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Philip Krause

Dr. Philip Krause is an American biotechnology consultant based in Bethesda, Maryland. He is the former Deputy Director of the Office of Vaccines Research & Review at the Food and Drug Administration (FDA).

History

Krause is a member of the International Council for Harmonisation (ICH)'s Working Group for E8(R1) (Guideline on General Considerations for Clinical Studies).1) He began his first term as a member of the Scientific Advisory Committee for the Coalition for Epidemic Preparedness Innovations (CEPI) in mid-2019.2)

COVID-19

Krause participated in a February 11-12, 2020 event titled “2019 novel Coronavirus Global research and innovation forum: towards a research roadmap” co-hosted by the World Health Organization R&D Blueprint and Global Research Collaboration for Infectious Disease Preparedness (GLOPID-R). He and Anuradha Poonepalli presented on the topic of “Candidate vaccines R&D”.3)

Krause was appointed Chair of the WHO R&D Blueprint COVID-19 Vaccines Working Group upon its creation in April 2020.4) He participated in the 2nd Global Consultation on SARS-CoV-2 Variants of Concern and the Impact on Public Health Interventions on June 10, 2021.5)

Krause began his second term on CEPI's Scientific Advisory Committee in June 2021.6)

In August 2021, Krause and his superior, Marion Gruber, announced they would be departing their leadership roles at the Food and Drug Administration's Office of Vaccines Research & Review as a result of pressure from the Joe Biden White House to push ahead with COVID-19 vaccine booster doses.7)

He joined Adjuvance Technologies as a consultant in January 2022,8) and Mesoblast in March 2022.9)

1)
Levenson, M., & Krause, P. (2019). E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. https://web.archive.org/web/20230312055636/https://qbdworks.com/storage/2019/08/Quality-by-Design-Clinical-Studies.pdf
2)
Summary of CEPI Scientific Advisory Committee (SAC) meeting. (2019, February 7). European Commission. https://web.archive.org/web/20230312060536/https://ec.europa.eu/research/participants/documents/downloadPublic?documentIds=080166e5d2bd5f63&appId=PPGMS
3)
2019 novel Coronavirus Global research and innovation forum: towards a research roadmap AGENDA. (2020). GLOPID-R. https://web.archive.org/web/20230208185417/https://www.glopid-r.org/wp-content/uploads/2020/02/covid-19-global-research-and-innovation-forum-2020-program.pdf
4)
WHO R&D Blueprint novel Coronavirus WHO Working Group - Target Product Profiles for COVID-19 Vaccines WHO reference number. World Health Organization. Retrieved March 12, 2023, from https://web.archive.org/web/20230312032002/https://cdn.who.int/media/docs/default-source/blue-print/tors-working-group-on-target-product-profiles-covid19.pdf?sfvrsn=f209d4b4_1&download=true
5)
2nd Global Consultation on SARS-CoV-2 Variants of Concern and the Impact on Public Health Interventions (p. 17). (2021). World Health Organization. https://web.archive.org/web/20230312032446/https://www.who.int/docs/default-source/coronaviruse/report-sars-global-consultation_10june2021.pdf
6)
Vaccine specialists and global health experts selected for CEPI’s Scientific Advisory Committee. (2021, June 9). CEPI. http://archive.today/2023.02.05-121837/https://cepi.net/news_cepi/vaccine-specialists-and-global-health-experts-selected-for-cepis-scientific-advisory-committee/
7)
Weiland, N., & LaFraniere, S. (2021, August 31). Two Top F.D.A. Vaccine Regulators Are Set to Depart During a Crucial Period. The New York Times. https://archive.ph/gSrJj
8)
Matzner, H., & Martin, T. (2022, January 25). Dr. Philip Krause to Provide Strategic Advice to Adjuvance. Business Wire. https://web.archive.org/web/20230312030822/https://www.businesswire.com/news/home/20220125005493/en/Dr.-Philip-Krause-to-Provide-Strategic-Advice-to-Adjuvance
9)
LaHucik, K. (2022, March 24). Former FDA vaccines deputy Krause heads down under as Mesoblast tries again on nearly entire pipeline. Endpoints News. https://archive.ph/HZdmJ
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