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FDA to beef up cell and gene therapy staff

Stock MarketsJan 15, 2019 01:17PM ET
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© Reuters. FDA to beef up cell and gene therapy staff
  • Citing the 800 active INDs for cell therapy and gene therapy candidates and the expectation that it will be receiving more that 200 INDs each year by 2020, FDA Commission Scott Gottlieb, M.D., outlines the agency's initiatives to support timely review and to enable the approval of 10 - 20 such therapies per year by 2025.
  • 50 new clinical reviewers will be added (certainly contingent on the resolution of the federal government impasse between President Trump and Congress).
  • New policy guidance will be issued this year. The agenda includes working with sponsors to make maximum use of accelerated programs, including regenerative medicine advanced therapy (RMAT) designation, a series of clinical guidance documents to inform product development, including gene therapies for blood disorders, and how to use the accelerated approval pathway in cases where the gene therapy addresses the underlying genetic defect.
  • The guidance will also include information designed to help in the development of CAR-T therapies (and other cellular products) and to promote a better understanding of the critical factors in manufacturing with the goal of allowing minor manufacturing changes without requiring new bridging studies.
  • Selected tickers: XLV, IBB, XBI, XPH, IHE, PPH, VHT, OTCQX:RHHBY, ABBV, AGN, AZN, BMY, GSK, JNJ, MRK, NVS, BHC, TEVA, AMGN, BIIB, GILD, VRTX, TAK, ESRX, WBA, CVS, UNH, PFE, CELG, LLY, XON, ALNY, CLLS, SRNE, ZIOP, CYAD, BLUE, NTLA, CRSP, EDIT, SRPT, SLDB, RCKT, RGNX, BGNE, SGMO, ONCE, VYGR
  • Now read: Why AbbVie Believes In Life After (Humira's) Death


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FDA to beef up cell and gene therapy staff
 

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