Cell therapy weekly: Scott Gottlieb resigns from FDA and Japan to commence iPSC trial for corneal disease
This week: Cell and Gene Therapy Catapult manufacturing center gains first manufacturing license variation and BioLife Solutions plans release of 2018 financial results.
The news highlights:
FDA Commissioner Scott Gottlieb to step down
Japanese health ministry approves iPSC clinical trial for corneal disease
Autolus to manufacture clinical trial products at Cell and Gene Therapy Catapult manufacturing center
BioLife Solutions plans release of 2018 financial results
FDA Commissioner Scott Gottlieb to step down
Following a statement earlier in the week, FDA Commissioner Scott Gottlieb has announced he is stepping down to spend more time with his family. Under Gottlieb’s leadership, FDA introduced a number of measures to enable more approvals of advanced therapies, and recently announced plans to increase the number of FDA reviewers overseeing cell and gene therapy products. A successor has not yet been named.
Japanese health ministry approves iPSC clinical trial for corneal disease
A group from Osaka University (Japan) has received government approval to trial the transplantation of a sheet of induced pluripotent stem cell (iPSC)-derived corneal epithelial cells for the treatment of corneal disease. In the trial, the team will use allogeneic cells obtained from Kyoto University (Japan) and implant the cultured cell sheet into four patients with damaged to their corneal limbus. This trial will be the 6th time the Japanese Ministry of Health, Labor and Welfare (Tokyo, Japan) has authorized a clinical study utilizing iPSCs.
Read more (in Japanese)
Autolus to manufacture clinical trial products at Cell and Gene Therapy Catapult manufacturing center
Autolus Therapeutics plc (UK), based at the Cell and Gene Therapy Catapult (CGT Catapult; London, UK) manufacturing center (Stevenage, UK) has had their manufacturing operations approved by the MHRA, enabling them to manufacture materials for future clinical trials from the center. This is the first time this authorization has been given to a company based at the CGT Catapult center in Stevenage.
“The positive outcome of the Autolus MHRA inspection demonstrates how our model of providing a fully supported best-in-class infrastructure works and is helping our collaborators receive the licenses required for developing these novel therapies. The variation of our MHRA licenses to incorporate Autolus is also a testament to the close engagement CGT Catapult and its collaborators have to accelerate the large-scale delivery of these innovative Advanced Therapies,” commented Keith Thompson, CGT Catapult CEO.
BioLife Solutions plans release of 2018 financial results
BioLife Solutions, Inc. (WA, USA) will report fourth quarter and full year 2018 financial results during a live webcast on 14 March, 2019. BioLife Solutions is a developed, manufacturer and supplier of clinical-grade biopreservation media for cells and tissues, and last year increased ownership in SAVSU Technologies (NM, USA) with a US$5 million investment.
For more weekly cell therapy news, read previous editions of the cell therapy weekly.