Navigating to the Safe Harbor: What to Know in Advance

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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

Presenters: Brian Coggio, Teresa Lavoie