Cambridge Healthtech’s 9th Annual
Commercialization of Diagnostic Tests
Current Landscape and Successful Strategies
August 21-22, 2019
Disruptive diagnostic tests are a critical part of the rapidly evolving health technology landscape. However, disruptive technologies are only disruptive when they become available. To do that, many traditional clinical laboratories and early stage startup
companies have entered the race of commercializing their products and struggle to evaluate the market and its offerings to come up with the strong market entry strategies that will optimize their business success. Cambridge Healthtech Institute’s
Ninth Annual Commercialization of Diagnostic Tests conference will convene key opinion leaders in product commercialization, discuss the current landscape and opportunities in diagnostic tests in addition to showcasing examples of those who have made
their successful product launches.
Final Agenda
WEDNESDAY, AUGUST 21
10:30 am Registration
Constitution A&B
11:30 Plenary Keynote Session
11:30 Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
11:40 NEW: Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future
Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.
12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)
Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
- How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
- How are policymakers addressing the role of CMS and CLIA in the VALID Act?
- How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
- What impact will changes in diagnostics regulation and oversight have on patient care?
Panelists:
Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)
Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings
Susan Van Meter, Executive Director, AdvaMedDx
Tara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)
Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:35 Ice Cream & Cookie Break in the Exhibit Hall with Poster Viewing
2:05 Chairperson’s Opening Remarks
Roger D. 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
2:10 NEW: PANEL DISCUSSION: Regulation and Policy for Diagnostic Tests – Enhancing or Restricting the Innovation and Progress In Diagnostics?
Moderator: Roger D.
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: NEW: Alberto Gutierrez, PhD, Partner, NDA Partners
Eric Konnick, MD,
MS, Assistant Professor; Associate Director, Genetics and Solid Tumors Laboratory, University of Washington
Brad Spring, VP, Regulatory
Affairs, BD Diagnostic Systems
Paul Gerrard, Chief Medical Officer and MolDX Director of Clinical Science, Palmetto GBA
- Differences between in vitro diagnostic test kits and laboratory developed tests and the needs of their respective customers
- Current legislative proposals that would revamp FDA's current regulatory paradigm for regulation of in vitro diagnostic tests
- Potential ways to modernize to CLIA to meet perceived regulatory gaps
- FDA approaches in the face of Trump-era regulatory philosophy
- The role of Medicare and its contractors as regulators through payment pathways and processes
- Regulatory approaches to test regulation in Europe
3:10 NEW: DTC/Patient Initiated Genetic Testing – Regulatory Landscape
Sheila D. Walcoff, J.D., CEO, Founder, Goldbug Strategies LLC
DTC/“Over the Counter” genetic tests that are initiated by consumers/patients rather than clinical physicians, are the most disruptive health technology of this decade. Combining clinical laboratory sequencing diagnostics with highly innovative
digital health information systems, digital health/artificial intelligence (AI) companies and clinical laboratories need to understand FDA regulatory requirements and dynamic compliance risk to develop and implement effective commercialization
strategies. Following the landmark FDA’s first-of-a-kind authorization of 23andMe’s DTC pharmacogenetic test system, establishing the federal regulatory framework for marketing “clinical grade” in vitro diagnostic
genetic test kits marketed directly to consumers/patients, FDA stepped up its enforcement activity against clinical laboratories and digital health companies with safety alerts warning physicians and patients about patient initiated genetic tests
that have not undergone FDA review. In an April 2019 Warning Letter to Inova Genomics Laboratory, FDA declared that certain LDTs ordered by the company/laboratory physicians “pose significant risks to patient safety.”
In that strongly worded letter, FDA further emphasized that, to protect public health, it can and will take enforcement action against LDTs for failing to comply with “premarket review and other FDA legal requirements that do apply to LDTs.”
As 23andMe’s external FDA regulatory counsel and nationally recognized FDA regulatory advisors for LDTs, digital health/AI, and NGS companion diagnostics, Goldbug Strategies is at the forefront of the evolving FDA regulatory landscape.
Sheila D. Walcoff, former FDA Associate Commissioner and the CEO and Founder of Goldbug Strategies, will discuss the evolving FDA regulatory landscape for commercializing genomic testing and information services.
3:40 Is Your IVD Software Prepared for the New IVD Regulations Coming in 2022
Nancy Knettell, Founder, Principle, SoftwareCyber510K, LLC
In vitro diagnostic (IVD) medical device Software, whether standalone or on a device, will now face a higher level of Regulatory Compliance based on the new IVD Regulations (IVDR) coming in May 2022. Any IVD Companies interested in commercializing
their IVD Software will also now require FDA 510K Clearance to be able to sell their products. Learn what is required to successfully support the IVDR standard/510k regulatory requirements by ensuring IEC62304 Compliance with software.
4:10 Refreshment Break in the Exhibit Hall with Poster Viewing
4:55 Chairperson’s Remarks
Roger D. Klein, MD, JD, Yale University; Principal, Consulting and Klein & Klein Co.
5:00 Genomic Health: Launching a Paradigm Shift ... and an Innovative New Test*
Joshua
Krieger, PhD, Assistant Professor, Entrepreneurial Management Unit, Harvard Business School
A business case study on “Genomic Health” will be presented. This case explores the decisions the Genomic Health team had to make in defining the marketing plan, pricing, and reimbursement strategies that would give it the greatest
chance of success in bringing its new product to market. This is an interactive session and the case material will be provided beforehand with a question list to be discussed during this session.
Learning Objective
To introduce market dynamics within the diagnostics segment of the medical devices industry, including issues related to traditional and emerging diagnostics business models, product development, government regulation and reimbursement; to
understand of how advancements in genomics impact the traditional diagnostics market and their potential effects on payers, patients, physicians, and the larger health care system; and to introduce the constraints, opportunities, and trade-offs
associated with launching an innovative product that also represents a paradigm shift within the traditional diagnostics industry.
Questions to be Discussed
1. How does Oncotype DX create value?
2. What determines the price that Genomic Health can charge for the diagnostic? Who influences the pricing decision? Ultimately, what should they charge?
3. What are the business challenges for diagnostic companies and why is it hard to turn services into profit?
*The case study materials have been sent out to attendees who signed up for the Commercialization of Diagnostic Tests meeting track to review PRIOR to this interactive session. If you have not received the case study materials or did not sign up for this track but wish to attend this session, please contact Emily Le at ele@healthtech.com for the case study.
6:30 Close of Day
6:30 Dinner Short Course Registration
6:45 - 9:15 pm Recommended dinner Short Course*
SC14: Generating Evidence and Creating a Winning Dossier for Regulatory and Reimbursement Needs
Mark Hiatt,
MD, Vice President, Guardant Health
John Sninsky, PhD, Consultant, Translational Sciences
Managing the clinical narrative for your diagnostic test requires careful evaluation of the evidentiary requirements of stakeholders. Using those evidentiary requirements to determine your clinical and economic study designs is the cornerstone
of effective product development.
*Separate registration required.
THURSDAY, AUGUST 22
7:15 am Registration
Independence B-E and Foyer
7:30 Problem Solving Breakout Discussions with Continental Breakfast
IVD Regulatory Paths: What is FDA Looking for?
Moderator: Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.
- De Novo submissions: timing and benefit/risk
- Companion Diagnostics: broad claims IHC, ISH, Digital Pathology: study designs
- Next-Gen Testing: intended use claims
- CLIA Waiver & Point of Care Devices
8:25 Chairperson’s Remarks
Larry K. Wray, PhD, Wray IVD Consulting
8:30 Bringing Single-Cell Genomics to the Clinic
Charlie Silver, Co-Founder, CEO, Mission Bio
Mission Bio provides targeted single-cell DNA solutions for high-impact applications, including oncology and CRISPR validation. Our technology helps cancer centers and drug companies identify every diseased cell so they can deliver durable
treatments. Our journey from university spin-out through launch and scale-up will be discussed.
8:50 Real-time in vitro Diagnostic Results at the Point-of-Care
Cary Gunn, PhD, Founder, CEO, Genalyte
The Maverick Detection System performs real-time detection of macromolecules in crude samples using biologically functionalized silicon photonic biosensors lithographically printed on disposable silicon chips. Test results are available
in 10-30 minutes depending on the type of assay performed. Our story of how we get to where we are will be discussed.
9:10 Commercializing Guardant360, The Industry Leading Liquid Biopsy
Nnamdi Ihuegbu, PhD, Director, BioPharma Business Development, Guardant Health
Commercializing a complex diagnostic while developing a new market requires a multi-pronged and multi-year approach. Changing MD behavior requires clinical utility data, KOL endorsement, clinical guideline support, clarity around patient
financial burden and reimbursement, a product that fits into practice, as well as traditional field force pull through. There are no shortcuts.
9:30 The Development and Commercialization of Companion Diagnostic (Cdx) Tests for Targeted Oncology and Immuno-Oncology Therapeutics
Lucas
Dennis, PhD, Director Clinical Product Development, Foundation Medicine Inc.
Through continued innovation, Foundation Medicine is dedicated to improving outcomes for individuals living with cancer. Our approach combines genomic profiling products and data services to generate insights that can help doctors match
patients to treatment options, as well as accelerates the development of new therapies. Our story will be discussed.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 PANEL DISCUSSION: Product Launch and Market Entry Approaches
Moderator: Larry K. Wray, PhD, Wray IVD Consulting
Panelists: All Speakers in the Session
- Current status on bringing your technology to market
- How do you develop your go-to-market strategy?
- What role did reimbursement play in your strategy and how did you address that?
- What were/are the major challenges incorporating your technology into healthcare and how did or are you addressing those? Are you planning on having your products incorporated into guidelines?
- How are regulatory requirements addressed as part of the marketing plan?
- What role are KOLs and/or institutions playing as you bring your technology to market?
11:50 PANEL DISCUSSION: From the Lab to the Market- Translating Early Stage Innovation and Successful Partnership Strategies
Moderator: Albine Martin, PhD, Executive in Residence, Johns Hopkin University
Panelists: Henry Ahn, Program Director, SBIR/STTR, Industrial Innovation and Partnerships, Directorate for Engineering, National Science Foundation (NSF)
Yukari C. Manabe, MD, Professor of Medicine, Infectious Diseases, Medicine, Johns Hopkins University School of Medicine
- Key considerations for developing an early translational roadmap and Angel Investment criteria
- Funding opportunities and business plan requirements
- Attracting early strategic partners
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 Dessert Break in the Exhibit Hall with Poster Viewing
2:15 Chairperson’s Remarks
Aldo Carrascoso, PhD, CEO, InterVenn
2:20 How Diagnostic Tests are Being Evaluated and Adopted at the Minute Clinic
Alexander Sbordone, JD, OTR/L, Senior Advisor, Operations, MinuteClinic, CVS Health
I will discuss the process and cycle that CVS MinuteClinic uses to evaluate new diagnostic tests. Criteria for efficiency, sensitivity, accuracy, robustness and cost will be reviewed.
2:50 Lessons Learned from Raising Capital for Diagnostic Start-Ups
Aldo Carrascoso, PhD, CEO, InterVenn
Venture capitalists have tended to shy away from diagnostics companies, whose products are not predicated on the blockbuster model of pharmaceuticals. However, several new diagnostics companies are developing products that can improve
healthcare delivery. It is in the start-ups’ hands to change this mindset and prove its added value to advance the standard of care. Lessons learned from raising capital for Dx start-ups will be discussed.
3:20 PANEL DISCUSSION: Commercialization and Validation of NGS Diagnostics
Moderator: Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA
Panelists:
Charles Chiu, MD, PhD, Professor, Laboratory Medicine and Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine
Kimberly Hanson, MD, MHS, Director, Transplant Infectious Diseases and Immunocompromised Host Service, Director, Medical Microbiology Fellowship Program, Section Head, Clinical Microbiology, University of Utah, ARUP Laboratories
- FDA submission guidelines and submission strategies
- Comparative methods
- Lab validation vs point-of-care
- Strategies around regulation and commercialization
4:20 End of Summit