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8:10 am Chair’s Opening Remarks

8:20 am A Virtuous Cycle of Medical Innovation Fueling Advances in Precision Oncology

Synopsis

  • Scientific advances have led to a renaissance in precision therapy and the potential to transform patient care. There is a deeper understanding of molecular targets that drive cancer and its evolution, more sophisticated and accessible genetic testing technology that enables the detection of a range of cancer mutations, and new precision medicines and combination treatment approaches being brought to patients.
  • These advances are reinforcing each other through a virtuous cycle. However, delivering novel precision therapies continues to involve a number of challenges, such as identifying patients most likely to benefit, empowering community oncologists with the latest information and ultimately, transforming traditional treatment paradigms to precision medicine approaches.
  • To address the barriers, our work is becoming more interdisciplinary – from integrating a variety of molecular and genomics data, to bringing clinical learnings back to research and working collaboratively on strategies to make biomarker testing available to more patients.

Keynote Address: A Candid Look at Value, Adoption & Patient-Centricity in Precision Medicine

8:50 am The Evolving Biomarker & Companion Diagnostic Landscape: Key Factors that Impact the Delivery of Precision Medicine

Synopsis

  • Laboratory and commercial factors that impact the utilization of biomarkers and companion diagnostics
  • The increasing role of cell and gene based therapies in the delivery of precision medicine

9:20 am Comprehensive Liquid Biopsy: Clinical & Commercial Use Cases

  • Elena Helman Head, Biopharma Bioinformatics, Guardant Health

Synopsis

  • Emerging data on ctDNA in clinical trials
  • Using ctDNA for immunotherapy development
  • Maximizing patient access commercially

9:50 am Speed Networking

10:10 am Morning Refreshments

10:30 am Keynote Panel Discussion: Women In Precision Medicine

  • Shirin Khambata Ford Head, Precision Medicine, Clinical Biomarkers & Companion Diagnostics, Daiichi Sankyo
  • Kathryn Becker Franchise Director, Oncology & Companion Diagnostics, Abbott Molecular
  • Robin Toft Chairman, Founder & CEO, Toft Group Executive Search
  • Megan Ann Greenfield Partner, McKinsey & Company
  • Allison Ballmer Vice President, Strategy & Business Development, Agilent Technologies
  • Steven Rosen Senior Director, External Innovation, Johnson & Johnson

Synopsis

Uniting scientific and business leaders from all key stakeholders of the community, this keynote session will highlight the importance of a diverse workforce and provide actionable takeaways for increased advocacy in individual workplaces.

11:10 am Progress in Data & Biomarker-Driven Precision Medicine Development

  • Jay Wohlgemuth Senior Vice President, R&D & Chief Medical Officer, Quest Diagnostics
  • David Freeman General Manager, Information Ventures, Quest Diagnostics

Synopsis

  • Leverage data and biomarker information in Precision Medicine
  • Tools that can be utilized to be effective
  • Examples with Case studies

12:00 pm Delivering Successful Companion Diagnostics Programs: A Large Global Central Laboratory’s Experience

  • Alan Wookey Scientific Advisor, Oncology & Companion Diagnostics, Q2 Solutions

Synopsis

  • Describing some of the trends in the data to support companion diagnostic submissions and approval, seen by a Central Laboratory, that
    is supporting over 100 CDx clinical trials
  • Other approaches required to maximize the potential of predictive biomarker assays, given the small number of CDx approvals since the first 20 years ago
  • Trends and best practice will be described on how CDx assays are supporting clinical development in China

12:30 pm Networking Lunch

Biomarker Discovery &
Translation

Clinical Biomarker Development

Drug-Dx Commercialization

Discovering the Next Generation of Robustly
Predictive Biomarkers

Chair: Robert Pomponio, Global Scientific Advisor, Biomarkers & Clinical Bioanalysis, Translational Medicine Early Development, Sanofi

Advancing Clinical Validation of Predictive
Biomarkers

Chair: Beth Trehu, Chief Medical Officer, Jounce Therapeutics

Overcoming Bottlenecks in Commercialization:
From Reimbursment to Market Access

Chair: Steven Rosen, Senior Director of External Innovation, Johnson & Johnson

13.30 NMR-Metabolite-Resonance Signature Predicts HR+ Breast Cancer Patient Response to CDK4/6 Inhibitors
• Correlating metabolite expression profiles to clinical outcomes to identify a metabolic signature that could differentiate CDK4/6 responders and resistant patients with a predictive accuracy of > 90%
• Identifying independent signatures predictive of response for individual CDK4/6 inhibitors palbociclib and ribociclib
• Discussing a paradigm shift in the administration of CDK4/6 inhibitors wherein prior to treatment and during treatment patient plasma is screened to determine whether that individual patient is responsive or resistant to a CDK4/6 inhibitor
Elizabeth O’Day, Founder & CEO, Olaris Therapeutics

13.30 Investigational Tepotinib: MET Exon 14 Skipping & the Power of Precision Medicine
• MET exon 14 skipping is an agressive tumor driver in NSCLC
• Tepotinib is a potent and selective inhibitor of MET
• Both tissue and liquid biopsy based testing for METex14 skipping identifies patients who may benefit from tepotinib treatment
Dennis Merkle, Head, Market Enabling Technologies & Companion Diagnostics, Merck KGaA, Darmstadt, Germany

13.30 Key Market Access Challenges For Drug-IVD Commercial Success
• Evaluating the pros and cons of commercial viability for established vs cutting edge technology: what are the key considerations for commercial success?
• Debating the current reimbursement paradigm for the spectrum of IVD tests to assess viability of commercial penetration
Omar Perez, Head, Precision Medicine & Diagnostics, GSK

14.00 The Increasing Adoption of RNA-Seq as a Biomarker Discovery Tool & How to Solve the Complex Data Challenge
• The opportunity of RNA-Seq as a biomarker discovery tool
• Challenges in analysing and interpreting large volumes of complex RNA-Seq data
• How Almac Diagnostic Services’ claraT report solves this challenge, simplifying the process whilst saving time & resource
• Detailed overview of the claraT reporting solution, including cohort and sample report interpretation
• Case Study: In a real world RNA dataset utilising claraT
Katarina Wikstrom, Head, US Operations, Almac Diagnostic Services

14.00 High Definition Multiplexing for Biomarker Strategies & CDx Development

•Showcasing the highest throughput and multiplex level for whole slide tissue marker studies

• Identifying complex phenotypes within the tumor microenvironment through the colocalization of multiple markers on individual cell compartments

• Discussing the complete ecosystem for Translational Research and Drug Biomarker programs

Philippe Mourere, Senior Vice President, Commercial Operations, Ultivue

14.00 Avoiding the Pitfalls & Setbacks in CDx Development: Reflections on 12 Years of Experience

• What’s the best approach to developing a test?
• So you think you want to bridge?
• Label extensions to current CDx tests are easy right?
• The IVDR Impact on development strategy

Kathryn Becker, Franchise Director, Oncology & Companion Diagnostics, Abbott Molecular

14.30 Utilizing In Silico Approaches to Design Translational Medicine Strategies

• Harnessing transcriptomic data sets for biomarker identification in Asthma
• Showcasing an approach for data analysis to understand and characterize subsets of Asthma
• Discussing the discovery of a biomarker of a subtype of Asthama with high unmet need
Michael Burczynski, Senior Director & Head, Translational Medicine, Teva Pharmaceuticals

14.30 PARPi Development in Prostate Cancer: Limitations & Opportunities for Companion Diagnostic Development

• PARP inhibitors have demonstrated clinical utility in treating metastatic prostate cancer due to enrichment of DNA repair deficiencies in a subset of these tumors

• NGS testing of tumor tissue to identify patients with BRCA defects or other homologous recombination repair deficiencies has limited utility due to limited amount of tumor isolated from bone biopsies • Opportunities of developing liquid biopsy-based companion diagnostics for this disease will be discussed

Mitch Raponi, Vice President, Biomarker Development & Translational Research, BeiGene

14.30 Payer Perspective: Demonstrating Value of Next Generation Biomarkers & Diagnostics for Precision Medicine

•Evaluating the impact of the CMS guidance on NGS reimbursement: From IVD to LDT, is there now a path forward for the commercial viability of these tests?

• What is the weighting of clinical evidence vs RWE needed

• A guide to generating evidence either in conjunction with or post trial to maximize the case for diagnostic reimbursement

Eugean Jiwanmall, Senior Research Analyst, Medical & Claim Payment Policy Department, Independence Blue Cross

15.00 Democratization & Globalization of Next Generation Sequencing for Companion Diagnostics
• Highlights of the success of OncomingDx for CDx development and global commercial expansion
• Advancements and future directions of cell-free DNA and RNA testing for clinical trials and CDx
• Novel biomarker assays for Immuno-Oncology enable discovery, translational research and new potential predictive CDx
Brian Kelly, Global Director, Diagnostic Partnering, Thermo Fisher Scientific

 

15.00 Antibody Discovery & Validation Programmes to Enhance Companion Diagnostic Development & Partnerships

• Abcam’s targeted antibody discovery and validation approach to deliver best-in-class antibodies, from research grade to IVD to support clinical trials and companion diagnostic development
• Case studies on how Abcam can support pharma and biotech partners in accelerating their companion diagnostic development through enhanced partnerships
• The value of partnering with Abcam and our strategy in helping driving precision diagnostics
Courtney Nicholson, Director, Business Development, Abcam

15.00 Overcoming Obstacles to Commercial Success Through a Pharma-Centric, Patient-Focused CDx Strategy
• Confronting the inherent challenges and tensions that arise between diagnostics and pharmaceutical development teams
• Understanding the guidance and support required for successful local market execution on an aligned plan
• Reaffirming the commitment to clinicians by partnering to ensure advocacy and accurate diagnosis of patients
Jess Lambe, CDx International Business Leader, Roche Tissue Diagnostics
Paco Delgado, CDx Senior Director, Project Leader, Roche Tissue Diagnostics

3:30 pm Afternoon Refreshments & Networking

Accelerating the Translational from Exploratory
Signature to Clinical Biomarker Candidate

Chair: Steve Anderson, Chief Scientific Officer, Covance

Executing Biomarker-Driven & Diagnostic Enabled Clinical Trials

Chair: Sharon Barr, Vice President & Head of Research, Alexion Pharmaceuticals

Commercializing Diagnostics as Fit-For-Purpose in the Real-World Healthcare Setting

Chair: Steven Rosen, Senior Director of External Innovation, Johnson & Johnson

16.00 Improving the Validation & Utility of Multiplexed Assays
• Using predictive biomarkers to better understand disease
• Complex biomarker profiles providing insights into complex health states
• Development of a cardiac prognostic multiplex biomarker assay
Sara Call, Business Development, Quansys Biosciences

16.00 DIKI Panel: Making Drug Development Safer
• Discussing biomarker qualification and assay development
• Technical and clinical assay validation
• Composite biomarker in the context of use
Claire Huguet, Head, Biomarker Services, Randox

16.00 Considerations for the Development of a Distributed Tissue & Liquid Biopsy NGS Companion Diagnostic
• Evolving product to meet market needs
• Overcoming V&V technical challenges
Josh Stahl, Chief Scientific Officer, Archer Dx

16.10 Strategizing Early Biomarker Decisions for Future Precision Medicine Success
• Utilizing response rate and predictive biomarkers in early strategy decision making
• From target engagement to surrogate endpoints
• Discussing Sanofi’s current thinking on the strategies for biomarker-CDx co-development
• Less is more: How harnessing fewer, yet more informed samples and biomarkers in large population sizes can be more beneficial than using a multitude
Gerard Sanderink, Global Head, Biomarkers & Clinical Bioanalyses, Sanofi

16.10 A Guide to Biomarker-Driven Precision Medicine Clinical Trials
• Discussing the landscape of biomarker use in clinical trials
• Showcasing recent data from MDACC and GENIE re: the percentage of patients with a potential biomarker or without and what the field is doing in terms of next steps for these patients
• Putting all of this into the context of precision oncology decision support
Kenna Mills Shaw, Executive Director, Sheikh Khalifa Bin Zayed Al Nahyan Institute for Personalized Cancer Therapy, MD Anderson Cancer Center

16.10 CDx Patient Leakage Mapping

• As pharma and diagnostics companies continue to place more focus on the success of their companion diagnostics, novel commercialization strategy techniques continue to evolve
• One such analytical technique is the concept of CDx patient leakage mapping, which is an objective means of segmenting and monitoring leakage points throughout the patient/tissue journey
• This session will review this concept through the lens of a case study in oncology

Gary Gustaven, Partner, Precision Medicine, Health Advances

16.40 HalioDx Immunogram & Cancer Immune Atlas: Application in Immuno-Oncology
• Data integration of biomarkers from the tumor microenvironment (Colon Cancer proof of concept)
• Application: Cancer Immune Atlas to guide pharma development
• From the Immunogram Cancer Immune Atlas to CDx
Corinne Danan, Executive Vice President, Partnerships BU, HalioDx

16.40 Preparing, Deploying & Monitoring Diagnostic Assays to Support Clinical Validation of Biomarker-Driven Clinical Trials
• Strengths of immuno oncology precision trials on industry: ability to predict more accurately which treatment and prevention strategies to use for a particular disease that takes into account, individual variability
• Pre-study preparations
• Assuring quality during the clinical trial through closeout
• Post study support
• Future concerns for the industry for device support during the clinical trials
Shirin Hasan, Senior Director, Global Clinical Affairs, Agilent Technologies

16.40 Commercialization of Precision Diagnostics in Europe: Challenges & Opportunities
• Challenges exist when introducing new precision diagnostic tests into the European market which impact rate of test adoption
• To deliver an effective European wide test access strategy, different approaches needs to be considered on a market by market basis
• Opportunities for centralized vs de-centralized testing approaches will be discussed with emphasis on access, TAT and quality
Jakob Gjørret, DVM, Managing Director, Unilabs Denmark

17.10 Developing Biomarkers for an NTRK Inhibitor in a Tissue Agnostic Indication
• From proof-of-concept to clinical: Showcasing the development of biomarkers for TRK inhibitors
• How to best design and execute an exploratory biomarker program to quickly inform a pivotal study
• Lessons learnt to develop rare biomarkers in tissue agnostic manner
Amanda Wang, Director, Biomarker Strategist, Bayer

17.10 Integrating Predictive Biomarkers in Phase III Clinical Trial Designs
• Discussing the strengths and weaknesses of different confirmatory phase III trial designs in the era of precision medicine in oncology
• Presenting recommendations about when specific trial designs are most appropriate
• Evaluating umbrella and basket trials that test multiple therapies simultaneously and identify biomarker-matched subgroups of patients who are mostly likely to benefit from novel targeted treatments
Antje Hoering, President & CEO, Cancer Research And Biostatistics

 

17.10 Key Considerations for Accelerating the Integration of Diagnostic Testing
• Building commercial diagnostic considerations earlier into clinical development Discussing infrastructure and the operationalization of CDx testing internationally
• Delivering NGS diagnostics in oncology, the value of panel based diagnostic testing, regulatory considerations for NGS panel based test development and approval
Benoit Destenaves, Director, Precision Medicine Lead, AstraZeneca

17.40 - 18.40 Panel Discussion: Multidimensional Biomarkers & Machine Learning Based Approaches for Precision Medicine
• Discussing the utility of multidimensional biomarkers in the translational and clinical space
• Distilling down complex biological signals into actionable biomarkers utilizing machine learning
• Evaluating the enhanced role of multiplexing in early biomarker selection

David Messina, Chief Operating Officer, Cofactor Genomics

Bonnie Anderson, Chairman & CEO, Veracyte

Wendell Jones, Principal Bioinformaticist & Scientific Advisor, Q2 Solutions

Gabriel Bien-Willner, Chief Medical Officer, Palmetto GBA

Yuri Fesko, Chief Clinical Officer, Oncology Strategic Collaborations & Medial Director, Oncology,  Quest Diagnostics

Douglas Adkins, Professor, Department of Medicine Oncology Division, Medical Oncology, Washington University School of Medicine in St. Louis

17.40 - 18.25 Panel Discussion: Executing Biomarker Driven & Diagnostic Enabled Clinical Trials
• Discussing the standard of care in precision immunotherapy – how are the use of biomarkers and diagnostics evolving to define response?
• How to best translate “continuum” biomarkers into robust patient selectors
• Analyzing timings for submitting PMAs and 510ks for companion diagnostics: When’s best to streamline clinical studies?
• How will precision medicine trials evolve given the hypercompetition for patient populations and sample biopsies?
• Is there a better way to manage studies and patient recruitment, particularly where a biomarker/disease is being heavily investigated, to get the maximum impact from every new trial?
• What Dx strategy do we use to support clinical drug development in cases of accelerated approval?
• How do you best match the assay used in the clinical study with the assay used in clinical practice?

Christina Bender, Exploratory Biomarker Lead, WW Oncology Commercialization, Bristol-Myers Squibb

Shirin Khambata Ford, Head, Precision Medicine, Clinical Biomarkers & Companion Diagnostics, Daiichi Sankyo

Alice Walsh, Head Analytics Innovation, Oncology Translational Bioinformatics, Bristol-Myers Squibb

17.40 - 18.25 Panel Discussion: Commercializing Diagnostics as Fit-For-Purpose in the Real-World Healthcare Setting
• Discussing International strategy for implementation of diagnostics in healthcare to create a global footprint
• Debating targeted vs broad panels and their comparisons for real-world application
• What are the respective roles and areas of improvement for CLIA and FDA regulation to drive advances in testing?
• How do you channel clinical and post market evidence generation to optimize access and uptake?
• Assessing the impact of platform cost pricing and TAT on the potential global commercialisation of a diagnostic-enabled therapeutic
• What impact does a centralized vs decentralized approach have on adoption and penetration?
• Discussing the role of the lab and their impact on precision medicine nearer patient care

Rebecca Brandes, Manager, Clinical Workflow Sales, Oncology Market Development, Agilent Technologies

Allison Ballmer, Vice President, Strategy & Business Development, Agilent Technologies

Philina Lee, Vice President, Commercial Strategy & Operations, Blueprint Medicines

Meggan Czapiga, Director, Companion Diagnostics, Autolus

6:25 pm End of Day One

6:30pm 10th Anniversary Clinical Biomarkers & World CDx Evening Reception