FDA names biotech entrepreneur, Stanford professor as new CDER chief
After weeks of anticipation, the US Food and Drug Administration (FDA) has announced that George Tidmarsh, a Stanford University adjunct professor and biotech industry veteran, will lead its drug center.On 21 July, FDA Commissioner Marty Makary notified staff in an email reviewed by Focus that Tidmarsh has been appointed director of the Center for Drug Evaluation and Research (CDER). He touted Tidmarsh’s more than 30 years of experience in biotechnology, clinical medicine, and regulatory science. He also noted that Tidmarsh was the founding co-director of Stanford's Master of Translational Research and Applied Medicine (M-TRAM) and has authored 143 scientific publications and patents.
“Dr. Tidmarsh has led the successful clinical development of seven FDA-approved drugs and served as founder and CEO of multiple biopharmaceutical companies focused on oncology and critical care medicine, and is widely recognized for his ability to bring forward innovative treatments that address serious unmet medical needs,” said Makary. “He has served on advisory boards across academia, government, and industry.”
“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development – from bench to bedside,” he added. “His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.”
Makary thanked outgoing acting CDER director Jacqueline Corrigan-Curay for agreeing to stay longer after announcing her retirement to ensure the center continued to have a leader.
Corrigan-Curay announced in June that she was retiring from FDA after almost a decade at the agency. The announcement came after BioCentury reported that Karim Mikhail, former CEO of Amarin Corporation, had been hired by Makary to serve as a senior adviser and was being considered as the next CDER director. (RELATED: Corrigan-Curay announces retirement from CDER, Regulatory Focus 23 June 2025)
According to Tidmarsh's LinkedIn Profile, he has founded or co-founded several biotech companies Threshold Pharmaceuticals, Metronome Therapeutics, Horizon Pharma, Solana Therapeutics, Revelation Biosciences, and Citizen's Oncology Foundation. He has also served as CEO of La Jolla Pharmaceutical and CSO of Spectrum Pharmaceuticals.
Tidmarsh has been a strong supporter of Jay Bhattacharya, director of the National Institutes of Health (NIH), and Makary and recently wrote on LinkedIn that “academic research has become riddled with fraud.” He also praised Bhattacharya’s nomination for NIH director by stating, “Now the work begins to make science great again!”
More recently, Tidmarsh criticized reporting by Endpoints News about Makary’s reported effort to issue a complete response letter (CRL) to KalVista for its hereditary angioedema drug Ekterly (sebetralstat) after the company said the agency’s decision on the drug was delayed due to “limited resources.”
"Endpoint News is terrible," Tidmarsh wrote on LinkedIn. "They wrote 'Makary's Kalvista rejection bid sparks concerns.'”
"Someone should tell them that even if Makary did suggest FDA issue a CRL (there is no evidence for this), a CRL is not a rejection," he added. "One would think that a 'journalist' would have some basic knowledge of the industry they cover. Endpoint News should be ashamed."
Tidmarsh has been critical of desiccated thyroid extract, an unapproved drug that was first used to treat hypothyroidism in the 19th century.
“The new FDA needs to remove harmful, useless drugs from the market,” said Tidmarsh on LinkedIn. “Let's start with desiccated thyroid extract.”
“An unapproved, crude pig tissue extract that is proven worse than synthetic thyroid hormone and harmful,” he added. “Working with the new FDA to remove it permanently from the market.”
Tidmarsh appeared alongside Makary in an FDA Direct episode that streamed on FDA’s YouTube channel on Monday, shortly after his appointment was announced. During the video, Tidmarsh mentioned that, while in Washington to help Bhattacharya prepare for Senate confirmation hearings, he spoke to Makary about how he thought he would be better suited to work at FDA.
Tidmarsh called himself an FDA historian and said he has watched the agency evolve over the past 30 years. He said he's had a very positive experience as a drug sponsor but there is room for growth and improvement at the agency. More specifically, he said the agency can make its review process more efficient and improve communications. He also said there's room to make the review process more consistent.
"FDA as great as it is, like anything else, can be improved," said Tidmarsh. "I've seen a massive amount of improvement and I'm hoping that I can be a part of even more."
During the podcast, Makary also addressed the fact that Tidmarsh is an FDA outsider. He noted that historically vacancies were filled internally at the agency in at least 90 percent of cases but now it's closer to 50 percent, which he said helps bring in new perspectives.
FDA
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