From Lab to Launch

Four dynamic presentations by leading healthcare experts

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

• Market Access in EU and other ex-US markets

• Regulatory Presentation

• Raising Capital

Securing Lab Market Access and Reimbursement in a Changing US Environment

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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.

Market Access in EU and other ex-US markets

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Presented by: Circular-Lab®

Precision Medicine professional with 25+ years of experience in development & commercial launch of IVD products in cancer, neurological disorders, infectious disease, and rare diseases. My key competencies & experience include business development, team building, cross functional team management, strategic partnership, product development, in-licensing/out-Licensing, market access, clinical/non-clinical evidence development, value communication, global launch for IVD and digital Dx

• Innovative and dynamic professional with +15 years of technical, entrepreneurial and leadership experience in Molecular Diagnostics and Precision Medicine.

• Recent work focused on strategic advice to major global pharmaceutical and Dx companies, Investment Funds, VCs, and Governments on precision medicine strategies and on the effective integration of Dx and Rx into drug development and market adoption pathways for seamless adoption of CDx tests to improve ROIs, development of companion diagnostics (CDx) for oncology drugs, market access and implementation ; Business Development and successful identification of short term and mid-to-long term business opportunities.

• Possesses unique combination of creative thinking and entrepreneurial character, and strong medical and laboratory background.

• European Commission advisor. ASCO evaluator.

• Spare time devoted to collaborations with Cancer NGOs, having founded 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.

Raising Capital

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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.