Last month, the FDA issued six draft guidance documents specific to gene therapy development as their latest effort to update regulatory framework in the cell and gene therapy sector. This follows the release of a series of guidances and draft guidances in late 2017 also aimed at sponsors in this space. This most recent release…
2018 has been a year of advancement for the cell therapy industry. With the first two approved CAR-T cell therapies now on the market, organizations are shifting their focus from commercialization to industrialization through well-designed supply chains, standardized quality assurance practices and long-term outcomes tracking to support current and future cell therapy products. Let’s take…
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…
Last month, Jamie Margolis, PhD, who has been with Be The Match BioTherapies® since its inception, was promoted to Director of Product Development Operations. We spoke with her about key challenges the cell therapy industry is facing and how Be The Match BioTherapies is positioned, and growing, to help companies advance their cell or gene…
You’ve recently joined Be The Match BioTherapies full time after two years as a consultant. What is most exciting to you about your new position? We are on the cusp of a major sea change in the way we treat disease, and in the way new therapies are produced and distributed. I am thrilled to…
Earlier this month, Dr. Steven Devine, a renowned blood and marrow transplant physician, joined our organization as the Be The Match BioTherapies Medical Director. He came to the organization from the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC-James). We spoke with Dr. Devine…
As Be The Match BioTherapies enters its third year, could you share what you see as some of the organization’s biggest achievements? There are three major achievements that I’d like to highlight. First, we are proud to be partnering with some truly innovative companies in the cell therapy space to help bring life-saving therapies to…
Cell therapy companies large and small face challenges in securing the raw materials they need for their research and therapy production. That was the message delivered by industry veteran Amy Hines, director of Collection Network Management, Be The Match BioTherapies, at this year’s Cell & Gene Therapy World, hosted by Phacilitate last month in Miami.…
In November, the FDA released its long-awaited regenerative medicine policy framework consisting of four guidance documents; two final and two draft. The guidance documents arrive at a time of rapid growth and expansion in the commercialization of regenerative medicines and represent the FDA’s attempt to ensure safety and effectiveness of the therapies, while spurring innovation…