Cambridge Healthtech Institute’s 10th Annual

Commercialization of Diagnostic Tests

Successful Strategies and Partnerships

August 26-27, 2020


Disruptive diagnostic tests are a critical part of the rapidly evolving health technology landscape. Traditional clinical laboratories and early-stage startup companies have entered the race of commercializing their products. Many of them struggle to evaluate the market and its offerings to come up with the strong market entry strategies that will optimize their business success. Others will find themselves making the decisions of production, distribution of products, and partnership strategy. Cambridge Healthtech Institute’s Tenth Annual Commercialization of Diagnostic Tests conference will convene key opinion leaders in product commercialization and discuss the current landscape and opportunities in diagnostic tests in addition to showcasing examples of those who have made their product launches successful.

Final Agenda

WEDNESDAY, AUGUST 26

10:30 am Registration

Plenary Keynote Session

11:30 AM Chairperson’s Remarks

11:35 Diagnostic Technologies that Will Shape Precision Medicine in 2020 and Beyond

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

Precision medicine is being driven by the ability to measure biomarkers at an unprecedented scale. New technologies that enable the measurement of proteomic and genomic signatures, engineered nanomaterials for diagnostics and imaging, smart watches, and new imaging modalities provide personalized profiling that can be used to guide therapies. In order for these technologies to have the greatest benefit, there will need to be profound changes in the entire diagnostics ecosystem.

12:05 PM PANEL DISCUSSION: What Technologies Will Shape Precision Medicine in 2020?

Moderator: Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia University Medical Center

Panelists: Jonathan Nowak, MD, PhD, Assistant Professor, Pathology, Harvard Medical School; Associate Pathologist, Brigham and Women’s Hospital

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

What is the clinical impact of some of the following technologies and what are the current bottlenecks and challenges that need to be surmounted? Examples of each will be given:

  • RNA sequencing
  • Single-cell sequencing and analysis
  • AI and machine learning
  • Tumor mutational burden measurement
  • Emerging uses of NGS
  • Tumor microenvironment
  • Multi-modality and transcriptomics
  • Microbiome

12: 35 Plenary Keynote Introduction

Charles Mathews, Principal, ClearView Healthcare Partners

12:45-1:15 Fireside Chat

Moderator: Charles Mathews, Principal, ClearView Healthcare Partners

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

1:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:45 Refreshment Break in the Exhibit Hall with Poster Viewing

NEW BUSINESS MODELS AND PARTNERSHIPS

2:15 Chairperson’s Opening Remarks

Charles Mathews, MPP, Principal, ClearView Healthcare Partners

2:20 Partnering to Drive Patient Impact and Growth at Exact Sciences

David Harding, Senior Vice President, Strategy and Business Development, Exact Sciences

Over the course of the last several years, Exact Sciences has made 3 crucial moves to accelerate patient impact and drive business growth: (1) Entered into a commercial partnership with Pfizer to drive patient and physician awareness of Cologuard and fundamentally increase adoption; (2) Forged a partnership with Epic to improve order management of Cologuard and eventually allow seamless ordering of the product within EHR systems; (3) Acquired Genomic Health to expand into entirely new areas of cancer patient care. Each of these actions positions Exact Sciences to serve an ever-greater number of patients on all phases of their journey.

2:50 Models and Partnerships for Bringing Genomics to Routine Health Care

Huntington Willard, PhD, CSO, Senior Vice President, Medical Affairs, Genome Medical, Inc.

As a national medical practice, our goal at Genome Medical is to facilitate genomic testing and downstream care for those whose clinical findings, family history, or interest in finding out their risk of actionable genetic disease indicates a need for genetic care. As a driver of commercial strategies, we establish key partnerships – with testing laboratories, employers, health systems, and treatment centers – that optimize access across a range of value-based products in both primary care and specialty care pathways.

3:30 Genetic Testing to Improve the Health of Millions of People Worldwide

Stephen Lincoln, PhD, Head, Scientific Affairs, Invitae

Invitae has rapidly grown to become one of the largest clinical genetics laboratories by providing high-quality, yet inexpensive medically actionable tests for hereditary cancer syndromes, cardiology, neurology, reproductive medicine, rare diseases, and proactive health assessment. Improving both access and utility of genetics in routine care requires more, however; in particular, laboratories must adopt new commercial models and new approaches to working with the medical community, the scientific community, and patients to deliver on the promise of personalized medicine. Our sponsored testing programs, use of chatbots and other tools to ease burden on clinicians, and clinical collaborations generating evidence of utility and effectiveness are each examples of this that we will discuss.

3:50 Optimized Lyophilization: Providing Options for You, Your Products, and Your IVD and RUO Customers

Meredith Pearcy, Application Consultant Business Development, BIOLYPH LLC

Lyophilization is the highest quality form of preservation, and LyoSpheres™ maximize the benefits of lyophilization. Enjoy room temperature stability, storage, and transport, more robust performance, greatly increased shelf life, superior ease of use, limitless reagent cocktails, instant rehydration, and device flexibility for your IVD and RUO products.

4:05 Sponsored Presentation (Opportunity Available)

4:20 Refreshment Break in the Exhibit Hall with Poster Viewing

NEW BUSINESS MODELS AND PARTNERSHIPS (CONT.)

5:05 Chairperson’s Remarks

Charles Mathews, MPP, Principal, ClearView Healthcare Partners

5:10 PANEL DISCUSSION

Moderator: Charles Mathews, MPP, Principal, ClearView Healthcare Partners

Panelists: David Harding, Senior Vice President, Strategy and Business Development, Exact Sciences

Huntington Willard, PhD, CSO, Senior Vice President, Medical Affairs, Genome Medical, Inc.

Stephen Lincoln, PhD, Head, Scientific Affairs, Invitae

  • Incorporating the consumer/patient into diagnostics
  • Potential value-added services that diagnostic players can provide
  • Innovative partnering models

INVESTMENT LANDSCAPE AND OPPORTUNITY FOR DIAGNOSTIC TESTS

5:40 PANEL DISCUSSION

Moderator: Roger Klein, MD, JD, Faculty Fellow, Center for Law Science and Innovation, Sandra Day O’ Connor Law School, Arizona State University; Expert, FDA & Health Working Group Federalist Society Regulatory Transparency Project

Panelists: Mark Jelley, Managing Director, OrbiMed Advisors LLC

Tom Miller, Founder and Managing Partner, GreyBird Ventures, LLC

William Harman, Senior Advisor, Special Limited Partner, VCFA Group

  • How to best frame value proposition
  • Investors’ portfolios in diagnostics space
  • The shift in Dx test investment and where this is going

6:40 Close of Day

6:40 Dinner Short Course Registration*

7:00 - 9:30 Dinner Short Courses*

Recommended Dinner Short Course*

SC8: The COVID-19 Case Study: Accelerated Development of Diagnostics for Novel Infectious Disease Threats

*Separate registration required.

THURSDAY, AUGUST 27

7:15 am Registration

7:30 Problem Solving Breakout Discussions with Continental Breakfast

HOW ONCOLOGISTS CHOOSE AND EVALUATE DIAGNOSTIC TESTS

8:25 Chairperson’s Remarks

Paul Gerrard, CMO and MolDX Director of Clinical Science, Palmetto GBA

8:30 PANEL DISCUSSION

Moderator: Paul Gerrard, CMO and MolDX Director of Clinical Science, Palmetto GBA

Panelists: Kashyap Patel, MD, CEO, Medical Oncologist, Hematology, Oncology, Internal Medicine, Carolina Blood and Cancer Care Associates

Additional Panelists to be Announced

  • Academic versus community hospitals’ requirements for diagnostics
  • Resources, processes, and outcomes
  • Reimbursement and regulations

9:30 Sponsored Presentation (Opportunity Available)

10:00 Coffee Break in the Exhibit Hall with Poster Viewing

SUCCESSFUL COMMERCIALIZATION STRATEGIES AND MARKET LAUNCH

11:00 Chairperson’s Remarks

Harry Glorikian, MBA, General Partner, New Ventures Funds

11:05 Launching Dx Tests Successfully: Is Product Performance and Regulatory Approval Sufficient?

Charudutt Shah, Director, Marketing, BioFire Products, Europe Middle East and Africa, BioMérieux

Launching innovative diagnostics tests has never been so challenging. You did all the right things – followed the voice of your customers, developed the product to meet performance requirements, conducted clinical validations, and obtained regulatory approvals. Yet, this is not sufficient to be successful in the marketplace. In fact, these are the prerequisites. This talk will cover several factors that drive successful commercialization and market access efforts required to make your product launch a success.

11:25 Foundation Medicine’s Strategy for Commercializing Liquid Biopsy Tests

Tesh Khullar, CCO, Foundation Medicine

Drawing from two decades of experience working in oncology, Foundation Medicine’s Chief Commercial Officer, Tesh Khullar, will discuss the importance of a patient-centered commercialization strategy. He will focus specifically on his team’s efforts to expand access to precision medicine for cancer patients through the company’s portfolio of comprehensive genomic profiling assays.

11:45 Current Planning and Strategy to Enter Companion Diagnostic Test Market at Guardant Health

Daniel Simon, MBA, Senior Vice President, BioPharma Business Development, Guardant Health

This presentation maps the path and discusses Guardant’s approach for entering the companion diagnostic test market.

12:05 pm PANEL DISCUSSION

Moderator: Harry Glorikian, MBA, General Partner, New Ventures Funds

Panelists: Charudutt Shah, Director, Marketing, BioFire Products, Europe Middle East and Africa, BioMérieux

Tesh Khullar, CCO, Foundation Medicine

Daniel Simon, MBA, Senior Vice President, BioPharma Business Development, Guardant Health

  • Define the priority checklist for executing a successful strategy and operational plan for commercializing diagnostic tests
  • Examine the process of bringing a product to market by highlighting all the key features required in today’s evolving healthcare environment
  • Financial resources needed to execute the project plan
  • Other key factors, including market entry strategy development, regulatory, reimbursement, health economic, key opinion leader engagement, and patient advocacy considerations

12:35 Sponsored Presentation (Opportunity Available)

1:05 LUNCHEON PRESENTATION: Commercialization of an IVD in a Changing Global Environment

Lynn Stephenson, PhD, Marketing Manager, Dx Manufacturing & OEM, MilliporeSigma

Changes in international standards and regulations have created challenges and roadblocks to the commercialization of diagnostic devices. The choice of a contract manufacturing (CM) partner with the expertise to provide guidance and manufacturing capabilities is one strategy diagnostics companies can use to mitigate risk. A well-chosen CM partner can accelerate the commercialization process by anticipating potential roadblocks. In this session, we will discuss best practices and key considerations for vetting contract manufacturing partners.

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

COMMERCIALIZING POINT-OF-CARE DIAGNOSTIC TESTS

2:15 Chairperson’s Remarks

Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.

2:20 CASE STUDY: From AIDS to Ebola, Commercializing Rapid Tests for Infectious Disease

Stephen Tang, PhD, President & CEO, OraSure Technologies, Inc.

OraSure CEO, Stephen S. Tang, PhD, will discuss OraSure’s experiences developing and commercializing industry-leading diagnostics to power public health. Dr. Tang will share OraSure’s experience commercializing its trailblazing rapid point-of-care tests for HIV and HCV, and its FDA-cleared, rapid antigen test for Ebola.

2:50 CASE STUDY: eRAPID Technology – A Universal Electrochemical Sensor Platform

Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University

A case of developing a sensitive and robust biosensor for early detection of allergies as part of Project ABBIE will be presented. I will also share my journey of how to transition from a university research project to a diagnostic start-up.

3:20 CASE STUDY: Federal Resources for Early-Stage Diagnostic Start-Up

Tiffani Lash, PhD, Program Director, National Institutes of Health

I will discuss the federal resources for early-stage companies that fall into the research portfolios of biosensors, platform technologies, and mHealth programs at NIH. NIBIB Point-of-Care Technologies Research Network will be explained, consisting of three centers charged with developing point-of-care diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need.

3:50 PANEL DISCUSSION: Commercializing Point-of-Care Tests – Translating Early-Stage Innovation

Moderator: Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.

Panelists: Stephen Tang, PhD, President & CEO, OraSure Technologies, Inc.

Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University

Tiffani Lash, PhD, Program Director, National Institutes of Health

  • Current status on bringing your technology to market
  • Key considerations for developing an early translational roadmap
  • Funding opportunities and business plan requirements
  • How do you develop your go-to-market strategy?
  • Attracting early strategic partners
  • What role are KOLs and/or institutions playing as you bring your technology to market?

4:20 End of Summit



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