Cambridge Healthtech Institute’s 11th Annual

Drug-Diagnostics Co-Development and Companion Dx

Innovative Strategies and Business Models in CDx and Precision Medicine

August 25 - 26, 2020 ALL TIMES EDT

The co-development of drugs and diagnostics delivers significant patient benefits, healthcare cost savings, and revenue opportunities. Historically, co-development brings about technological advances in IVD products and in laboratory developed tests with gene panels, whole exome and whole genome sequencing that play a role in patient selection. The space of companion and complementary diagnostics is highly sensitive to regulatory and reimbursement fluctuations, and it requires specific market access strategies. Cambridge Healthtech Institute’s 11th Annual Drug-Diagnostics Co-Development & Companion Dx 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 will be presented.

Tuesday, August 25

NOVEL INTEGRATED APPROACHES

9:05 am Leveraging Gene Expression Subgroups to Enrich Patient Population
Neeraj Adya, PhD, Head, Diagnostics, Genmab

Precision medicine is transforming treatment paradigms using complex biomarkers in the interpretation of clinical data. Biomarkers, such as TMB and GEP that can identify immune status of a tumor as well as the tumor’s microenvironment, may help optimize treatment decisions, individually or in combination. New technological innovations offer the capability to further develop this field. Potential considerations in approving an IVD for complex biomarkers will be discussed.

9:25 am

Fully Integrated Drug-Diagnostics Co-Development – A New Approach to Targeting Cancers with High Copy Number Amplification

Jason Christiansen, PhD, CTO, Boundless Bio, Inc.

Cancers driven by genetic amplification are dominated by poor prognosis, and have been a problematic target for therapeutics to date; however, the recent elucidation of ecDNA as a mechanism for supporting high copy number cancers and for driving tumor heterogeneity has also provided insight on previous therapeutic failures and new avenues for potential treatment. Using multiple laboratory approaches, new ecDNA specific targets can be identified to precisely select patient groups that can benefit from new treatments.

9:45 am The Importance of Shaping the Precision Medicine Ecosystem
Kara O’Brien, Senior Director, Global Precision Medicine Strategy, Novartis Oncology

With the growth in on-market targeted therapies & strong precision medicine oncology pipelines the importance of shaping the associated ecosystem is increasing in importance.

Mark Landers, Vice President BioPharma Business Development, Guardant Health

As precision medicine continues to evolve, so does the role of liquid biopsy.  At Guardant Health, we work with our pharma partners to provide value from biomarker discover, to companion diagnostic development through commercial launch.

10:30 am Coffee Break - View Our Virtual Exhibit Hall

NAVIGATING POLICIES & MARKETS, AND PARTNERING WITH PATIENTS

10:45 am

From Proof-of-Concept to Market Approvals: Regulatory Insights into Drug and Diagnostic Co-Development Programs in Oncology

Eunice Lee, PhD, Executive Director, Global Regulatory Affairs, Merck & Co, Inc.

Biomarker diagnostics play a critical role in guiding decision making and delivering precision medicine to patients. This session will describe successful co-development cases that illustrate different approaches for incorporating biomarkers into drug clinical trials, and highlight the opportunities and challenges of co-development strategies for complex biomarkers, low frequency molecular subsets, and tumor agnostic indications. In addition, the current regulatory framework for companion diagnostics will be discussed in the context of recent FDA proposals for broader labeling of companion diagnostics for oncology therapeutics.

11:00 am FDA Perspective: Regulatory Framework for Co-Development of Companion and Complementary Diagnostics with Therapeutic Products
Reena Philip, PhD, Director, Division of Molecular Genetics and Pathology, CDRH, FDA

Precision medicine uses approved CDx tests to select patients to receive the right drug, at the right dose, and at the right time. Addressing regulations for drug and companion diagnostics has challenges running the gamut, from global clinical trial enrollment, to co-approval, to post-market commitments.

11:20 am

CDER Perspective on Drug-Diagnostics Co-Development: Leading Industry Partnerships by Example

Julie Schneider, PhD, Associate Director for Research Strategy and Partnerships, Oncology Center of Excellence, FDA
Charles Mathews, Principal, ClearView Healthcare Partners

Successful commercialization of Rx/Dx combinations requires alignment between pharma and Dx players in a number of key areas.  In this session, we will review a framework to organize market development, test execution dynamics, quality, market access, partnering best practices.  We will also discuss innovative Dx life-cycle management concepts. 

11:55 am Navigating Policies and Markets
Christine Vietz, PhD, Senior Vice President, Product Development, Foundation Medicine Inc.

This presentation will share the Foundation Medicine perspective and case studies in oncology and other therapeutic areas.

12:15 pm Lunch Break - View Our Virtual Exhibit Hall

HARNESSING POLICIES AND PARTNERING WITH PATIENTS (CONT.)

12:45 pm Best Practices and Study Design Options for Incorporating Biomarker Strategies to Expedite Drug and Diagnostic Development
Jennifer Shen, PhD, Director, Regulatory Affairs, ORIC Pharmaceuticals

With more personalized medicines being approved and available for patients with cancer, a wealth of knowledge and experience with developing targeted oncology therapies has accumulated in recent years. By delineating the development strategies that led to recent oncology therapeutic and diagnostic approvals, common patterns in study designs and development approaches can be identified. Building on these successful co-development examples, this presentation aims to discuss when and how to incorporate a biomarker strategy into a clinical trial to expedite drug development, and to consider best practices for co-development of a companion or complementary diagnostic.

1:05 pm Opportunities for Optimizing Co-Development of Drugs and Diagnostics
Mark Stewart, PhD, Vice President, Science Policy, Friends of Cancer Research

Molecular diagnostic tests are being used with increasing frequency, especially in oncology. Opportunities and strategies to help guide clinical trials for drug-diagnostic co-development are necessary to align patient and regulatory needs in the era of breakthrough drugs and complex biomarkers.

1:25 pm LIVE Q&A:

Session Wrap-Up

Panel Moderator:
Eunice Lee, PhD, Executive Director, Global Regulatory Affairs, Merck & Co, Inc.
Panelists:
Reena Philip, PhD, Director, Division of Molecular Genetics and Pathology, CDRH, FDA
Charles Mathews, Principal, ClearView Healthcare Partners
Julie Schneider, PhD, Associate Director for Research Strategy and Partnerships, Oncology Center of Excellence, FDA
Christine Vietz, PhD, Senior Vice President, Product Development, Foundation Medicine Inc.
Jennifer Shen, PhD, Director, Regulatory Affairs, ORIC Pharmaceuticals
Mark Stewart, PhD, Vice President, Science Policy, Friends of Cancer Research
2:10 pm Refresh Break - View our Virtual Exhibit Hall

PRECISION MEDICINE BEYOND ONCOLOGY: FDA & PHARMA PERSPECTIVE

2:30 pm RWD in Precision Medicine and Companion Diagnostics: FDA’s Perspective
Wendy Rubinstein, MD, PhD, Director, Personalized Medicine, Center for Devices and Radiological Health, FDA

This presentation will address real world data considerations and how RWD can be utilized for regulatory purposes.

2:50 pm PANEL DISCUSSION:

Companion Diagnostics and Precision Medicine beyond Oncology

Panel Moderator:
Renee Yura, PhD, Director & Lead, Diagnostics, Pfizer Inc
  • Best practices and lessons learned within oncology that can likely be applied outside of oncology
  • Challenges for precision medicine and CDX outside of oncology, e.g. lack of familiarity with CDX process in other therapeutic areas, opportunity for classifiers/gene signatures vs 1 gene target model often seen in oncology
  • Best practices or advice to overcome said challenges e.g. identification of the right biomarkers early, introducing CDX as early as possible, implement effective experiment design
  • Consortia and collaborations to move personalized medicine beyond oncology
Panelists:
Wendy Rubinstein, MD, PhD, Director, Personalized Medicine, Center for Devices and Radiological Health, FDA
Mark Curran, PhD, Vice President, Companion Diagnostics, Immunology Therapeutic Area, Janssen R&D LLC
Jason Christiansen, PhD, CTO, Boundless Bio, Inc.
Neeraj Adya, PhD, Head, Diagnostics, Genmab
3:30 pm Happy Hour - View Our Virtual Exhibit Hall
4:00 pm Close of Day

Wednesday, August 26

ACHIEVING REIMBURSEMENT SUCCESS IN THE ERA OF PRECISION MEDICINE

9:00 am

Chairperson's Remarks

Joseph Ferrara, President & CEO, Boston Healthcare
9:05 am The Reimbursement Outlook for Liquid Biopsy: Liquid Gold or Fool’s Gold?
Mark Hiatt, MD, MBA, MS, Vice President, Medical Affairs, Guardant Health

Liquid biopsy represents a revolution in cancer care, precipitating seismic paradigm shifts: (1) from tissue- to liquid-diagnosis; (2) from single- to multi-gene panels; (3) from tumor-specific to tumor-agnostic diagnosis and treatment; and (4) from late-stage detection to screening. The acceptance (and consequential reimbursement) of liquid biopsy will depend upon these pivotal transitions in thought and technology.

Joseph Ferrara, President & CEO, Boston Healthcare

The testing paradigm in precision oncology is growing increasingly complex, including multi-gene, multi-modality approaches. Add to this the considerations of clinical, policy, and funding stakeholders and geographic variability in test access, and routine companion diagnostic testing becomes a goal that often takes too long to reach. The talk outlines typical barriers encountered, and some key planning and mitigation approaches that biopharmaceutical and diagnostics companies can take to meet key commercial implementation challenges in precision medicine.

9:50 am

NGS-Based Companion Diagnostic Access

Maude Champagne, Associate Director, Market Access Strategy, Illumina

Access and reimbursement are key factors in a successful diagnostic product go-to-market strategy. For a companion diagnostic, the complexity increases based on the pharmaceutical partner(s)’ drug access timeline, regulatory considerations, and fast changing or opaque in-country diagnostic access framework. This session will outline some key considerations in building a roadmap for CDx access.

10:10 am PANEL DISCUSSION :

Joining Forces to Achieve Co-Commercialization Success for Drugs and Diagnostics

Panel Moderator:
Joseph Ferrara, President & CEO, Boston Healthcare
  • Aligning commercialization activities and timelines
  • Understanding global commercial dynamics and complexity
  • Best practices in establishing partnerships: Cross-industry, payers, distributors, etc.
  • Stakeholder engagement and value communication
Panelists:
Kara O’Brien, Senior Director, Global Precision Medicine Strategy, Novartis Oncology
Maude Champagne, Associate Director, Market Access Strategy, Illumina
Mark Hiatt, MD, MBA, MS, Vice President, Medical Affairs, Guardant Health
10:30 am Coffee Break - View Our Virtual Exhibit Hall
10:40 am Problem Solving Discussions and Coffee Break - View Our Virtual Exhibit Hall

BREAKOUT 6: Disruptive Technologies and Approaches for Companion Diagnostics and Clinical Biomarkers

Neeraj Adya, PhD, Head, Diagnostics, Genmab

PLENARY KEYNOTE SESSION

11:10 am

Organizer's Opening Remarks

Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute
11:15 am

Ultrasensitive SARS-CoV-2 Protein Assays for Precision Clinical Decisions

 

David Walt, PhD, HHMI Professor; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School; Professor of Pathology, Department of Pathology-Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University

We have developed ultrasensitive single molecule assays for multiple relevant SAR-CoV-2 proteins that can detect both active virus and prior infection. The assays have been tested in thousands of individuals, including patients and healthcare workers and exhibit exceptional sensitivity and specificity. Additionally, we have followed these protein concentrations over time during the course of disease in many patients and can predict outcomes based on the dynamics of the protein responses.

 

11:40 am PANEL DISCUSSION :

Lessons Learned for Diagnostic Testing During the COVID-19 Pandemic

Panel Moderator:
Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center
  • Supply chain challenges
  • Navigating and validating multiple platforms
  • Reimbursement
  • Value of distributed testing
  • Value of tests available: PCR vs. antigen vs. serology
  • Developing sustainable testing protocols
Panelists:
Alex Greninger, MD, PhD, MS, MPhil, Assistant Professor, Laboratory Medicine, University of Washington
Jordan S. Laser, MD, Medical Director, Department of Pathology and Laboratory Medicine; LIJMC; Associate Medical Director, Core Laboratories; Director, Division of Near Patient Testing, Northwell Health; Associate Professor, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
David Walt, PhD, HHMI Professor; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School; Professor of Pathology, Department of Pathology-Brigham and Women’s Hospital; Core Faculty, Wyss Institute for Bioinspired Engineering, Harvard University
Alex Greninger, MD, PhD, MS, MPhil, Assistant Professor, Laboratory Medicine, University of Washington
Charles Mathews, Principal, ClearView Healthcare Partners
12:30 pm PANEL DISCUSSION : Fireside Chat
Panel Moderator:
Charles Mathews, Principal, ClearView Healthcare Partners
Panelist:
Sara Brenner, MD, MPH, Associate Director for Medical Affairs; CMO, In Vitro Diagnostics, Office of In Vitro Diagnostics & Radiological Health (OIR), Office of Product Evaluation & Quality (OPEQ), Center for Devices & Radiological Health (CDRH), U.S. Food & Drug Administration
12:55 pm Lunch Break - View Our Virtual Exhibit Hall
1:25 pm Close of Drug Diagnostics Co-Development and Companion Dx Conference