Public Calendar: November 17-23, 2019
This public calendar is issued by the Food and Drug Administration. It lists significant meetings held by designated FDA policy makers with persons outside the executive branch of the federal government.
Official Name: Brett P. Giroir, M.D, Acting Commissioner of Food and Drugs
No Significant Event
Official Name: Amy Abernethy, M.D., Ph.D, Principal Deputy Commissioner
Event Date: 11/21/2019
Location: Boston, MA
Subject: Massachusetts Biotechnology Council (MassBio) Meeting
FDA Participant/Group: STEPHANIE CACCOMO;
Non FDA Participant/Group: Bob Coughlin, Zach Stanley (MassBio); Katie Oppenheimer (Sanofi); Paul Kim, Tom Barker (Foley Hoag LLP); Josh Cohen, Justin Klee (Amylyx Pharmaceuticals); Alex Waldron, Yuri Maricich (Pear Therapeutics); Ramani Varanasi (X-Biotix Therapeutics); Michelle Avery (Summit Therapeutics); David Altarac (Entasis Therapeutics); Kristin Wolff (Bluebird Bio);
Event Date: 11/21/2019
Location: Boston, MA
Subject: 2019 STAT Summit; Fireside Chat - Where No FDA Has Gone Before
FDA Participant/Group: STEPHANIE CACCOMO;
Non FDA Participant/Group: Attendees from industry, academia, and the media
Official Name: Anna Abram, Deputy Commissioner for Policy, Legislation, and International Affairs
No Significant Event
Official Name: Jim Sigg, Deputy Commissioner for Operations
No Significant Event
Official Name: Frank Yiannas, Deputy Commissioner for Food Policy and Response
No Significant Event
Official Name: Lowell Schiller, Principal Associate Commissioner for Policy
No Significant Event
Official Name: Mark Abdoo, Associate Commissioner for Global Policy and Strategy
No Significant Event
Official Name: Melinda Plaisier, Associate Commissioner for Regulatory Affairs
No Significant Event
Official Name: Mary Lou Valdez, M.S.M., Associate Commissioner for International Programs
No Significant Event
Official Name: Laura Caliguiri, Associate Commissioner for External Affairs
No Significant Event
Official Name: RADM Denise Hinton, Chief Scientist
No Significant Event
Official Name: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research
No Significant Event
Official Name: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Event Date: 11/18/2019
Location: Washington, DC
Subject: National Hemophilia Foundation Gene Therapy Summit Panel: Who Needs What Data When, to Aid in Decision Making?
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and the media
Event Date: 11/19/2019
Location: Rockville, MD
Subject: Cure Sickle Cell panel: Consistency in Measurements
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and media
Event Date: 11/20/2019
Location: Boston, MA
Subject: Gene Therapy Analytical Development Summit: FDA Perspective on Analytical Regulatory Expectation
FDA Participant/Group: N/A
Non FDA Participant/Group: Attendees from industry, academia, and the media
Official Name: Jeffrey Shuren, M.D., J.D., Director, Center for Devices and Radiological Health
Event Date: 11/21/2019
Location: Silver Spring, MD
Subject: Pharmacogenomic Testing
FDA Participant/Group: TIFFANY FARCHIONE; ELLEN FLANNERY; TOBY LOWE; TIMOTHY STENZEL; JOHN CONCATO; BRITTANY SCHUCK; MICHAEL PACANOWSKI; PATRIZIA CAVAZZONI; PETER STEIN; ROBERT BERLIN; KATHERINE DONIGAN; COURTNEY LIAS; JENNIFER TOMASELLO; ELIZABETH HILLEBRENNER; JACQUELINE CORRIGAN CURAY; WENDY RUBINSTEIN;
Non FDA Participant/Group: Al Guida (Guide Consulting Services); Phyllis Foxworth (Depression & Bi-Polar Support Alliance); Andrew Sperling (National Alliance for Mental Illness); Joe Parks, Reyna Taylor (National Council for Behavioral Health); Madeline Reinert (Mental Health America);
Official Name: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Applied Nutrition
No Significant Event
Official Name: Mitchell R. Zeller, J.D., Director, Center for Tobacco Products
No Significant Event
Official Name: Steven Solomon, Director, Center for Veterinary Medicine
No Significant Event
Official Name: William Slikker, Jr., Ph.D., Director, National Center for Toxicological Research
No Significant Event
Official Name: Stacy Cline Amin, Chief Counsel
No Significant Event