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Webinar | Navigating to the Safe Harbor: What to Know in Advance

Tuesday, July 21st, 2020, 1:30 pm EDT

Webinar | Navigating to the Safe Harbor: What to Know in Advance

This webinar took place on: Tuesday, July 21st, 2020, 1:30 pm EDT

This webinar has ended.

The last decade has been a time of tremendous growth in the biotechnology and biopharmaceutical industries, not only in the United States, but globally. At the same time, advances in drug development technologies and accelerated approval pathways in the USFDA and in other regulatory bodies have dramatically shortened the timeline and reduced the clinical risk profile in going from concept to commercial product. During this time of accelerated global research and development regarding diagnostics and treatments–especially for COVID-19 (SARS-CoV2)–it is more important than ever for pharma/biotech companies to determine in advance whether their programs are headed for rocky seas or the safe harbor.

In this webinar, Fish attorneys Teresa Lavoie and Brian Coggio cover these issues and more, including:

  • The basics of § 271(e)(1) safe harbor
  • “Basic research” and the Coronavirus
  • Developments regarding
    • Stockpiling
    • Research tools
    • Companion diagnostics
    • Genetically-engineered animals

Click the link to download a copy of the webinar slides.

Presenters: Brian Coggio, Teresa Lavoie

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