.

By better selecting and stratifying the responder patient populations for your drugs, World CDx will not only help you to de-risk, but also accelerate the demonstration of efficacy

and clinical value of your targeted therapeutics: for both oncology and non-oncology indications.

World CDx offers solution-led thinking on the challenges facing the real world application of precision medicines and companion diagnostics to specific patients in need.

The event will help you uncover solutions to key challenges, including revamping reimbursement strategy to focus on clinical outcomes, selecting the most appropriate CDx platform to maximize real-world adoption, and gaining buy-in from physicians and patients alike.

Be at the pinnacle of crucial and candid conversation to discover why, how and when to adopt a CDx strategy early in your drug development programs and ensure you have the right collaboration to ultimately deliver a readily adopted drug-CDx combination to patients.

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Why Attend World CDx in 2017?Progress the way you approach and structure partnership deals to maximize ROI and working relationship to ensure the smooth development and commercialization of your drug-Dx combination, with insight from Ignyta

Get the Pfizer take on how multiplexed signatures and universal assaying platforms are revolutionizing the development of predictive signatures

Learn how to clinically validate predictive responder and outcome signatures for IO therapies, utilizing inflammatory and neoantigen derived signatures to guide patient selection - hear case studies from Gritstone Oncology and EMD Serono

Improve the operational execution of precision medicine clinical trials, from sample collection to patient recruitment and engagement, with the help of Novartis and Ignyta

Enhance the development of ‘omic derived predictive biomarker signatures through the advancement of WES, RNA and proteomic based assays, with insight from Novartis, Siamab and H3 Biomedicine

Understand the impact of shifting regulatory and policy landscapes for IVDs and diagnostic enabled therapeutics, with help from the FDA and Pfizer

Overcome discrepancies in the definition of value between all industry stakeholders, with perspectives from Astrazeneca and AdvaMedDx

Get the biotech view from Aevi Genomic Medicine and Alzheon on how to innovate in your approach to diagnostic co-development and the utilization of bridging studies to streamline diagnostic development from clinical assay to commercial IVD

Assess the real world application and adoption of drug-Dx products, with the help of Novartis and Janssen, to ensure your chosen Dx platforms delivers commercial success for your drug

Get the Teva and Enterome perspectives on the hottest areas advancing the precision medicine field, from digital technology to the microbiome

Evolve your patient access strategy to improve patient advocacy and physician adoption and promote adoption of your targeted therapeutic, with the help of the Center for Medicine in the Public Interest

Get the Astrazeneca case study on proving the clinical utility of ctDNA to advance the clinical application and implementation of liquid biopsy testing



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World CDx Expert Speaker FacultyDrug Developers

Jason ChristiansenVice President, DiagnosticsIgnyta

Christina BenderDirector, GlobalOncology, DiagnosticPipeline StrategyNovartis

Jeffrey EmchBiomarker & Companion Diagnostic LeadMerck

Ron KamienchickSenior Director, Diagnostics & Personalized MedicineTeva Pharmaceuticals

Dmitri MikhailovHead, Biomarker CoordinationNovartis

Jonathan PanVice President & Head of Biomarker Strategy & DevelopmentAevi Genomic Medicine

Hakan SakulVice President & Head of DiagnosticsPfizer

Zhen SuVice President & Head of Global Medical Affairs OncologyEMD Serono

Sunita BadolaDirector, Functional GenomicsTakeda

Rodolphe ClervalChief Business Officer & Vice President, US OperationsEnterome Bioscience

David KaufmanExecutive Director, Translational Immuno-OncologyMerck

Catherine Lofton-DayMedical Sciences Director Amgen

Charles PauldingDirector, PharmacogenomicsRegeneron Pharmaceuticals

Debra Rasmussen Diagnostics Leader & Senior Director, Global Regulatory Affairs Janssen Pharmaceuticals

Martin TolarFounder, President & Chief Executive OfficerAlzheon

Miro VenturiGlobal Head, Diagnostics BiomarkersRoche

Sudha VisvanathanImmunology & Respiratory Team Lead, Translational Medicine & Biomarker Experts GroupBoehringer Ingelheim

Carl BarrettVice President, Translational Sciences, OncologyAstrazeneca

Jean-Marie CuillerotChief Medical OfficerAgenus

Emmanuelle di Tomaso Vice President & Head of Translational MedicineSyros Pharmaceuticals

Benoit Destenaves Director, Diagnostics LeadAstraZeneca

Kenneth EmancipatorExecutive Medical Director & Head of Companion DiagnosticsMerck

Sarah HerseyCompanion Diagnostics & Precision Medicine HeadCelgene

Eric MeadowsResearch Advisor, Global Patient Outcomes & Real World Evidence, Alzheimer’s DiagnosticsEli Lilly

Jennifer MatarazaSenior Investigator & Group Leader, Translational & Exploratory Immuno-OncologyNIBR

Matthew OnsumDirector & Head of BioinformaticsSeattle Genetics

Victoria RimkunasSenior Scientific InvestigatorH3 Biomedicine

Roman YelenskyExecutive Vice President & Chief Technology OfficerGritstone Oncology

Jakob DupontVice President & Global Head, Breast & Gynecologic Cancer DevelopmentGenentech

Nicholas DracopoliVice President, Oncology Diagnostics Janssen R&D

Dan DransfieldSenior Vice President Research & DevelopmentSiamab Therapeutics



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World CDx Expert Speaker FacultyAssociations, Academics & Advocates

Chandra BranhamVice President, Payment & Health Care Delivery PolicyAdvaMed

Adam BergerSenior Staff Fellow, Personalized Medicine FDA

Jeff AllenPresident & CEOFriends of Cancer Research

Nicholas SchorkProfessorThe Translational Genomics Research Institute

Joshua Xu Principal Investigator, National Center for Toxicological Research (NCTR) FDA

Khatereh CallejaSenior Vice President, Technology & Regulatory AffairsAdvaMedDx

Stuart MartinProfessorUniversity of Marylandspeaking on behalf of ANGLE plc

Daniel CatenacciAssociate Director, Gastrointestinal Oncology ProgramThe University of Chicago Medical Center

Robert GoldbergVice President & Co-FounderCenter for Medicine in the Public Interest

Ferran PratVice President, Strategic Industry VenturesMD Anderson Cancer Center

Phillip LernerVice President & National Medical Director Aetna

Diagnostic & Technology Developers

Eric FaulknerVice President, Precision & Transformative Technology Solutions Evidera

Dan EdelsteinSenior Manager, Medical Scientific AffairsSysmex Inostics

Steve AndersonCSOCovance

Michael NatanCEOUltivue

Scott ReidDirector of Strategic Accounts & Companion DiagnosticsNeoGenomics Laboratories

Dawn McHughVice President, Business Development, Personalized DiagnosticsCorgenix

Matthew McManusCEOAsuragen

Joseph KruegerChief Scientific OfficerFlagship Biosciences

Jay FoustVice President, Companion Diagnostics & Business DevelopmentVentana Companion Diagnostics

Jim GodseyVice President, R&D, Clinical Sequencing DivisionThermo Fisher Scientific

Karen GutekunstVice President, Diagnostic DevelopmentIllumina

Kalyan HandiqueChief Executive Officer & PresidentCelsee Diagnostics

Claire HuguetHead, Biomarker ServicesRandox

Patrick HurbanSenior Director & Global Head, Translational Sciences Q2 Solutions

David KernSenior Director, Regulatory Affairs Illumina

World CDx was a fantastic event both in terms of science and networking opportunities. Highly recommended to everybody working in the “biomarkers to companion diagnostics” field. Roche



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Rosanne Welcher Senior Director, Regulatory, Quality & Clinical AffairsAgilent Technologies

Steen ThaarupBusiness Development Manager, PharmaUnilabs

Vishal Sikri US General ManagerBiocartis

John SimmonsDirector, Translational Sciences & DiagnosticsPGD

Dan SnyderPresident & Chief Executive OfficerMolecular MD

Daniel SimonVice President, Pharma Business DevelopmentGuardant Health

Katarina Wikstrom Director of US OperationsAlmac Diagnostics

Jay Wohlgemuth Senior Vice President & Chief Medical Officer, R&D, Medical & Employee Health Quest Diagnostics

Elodie SollierChief Scientific OfficerVortex Biosciences

Craig ShimasakiPresident & CEOMoleculera Labs

Jessica RileySenior Director, Business Development, Pharma PartnershipsLeica Biosystems

Mark RobertsSenior Director, Diagnostics DevelopmentCovance

Christophe RoosChief Scientific OfficerEuformaticsspeaking on behalf of Horizon Discovery

Diagnostic & Technology Developers

Conference Day One | Wednesday, October 18, 20177.00 Registration Opens, Breakfast & Networking

Miro Venturi, Global Head, Diagnostics Biomarkers, Roche

7.50 Chair’s Opening Remarks

Keynote Address: “Precision Medicine” Under the Microscope: A Frank Look at the Impact of Precision Medicine on Patient Welfare

Kenneth Emancipator, Executive Medical Director & Head of Companion DiagnosticsMerck

8.00 The First Biomarker-Defined Tumor Indication: FDA Approval of Pembrolizumab For MSI-High Cancer• Reviewing the approval of Pembrolizumab based on MSI-High biomarker, independent

of tumor location• Challenges faced along the process• Lessons learned for future endeavors

Jakob Dupont, Vice President & Global Head of Breast & Gynecologic Cancer Development, Genentech

8.30 The Pharmaceutical Perspective on the Advancement of Precision Medicine • Current outlook on R&D endeavours in the oncology space, are we still only capturing the

lowest hanging fruit?• Discussing how to better invest in precision medicine and adjust business strategy to

bring better medicines, with better outcomes, to more patients

Stuart Martin,ProfessorUniversity of Marylandspeaking on behalf of ANGLE plc

9.00 Microfluidic Cell Tethering Enables Rapid Analysis of Drug Responses in Live Patient CTCs• Developing a novel microfluidic medical device for imaging cytoskeletal dynamics in

non-adherent patient tumor cells and integrating hydrophobic lipids into an engineered surface to tether tumor cells to improve high-resolution imaging and preserves the dynamic cytoskeletal behavior of non-adherent tumor cells

• Utilizing live-cell confocal microscopy to demonstrate that McTNs are detectable within hours of when tumor cells are recovered from breast cancer patients, either via surgery or microfluidic isolation of CTCs from patient blood samples

• Enabling immediate testing of patient cells for responses to cytoskeletal drug treatments that could influence CTC reattachment during metastasis

Mark RobertsSenior Director, Diagnostics DevelopmentCovance

9.30 Leveraging Companion Diagnostics in Support of Clinical Trial Design and Execution • Discussing how to differentiate your compound, in a market of multiple biopharma

companies chasing the same biomarker • Understanding the role of CDx to enhance trial enrollment and execution • How to best prepare for critical regulatory and commercialization considerations

Adam BergerSenior Staff Fellow, Personalized Medicine FDAPhillip LernerVice President & National Medical Director AetnaMatthew McManusCEOAsuragen

Jeff AllenPresident & CEOFriends of Cancer ResearchDebra Rasmussen Diagnostics Leader & Senior Director, Global Regulatory Affairs Janssen Pharmaceuticals

Khatereh Calleja, Senior Vice President, Technology & Regulatory Affairs, AdvaMedDx

10.00 Keynote Panel: “Precision Medicine” Under the Microscope: A Frank Look at the Impact of Precision Medicine on Patient WelfareThe keynote will take a candid look at the precision medicine to-date. What current success and tangible real-world benefit are we seeing for patients? Is this enough? And what can we do to ensure we enter the next decade with precision medicine to change the lives of as many patients as possible?

The panel aims to address the following perspective and considerations: • Innovator: Discussing how to better invest in precision medicine and adjust business

strategy to bring improved outcomes to more patients. Considering the role of big data, scientific progress, and current and future technological advances including diagnostics and therapeutics.

• Patient: Elevating the role of patient power and advocacy on the real-world impact of precision medicines and current and future technological advances.

• Payer: Getting to the crux of value/outcomes based healthcare and how we address drug and diagnostic reimbursement across the US.

• Policy: Changing healthcare policy and impact on future precision medicine endeavors. From Moonshot to the NCI and PMI and forging a path for integration of precision medicine into US healthcare.

Panellists:

Panel Moderator:



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Discovery & Development Clinical Implementation & Validation

Drug & Diagnostic Commercialization

Enhancing the Development of ‘Omic Derived Predictive Biomarker

Signatures

Clinically Validating Predictive Responder & Outcome Signatures

for IO Therapies

Overcoming Discrepancies in the Definition of “Value” Between All

Industry Stakeholders

11.45 The Discovery and Development of a STn Antibody Biomarker Signature and Diagnostic for Ovarian Cancer• Discovering and developing a panel

of novel, highly-selective, high-affinity monoclonal antibodies to STn using a proprietary immunization strategy and core glycan screening technologies

• Discussing the development of a novel tissue-based companion diagnostic for Siamab’s anti-STn antibody drug conjugate to select patients that possess elevated levels of the STn carbohydrate

• Proposing a novel exploration of correlations between an IHC signal in ovarian tumors with genetic and protein markers that offers the chance to enhance the strength of each biomarker alone

Dan Dransfield, Senior Vice President Research & Development, Siamab Therapeutics

11.45 A Review: Improving Clinical Patient Selection and Stratification for Immunotherapy • Getting a clean signature: How do

we do robust patient selection for immunotherapies?

• Getting granular on responder/non-responder patient populations: Promoting strategies for subpopulation identification of long-term responders to immunotherapy

• Optimize selection of patients beyond prognostic markers to avoid excessive toxicity in IO clinical studies

Zhen Su, Vice President & Head of Global Medical Affairs Oncology, EMD Serono

11.45 Reinventing Reimbursement Strategy to Demonstrate Value to Payers and Other Stakeholders• Understanding what stakeholders,

including payers, providers and patients, need to see in order to reach the threshold for sufficient value demonstration

• How do we demonstrate stand-alone value for a diagnostic test?

• Revamping your reimbursement strategy to focus on the clinical application, validity and outcome to ensure alignment with requirements in value demonstration

Chandra Branham, Vice President, Payment & Health Care Delivery Policy, AdvaMed

12.00 Learnings from Development of a Biochip Multiplex Inflammation Panel for Assessment in Psoriasis• A how to guide for success development

of assay panels• The Randox perspective on lessons

learnt and best practice for future collaborations

Claire Huguet, Head, Biomarker Services, Randox Sudha Visvanathan, Immunology & Respiratory Team Lead, Translational Medicine & Biomarker Experts Group, Boehringer Ingelheim

12.15 Leveraging Diagnostic Quality as a Means to Align Clinical Trial with Real World Results• Quality of result: Assessing assay

performance and pathologist interpretation to ensure improved selection of patient responders

• Impact: Dissecting data integrity and confidence to support submission and approval of clinical validation to ensure real world clinical results best align with clinical trial data

Rosanne Welcher, Senior Director, Regulatory, Quality & Clinical Affairs, Agilent Technologies

12.15 A Fully Automated, Highly Accurate, Easy to Use MDx Platform: Too Much to Ask For?• Discussing the development of a fully

automated, highly accurate MDx platform

• Demonstrating the value of such a platform to the advancement of patient access to ensure the right treatment at the right time

Vishal Sikri, US General Manager, Biocartis

12.30 Developing Robust RNA Sequencing Gene Expression Profiles as Predictive Signatures• Discussing the benefits of RNA-

sequencing as a platform for robust biomarker identification

• Harnessing RNA-Seq for targeted gene expression assays

• Realizing the emerging role of RNA-Seq in developing predictive biomarkers signatures for IO therapy

12.45 Advancing the Precision Medicine Approach to IO Combination Trials• Learning how to best derive

combination signatures to improve trial strategy

• Harnessing innovative trial design to compare effectiveness of combination versus monotherapy for biomarker signature and therapeutic validation

• Utilizing biomarker data, in conjunction with target interaction to enhance dose selection in combination studies

David Kaufman, Executive Director, Translational Immuno-Oncology, Merck

12.45 Implementing Real World Evidence and Data Strategies to Robustly Demonstrate Value to Healthcare Insurers• Understanding how to harness real

world evidence studies to generate robust data for the clinical relevance of drug and diagnostic

• Incremental benefits: How can we really engage payers to drive buy-in as to what measures of success look like other than just incremental benefit

• What evidence can we generate either in conjunction with or post trial to maximize the case for diagnostic reimbursement

Eric Meadows, Research Advisor, Global Patient Outcomes & Real World Evidence, Alzheimer’s Diagnostics, Eli Lilly

11.00 Morning Refreshments & Speed Networking

Discovery & Development

Enhancing the Development of ‘Omic Derived Predictive Biomarker

Signatures

11.45 The Discovery and Development of a STn Antibody Biomarker Signature and Diagnostic for Ovarian Cancer• Discovering and developing a panel

of novel, highly-selective, high-affinity monoclonal antibodies to STn using a proprietary immunization strategy and core glycan screening technologies

• Discussing the development of a novel tissue-based companion diagnostic for Siamab’s anti-STn antibody drug conjugate to select patients that possess elevated levels of the STn carbohydrate

• Proposing a novel exploration of correlations between an IHC signal in ovarian tumors with genetic and protein markers that offers the chance to enhance the strength of each biomarker alone

Dan Dransfield, Senior Vice President Research & Development, Siamab Therapeutics

12.15 Introducing Corgenix: Personalizing Protein Diagnostics for Personalized Medicine• Corgenix has more than 20 years’

experience and expertise in developing liquid biopsy protein diagnostics, having developed and launched more than 50 IVDs (510K/CE)

• Collaboration is at the heart of everything we do – we have partnered with more than a dozen companies to support their protein diagnostic development manufacturing needs

• Corgenix Personalized Diagnostics offers partnerships for the development and commercialization of protein-based Liquid Biopsy Companion Diagnostic (LB-CDx)

• From proof-of-concept to IVD, Corgenix can help make Personalized Medicine a reality for patients

Dawn McHugh, Vice President, Business Development, Personalized Diagnostics, Corgenix

12.25 Learnings from Development of a Biochip Multiplex Inflammation Panel for Assessment in Psoriasis• Rationale for biomarker and technology

selection• Custom array development highlights• Data contribution to study outcome• Technology improvement – the power

of long-term partnershipClaire Huguet, Head, Biomarker Services, Randox Sudha Visvanathan, Immunology & Respiratory Team Lead, Translational Medicine & Biomarker Experts Group, Boehringer Ingelheim



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13.15 Turning Tumor Mutations into Personalized Cancer Therapies• Evaluating each patient’s tumor using

next-generation sequencing and to identify candidate TSNAs

• Using proteomics and machine learning to predict which TSNAs can activate tumor-specific T cells

• For each patient, manufacturing a TSNA-based vaccine and delivering it in combination with immune checkpoint blockade

Roman Yelensky, Executive Vice President & Chief Technology Officer, Gritstone Oncology

13.15 NGS Panels: From Patient Selection to CDx• Harnessing NGS to facilitate biomarker

discovery in early phase clinical trials and subsequent development of CDx assays with potential utility across multiple drug targets

• Case studies: Exploring the main considerations for development and analytical validation of such panels and

• Identifying important technical and regulatory challenges in CDx development

Katarina Wikstrom, Director of US Operations, Almac Diagnostics

Developing Novel Biomarker Signatures for the Next Wave of

Immuno-Oncology Targets

Improving the Operational Execution of Precision Medicine

Clinical Trials

The Regulatory & Policy Landscape of Diagnostic Enabled Therapeutics

& IVDs

14.30 Analyzing Biomarker Identification in Immuno-Oncology• Discussing approaches to biomarker

identification to guide the use of small molecules and biologics in the context of an integrated translational research program

• What signatures are we looking for and where should we be looking?

• Discussing which markers hold promise for being most clinically relevant

Jennifer Mataraza, Senior Investigator & Group Leader, Translational & Exploratory Immuno-Oncology, NIBR

14.45 Innovating in Sampling and Biomarker Detection to Lay the Foundations of Success for Global Clinical Trials• Discussing the variability in clinical

sample quality from clinical trial sites and how to best standardize sample collection and preparation across multiple geographies

• Rolling out global training and support to best mitigate risk of quality, complex sample collection

• Discussing the role of sample collection, both tissue and fluid, on the advancement of biomarker driven drug development

• Discussing liquid biopsy driven trials and considerations for sample collection and downstream clinical relevance

Dmitri Mikhailov, Head, Biomarker Coordination, Novartis

14.45 FDA Presentation: The Inside Track on NGS IVD Regulation• Understand how the FDA are viewing

the shift beyond the one marker-one platform mantra

• Views on the regulation of NGS based, universal and pan-tumour diagnostic platforms

Adam Berger, Senior Staff Fellow, Personalized Medicine, FDA

15.00 From Research to the Clinical: Advancing RNA-ISH Detection in Companion Diagnostics• Advantages and applications of in situ

RNA detection • Collaboration of key stakeholders for

co-development of a drug and RNA-ISH diagnostic device

• Regulatory and commercial considerations for new innovative technologies in companion diagnostics

Jessica Riley, Senior Director, Business Development, Pharma Partnerships, Leica Biosystems

15.15 Improving Patient Recruitment and Retention on Precision Medicine Clinical Trials• What can be done to improve clinical

trial enrolment using NGS?• Discussing the challenges and pitfalls of

patient enrolment • Understanding what can be done by

drug developers and testing companies do make getting patients onto trials easier

• Improving patient advocacy and educating to promote the enrolling and retention of patients into “precision medicine” clinical trials

Daniel Simon, Vice President, Pharma Business Development, Guardant Health Daniel Catenacci, Associate Director, Gastrointestinal Oncology Program, The University of Chicago Medical Center

15.15 NGS Solutions Across the Oncology Drug Development Continuum: From Biomarker Discovery to IVD• Applications of ctDNA analysis in

pharmaceutical research and clinical development

• Challenges in development of IVDs based on liquid biopsy

• How can the decentralized assay model be applied to liquid biopsy approaches

John Simmons, Director, Translational Science & Diagnostics, Personal Genome Diagnostics

13.45 Networking Lunch

12.55 Regeneron Genetics Center: From Target Discovery to Pharmacogenomics• Discussing the establishment

and mission of the Regeneron highthroughput genetics center

• Evaluating current case studies performing a large number of genomic studies, including family-based mendelian studies, founder population studies, and large-scale population based studies

• Analyzing current clinical pharmacogenomic studies for a number of Regeneron clinical programs

Charles Paulding, Director, Pharmacogenomics, Regeneron Pharmaceuticals

13.25 Development of a Pharmacodynamic Biomarker Assays for a First-in-Class Oral Selective ERa Covalent Antagonist (SERCA) for the Treatment of ERaWT and ERaMUT Breast Cancer ERa mutations functionally confer resistance to existing classes of endocrine therapies, likely through gaining constitutive activity• Current ER-directed therapies are

only partially effective in the ERa mutant setting, and that a significant proportion of resistant breast cancer metastases continue to remain dependent on ERa signaling for growth/survival, highlights the critical need to develop the next generation of ERa antagonists that can overcome aberrant ERa activity

• The role and development of pharmacodynamic biomarker assays to establish SERCA activity in clinical trial samples will be discussed

Victoria Rimkunas, Senior Scientific Investigator, H3 Biomedicine


Developing Novel Biomarker Signatures for the Next Wave of

Immuno-Oncology Targets

14.45 Analyzing Biomarker Identification in Immuno-Oncology• Discussing approaches to biomarker

identification to guide the use of small molecules and biologics in the context of an integrated translational research program

• What signatures are we looking for and where should we be looking?

• Discussing which markers hold promise for being most clinically relevant

Jennifer Mataraza, Senior Investigator & Group Leader, Translational & Exploratory Immuno-Oncology, NIBR



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15.30 Beyond ICI: Discovery and Validation of Predictive Profiles and Platforms for T-Cell Based Therapeutics • Discussing novel ways of looking at

TCR rearrangements and epitope identification

• Evaluating strategies for developing predictive biomarkers for T cell therapies

• An eye downstream: Developing IVD strategies for T cell based therapies

15.45 Umbrella and Basket Trials for Molecular Targets in Precision Medicine• Utilizing basket and umbrella trials to

enrich for responders to statistically power smaller, shorter and more cost-effective late stage trials

• Harnessing these trial designs to more granularly define the best plan of action for subpopulations of patients

• Understanding how basket and umbrella trials can be utilized to improve patient recruitment and retention on clinical studies

Jason Christiansen, Vice President, Diagnostics, Ignyta

15.45 Understanding the Impact of Recent NGS Regulatory Success on Future R&D and Approval Efforts • Discussing the IDE and PMA process

for NGS based platforms: Lessons for streamlining future approval

• Debating the impact of NGS platform approval on the future development of multigene assays

• What can we learn and apply from tissue based NGS platforms to advance the approval of liquid based multigene assays

Hakan Sakul, Vice President & Head of Diagnostics, Pfizer

Evolving the One Marker-One Platform Mantra: Progressing

Multiplexed & Universal Signatures & Platforms

Successful Implementation of Biomarker Signatures: Clinical Trial

Case Studies

Streamlining Diagnostic Co-Development from Clinical Assay to

Commercial IVD

16.15 Developing Multi-Analyte Signatures for Next Generation Multiplexing Platforms • Overcoming inadequacies in single

analyte testing for patient selection to prove the value of a multiplexed approach

• Validating multimarker signatures on novel technology to drive multi-analyte testing: Discussing limits of detection, sensitivity, cross reactivity and sample integrity and availability

• Contextualizing disease pathogenesis utilizing multimarker signatures to expedite the development of more robust patient selection signatures

16.30 Precision Medicine for Alzheimer’s Disease: Applying Genomic Stratification of Patients Based on APOE4 for Clinical Efficacy• By integrating information from a

large dataset in patients treated with the active molecule tramiprosate, genetic markers and new insights into the pathology of Alzheimer’s disease, we have identified a group of high risk patients for our initial pivotal trial, with an earlier onset of Alzheimer’s and more aggressive disease course, patients in which tramiprosate appears to stabilize their cognitive performance

• We have created ALZ-801, an optimized prodrug of tramiprosate, that substantially improves the pharmacokinetic and tolerability profile of the active molecule

• ALZ-801 is one of the few oral drug candidates in advanced stages of clinical testing in Alzheimer’s disease, a pill with a favorable safety profile and the potential to slow the course of the disease in all Alzheimer’s patients

Martin Tolar, Founder, President & Chief Executive Officer, Alzheon

16.30 Which Comes First, Diagnostic or the Drug?• Discussing a novel paradigm in

diagnostic development paired with drug development

• Evaluating a “diagnostic first” process for matching drug development to Dx design

• Debating the impact of such a re-think in drug-Dx co-development on commercial success

Jonathan Pan, Vice President & Head of Biomarker Strategy & Development, Aevi Genomic Medicine

16.15 Afternoon Refreshments

15.15 From Research to the Clinical: Advancing RNA-ISH Detection in Companion Diagnostics• Advantages and applications of in situ

RNA detection • Collaboration of key stakeholders for

co-development of a drug and RNA-ISH diagnostic device

• Regulatory and commercial considerations for new innovative technologies in companion diagnostics

Jessica Riley, Senior Director, Business Development, Pharma Partnerships, Leica Biosystems

15.45 Advancing the Precision Medicine Approach to IO Combination Trials • Learning how to best derive

combination signatures to improve trial strategy

• Harnessing innovative trial design to compare effectiveness of combination versus monotherapy for biomarker signature and therapeutic validation

• Utilizing biomarker data, in conjunction with target interaction to enhance dose selection in combination studies

Jean-Marie Cuillerot, Chief MedicalOfficer, Agenus

16.15 Afternoon RefreshmentsEvolving the One Marker-One Platform Mantra: Progressing

Multiplexed & Universal Signatures & Platforms

16.30 The Pan-Tumor Paradigm: A Biotech Approach• Discussing the Syros platform for the

identification of a super enhancer driving the RARA gene

• Evaluating RARA overexpression in subsets of patients across indications including AML and breast cancer

• Demonstrating that tumors with RARA high expression respond to the RARA agonist SY-1425

• Quantifying RARA in heme malignancies and solid tumors with a companion diagnostic to allow for pan-tumor, genomically guided treatment

Emmanuelle di Tomaso, Vice President & Head of Translational Medicine, Syros Pharmaceuticals



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17.00 Panel Discussion: Advancing the Development and Clinical Application of Universal and Multi-Analyte Biomarker Assays • Debating the clinical relevance of

multiplex technology: What is the best platform and type of signature to develop?

• Discussing the benefits and applicability of multi-analyte testing over single-marker platforms

• Transitioning from single to multi-analyte as a paradigm: What need to do now to streamline this transition as an industry?

• How to validate multiplexing platform and discussing the standards required to perform exploratory testing

• How does the approval of universal companion diagnostics and multigene panels impact future biomarker discovery and development?

Emmanuelle di Tomaso, Vice President & Head of Translational Medicine, Syros PharmaceuticalsMichael Natan, CEO, Ultivue

Additional panelists confirming

17.00 Vetting Precision Medicine• Without proof that technologies

enabling precision medicine actually work, no one will buy into them (e.g., payers, regulatory agencies, the academic community, investors, physicians and patients)

• Vetting precision medicine-enabling technologies and workflows are not trivial and yet there are some emerging strategies; e.g., aggregated N-of-1 trials, testing drug-profile matching algorithms, leveraging personal thresholds, and developing learning systems

• Recent regulatory legislation and positions suggest that the time is right to think about what would constitute sufficient evidence to convince the community that precision medicine has merit and is worth investing in

Nicholas Schork, Professor, The Translational Genomics Research Institute

17.00 Dx Strategy Considerations for Commercial Targeted Therapeutic Success• Discussing the commercial impact

of complementary vs companion diagnostics and the implications for market penetration and physician adoption of a targeted therapeutic

• How do you handle a complementary diagnostic commercially, when it’s not in the Rx label and it’s not required for Rx treatment, to ensure your drug is adopted?

• To CDx or not to CDx: Discussing the impact of the current LDT climate on the adoption and integration of IVDs into healthcare

• Discussing the commerciality of multigene panels: How do we harness these platforms in the real world to get drugs adopted?

• Does the price of multigene NGS panels rule out their commercial viability? Do we need a multi-panel approach or is the refinement and utility of a few selective markers the best approach?

• What are the advantages of developing a multi-analyte CDx and how can they improve market share?

• Discussing the merits and shortfalls of centralized and de-centralized models for testing

Hakan Sakul, Vice President & Head of Diagnostics, Pfizer

Jeffrey Emch, Biomarker & Companion Diagnostic Lead, Merck

Rosanne Welcher, Senior Director, Regulatory, Quality & Clinical Affairs, Agilent Technologies

Eric Faulkner, Vice President, Precision & Transformative Technology Solutions, Evidera

Scott Reid, Director of Strategic Accounts & Companion Diagnostics, NeoGenomics Laboratories

17.50 Close of Day One

18.00 World CDx Gala Dinner hosted by ANGLE plc

***Personal Invitation Only***

17.45 Chairs’ Closing Remarks





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Conference Day Two | Thursday, October 19, 2017

7.00 Breakfast & Networking

Miro Venturi, Global Head, Diagnostics Biomarkers, Roche

8.05 Chair’s Opening Remarks

Plenary Address: Dissecting the Progression from Predictive Biomarker Signature to Companion Diagnostic for Commercial Launch and Adoption

Sarah Hersey,Companion Diagnostics & Precision Medicine Head,Celgene

8.15 Collaborations & Technology to Deliver Precision Medicine• Pre-competitive collaborations – winning for our patients• Evolution of diagnostic testing• Strategies for standardization

Nicholas Dracopoli, Vice President, Oncology Diagnostics, Janssen R&D

8.45 Key Trends in CDx Development for Precision Medicine Success• Why, when and how should you decide to translate your biomarker strategy into a high

value CDx approach• Discussing how assay platforms can evolve to better inform patient selection to provide

more meaningful insights into outcomes?• Evaluating the value of complementary diagnostics in validating “continuum”

signatures to guide therapy• Discussing how assay platforms can evolve to better inform patient selection to provide

more meaningful insights into outcomes?• Understanding how to build a companion diagnostic program into your therapeutic

development without compromising timeline goals

Jim Godsey,Vice President, R&D, Clinical Sequencing Division Thermo Fisher Scientific

9.15 Successful Development of an NGS-Based Companion Diagnostic Test to Support Multiple NSCLC Drug Therapies• Challenging considerations• Lessons learned from the successes • Insight and an assessment into future directions

Dan Snyder, President & Chief Executive Officer, Molecular MD

9.45 Mitigating Risk when Navigating the Journey from Clinical Trial Assay Validation to the Commercial Deployment of a Companion Diagnostic• Delivering insight into how to smooth the transition of assay development from proof

of concept to registrational clinical trial to regulatory approval by identifying the true diagnostic need and developing an assay that is more suitable for each phase of the lifecycle that avoids multiple bridging studies

• Developing a framework for commercial/market considerations to help pharma avoid making poor decisions which can delay uptake after launch

• From CTA validation and IDE strategies to commercial CDx implementation, insights and examples will be provided on how to effectively manage a co-development project with ever compressing timelines

Jay Foust, Vice President , Companion Diagnostics & Business Development, Ventana Companion Diagnostics

10.15 Taking a Well Measured Biomarker and Executing a Robust IVD Development Strategy for Your Targeted Therapy• How best can you measure and clinically validate your novel signature• Earlier may not always be better – when should you invest and how should to start your

CDx development piece• What role should bridging studies play and how should how clinical trial design should

have a strategic impact on targeted therapy development• Case studies of opportunities where this strategic impact is experienced when

developing companion diagnostics and what that might mean for future commercialization best practice

10.45 Morning Refreshments & Networking



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Discovery & Development

Clinical Implementation & Validation

Drug & Diagnostic Commercialization

Advancing the Development & Clinical Utility of Liquid Biopsies

Bridging Validation to Real-World Application

Advancing the Real World Adoption of Drug-Diagnostic Products

11.30 Proving the Clinical Utility of ctDNA• Advancing the practical applications of

ctDNA for patient selection, monitoring and therapeutic recommendations

• Validating the impact of ctDNA testing on the accuracy of clinical decision: What’s real, what’s technical, what’s just tumor heterogeneity?

• Harnessing ctDNA to identify responder population by their tumour burden

Carl Barrett, Vice President, Translational Sciences, Oncology, Astrazeneca

11.30 Panel Discussion: The Real World Application of Drug and Dx and the Impact on What Platform to Choose and Why• Selecting the right assay for your biomarker

to promote physician adoption• Discussing different assay merits on cost,

turn around time, assay sensitivity, labor resources on selecting the appropriate assay to maximize chance of adoption

• With such rapid advancement in molecular diagnostics how do we ensure commercialized and adopted tests don’t become obsolete?

• Debating IP, propriatary assays and the impact of platform standardization

• How to improve the commercial launch of drug-dx products to gain early buy-in and adoption

• Debating the prevalence of the biomarker and the transition from what is relevant in the clinical trial setting with what is viable in the real world

• Discussing the health economics around CDx deployment and acceptance to improve adoption of the diagnostic test

• A stark look at the post market real world: How is the diagnostic impact adoption and market penetration for my precision medicine?

• Are we progressing the IVD vs LDT debate and how is the current situation impacting on the real world adoption of diagnostics?

Nicholas Dracopoli, Vice President, Oncology Diagnostics, Janssen R&D Ferran Prat, Vice President, Strategic Industry Ventures, MD Anderson Cancer Center Sarah Hersey, Companion Diagnostics & Precision Medicine Head, Celgene Ron Kamienchick, Senior Director, Diagnostics & Personalized Medicine, Teva Pharmaceuticals Robert Goldberg, Vice President & Co-Founder, Center for Medicine in the Public Interest

11.30 Best Practices and Lessons Learned for NGS Companion Diagnostics• Join Illumina’s panel of industry experts

to discuss the latest advances in NGS based diagnostics and what the future holds for the commercialization and adoption of these tests.

Panelists:

Benoit Destenaves, Director, Diagnostics Lead, Astrazeneca

Catherine Lofton-Day, Medical Sciences Director, Amgen

Patrick Hurban, Senior Director & Global Head, Translational Sciences, Q2 Solutions

David Kern,Senior Director, Regulatory Affairs, Illumina

Moderator:

Karen Gutekunst, Vice President, Diagnostic Development, Illumina

12.00 The OncoBEAM™ Platform: The Use of a High Sensitive Technology for Liquid Biopsies in Clinical Practice• The OncoBEAM™ Platform has been

validated across cancer types with sensitivity of around 0.02% MF

• Sensitivity matters in liquid biopsies for accurate biomarker detection and patient classification

• Sysmex Inostics OncoBEAM™ assays are available for CRO services and/or Patient testing globally

Dan Edelstein, Senior Manager, Medical Scientific Affairs, Sysmex Inostics

12.30 Validation of NGS Workflows for Precision Medicine • Discussing best practice clinical guidelines

for the validation of NGS pipelines in a personalised medicine context to support the increasing complexity of biomarkers in precision genomics, NGS-based patient stratification for therapy and/or clinical trials

• Validating NGS pipeline depends upon processes for calibrating and implementing quality thresholds for NGS data files as well as for optimising accuracy by maximising sensitivity without losing specificity

• Analyzing the importance of NGS data validation together with data interpretation for actionable clinical outcome

Christophe Roos, Chief Scientific Officer, Euformatics, speaking on behalf of Horizon Discovery



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Investigating Future Disruptive Technologies Advancing Precision Medicine: The

Microbiome, mHealth & Digital Biomarkers

Utilizing Downstream Analytics to Power Positive Clinical Trial Outcomes Rx-Dx Partnering Roundtable

14.20 Evaluating the Role of Microbiome Diagnostics in Precision Medicine• Overcoming wide variation in

microbiome sequencing and analysis to establish standards and enhance the prospect of clinically useful microbiome based signatures

• Evaluating standardization methods and bioinformatics approaches for interrogating microbiome based signatures

• Understanding the impact of the microbiome on drug metabolism and sensitivity and the potential for harnessing the microbiota for personalized therapeutics

Rodolphe Clerval, Chief Business Officer & Vice President, US Operations, Enterome Bioscience

14.20 Harnessing Bioinformatics Analysis of Complex Datasets to Support Development Decision Making• Delineating statistical significance

and biological significance: What is enough statistical significance to drive a meaningful change in a patient population?

• Analytical strategies for robustly delineating beyond “biomarker positive” to enrich for “responder positive populations”

• Realizing the power of translational bioinformatics and interpretive methods to optimize the transformation of data analysis into proactive measure of drug activity

Matthew Onsum, Director & Head of Bioinformatics, Seattle Genetics

14.20 Breakout Roundtables: Evolving Rx-Dx Partnering Models to Maximize ROI for Both PartiesThis years’ interactive World CDx roundtable focusses exclusively on the Rx-Dx paradigm and how to ensure continued CDx development with appropriate risk and reward. Jason Christiansen will lead discussion on the following topics:• Debating cost and ROI for a pharma

company embarking on the development and commercialization of a CDx: How to ensure your diagnostic provides the upmost value to your market access strategy?

• Money Talks: Discussing the imbalances in value and ROI in an Rx-Dx partnership

• Evolving deal structure: how do we build better partnerships to improve the market share of both drug and diagnostic?

• Bringing partnering global: How to align your partnering strategy to improve the global reach of commercial launch into

Moderators: Jason Christiansen, Vice President, Diagnostics, Ignyta Steve Anderson, CSO, Covance

12.30 Deep Sequencing QC: A Component Study of the FDA-led Sequencing Quality Control Project Phase 2 (SEQC2) • QC assessments of reproducibility and

detection sensitivity to translate DNA sequencing from lab development to clinical application

• Benchmarking samples to empower a cross-lab evaluation of pan-cancer panels and liquid biopsy kits

• Developing quality metrics to inform the confidence of each mutation call

Joshua Xu, Principal Investigator, FDA

13.00 Using Computational Tissue Analysis to Deliver Clinical Response Profiles for Diagnostic Approaches• Using image analysis of IHC stained

tissues to create a response profile from clinical outcome data.

• Determining what computational scores are relevant to the biological mechanism.

• Delivering tissue image analysis based patient selection tools in a regulated clinical setting to support drug development and commercialization

Joseph Krueger, Chief Scientific Officer, Flagship Biosciences

12.30 Integrated Diagnostic Information Services to Power Development and Clinical Implementation of Precision Medicine• Evaluating the role of clinical labs in

setting up and implementing a Dx test and registering the new technologies with the reimbursement parties

• Understanding how the diagnostic is utilized and integrated into a labs workflow to streamline strategy for further healthcare adoption

• Defining the role of the pathology lab in precision medicine adoption and pricing impacts associated with running diagnostic

• Strategies to overcome reimbursement challenges and include our semi-centralized lab strategy

Jay Wohlgemuth, Senior Vice President & Chief Medical Officer, R&D, Medical & Employee Health, Quest Diagnostics

13.00 The Celsee™ PREP platforms: Simplified Rare Single Cell Isolation, Analysis and Retrieval • Discussing a validated, label-free

integrated platform to isolate, characterize, and retrieve rare cells from whole blood or cell suspensions

• Simplifying workflows to be used alone or in tandem to enrich either individual cells or cell populations

• Evaluating analyisis using IHC, DNA/mRNA FISH, PCR, NGS, live cell imaging or culture

Kalyan Handique, CEO & President, Celsee Diagnostics

13.10 Improved Sensitivity for EGFR Mutation Profiles in Liquid Biopsies Using the VTX-1 Liquid Biopsy System • Discussing VTX-1, a simple, fully

automated system that uses the physical properties of CTCs to isolate them directly from whole blood

• Demonstrating a workflow for the collection and EGFR mutation analysis of both cfDNA and CTCs from a single blood tube using the VTX-1 platform

• Case study: Comparing the results to matched tumor samples for NSCLC patients

Elodie Sollier, CSO, Vortex Biosciences

13.10 Companion Diagnostics: Challenges and Solutions• When development of drug and

diagnostics is not aligned = risk of economical loss

• What are the risk factors to be aware of? • How to reduce the risk? • Real-life example using a centralized

laboratory approachSteen Thaarup, Business Development Manager, Pharma, Unilabs

13.10 Autoimmune Dysfunction as a Mechanism in Neuropsychiatric Disorders• Neuropsychiatric disorders contribute the

greatest burden on society and eclipse cancer and heart disease

• Not to mention causing distress and disability to the individual and their family

• Traditional therapeutic intervention is symptomatic treatment with psychotropic drugs

• Growing clinical and scientific evidence is pointing to the immune system and inflammation as a potential etiology and target for intervention

• Evidence for new therapeutic targets will be presented

Craig Shimasaki, President & CEO, Moleculera Labs




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14.50 Beyond CDx, Beyond Oncology: How Biological and Digital Markers are Redefining Personalized Medicine• Harnessing digitally based biomarkers

and wearable technology to create novel predictive markers

• Evaluating the impact of digital technology on commercial success

• Leveraging remote patient monitoring technologies to create novel surrogate markers: Case study from outside of oncology

Ron Kamienchick, Senior Director, Diagnostics & Personalized Medicine, Teva Pharmaceuticals

14.50 Building and Implementing Analytical Capabilities for Clinical Studies• Understanding how to build and integrate

an analytical framework to implement advanced analytic strategies

• Pre-selecting non-responsive patients to simultaneously better set up clinical trials for success and identify unmet medical need for new, innovation personalized treatment

• Defining cut offs for patient selection: Criteria for defining cutoffs, protocols of robust validation and downstream impact on clinical success

Sunita Badola, Director, Functional Genomics, Takeda

15.20 Close of World CDx Educational Program

15.25 World CDx Afternoon Networking SessionJoin us after our educational program for an informal networking event. Make those final connections, wrap up your business conversations and become a central part of our World CDx family.

16.30 Close of Day Two & End of World CDx

Focused speakers allowed for streamlined discussion and open conversation. I left the meeting aligned on the latest developments in CDx, and carried away clear messages. Genentech



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MORNING PRE-CONFERENCE WORKSHOPTuesday, October 17, 2017

Precision Medicine holds the promise of therapeutics driving improved patient outcomes through targeted molecular approaches that transform historically fatal diseases into chronic, manageable ones. Oncology has spearheaded many of the advances in the recent Precision Medicine but with ever changing healthcare needs and investment we are now also observing an expanding focus into other disease spaces including autoimmune, neurodevelopmental and neurodegenerative diseases.

Join Asuragen Inc. and their panel of cross-healthcare experts in this workshop to do a deep dive into how the 4 key stakeholders – Payer, Pharma, Provider and IVD Companies – can come together for the vision of Precision Medicine to become reality. The workshop will examine themes including the roles of decentralizing testing and evolving CDx offerings to support testing across the entire risk stratification to outcome assessment continuum.

The format for the workshop will be four 40 minute tracks followed by a 30 minute interactive panel discussion.

Topic One: The IVD Role in Driving Precision Medicine

• With a broadening of the needs from Dx in therapy selection and management the testing technologies and test characteristics required are evolving. What is required in the IVD space to ensure maximal reach, effectiveness and performance for a complementary or companion diagnostic?

Topic Two: A Healthcare System Perspective

• New Molecular Dx technologies have created data sets of unprecedented complexity which are not always immediately conducive to aiding clinical decisions. What are the attributes of Complementary and Companion Dx tests that make them effective and usable by healthcare professionals?

Topic Three: The Evolving Payer Landscape

• As risk-sharing & outcome-based payment models become increasingly present around the world, how will the Payers change the Complementary and Companion Dx model for all the other stakeholders?

Topic Four: Evolving Pharma Needs from CDx

• With increasing regulatory requirements for Companion Diagnostics and evolving reimbursement landscapes now including “pay for performance” type approaches, the critical nature of selecting biomarkers and the appropriate testing strategies has increased. What characteristics define the optimal CDx partner and test for Pharma success?

Precision Medicine & Companion Dx – The Evolving Role of In Vitro Diagnostics Guiding Patient Management from Risk Stratification to Outcome09.00 - 12.00

Speakers confirming from Asuragen, payers, healthcare providers and the pharmaceutical industry.

In collaboration with:

HOW TO APPLYIf you are interested in joining the pre-conferenceworkshop hosted by Asuragen, please [email protected]

If accepted, the workshop will be free to attend as part of your conference registration. Confirmation of attendance will be given via email.



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AFTERNOON PRE-CONFERENCE WORKSHOP

Tuesday, October 17, 2017Navigating the Companion Diagnostics Co-Development Process13.00 – 17.00

HOW TO APPLYIf you are interested in joining the pre-conferenceworkshop hosted by Covance, please [email protected]


Join Covance and their panel of industry expert speakers before the start of World CDx in this workshop to take a deeper dive into the strategy behind drug and companion diagnostic co-development. Benefit from multi-stakeholder perspectives, granular discussion and extended networking with the brightest biomarker, precision medicine and diagnostic minds in the field. This workshop will address the following aims:• Understanding the different pathways, cost structures and risks to drive better

decision making • Asking the right questions and choosing the best pathway for clinical

development and commercial success

AgendaTopic One: Regulatory and Operational framework• Understand and address the necessary the global regulatory requirements.When is an IVD partnership the best path? What are the appropriate applications for the lab-developed test model? Bill Pignato, Principal, W.J. Pignato & AssociatesTom Turi, PhD, Vice President, Companion Diagnostics, Covance, Inc.

Topic Two: Technical Platforms• Recognize the role of emerging technologies, with an appreciation for factors

such as access / scale / application of a given technology. How do you assess fit?

Sarah Hersey, Companion Diagnostics and Precision Medicine Head, Celgene Corp.Speaker to be named, Qiagen

Topic Three: Commercialization • Launching a diagnostic is different from launching a drug. With that

understanding, how do you ensure adequate access to both the drug and the CDx on Day 1?

Keith Hanigan, Vice President, Integrated Oncology (LabCorp)

Panel Discussion – Moderated by Steve Anderson, Chief Scientific Officer, Covance, Inc

Speakers confirming from Covance, payers, IVD developers, biopharma

In collaboration with:



16

Sam SarwarCommercial Director – Biomarkers & Diagnostics Event SeriesT.+44 (0) 20 3141 8716E. [email protected]

BECOME A PARTNER

World CDx is a dedicated platform for drug developers, big and small, to discuss the tangible benefit of biomarker driven precision medicine and diagnostic enabled therapies, and identify the solutions they need to make their therapies a clinical and commercial reality.

The meeting brings together the who’s who of the biomarker and clinical diagnostics sectors to showcase advances in assaying technology and fully fledged diagnostic platforms. From NGS to multiplexing and liquid biopsies, showcase the real-world impact and provide thought leadership on the adoption of these technologies for safer, more effective and value-based personalized healthcare.

Open the door and develop relationships with the most influential leaders in the precision medicine, biomarkers and diagnostics fields and network with the biggest, most innovative and under-the-radar drug developers

Demonstrate your thought leadership throughout the development and commercialization of a drug-diagnostic product to an exclusive community of high level decision makers

Be the one to define the commercial conversation, as drug developers scramble to define their strategies to improve market penetration and share in this über-competitive landscape

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OUR PARTNERSEXPERTISE PARTNERS

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SPOTLIGHT PARTNERS, PANEL PARTNERS, MEETING PARTNERS & EXHIBITORS DIGITAL PARTNER



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