2023 Archived Content

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Cambridge Healthtech Institute’s 2nd Annual

Diagnostics Innovation and Market Access

Investment, Regulatory, Reimbursement, and Market Access Strategies for Advanced Diagnostics

MARCH 7 - 8, 2023 ALL TIMES PST

The COVID-19 pandemic has fueled explosive innovation, investment, and market opportunities for advanced diagnostics. Cambridge Healthtech Institute’s 2nd Annual Diagnostics Innovation and Market Access conference will highlight investment, regulatory, reimbursement, and market access strategies for advanced diagnostics and precision medicine in the post-pandemic era. An emerging technology showcase will highlight selected next-generation molecular diagnostic tests, AI and digital platforms, point-of-care and at-home diagnostics, and more.

Tuesday, March 7

2:00 pm

Chairperson's Remarks

Lon Castle, MD, CMO, Molecular Genetics & Personalized Medicine, eviCore Healthcare

2:05 pm

Payers 301: An Upper-Level Class

Lon Castle, MD, CMO, Molecular Genetics & Personalized Medicine, eviCore Healthcare

How do you get a Payer’s attention? Hint: e-mail, LinkedIn and TikTok won’t do it. To have meaningful conversations with a Payer, you have to get to know them. This session will review the different types of payers, what they are likely to find interesting and the types of risks they are willing to take. Passing this course should help you find common ground for partnerships.

2:35 pm

An Innovative Partnering Model to Generate Evidence and Increase Access to Genomic Medicine

Stacey DaCosta Byfield, PhD, MPH, Vice President, Genomic Health Economics and Outcomes Research, Optum Labs

Damon Hostin, Lead, Health System Market Access, Illumina, Inc.

Illumina and Optum Genomics started collaborating in 2021 with the vision to accelerate the evidence-based application and coverage of genomic testing and connect impact of genomics to the Quadruple Aim. Projects span: Core Market Access application value dossier reviews; real-world data evidence assessments; implementation studies – TCOC measurement; stakeholder engagement; and the newly formed Clinical Catalyst Program is a critical industry node to progress test acceleration by supporting innovative applications.

3:05 pm PANEL DISCUSSION:

Payer Partnerships: Urban Myth or Golden Ticket?

PANEL MODERATOR:

Lon Castle, MD, CMO, Molecular Genetics & Personalized Medicine, eviCore Healthcare

New tests can provide great value to payers — particularly when the test addresses a specific area of interest. In the words of Rick Blaine, a partnership in these areas can be “the beginning of a beautiful friendship.” But how does a lab gauge a payer’s interest? Our panel will discuss how their organizations identify partners for pilots and value-based contracts that benefit both the lab and the payer.

PANELISTS:

Michael Astion, MD, PhD, Medical Director & Clinical Professor, Lab Medicine, Seattle Children's Hospital

Matthew Fickie, MD, Senior Medical Director for Medical Policy, Highmark

Damon Hostin, Lead, Health System Market Access, Illumina, Inc.

John L. Fox, MD, Senior Medical Director for the Americas, Illumina, Inc.

Stacey DaCosta Byfield, PhD, MPH, Vice President, Genomic Health Economics and Outcomes Research, Optum Labs

3:35 pm

Diagnostic Coverage in the Digital Era: A Comparative Case Study of a Traditional RCT vs. a Simulated-Patient RCT

Randy David, Vice President, Life Science, QURE, a TRC healthcare brand

Clinical utility evidence is increasingly integral to establishing a diagnostic test or other commercial medical product as worthy of payer coverage and reimbursement. Study design and execution is often resource-intensive and time-consuming, with favorable results dependent on many external, non-scientific variables. Simulated-patient RCTs are a clinically-validated method of engaging physicians in scientific research, to quickly and affordably establish the requisite evidence for payer coverage and reimbursement.

3:50 pm

The Centinela™Diagnostics Platform Provides Commercial and Academic Research Labs with a Remarkably Content-rich, Cost effective, End to end solution for Complex Disease Research

William Page, MD, Senior Scientific Director, Diagnostics, Ciencia, Inc.

Our Centinela diagnostics platform has demonstrated extraordinary accuracy, precision, and cost efficiency in diagnosing very complex infectious conditions (Lyme,Covid). Leading research universities (SUNY Poly, UConn) and hospitals to collaborate on both bench research projects targeting high complexity/high cost diseases, and as a novel POC solution for an array of complex iconditions. We seek commercial collaborations to further expand our offering, and create licensing opportunities.

Refreshment Break in the Exhibit Hall with Poster Viewing (Sapphire Ballroom)4:05 pm

4:45 pm

Chairperson's Remarks

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

4:50 pm PANEL DISCUSSION:

Evaluation and Implementation of Multi-Cancer Early Detection Tests

PANEL MODERATOR:

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

Multi-cancer early detection promises to improve cancer diagnosis, treatment and patient care. However, introducing MCED technologies into clinical care requires evaluation and assessment of benefits and risks, potential outcomes, costs, and value. The multi-stakeholder expert panel will address how MCED will impact clinical care, outstanding challenges in evidence generation, test reimbursement, market adoption, and equitable patient access.

PANELISTS:

Philip E. Castle, PhD, Director, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health

Tomasz Beer, MD, CMO, Multi-Cancer Early Detection, Exact Sciences

Omar Perez, PhD, Head, Medical Diagnostics, AstraZeneca

Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC

Hakan Sakul, PhD, Vice President and Head, Diagnostics, Pfizer Inc.

Razelle Kurzrock, MD, Professor, Medicine, Associate Director, Clinical Research, Linda T. and John A. Mellowes Endowed Chair of Precision Oncology, Medical College of Wisconsin; CMO, Worldwide Innovative Network (WIN) for Personalized Cancer Therapy

Close of Day5:45 pm

Wednesday, March 8

Registration and Morning Coffee (Sapphire West Foyer)7:30 am

8:00 am

Chairperson's Remarks

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

8:15 am KEYNOTE PRESENTATION:

Failure: The Best Way to Learn

Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation

The thought of failure creates fear. The reality of failure creates opportunity. We must embrace failure and all it can teach. As Arianna Huffington said: “Failure is not the opposite of success – it’s part of success.” We will discuss how to think differently about failing – how to motivate yourself and your teams.

8:30 am PANEL DISCUSSION:

Diagnostics Innovation and Investment Trends

PANEL MODERATOR:

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

Diagnostics investing experts will review what is hot and what is not in the field. Technological trends and white spaces will be identified, and entrepreneurs will be given best practices to maximize chances for successful financing. The panel will also provide guidance to founders to optimize operational success post-financing and what to do in the event of a stumble, the dreaded pivot, or in dealing with failure.

PANELISTS:

Ajit Singh, PhD, Partner, Artiman Ventures

Nathan Davis, Analyst, RA Capital Management

Bruce J. Tromberg, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; Lead, NIH’s Rapid Acceleration of Diagnostic Technologies (RADx Tech) Program

Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation

Nick Naclerio, PhD, Founding Partner, Illumina Ventures

Transition to Sessions9:15 am

9:20 am

Chairperson's Remarks

Sherie Smalley, MD, Vice President & Medical Director, ADVI

9:25 am

Overcoming Challenges to Enhance Commercial Success of Advanced Diagnostics

Lauren Feldman, Vice President and Head, Value, Access, and Pricing, ADVI

An overview of key considerations for advanced diagnostic innovators to achieve reimbursement success in a competitive environment. This presentation will provide insights into how reimbursement planning can be incorporated into test development to optimize coverage and payment, observations on market access strategies that work and ones that don’t, and pitfalls to avoid when launching molecular diagnostics in the marketplace.

9:55 am

CVS Health and Tempus: Successful Partnerships are Built on Aligned Incentives

Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.

Brooke Byrd, PharmD, Clinical Oncology Pharmacist, Enterprise Oncology, CVS Health

A case study that explores the use of comprehensive Tempus sequencing for oncology patients in the CVS transform oncology program. The session will explore the motivating factors for both CVS Health and Tempus to enter into the partnership and how they stayed focused on shared incentives as the program moved forward.

10:25 am

Partnerships that Evolved Diagnostics for COVID-19 (and Beyond)

Tim Wesselman, CEO & Founder, Rosalind

A case study that presents a global collaboration effort as the key to unlocking increased performance and affordability of diagnostics. Join Rosalind as we discuss the national program for variant detection, genotyping-based identification, and what lies beyond COVID diagnostics in a partnership with the NIH Variant Task Force, Helix, Thermo Fisher, Aegis, Ovation, UW, & Rosalind.

Coffee Break in the Exhibit Hall with Poster Viewing10:55 am

11:35 am

Chairperson's Remarks

Sherie Smalley, MD, Vice President & Medical Director, ADVI

11:40 am

Horizon & Adaptive Biotechnologies: A Collaboration to Optimize Therapy for Multiple Myeloma

Shaunna Kobilis, National Director, Market Access, Adaptive Biotechnologies

Steven R. Peskin, MD, MBA, MACP, Senior Advisor, ADVI; Associate Clinical Professor, Medicine, Rutgers RWJ Medical School; Course Director, Internal Medicine Grand Rounds, Penn Medicine Princeton Healthcare

A case study to explore use of the ClonoSEQ test for minimal residual disease to optimize therapy for multiple myeloma patients. This session will explore both the payer and laboratory perspectives on why this collaboration was established, how it was implemented, and learnings for future collaborations.

12:10 pm PANEL DISCUSSION:

Key Factors to Building Successful Partnerships

PANEL MODERATOR:

Sherie Smalley, MD, Vice President & Medical Director, ADVI

Experts will present ideas on how to collaborate to demonstrate the value of advanced diagnostics and precision medicine. Panelists will share insights on the innovative partnerships they have established and the goals each aims to achieve.

PANELISTS:

Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.

Brooke Byrd, PharmD, Clinical Oncology Pharmacist, Enterprise Oncology, CVS Health

Shaunna Kobilis, National Director, Market Access, Adaptive Biotechnologies

Joe McKenna, Vice President, Commercial Partnerships & Growth Strategy, GRAIL

Enjoy Lunch on Your Own12:40 pm

Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing1:45 pm

2:25 pm

Chairperson's Remarks

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC

2:30 pm

PAMA Reform: Ongoing Efforts and Pathways Forward

Nicholas Halzack, MPH, Director, Health Policy, Roche Diagnostics

Since implementation of new Medicare Clinical Laboratory Fee Schedule rate-setting methodologies under PAMA began in 2017, there have been consistent efforts to delay and/or reform the underlying statute. Most recently, the Saving Access to Laboratory Services Act (SALSA) was introduced in 2022 which endeavored for long-term reform. This session will address some PAMA policy history, the contents of SALSA, ongoing reform efforts, and what might come next.

3:00 pm

Medicare's Transitional Coverage for Emerging Technology – Something Old and Something New

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC

Despite the confusion of reversing policies between the Trump and Biden administrations, Medicare remains committed to better pathways for new technologies. For 2023, the new title for these efforts is "TCET – Transitional Coverage for Emerging Technologies." CMS has held town halls and associations have chimed in with positions or webinars. TCET may flag renewed CMS interest in Coverage with Evidence Development, which is controversial with industry.

3:30 pm

Demystifying Molecular Diagnostics Coverage and Reimbursement in Medicare: MolDX

Gabriel Bien-Willner, MD, PhD, Medical Director, MolDx, Palmetto GBA

This talk will explore the complexities of molecular diagnostic billing for Medicare and provide explanations of the processes and requirements of submitting for coverage and reimbursement under existing or prospective policies.

Close of Conference4:00 pm