BayBio Meets with Commissioner Hamburg and Director Shuren in DC

BayBio CEO Gail Maderis and Manager of Federal Government Affairs Mallori Merandino joined Congresswomen Jackie Speier (D-CA14) and Anna Eshoo (D-CA18) for a stakeholder meeting with FDA Commissioner Margaret Hamburg and Director Jeff Shuren of the Center for Devices and Radiological Health.  The roundtable included participants from Bay Area biotech companies, CHI, BIO, and the National Venture Capital Association, and focused on FDASIA implementation.  

Since passage of FDASIA in 2012, the biomedical industry has seen an improved regulatory climate, due to both an increasingly responsive and accessible FDA and initiatives and enhancements that have begun to modernize the agency.  At this meeting, participants discussed the status of both broad and specific programs, including the Accelerating Medicine’s Partnership (AMP) and the Breakthrough Therapy Designation.  Other topics included the timeline for laboratory developed test and Biosimilars guidance, user fee sequestration, and drug shortage issues.

BayBio enjoyed the informative, and productive meeting, and would like to thank the Bay Area CEOs who participated: Bill Newell of Sutro Biopharma and Vice-Chair of the BayBio board, Paul Hastings of OncoMed and former BayBio board Chair, Martin Babler of Principia Bio, Dr. Peter Milner of Heart Metabolics, and Donald Santel of Hyperion Therapeutics.

If you would like more information on the event, or how you can participate in Washington, please contact Mallori Merandino at