From Lab to Launch

Four dynamic presentations by leading healthcare experts

• Securing Lab Market Access and Reimbursement in a Changing US Environment

• Navigating Complexities Related to Market Access and Commercial Implementation of IVDs in EU and Expanded Global Markets

• FDA & U.S. Healthcare Regulatory Considerations

• Best Practices When Pitching to VCs

The session will also include real-world case studies and references to established and innovative frameworks. Don’t miss this opportunity to gain understanding of actionable strategies in a fast-evolving diagnostics landscape.

This webinar is designed for diagnostic and CDx developers, biopharma executives, commercial teams, market access strategists, and cross-functional leaders involved in clinical validation, stakeholder engagement, and payer strategy across the precision medicine landscape & value channel.

Securing Lab Market Access and Reimbursement in a Changing US Environment

Dx product commercial success hinges on sustainable 3rd party payor reimbursement. This session outlines key considerations when launching a lab developed or in vitro diagnostic test (LDT / IVD) in the US market.

Damon R. Cox, RMC

Mr. Cox leads the healthcare consulting company, GenoSan, a specialty market access and reimbursement consulting firm with an emphasis on business development, payor value-based messaging and contracting, medical coverage/policy development, coding strategies, market analysis, and product pricing.

He has served in multiple senior healthcare roles including President & CEO of a medical device company, Chief Business Officer for a national next-generation sequencing (NGS) laboratory, Vice President of Health Plans (Market Access/Payor Strategy) for a leading national women’s health genetic testing laboratory, a U.S. Director of National & Strategic Accounts, and a U.S. National Sales Director for a multinational biopharmaceutical company.

His experience includes commercializing numerous specialty lab diagnostic and genetic tests, biotech injectables, and medical device products into diverse markets. Previous companies include Illumina, Johnson & Johnson, Allergan, AdvanDx, StreamDx, BioFire Diagnostics, and Counsyl Genetics.

Damon has been a contributing member of the Coalition for 21st Century Medicine (C21), the Association for Molecular Pathology (AMP), the American Clinical Laboratory Association (ACLA) Billing/ Reimbursement and CPT Coding Committees, the Coalition for Access to Prenatal Screening (CAPS) Steering Committee Director, a committee member of RadSite (an official Medicare accrediting body for diagnostic imaging), and an Executive Council Member for the National Association of Managed Care Physicians (NAMCP).

He presents nationally on the rapidly evolving diagnostic and genetic landscape, is a Registered Medical Coder (RMC), and brings an in-depth understanding of healthcare finance-related issues with expertise in establishing billing and reimbursement processes and protocols.

Damon is a highly decorated veteran military officer who has served as an Airborne Ranger Commander in the United States Army and is an accomplished private pilot.

Navigating Complexities Related to Market Access and Commercial Implementation of IVDs in EU and Expanded Global Markets

Bringing an in vitro diagnostic (IVD) test to market in the EU and ex-U.S. regions demands smart market access strategy, deep stakeholder engagement, and strong local partnerships.

In this session, we’ll explore the critical barriers to testing, implications to pharma and Dx innovators, and how precisely designed market development and Dx access strategies influence successful commercial implementation of IVD tests. We'll also highlight the importance of engagement with clinicians, HTA bodies, payers, laboratories, and strategic partners to ensure market readiness and long-term success.

Key takeaways:

• What are critical Dx access barriers that are unique/common to certain markets

• Building fit-for-market Dx strategies

• Stakeholder engagement strategies to drive clinical and commercial adoption

• Leveraging C-Lab platform to understand test adoption and geographical benchmarking

Presented by: Circular-Lab®

Amit Jain brings over 25 years of global experience in In vitro diagnostic (IVD)

development and commercialization, with a strong track record across oncology,

infectious diseases, general medicine, and digital health. His career spans leadership

roles in R&D, program management, business and corporate development, and

strategic consulting.

Amit is currently working as Chief Business Officer at Connect By Circular-Lab and is

responsible for leading the company's product and global expansion strategies. Prior to

Circular-Lab, Amit served as Vice President of Precision Medicine at Veranex, where he

played dual roles as Business Development Lead and Subject Matter Expert (SME). In

this capacity, he supported biopharma and diagnostics clients in market research,

capability building, and Rx/Dx strategy development, guiding projects from early-stage

innovation through commercialization launch, and Life Cycle Management.

Prior to Veranex, Amit was Managing Director at Diaceutics, where he led corporate and

business development initiatives while managing client engagements. At Leica

Biosystems, he led companion diagnostics (CDx) development programs oriented

towards global regulatory submissions.

At Immunetics, Amit headed Molecular Diagnostics programs for infectious diseases,

successfully advancing IVD tests from concept to commercial implementation in areas

such as multi drug resistant bacteria, invasive fungal infections, and parasite

identification.

Earlier in his career, Amit held client-facing technical consulting and application

development roles with increasing responsibility at Febit and Kamtek Inc.

Amit holds an MBA from Babson College (Massachusetts, USA) and an M.Sc. in

Genetics from Haryana Agricultural University (India).

María Fe Paz de Paz is a highly accomplished and innovative leader with over 20 years of

extensive experience in healthcare innovation, biotechnology, and strategic advisory.

She is the founder of Circular-Lab and has a remarkable track record of successfully

founding seven companies in this field, including Diaceutics.

Her impressive career spans leading multiple companies, holding key positions such as

Chief Medical Officer and President. She is a trusted advisor to major global

pharmaceutical, biotech, and diagnostic companies, and has provided strategic counsel

to investment funds, VCs, and governments on precision medicine strategies. Notably,

she has served as an external advisor to the European Commission, the European Union,

and the OECD, focusing on the effective integration of diagnostics and therapeutics into

drug development and market adoption pathways, particularly for companion

diagnostics (CDx) in oncology.

With a strong biomedical and laboratory background, María Fe possesses a unique

blend of creative thinking and entrepreneurial drive. Her expertise is evident in her prolific

publication record, numerous honors, awards, and patents, all contributing to her

significant impact on personalized medicine. She has also built an extensive global

network within the medical industry.

Beyond her professional achievements, María Fe is dedicated to philanthropic

endeavors, collaborating with cancer NGOs and founding children's NGOs in Africa and

Europe.

FDA & U.S. Healthcare Regulatory Considerations

Overview of key FDA regulatory considerations and go-to-market strategies for diagnostic products, including research use, investigational use, and commercial use cases, as well as key U.S. federal and state healthcare laws that apply to clinical laboratories and testing services. 

Eva Yin, JD, PhD, MPH

Eva F. Yin, PhD, MPH, JD, is a partner in Wilson Sonsini Goodrich & Rosati’s FDA & healthcare regulatory practice group. She advises life sciences companies at all stages of growth, including medical device, digital health, pharmaceutical, diagnostic, cosmetic, dietary supplement, and general wellness companies. Her areas of focus include providing strategic regulatory counseling; assisting companies with their go-to-market strategies and FDA regulatory pathways; regulatory review of clinical trial, research use, and commercial contracts, informed consents, advertising and promotional materials; assisting companies with their healthcare compliance program policies and procedures and risk assessment of business arrangements and fee structures under federal and state healthcare fraud and abuse laws; regulatory due diligence in diverse corporate transactions; and assisting manufacturers with their reporting obligations under the Sunshine Act.

Best Practices When Pitching to VCs

Positioning your product is key when engaging the investment community. This session explores the critical value components to help differentiate your offering from the rest of the market.

Matt Meyer, JD

High-impact life science C-level executive with broad experience and demonstrated success in large and small private and public biopharma and personalized medicine companies globally. Track record of building high-performing business/corporate development, commercial, digital health, strategic planning, financing and legal teams. Talented at articulating a vision, developing a strategy, and delivering high-impact results. Led in- and out-licensing and acquisition of multiple clinical-stage therapeutic and diagnostics assets, debt and equity financings of several private companies (including successful IPO), management of complex international Rx and Dx alliances, acquisition and sale of companies, and implementation of digital marketing and sales effectiveness programs.

Matthew has held diverse roles of increasing responsibility across a wide range of dynamic and successful private and public biopharma, digital health, med tech and diagnostics companies in the US and Europe, including Pfizer, Novartis, Myriad Genetics and CareDx.