MDisrupt Webinar

How will regulation of digital health products be impacted with the new administration?

Date: March 9, 2021
Time: 11:00AM – 12:00PM PST

With the transition to the Biden-Harris Administration, appointing new leadership within the healthcare focused agencies, and the swearing in of the new Congress, the precision medicine industry can expect new attention to critical policy issues including regulation of diagnostic testing, digital health platforms, and at home testing. Is your regulatory team prepared for these changes?

In this webinar, we’ll cover:
  • What are the priorities of the incoming administration and new Congress?
  • How will these priorities shift the way the FDA is thinking about regulating laboratory developed tests and digital health software?
  • How should regulatory teams in healthtech companies start to prepare for these shifts?
  • How will your legal team be thinking about recently implemented regulations during and after the transition?

Meet the Panelists

Jennifer Leib

Jennifer Leib Sc.M., C.G.C. (Moderator)

Founder at Innovation Policy Solutions

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Jennifer Leib founded Innovation Policy Solutions, a government relations firm specializing in genomics and precision medicine policy. Some of her accomplishments include leading the advocacy effort in support of the plaintiffs in the Supreme Court’s unanimous decision in the Association for Molecular Pathology vs. Myriad Genetics Inc. that invalidated gene patents, serving on the Executive Committee of the Coalition for Genetic Fairness which successfully advocated for passage of the Genetic Information Nondiscrimination Act, and more recently, assisting companies with navigating the evolving regulatory and reimbursement landscape for diagnostic testing for SARS-Cov-2. Previously, Jennifer co-founded another consulting firm, HealthFutures, which was acquired by CRD Associates in 2009. Board certified in genetic counseling, she also worked at the National Institutes of Health, the Senate Committee on Health, Education, Labor and Pensions, and in the biotechnology industry.

Marisa Cruz MD

Marisa Cruz M.D.

Executive Vice President for Clinical and Regulatory Affairs at Everlywell

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Dr. Marisa Cruz is the Chief Medical Officer of Limbix Health, a startup company focused on building prescription digital therapeutics for adolescent mental health. In her current role, she leads development of clinical and regulatory strategies for Limbix, and oversees clinical development programs from feasibility studies through pivotal trials. Prior to Limbix, she served as the Senior Medical Advisor for the Digital Health Unit in the Center for Devices and Radiological Health at the US Food and Drug Administration, providing leadership in the development and implementation of digital health policy for medical devices. Shereceived her M.D. from the Johns Hopkins School of Medicine, completed an Internal Medicine residency and Endocrinology fellowship at the University of California, San Francisco, and continues active clinical care.
Amy Divaraniya

Kevin Coker M.S., M.P.H., J.D.

Co-Founder and CEO of Proxima Clinical Research

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Mr. Coker is the Co-Founder and CEO of Proxima Clinical Research a partner for the emerging biotech and medical device industry. Over his career, Mr. Coker has served in a number of executive roles. Previously, he was CEO and Director of MolecularMatch a decision support platform for molecular laboratories conducting next generation sequencing. He served as the Vice President and Oncology Franchise Lead for Worldwide Clinical Trials, a global CRO working in over 50 countries, and the Vice President of Research for McKesson/US Oncology. Mr. Coker is a Board Director for Volumetric, a 3D bio printing company and an advisor for Bioverge, an investment platform focused on life science companies.

Mr. Coker received a B.S. in Biology from the University of Central Arkansas, a M.S. in Pathology from the University of Arkansas for Medical Sciences, and J.D. and M.P.H. degrees from Case Western Reserve University.

Delphine ORourke

Delphine O’Rourke J.D.

Partner at Goodwin

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Delphine O’Rourke counsels innovative disrupters in the health and wellness industry. She is a partner with Goodwin in the firm’s life sciences and healthcare practices and a member of the corporate social responsibility initiative. Delphine’s healthcare and #femlaw practice serves innovative founders, health & pharma companies, and funders in the health and wellness industry.

From structuring private equity investments to comply with fraud and abuse laws, to providing regulatory counsel to cancer drug developers in connection with IPOs in the US, to advising on telemedicine laws’ impact on digital health services for menopausal women, she guides clients to success in one of the most highly regulated industries in the US. Delphine advises companies at all different growth stages within the business life cycle that are accelerating health innovation through technology, products, services, advocacy and education.

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