Industry Insights

  1. An Immunologist’s Journey To Get An Ovarian Cancer T Cell Therapy Into Clinical Trials
    12/5/2019

    Ovarian cancer is a formidable foe, killing about 15,000 women a year in the United States alone. It’s especially hard to treat because there are no effective screening tests. That means that the disease is usually only diagnosed after it has significantly advanced, leaving women with a five-year survival rate of less than 25 percent.

  2. Former Novartis CEO: Cell And Gene Therapies Will Drive Innovation
    12/2/2019

    Joe Jimenez joined Novartis as division head of Consumer Health. A few months later, he was asked to run the pharmaceutical division. Shortly after his promotion to CEO, Novartis was the first company to pursue a CAR T therapy. Today, Jimenez marvels at the innovation taking place in the industry, and believes cell and gene therapies will drive future development. 

  3. Sampling And Testing Of ATMPs: Gaining Insights From PIC/S Annex 2A
    11/26/2019

    With minimal specific guidance on commercial manufacturing from the FDA and a lack of robust platform commercial processes, some of the finer details of cell and therapy manufacturing can make operating companies feel like they are walking on a precarious limb.

  4. Quality Starting Material: The Driving Force Behind Life-Saving Cell Therapies
    11/12/2019

    As apheresis centers look a few years into the future to offering perhaps 15-30 approved medicines, and hundreds more clinical trials, this current situation will very soon become untenable.

  5. Synthetic Biology Data Management Solutions Enabling Early Gene Therapy Discovery
    11/7/2019

    The last decade spurred enormous advances in the field of synthetic biology and gene therapy. This article aims to highlight the difficulties in searching for and storing biomedical general and sequence related information with traceable meta-data. This articles also provides a snapshot of some of the available resources for electronic data management, including guidelines, data consolidation, design tools, documentation and sharing for synthetic biology and molecular biology-based human therapeutics.

  6. Are Allogeneic MSCs Ready For Primetime?
    11/5/2019

    Pre-clinical data suggests that allogeneic mesenchymal stem cells (MSCs) do not elicit robust immune responses in vivo which may make them candidates for broadly applied therapeutic applications. This article details whether allogeneic MSCs are ready for primetime.

  7. CDMO Selection: How To Kick Off A Game-Winning Project
    11/1/2019

    This article explores the execution phase of outsourcing with a focus on the context and planning of the kickoff meeting. At this meeting, the handoff from the existing procurement team to the operations team will require close attention.

  8. FDA FY2018 Human Tissue And Cell Therapy Observations And Trends
    10/24/2019

    This article presents the most recent publication of GMP Human Tissue for Transplantation Form 483 observation data from the FDA. We examine data from FY2018 and evaluate a total of four years’ worth of trends in GMP inspection enforcement in this area.

  9. 5 Essential Factors For A Successful Biopharma Product Launch
    10/23/2019

    Rapid changes in the biopharma industry—including novel treatment modalities (i.e. gene and cell therapy); increased use of biomarkers; rare diseases that are hard to identify, diagnose, and access; and expanded requirements to demonstrate economic value—make new product launches increasingly difficult.  

  10. Building A $1 Billion Gene Therapy Company — In 6 Years
    10/21/2019

    Matt Patterson, chairman and CEO of Audentes Therapeutics, shares the experiences that prepared him for building the gene therapy company he cofounded into a publicly traded business valued at nearly $2 billion, in just seven years.