Diagnostics Innovation and Market Access Track Banner

Cambridge Healthtech Institute’s Inaugural

Diagnostics Innovation and Market Access

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

February 22-23, 2022


The COVID-19 pandemic has fueled explosive innovation, investment, and market opportunity for advanced diagnostics. Cambridge Healthtech Institute’s Inaugural 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, February 22



1:00 pm

Chairperson's Remarks

Lisa M. Suennen, Lead/Senior Managing Director, Digital & Technology Group, Manatt Phelps & Phillips LLP
Anne Wyllie, PhD, SalivaDirect Principal Investigator, Research Scientist, Epidemiology of Microbial Diseases, Yale School of Public Health
1:15 pm

Innovating Diagnostics to End a Pandemic: The RADx Tech Experience

Steven Schachter, MD, Professor, Neurology, Harvard Medical School; Chief Academic Officer and RADx Chief, CIMIT

Rapid Acceleration of Diagnostics (RADx) Tech is an NIH-funded program launched on April 29, 2020, to accelerate development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to clinical laboratory tests, that can directly detect the virus that causes COVID-19 and its variants. After 15 months, the program generated 27 FDA Emergency Use Authorizations for COVID-19 diagnostic tests, including the first over-the-counter test for use at home without a prescription, and produced 500 million tests. RADx Tech has proven to be a model of academic-industry-government collaboration for translational medtech development.

1:45 pm

Innovative Tests for COVID-19, Future Pandemics, and Potential Use in Non-Pandemic Test Development

Timothy Stenzel, MD, PhD, Director, Office of in vitro Diagnostics and Radiological Health, FDA

Investing in Precision Medicine: Trends in Diagnostics, HealthTech and Digital Health

Panel Moderator:
Lisa M. Suennen, Lead/Senior Managing Director, Digital & Technology Group, Manatt Phelps & Phillips LLP

Precision Medicine is driven by the innovation continuum spanning genomics and diagnostics, MedTech and HealthTech, AI and Digital Health. The panel will explore investment opportunities and growth trends in the post-pandemic era, as well as the impact of precision medicine innovation on improving health outcomes and patient experience, managing healthcare costs, and advancing health equity.

Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC
Mara G. Aspinall, Managing Director, BlueStone Venture Partners, LLC
Jenny Rooke, PhD, Managing Director, Genoa Ventures
Taha Jangda, Partner, HealthX Ventures
Michele Colucci, Founder & Managing Partner, DigitalDx Ventures
2:45 pm Refreshment Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)



3:25 pm

Chairperson's Remarks

Michele Colucci, Founder & Managing Partner, DigitalDx Ventures
3:30 pm

Investing in Precision Medicine Diagnostics

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

GreyBird Ventures has an exclusive investment focus on precision diagnostics.  We have reviewed over 1500 diagnostic start-up firms investing in fewer than one for every 150 that we review.  We will present an overview of this experience, our thoughts about how we (and others) make diagnostic investment decisions, some advice for firms seeking funding, and present a few “Grand Challenges” in diagnostics that would automatically warrant careful consideration.

4:00 pm

COVID-19 Diagnostics: The Key to the Beginning, Middle & End of the Global Pandemic

Mara G. Aspinall, Managing Director, BlueStone Venture Partners, LLC

Diagnostics have never been more important or visible on the world stage as they are today in the midst of the COVID-19 global pandemic. Mara will speak about how COVID diagnostics have been developed, and how they are and should be used to fight the virus through timely diagnosis and monitoring – as well as introduce you to the largest database of COVID tests worldwide, TestingCommons.com, which she created with the team at Arizona State University and The Rockefeller Foundation. 

Bryan Bothwell, Senior Director of Strategy and Business Development, Qorvo Biotechnologies

The pandemic highlighted historical gaps in diagnostics infrastructure. Significant private and government resources have been activated, and Qorvo Biotechnologies has developed Point-of-Care diagnostics capability based on orthogonal technology to address todays testing needs. This presentation focuses on product technological innovation, the government partnerships that have established volume market access, and how this positions the platform for future testing success beyond COVID-19.

David Parker, Senior Vice President, Diagnostics Solutions, Precision for Medicine

Often, assay validation requires additional mutated or wild type samples to supplement reserved tissue from trial subjects. In response, Precision has embarked on a large-scale initiative to sequence curated samples from our massive tissue archive, Project P.O.S.I. – the Precision Oncology Sequencing Initiative. In this talk we will discuss how CDx development programs can be accelerated by overcoming the barriers of exhausted or insufficient clinical trial material with pre-characterized disease-specific specimens.  

5:00 pm

Tech-Nostics: An Industry in Transition

Michele Colucci, Founder & Managing Partner, DigitalDx Ventures

Technology has changed the way we diagnose and treat illness. A doctor used to diagnose using a stick and small flashlight. Doctors had an incredibly small amount of information. Today they have way too much. Diagnostics has evolved into Tech-nostics. Our understanding of genetics, epigenetics, microbiome, epibiome, proteome, communicome and virome, along with the diseases they spawn, has skyrocketed with new ways of collecting and analyzing data. We are innovating at the intersection of science, chemistry and technology. This tectonic shift is forever changing the way we think about, and approach, the science of medicine.

5:30 pm Close of Day

Wednesday, February 23

7:30 am Registration Open and Morning Coffee (Indigo West Foyer AB)



8:05 am

Chairperson's Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition
8:10 am

Personalized Healthcare in Big Pharma: A 2022 Perspective

Jeffrey Venstrom, MD, Chief Medical Partner, US Medical Affairs, Genentech

Realizing the promises of PHC can deliver improved outcomes for patients at a lower cost to them and to society. At Genentech, we believe the key to rapidly deploying personalized solutions and delivering optimal outcomes for patients faster is through strategic partnerships from a range of different sectors and disciplines across the healthcare system, collaborating and innovating together.

8:40 am

Increasing Access to Precision Medicine – The Next-Generation of Companion Diagnostics

Ruth E. March, PhD, Senior Vice President & Head, Precision Medicine & Biosamples, AstraZeneca

Precision medicine uses diagnostic tests to match the right drugs to patients most likely to respond. As science advances through the use of advanced analytics, artificial intelligence and integrated sources of biomarker data, we need a new generation of diagnostic tests. Following the patient journey in different treatment settings offers opportunities to all patients to be able to gain access to appropriate diagnostic solutions.


Implementing Precision Medicine at Big Pharma

Panel Moderator:
Edward Abrahams, PhD, President, Personalized Medicine Coalition

Over the past decade, precision medicine promised to impact drug development by targeting the right medicine to the right patient. The panel of pharma thought leaders will discuss strategies to implement precision medicine in the drug discovery and development pipeline, including biomarker and companion diagnostic development, patient stratification, precision oncology advances, and emerging molecular tools for disease characterization.

Jeffrey Venstrom, MD, Chief Medical Partner, US Medical Affairs, Genentech
Maria C. M. Orr, PhD, FRSB, Head of Precision Medicine, Biopharmaceuticals, AstraZeneca
Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.
Christopher Conn, PhD, Director, Companion Diagnostics, AbbVie
Andrea L. Stevens, PhD, Director, Precision Medicine Access Strategy, Janssen Pharmaceuticals, Inc.
9:40 am Coffee Break in the Exhibit Hall with Poster Viewing (Indigo BFGCDH)



10:20 am

Chairperson's Remarks

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates, LLC
10:25 am

Demystifying Molecular Diagnostics Coverage and Reimbursement in Medicare

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

MolDX is a program operated by PalmettoGBA to set molecular diagnostics policy and payor controls in 28 states. This talk will cover the scope and philosophy of the program, as well as provide instruction to providers on how to approach payors seeking coverage and reimbursement.

10:55 am

Medicare Local and National Coverage: How It's Shaping the Genomics Industry

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

Medicare remains one of the largest payors for molecular diagnostics, with over $1.5B in payments in CY2019. Both national and local decisions are coming out at a rapid pace, and the Medicare agency is so large it impacts both investment and development. Recent decisions reshape germline testing, cancer tissue testing, and preventive testing. Understand what areas are "pre-covered" and how your test can qualify. We'll also discuss implications for the 40% of patients in Medicare Advantage plans.

11:25 am

Commercial Test Coverage: Unlocking the Door

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

Only one hurdle remains: Commercial payer coverage. But the door is locked (and dead-bolted). Getting through seems impossible—but it’s not. All you need are the right keys. Fortunately, you can make them yourself. But they’ll only work if you adhere to certain specifications. In this session, we’ll talk about those specifications, how to make the keys you need, and what to expect on the other side of the door.

11:55 am Enjoy Lunch on Your Own
1:30 pm Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing (Indigo BFGCDH)


2:00 pm

Chairperson's Remarks

Damon Hostin, Lead, Health System Market Access, Illumina, Inc.
2:05 pm

Market Access in the Post-Pandemic Era: Leveraging Innovative Approaches to Drive Access

Brock Schroeder, PhD, Senior Director, Global Market Access Strategy & Health Economic Outcomes Research, Illumina, Inc.

Traditional market access – with a primary focus on coverage, coding, and reimbursement – is evolving. The COVID-19 pandemic has accelerated these changes and has created new challenges and opportunities. Innovative approaches, focusing on partnership and high-quality evidence generation, can help accelerate access.

2:35 pm

The COVID Effect: How Relationships Have Changed

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

Market access is a business of relationships. It is a business driven by market knowledge and how that market knowledge can be translated and communicated to industry stakeholders. The global pandemic has shifted the way we do business. This session will focus on redefining market access to align with our new realities.

3:05 pm

The Future of Clinical Diagnostics after the COVID-19 Disruption

David Cavanaugh, Founding Partner, DeciBio Consulting LLC

COVID-19 significantly disrupted the diagnostics industry as manufacturers raced to develop and manufacture millions of SARS-CoV-2 tests, testing laboratories struggled to source enough SARS-CoV-2 tests, governments and payers spent tens of billions of dollars on testing, investors entered to capitalize on this windfall and clinicians managed many of their patients remotely. We will examine this unprecedented moment in the history of diagnostics and how our world has changed.


3:35 pm Interactive Discussions (In-person only)

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

4:05 pm Session Break


4:15 pm

Engineering Biology for Diagnostic Solutions

William Blake, PhD, CTO, Sherlock Biosciences

Sherlock Biosciences is engineering biology to develop products that enable people to access answers and have more control over their health decisions. In this talk, we will discuss how Sherlock is harnessing proprietary CRISPR and synthetic biology tools, together with deep learning, to solve a range of diagnostic challenges in environments ranging from clinical labs to low resources areas, including the home. 

4:45 pm

Autonomous AI and Health Equity

Michael D. Abramoff, MD, PhD, Founder & Executive Chairman, Digital Diagnostics

Autonomous AI allows for immediate point-of-care diagnosis which can increase access, address health disparities, and lower costs. But to address health equity with AI it’s important to start with an ethical framework then address liability, standard of care, (FDA) regulation, CPT coding, reimbursement, and HEDIS/MIPS quality measurements. Autonomous AI can have a positive impact in healthcare, but it must be done the right way.

5:15 pm

Wearable Electrochemical Sensors for Healthcare, Wellness, and Nutrition Applications

Joseph Wang, PhD, Distinguished Professor & Chair, Nanoengineering, University of California, San Diego

Wearable sensors have received a major recent attention owing to their considerable promise for monitoring the wearer’s health and wellness. The medical interest for wearable systems arises from the need for monitoring patients over long periods of time. These devices have the potential to continuously collect vital health information from a person’s body and provide this information to them or their healthcare provider in a timely fashion. Such sensing platforms provide new avenues to continuously and non-invasively monitor individuals and can thus tender crucial real-time information regarding a wearer’s health. This presentation will discuss recent developments in the field of wearable electrochemical sensors integrated directly on the epidermis, under the skin, or within the mouth for various non-invasive and minimally invasive biomedical monitoring applications. Particular attention will be given to non-invasive monitoring of metabolites and electrolytes using flexible electrochemical sensors, to multiplexed microneedle sensor arrays, along with related materials, energy, and integration considerations. The preparation and characterization of such wearable electrochemical sensors will be described, along with their current status and future prospects and challenges.

5:45 pm Close of Conference

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