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Strategies for biotech/medtech startups: Successfully navigating the USPTO and FDA

Hear from experts about the intricacies biotech and medtech startups face when securing Intellectual Property (IP) rights from the USPTO and seeking regulatory approval from the FDA.  Government officials and industry professionals will offer their insights and highlight best practices for startups navigating USPTO and FDA procedures.


This event is free and open to the public.


The discussion will cover:



  • Navigating the USPTO patent process, with an emphasis on biotech and medtech industries

  • Navigating the FDA regulatory process

  • Strategies, tips, and best practices to maximize IP protection and exclusivity


Agenda


12:00 p.m.:  Registration


12:00 - 12:30 p.m.:  Lunch


12:30 - 12:45 p.m.:  Introductory remarks




  • John Cabeca, USPTO - Director, West Coast Region




12:45 -  2:00 p.m.:  Navigating through the USPTO



  • Daniel Sullivan, USPTO - Director, Technology Center 1600 (Biotechnology)

  • Jerry Lorengo, USPTO - Director, Technology Center 3700 (Medical Devices/Processes)

  • Chris Walsh, Ph.D., Denali Therapeutics - Vice President, Legal

  • Cary Miller, Ph.D., Jones Day - Partner


2:15 - 3:30 p.m.:  Navigating through the FDA




  • Forest “Ray” Ford, Jr., PharmD, FDA - Consumer Safety Officer




3:45 - 4:45 p.m.:  Beyond the FDA + USPTO - Strategic considerations panel



  • Moderated by Laure Fabrega, Biocom - Director, Federal Policy and Government Affairs

  • Daniel Sullivan

  • Jerry Lorengo

  • Chris Walsh, Ph.D.

  • Ray Ford, Jr.

  • Cary Miller, Ph.D.


5:00 p.m.Networking reception


Lunch and networking reception provided courtesy of Jones Day, through Biocom.


For all inquiries, please contact: siliconvalley@uspto.gov. For more information, please see event flyer.