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# Former FDA Vaccine Official Joins Mesoblast Board
- URL: https://www.fdaweb.com/former-fda-vaccine-official-joins-mesoblast-board/
- Published: 2022-03-24T12:00:00.000Z
- Updated: 2026-09-14T17:38:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151451

Former CBER Office of Vaccines Research and Review (OVRR) deputy director **Philip Krause** has joined Mesoblast’s board of directors. Mesoblast says Krause’s “biologics development and regulatory expertise that he brings will be invaluable in our ongoing FDA interactions on our lead and follow-on product candidates.”

In 2020, the company received a complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease ([see story](https://www.fdaweb.com/mesoblast-bla-gets-complete-response-letter-for-remestemcel-l/)). The agency letter recommended that the company conduct at least one additional randomized, controlled study in adults or children to provide further evidence of the therapy’s effectiveness. Additionally, FDA identified a need for further scientific rationale to “demonstrate the relationship of potency measurements to the product’s biologic activity,” the company said at the time. The company’s Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain.  

Krause and OVRR director **Marion Gruber** retired last year in protest over how the agency and Biden Administration were handling Covid-19 vaccine reviews and approvals. In September, Krause and Gruber joined outside researchers to argue against requiring Covid-19 booster shots until data can show a necessary benefit. Writing in a 9/13/2021 *Lancet* [viewpoint article](https://www.thelancet.com/pb-assets/Lancet/pdfs/S0140673621020468.pdf?ref=fdaweb.com), the then-FDAers and researchers said current evidence did not show a need for boosters for the general population because efficacy against severe disease remains high. The two former officials also reportedly had been frustrated by CDC and its Advisory Committee on Immunization Practices for making decisions on issues that should be reserved for FDA, and by a lack of support from CBER director **Peter Marks** *.*