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BioCommunique Article

The half-day workshop detailed the patent and regulatory processes and concluded with a panel discussion moderated by Biocom’s Director of Public Policy.

Biocom Bay Area Brings Entrepreneurs & Regulators Together at Workshop with USPTO and FDA

  • 2019-08-09T05:43:00.000+0000
  • Bay Area
  • Author: Michelle Nemits

Biocom Bay Area hosted a workshop in partnership with the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) on July 16th to help life science startups work with these two important agencies. Biotech and medtech startups face innumerable challenges trying to get their innovations to market, but securing intellectual property (IP) rights, patents and regulatory approval are among the most daunting.

The IP, patent, and regulatory processes are arduous and often incomprehensible to even the most knowledgeable industry professionals. As startups work through strategies to maximize their patent protection and ensure robust exclusivity for the products of their research, knowing the best way to navigate these agencies can mean the difference between the company’s success and its failure. This recent half-day workshop in Biocom's South San Francisco facility laid out how these processes work, and how companies can develop successful IP and regulatory strategies.

Experience tells us that by bringing regulators together with entrepreneurs and business leaders that are new to the approval and regulatory process, they can improve the efficiency of these systems. The interactions also provide the USPTO and FDA first-hand feedback about what is and what is not working for life sciences entrepreneurs and researchers, and any unintended consequences of their agencies’ actions.

Over 100 attendees heard in-depth insights through a series of facilitated discussions from three USPTO representatives—John Cabeca, West Coast Region Director for USPTO, Daniel Sullivan, USPTO Director, TC 1600 (Biotechnology), and Jerry Lorengo, USPTO Director, TC 3700 (Medical Devices/Processes), and from Ray Ford Jr., FDA Consumer Safety Officer. They spoke about their agencies and thoughtfully answered audience questions about the patent and regulatory process. A panel discussion facilitated by Biocom’s Washington DC-based Director of Federal Policy, Laure Fabrega, also included Chris Walsh, Vice President of Legal at Denali Therapeutics, and Cary Miller, Partner at Jones Day, for their insights from the industry perspective.

All of the presentations and discussions were incredibly valuable and informative to Biocom members in attendance. A networking reception sponsored by Jones Day followed the event.

Biocom recognizes the significant value of bringing together regulatory agencies and life science companies to strengthen relationships and help companies succeed in their quest to improve human life. We look forward to continuing to create new ways to provide these opportunities to our members throughout California.