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Pre-clinical Studies for Cellular Therapies: CBER Office of Cellular, Tissue and Gene Therapy Director Discusses FDA Expectations | BioQuality.biz

Dr. Celia Witten, Director of the Office of Cellular, Tissue and Gene Therapy at FDA Center for Biologics Evaluation and Research, otherwise known as CBER, gave a talk at a recent FDA workshop on FDA’s twin role with regards to cellular therapies. Here are some of the points she made:

  • “Just to make a comment about our mission, everybody thinks of FDA as being the organization responsible for regulation and protecting public health by looking at safety and efficacy. We also do have as part of our formal mission statement advancing public health by helping to speed innovations and our efforts with groups like this one that have dialogue with the scientific community Is part of our way of accomplishing that innovations part of our mission.”
  • ” what i want to highlight is this, our program priority, the highest program priority for this year is publishing a draft guidance for cellular an gene therapy products so I hope that we — I can make no promises about timing but I hope we’re able to come up with that sometime this this calendar year.”

She also gave a recap of a previous meeting, so that all attendees could be ‘on the same’ page when it comes the topics discussed at this, the second in a series of FDA meetings on cellular therapies. Some of her  take-away messages from that first meeting included:

  • Issues surrounding Consent are looming large and there a draft rules being drawn up based on discussions with a variety of stakeholders
  • It is important, for cellular, as well as for more traditional therapuetics, “to do pre-clinical studies with the product you’re going to finally manufacture by the process you have already manufactured (product with)”
  • “you have the think about going towards the clinical trial in terms of manufactured product, in terms of thinking about sourcing, derivation of the cells, sort the cells, engineer the cells depending on what the end goal is and perform pre-clinical studies, clinical studies an apply for license insure of new drug”


See our August Issue for more details on this important talk!  It is our lead story. To Subscribehttps://www.formstack.com/forms/bqform-subscription



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