The revolving door of FDA staffers into the life science industry continues apace as no less than four former executives at the U.S. regulator have joined the CRO’s ranks.
The four are Kurt Brorson, Ph.D., coming off a 26-year stint within the FDA, primarily in the CDER; Changting Haudenschild, M.D., who spent 12 years at the Office of Tissue and Advanced Therapies at the CBER; Mohammad "Mo" Heidaran, Ph.D., a nine-year vet at the CBER; and Mwango Kashoki, M.D., who spent 16 years at FDA on drug review, development and regulatory work.
Unsurprisingly, they will all be integrated into its Regulatory Consulting group, which essentially helps biopharma companies understand how to get their drugs onto the market and through regulatory barriers, as well as best practices for clinical trials to help reduce the risk of an FDA rejection.
Brorson, an expert in viral safety of biopharmaceuticals and clearance during manufacturing, will be focused on supporting clients in the development and regulatory strategy for biosimilars and biotech products.
Haudenschild, meanwhile, will be responsible for “strategic, scientific, clinical, and regulatory support during all stages of product development to help companies achieve their objectives,” the CRO says, while Heidaran, who focuses on cell and gene therapies and also has 9 years under his belt at the National Cancer Institute, will work on strategic CMC technical and regulatory support during all stages of cell and gene therapy product development.
Last but not least, Kashoki will provide Parexel’s clients with “strategic and technical guidance on various regulatory and clinical aspects of drug development, leveraging her expertise in clinical review as well as pharmacovigilance and other postapproval safety requirements,” according to the company.
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Boston-based Parexel went private back in 2017 with a $5 billion Pamplona Capital buyout deal. Not long after, Josef von Rickenbach, its former chair and CEO, retired from his daily CEO duties at the CRO after a 35-year tenure, passing the baton to Jamie Macdonald, who was previously the helmsman of rival CRO INC Research.
“As promising new innovations, such as regenerative medicines, use of real-world evidence, and patient-centric approaches to clinical and product development continue to advance in the industry, it will be essential for sponsors to have the expertise to navigate the changing regulatory environment,” said Paul Bridges, worldwide head of Parexel Regulatory Consulting, in a release. “With these new additions to our Regulatory Consulting Services team, Parexel will deepen its leadership and expertise in areas that are priorities of the FDA, and are critical to our clients on their journeys to deliver important new treatments to patients in need across the globe.”
The addition of these four ex-FDA staffers follows a long-standing trend of former regulatory employees moving into the life sci industry. They are so sought after given that they hold invaluable information on the inner workings of an organization that can mean the difference between a drug being approved, with potentially billions of dollars in sales as a result, or being delayed, or even rejected, which can cost hundreds of millions of dollars.
Last spring, the FDA’s Badrul Chowdhury, M.D., Ph.D., became SVP for research and development at MedImmune and head of its innovative medicine early development unit, which is focused on respiratory, inflammatory and autoimmune diseases. This capped off a 21-year stint at the U.S. regulator.
In 2017, AstraZeneca also poached Sarah Pope Miksinski, Ph.D., former acting director of CDER’s office of new drug products, and Geoffrey Kim, M.D., director of the center’s division of oncology products.
One of the most notable and controversial moves was the former head of the European Medicines Agency (EMA), Thomas Lonngren, who went to work for consultancy the NDA and was hit by a backlash for setting up a consultancy business under the NDA to advise private-sector pharmaceutical clients while in fact still employed by the EMA.