Cambridge Healthtech Institute’s Eighth Annual
Companion Diagnostics: Strategy & Partnerships
Diagnostics and Pharma: Reaching for Common Ground and Profitability
August 15-16, 2017 | Grand Hyatt Washington | Washington, DC

The co-development of drugs and diagnostics, i.e. companion diagnostics development, is delivering significant patient benefits, healthcare cost savings, and revenue opportunities. Historically, it carries out most technological advances both as IVD products and as laboratory developed tests with gene panels and even whole exome sequencing playing a role of companion tests. The space of companion diagnostics is highly sensitive to the regulatory and reimbursement fluctuations and it requires specific market access strategies. Cambridge Healthtech Institute’s 8th Annual Companion Diagnostics: Strategy & Partnerships conference is designed to facilitate knowledge and opinion exchange between pharmaceutical and diagnostics executives, translational scientists, clinicians, business experts, regulators, international companion diagnostics leaders, and other parties involved in drug-diagnostics co-development and precision medicine. Case studies of successful collaboration between pharmaceutical and diagnostics companies’ researchers and executives will be presented.

Final Agenda

Recommended Short Course(s)*

SC9: Genomics in the Service of Cancer Immunotherapy - Connecting DNA Repair, Mutational Processes and Genotoxic Therapy to Successful Cancer Immunotherapy

SC12: Regulatory Compliance in Advanced Diagnostics

SC13: Regulatory and Reimbursement Issues with Advanced Diagnostics and Circulating Biomarkers

*Separate registration required

TUESDAY, AUGUST 15

7:30 am Main Conference Registration & Morning Coffee

NEW PARADIGMS IN COMPANION DIAGNOSTICS

8:30 Chairperson’s Opening Remarks

Jonathan Pan, Ph.D., Head of Biomarker Strategy and Development, Aevi Genomic Medicine, Inc.

8:40 Liquid Biopsy as a Companion Diagnostics Platform: Is It Reliable and Robust?

J. Carl Barrett, Ph.D., Vice President, Translational Sciences, Onc iMed, AstraZeneca

The increased usage of circulating tumor DNA (ctDNA) sequencing for oncology clinical research demonstrates a critical need for sensitive and specific testing. While we have observed a high degree of concordance between single tumor mutations in tumor and plasma, several recent studies have highlighted a lack of concordance between plasma and tumor panel NGS gene panel testing due to biological and technical factors. While factors such as tumor heterogeneity and timing of plasma-tumor collection can lower concordance rates, discordance may also be due to technical factors. Assay analytical variance and the impact of reporting false positive variants are key factors that need to be addressed as plasma-based NGS testing is more widely incorporated into translational and clinical research.

9:10 Developing the Precision Medicine Opportunity Outside of Oncology

Jonathan Pan, Ph.D., MBA, Vice President, Head of Biomarker Strategy and Development, Aevi Genomic Medicine, Inc.

While oncology has been an area of focus, precision medicine principles and concepts are applicable in other diseases areas, such as CNS, GI and rare diseases. As R&D pipelines begin to build in these therapeutic areas, the focus begins to shift from a limit of detection issue as is the case in oncology to volume-base issues, from larger numbers of patients and larger germline variants that contribute to disease. In this talk, we explore some of these concepts and downstream considerations.

9:40 Beyond Oncology: Implementing New Technologies as Companion Diagnostics in Other Therapeutic Areas

David Chianese, Scientific Project Leadership, Precision Medicine and Diagnostics,GSK

Precision medicine is often associated with oncology where the ability to select patients based on target expression and/or genetic aberrations has resulted in increased efficacy. Yet, the use of biomarkers and companion diagnostics is becoming an important strategy to better identify the patients that will benefit the most from the safe and efficacious use of treatments in other therapeutic areas. Frequently, the detection of these biomarkers may require a different set of technologies for the development of these diagnostics. We will review the current state of precision medicine and its associated and emerging technologies within and outside of oncology.

10:10 Coffee Break in the Exhibit Hall with Poster Viewing

NEW PARADIGMS IN COMPANION DIAGNOSTICS (Continued) 

10:55 Chairperson’s Remarks

Joseph Krueger, Ph.D., CSO, Flagship Biosciences

11:00 Not All Panels Are Alike, an Assessment of Various NGS Panels for Measurement of Circulating Tumor DNA

Michael Teufel, Director Biomarker Strategy,Translational Medicine Oncology, Bayer AG

The success of precision medicine relies on sensitive and accurate technologies that reliably identify actionable targets. However, with the ever changing landscape of circulating tumor DNA and the availability of NGS platform panels, which panel makes the most sense to be used in early clinical studies and also has the capacity to be further developed into a companion diagnostic? In this talk an overview of how Bayer approaches new technologies will be reviewed in addition data from a pilot study that compared four leading companies in the circulating tumor DNA space will be discussed. As more and more pharma companies are including circulating tumor DNA measurements into their trials, it is important to understand which panel meets your expectations.

 11:30 Biomarker and Diagnostic Strategies for Making Precision Medicine a Reality in ImmunoOncology

Shirin Khambata Ford, Ph.D., Executive Director, Global Head Biomarker & Diagnostics, Oncology Global Medical Affairs, Merck

This presentation will focus on the development and implementation of the PD-L1 test globally to select patients for pembrolizumab treatment. It will also highlight some of the next generation biomarker approaches that are being utilized to optimally select patients who will benefit from anti-PD1 therapies such as gene expression profiling, microsatellite instability assessment and tumor mutation burden.

12:00 pm Rapid Diagnostics to Facilitate Pathogen-Specific Antibody Development for the Prevention of Staphylococcus aureus and Pseudomonas aeruginosa Ventilator Associated Pneumonia

Mark T. Esser, Ph.D., Sr. Director, Translational Medicine, Infectious Diseases and Vaccines, MedImmune

This presentation will discuss how MedImmune is using rapid diagnostics, next generation sequencing and classical microbiology in clinical trials to develop novel monoclonal antibodies for the prevention of P. aeruginosa and S. aureus Ventilator Associated Pneumonia.

12:30 A Meta-Network for Validating Liquid Biopsies Including Patients on New Immune Therapies

Pascal Puchois, Québec CEO, Trans-Hit Bio

Liquid biopsy has the potential to identify patients for a particular therapy and can monitor patients on therapy. This can be particularly useful for patients undergoing immune-oncology therapy. The best results are obtained using unique patient profiles, state-of-the-art processing, and specimen transport systems. Despite these efforts, the organization and conduction of large studies are slow and many times impractical. The development of an international consortium is one solution to these issues.

 1:00 Luncheon Presentation: Convergence of Next Generation Digital Health and Biomarker Technologies is Enabling a Transformation to Asymptomatic Medicine and Precision Health

Kevin Hrusovksy, Executive, Chairman & CEO, Quanterix

1:30 Refreshment and Cookie Break in the Exhibit Hall with Poster Viewing

CO-COMMERCIALIZATION OF DRUGS AND DIAGNOSTICS

2:00 Chairperson’s Remarks

Cecilia Schott, PharmD, MBA Vice President, Precision Medicine, Global Product & Portfolio Strategy, AstraZeneca

2:05 CO-PRESENTATION: Internal Commercial Capabilities for Precision Medicine

Cecilia Schott, PharmD, MBA., Vice President, Precision Medicine, Global Product & Portfolio Strategy, AstraZeneca

Lourdes Barrera, Ph.D., Global Capability Director, Diagnostics, AstraZeneca

Capability Building is a scalable approach that enables organizations to rapidly identify, build, and sustain the targeted capabilities needed to continuously improve performance and deliver impact. Diagnostics is a pillar of precision medicine and its complex evolution requires different approaches to build strong capabilities to systematically identify gaps, that can be fulfilled and result in greatest impact on the drug development and patient’s healthcare. As part of this approach, we developed The Core Diagnostic Capabilities Learning program, which underpins and connects the best learning assets on diagnostics ensuring a flexible approach that can be adapted to meet all cross-functional diagnostic needs.

2:35 From LDT to CDx: The First Example of a Comprehensive NGS Test Moving to FDA Approval and Impacts for CDx Development & Commercialization

Lakshman Ramamurthy, Global Regulatory Lead, Foundation Medicine, Inc

In December 2016, Foundation Medicine launched FoundationFocus™ CDx BRCA, the first FDA-approved next-generation-sequencing (NGS) companion diagnostic assay for the identification of women who may benefit from Rubraca™ (rucaparib), a PARP inhibitor. This presentation will discuss the development and FDA registration of FoundationFocus™ CDx BRCA and how the assay has fared in the companion diagnostic market – both successes and lessons learned. We will also discuss benefits and challenges of developing a pan-cancer platform, as Foundation Medicine is currently working with the FDA and CMS to bring FoundationOne®, our flagship assay for solid tumor cancers, through the parallel review process

3:05 The Next Frontier: Pursuing an IVD for a ctDNA-based NGS Panel

Daniel Simon, Vice President, BioPharma Business Development, GuarrdantHealth

With recent IVD approvals for NGS, multi-gene panels, and liquid biopsy testing, Guardant Health is seeking to combine all three. This presentation maps the path and discusses Guardant’s approach for obtaining a PMA approval at the intersection of three innovative advances in IVD approvals.

3:35 NGS Panels - from Patient Selection to CDx

Katarina Wikstrom, Ph.D., Director, US Operations, Almac Diagnostics, Almac Group

With recent IVD approvals for NGS, multi-gene panels, and liquid biopsy testing, Guardant Health is seeking to combine all three. This presentation maps the path and discusses Guardant’s approach for obtaining a PMA approval at the intersection of three innovative advances in IVD approvals.

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

4:50 PANEL DISCUSSION: Bridging the Gap between Pharma and Diagnostics

Moderator:
Cecilia Schott, PharmD, MBA Vice President, Precision Medicine, Global Product & Portfolio Strategy, AstraZeneca

• Two worlds – two languages, two goals?
• Ways to increase the value for the diagnostic partners
• Ways to maximize the outcomes for the pharma partners
• Current examples

Panelists: 

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

Gary Gustavsen, Partner Personalized Medicine, Health Advances

Katarina Wikstrom, Ph.D., Director, US Operations, Almac Diagnostics, Almac Group

5:50 Wine & Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing

6:50 Close of Day

WEDNESDAY, AUGUST 16

7:15 am Registration

7:30 Problem-Solving Breakout Discussions with Continental Breakfast

RxDx Partnerships

Moderators: Cecilia Schott, Ph.D., Vice President, Precision Medicine, Global Product & Portfolio Strategy, AstraZeneca

Lourdes Barrera, Ph.D., Global Capability Director, Diagnostics, AstraZeneca

• Building Partnerships Beyond Diagnostics Development
• Preparing for Launch of Drug/Diagnostics
• Building Internal Diagnostics Capabilities Through Partnerships

Beyond Oncology in Companion Diagnostics

Moderator: David Chianese, Scientific Project Leadership, Precision Medicine and Diagnostics,GSK

• What policy/regulatory changes are needed to improve CDX partnerships?
• What business models need to emerge to shift the paradigm in Precision Medicine?
• Is the current political climate supportive of Precision Medicine? How?

REGULATORY AND REIMBURSEMENT POLICIES AND THEIR IMPACT ON DRUG-DIAGNOSTICS CO-DEVELOPMENT

8:25 Chairperson’s Opening Remarks

Mitch Raponi, Ph.D., Vice President, BeiGene

8:30 Regulatory Considerations for Companion and Complementary Diagnostics

Hisani Madison, Ph.D., M.P.H., Scientific Reviewer, Division of Molecular Genetics and Pathology, OIR/CDRH, U.S. Food & Drug Administration

The U.S. Food and Drug Administration (FDA) regulates an array of products including drugs, devices and biologics. Certain regulatory considerations are required when different classes of products (i.e., a drug or device) require codevelopment to ensure the safe and effective use of the individual products. This talk will provide an overview of FDA’s regulation of in vitro diagnostic, highlighting companion and complementary diagnostics. We will also explore the concept of codevelopment and some emerging complexities that are unique to the precision medicine era.

8:50 Next Generation Companion Diagnostics: A Public Payer Perspective

Joseph Chin, M.D., M.S., Deputy Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)

9:10 CO-PRESENTATION: Commercialization of Companion Diagnostics: Specifics and Solutions

Companion diagnostics based upon next generation sequencing present opportunities and challenges to providers, patients and payers. These concepts will be discussed along with potential evidence gaps and standards from the research community.

Omar Perez, Ph.D., RAC, Director and Diagnostics Lead, Oncology Programs, Worldwide R&D, Pfizer Inc

Richard Watts, Vice President, Companion Diagnostic Partnerships. Global Business Development, QIAGEN

10:00 Partnership Strategy Evolution over the CDx Lifecycle  

Gary Gustavsen, Partner Personalized Medicine, Health Advances

A strong CDx partnership strategy that spans the lifecycle of the associated therapeutic is critical for success. Partnership considerations evolve from clinical development to post-launch when creative engagements are necessary to ensure that the CDx is an advantage to the therapeutic rather than a barrier. This discussion will utilize case studies to highlight the evolution of these partnership considerations.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

1:05 pm Luncheon Presentation: Bridging Studies: A Reality in the Clinical Development of Diagnostic Associated Oncology Drug Programs

Dan Snyder, President & CEO, MolecularMD

Precision medicine efforts are yielding breakthrough therapy designations with accelerated approvals. Many of these programs utilize a Companion Diagnostic. Best demonstrated practices indicate that a bridging strategy needs to be deployed to manage risk and meet compressed NDA submission timelines. All codevelopment programs prefer to avoid a bridging study, but reality dictates that a plan is needed. Experiences with codevelopment and case studies will be shared with the audience.

1:35 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing

1:35 Close of Companion Diagnostics: Strategy & Partnerships