Industry Insights

  1. The Role Of Technology In Improving The Reputation Of The Life Science Industry 1/16/2020

    2019 marked another remarkable year for the life science industry as evidenced by the surge in FDA approvals and M&A deals. Yet, for the increasingly discerning public, there is very little knowledge about these new therapies.

  2. CAR T-Cell Therapy In Non-Hodgkin’s Lymphoma: Where Do We Go From Here? 1/16/2020

    Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, many key players are now pursuing development of therapies in earlier treatment settings and in other non-Hodgkin’s lymphoma subtypes, such as mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.

  3. FDA FY2019 Human Tissue And Cell Therapy Observations And Trends 1/9/2020

    Very soon after publication of the FY2018 data on human tissue and cell therapy products, the FDA released the data from FY2019, which we address here. We examine data from FY2019 and a total of five years’ worth of trends in GMP inspection enforcement in this area. The regulations that govern this area, 21 CFR 1271, are the same regulations that govern segments of human cell therapy and gene therapy products. Human cell and gene therapy products are part of FDA’s Regenerative Medicine framework.

  4. 4 Top Challenges Facing Gene Therapy 1/3/2020

    It’s never too early to start thinking about the end goal. That’s been my philosophy throughout my career, and in the rapidly maturing field of gene therapy, it’s non-negotiable.

  5. The Need For Digital Networks To Support Cell And Gene Therapies 12/30/2019

    Cell and gene therapies have a level of complexity from a supply chain perspective that needs new approaches, including a high level of information sharing and integration. This topic was covered from different perspectives at two recent conferences.

  6. Recap Of USP's 8th Annual Bioassay Workshop 12/27/2019

    USP held its 8th Bioassay workshop September 18-19 and expanded its scope to cover challenges related to potency assays for cell and gene therapy (CGT) products. Read more about the speakers and breakout sessions from the event.

  7. Best Practices In Preclinical Development Of Cell Therapy Products 12/19/2019

    Preclinical studies must be customized to support the feasibility of the proposed administration route and appropriate application procedure, address the candidate product’s specific therapeutic properties, and fully characterize any potential safety concerns.

  8. Conference Puts Human Face On Cell And Gene Therapies 12/12/2019

    Cell and gene therapies will unquestionably comprise a large part of biotech companies’ portfolios in the coming decades. Unlike traditional large molecules, these products have different manufacturing and supply chain needs, requiring a fresh look at existing regulations. Yet these challenges will need to be addressed due to the promise of these products to cure a variety of diseases and disorders. The opening talk of the 2019 PDA Cell and Gene Therapy Conference in Long Beach, Calif. on May 6 illustrated this last point in particular

  9. 3 Keys To Realizing FDA’s Vision For CAR-T And Other ATMPs 12/12/2019

    While cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost effectively available to patients.

  10. The Journey To Get An Ovarian Cancer T Cell Therapy Into Clinical Trials 12/5/2019

    Daniel J. Powell Jr., Ph.D., and his research team at the University of Pennsylvania has launched a new clinical trial to treat ovarian cancer with a pioneering therapy involving genetically modified T cells. The trial, which has treated its first patient, almost didn’t happen.