Toward a Therapy for COVID-19: The Science and Legal Considerations

Researchers around the world are working at record speed to find the best ways to treat and prevent COVID-19. In this last episode of our four-part podcast series, we discuss the science, regulatory framework, and commercial transaction considerations of a COVID-19 therapy. Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and Patent Group, discusses these issues among others with:

• Janet Xiao, patent partner and head of our China Life Sciences Group: What are the main differences between vaccines and therapeutics? How does COVID-19 infect our bodies? What types of COVID-19 treatments are currently being considered?
• Bethany Hills, partner and head of MoFo’s FDA Regulatory + Life Sciences Compliance practice: What is FDA’s overall drug approval process? Are there any FDA programs that would facilitate accelerated development of a therapy? How does the FDA regulate off-label, or unapproved drugs?
• Rufus Pichler, partner in MoFo’s Commercial Life Sciences Transactions + Licensing Group and Technology Transactions practice: What kinds of partnerships and collaboration efforts are you seeing? How about the repurposing of approved drugs? Are there specific legal issues that companies developing therapeutics should be aware of? Are there any particular challenges associated with manufacturing capacity?