02.02.23 -- Inside FDA's New Guidance On Early-Phase Cell & Gene Therapy Trials

One of the greatest challenges for small pharma and biotech companies always seems to be CRO selection. Aside from the difficult decision of whether to select a large or small CRO, sponsors grapple with CRO location, international presence, and culture. Of course, another primary concern is the quality of the team you will be working with and whether they will provide you with the attention you need.

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KPS Life brings "A" team resources that are 100% dedicated to sponsors and create a collaborative, supportive process where complete control of operations is maintained.

The cell and gene therapy development process involves screening different variants of a product type. To aid this process and to ensure that suitable evidence is gathered so that effective variants of the product are taken through to later-stage trials, the FDA has produced a final guidance.

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Discover how offering sponsors end-to-end strategic drug development and technology-enabled regulatory services helps reduce time, cost, and risk, from discovery through post-registration.