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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
|
|
|
|
|
|
|
|
|