HemaCare is pleased to announce the publication of our latest article [1] in the journal International Clinical Trials (ICT). The paper, entitled “The Landscape of Clinical Approval” describes how changes in the clinical drug approval process are impacting starting material suppliers, and what suppliers are doing to meet increased demands.
A major breakthrough in Immunotherapy drug coverage was announced last week. Medicare will now cover high-priced blood cancer cell therapies nationwide. The news, announced by officials at the Centers for Medicare and Medicaid Services (CMS), comes two years after the FDA approved the first CAR-T therapy in 2017, Novartis’ Kymriah®, a treatment for acute lymphoblastic leukemia. This long sought-after coverage decision will now ensure patients have consistent and predictable access to potentially life-saving therapies.[1]
HemaCare has just announced the publication of their latest article in the popular stem cell industry periodical BioInformant. [1] The article focuses on the need for healthy donor starting material to keep up with growing demands in the cell and gene therapy industry.
Scientists at the Cell and Gene Therapy Catapult in the U.K. cite using HemaCare leukopaks to study a new method of scrutinizing cellular quality markers during cell therapy bioprocessing. [1]
The publication represents a collaborative effort among scientists developing cellular therapies in the United States and Canada as well as in the U.K. They are working together to solve a key issue; how to ensure the consistent high quality of their living products.
Last week in Part 1 of our series, we presented observations from industry leaders into how they plan for success by installing comprehensive quality management systems and laying down detailed groundwork for an optimized transition to GMP-compliant starting materials and technologies. This week in Part 2 of our series, cell therapy manufacturers present their own perceptions of what constitutes an ideal cell therapy starting material supplier, as well as what can be done on their end to ensure their cell therapy retains consistent quality and potency.