Precision Medicine: Challenging the Regulatory Landscape - Webinar Recording/Transcript

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Precision Medicine: Challenging the Regulatory Landscape

“Precision Medicine,” a/k/a “Personalized Medicine,” promises a new and rich path to drug and device profits. But a top Washington FDA lawyer offers a list of precautions as you take the plunge.

Kupchyk Esq., former Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation, reveals what FDA insiders are thinking as they confront this challenge to traditional regulatory structures … and how they plan to move forward.

Over the course of 90 fast-paced minutes, Ms. Kupchyk, now a top member of the Washington FDA bar, will cover:

  • Top FDA concerns: Precision medicine products, including how to ensure accuracy of next-generation sequencing tests
  • Draft guidances: Discover key points in FDA’s two pending draft guidance documents, including allowing NGS developers to use data from FDA-recognized public databases of genetic variants to help support a test's clinical validity
  • Industry blowback: The level of evidence the FDA will accept to analytically validate additional or expanded application of NGS tests
  • Pros and cons of various approaches, including implications of  binding or non-binding recommendations
  • What’s been approved : A look at FoundationOne CDx (F1CDx), the first breakthrough-designated NGS-based IVD test (it claims to detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type)
  • And much more

Should you cash in on the precision medicine bonanza? By all means. Should you take appropriate regulatory precautions beforehand? But of course. This is the quick, easy, reliable way to do so.

Drug and device makers whose products could be considered components of personalized medicine. Specific job titles include:

  • C-suite
  • Regulatory/compliance
  • Quality control
  • Strategic planning
  • Product developers
  • Design engineers
  • Software engineers
  • Medical directors

Areta Kupchyk Esq., Partner, Foley Hoag LLP, is a former FDA official who now advises drug, device and biotech companies, as well as healthcare providers and institutions, researchers, and investors. She co-chairs Foley Hoag’s Food and Drug Law Practice group in the firm's Washington, D.C. office. Ms. Kupchyk draws upon almost 10 years of experience as FDA Associate Chief Counsel for Drugs and Biologics and Assistant General Counsel for Litigation to provide nuanced counsel on current agency views for meeting pre- and post-approval requirements.