Efficiencies gained from the Quality System Audit Program

Three things to know about efficient qualification of collection centers

Ensuring cell collection centers and cell therapy labs are meeting FDA regulatory requirements and providing high-quality starting material for your cell or gene therapy is critical to your therapy’s success. As the industry continues to rapidly advance, it is becoming more critical to integrate process efficiencies wherever possible. There is a solution: using an established…

Amy Hines, director of Collection Network Management, Be The Match BioTherapies

Q&A with Amy Hines, director of Collection Network Management

Amy Hines, BSN, RN, oversees the Be The Match BioTherapies® Collection Network, which includes apheresis centers, marrow collection centers and cell therapy labs. She talked to us about some of the challenges the Network is facing, how Be The Match BioTherapies can help build efficiencies and how the organization plans to save more lives internationally.…

Reimbursement uncertainties hinder patient access to CAR-T therapies

The approval of CAR-T therapies Kymriah® and Yescarta® in late 2017 represented an enormous milestone for patients with leukemia, lymphoma, and other blood cancers. However, the ongoing uncertainty over reimbursement has made it difficult for patients to access the CAR-T treatments. Despite the months passed since the therapies were FDA approved, only some patients that…

car-t cell

CAR-T 2.0

The field of cancer immunotherapies was buoyed last year by the FDA’s approval of the first autologous CAR-T drugs on the market, Novartis’ Kymriah and Gilead’s Yescarta. But, many drug makers are already looking in a new direction — off-the-shelf, or allogeneic, CAR-T therapies. In autologous therapies, like Kymriah and Yescarta, scientists isolate T cells from…