BioLife Solutions Positive About FDA’s Proposed New Policies To Advance Cell And Gene Therapies

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BioLife Solutions, Inc., has announced that the company expects to benefit from the new policies to advance the development of safe and effective cell and gene therapies as set forth in a statement issued by the U.S. Food and Drug Administration (FDA) on January 15, 2019.

BioLife Solutions, founded in 1987, headquartered in the Greater Seattle Area, West Coast USA, is the leading developer, manufacturer and supplier of proprietary biopreservation media for cells and tissues. According to the company, HypoThermosol® hypothermic storage and CryoStor® cryopreservation freeze media are highly valued in the regenerative medicine, biobanking and drug discovery markets. These novel biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function.

In the FDA statement the surge of cell and gene therapy products entering early development was cited, as well as the anticipated increase in the number of product approvals in the coming year. The following projections were provided on approvals of new cell and gene therapies and the FDA staffing to support the review of new applications:

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  • Based on a “surge of cell and gene therapy products entering early development, we anticipate that by 2020 we will be receiving more than 200 INDs per year, building upon our total of more than 800 active cell-based or directly administered gene therapy INDs currently on file with the FDA.”
  • “…by 2025, we predict that the FDA will be approving 10 to 20 cell and gene therapy products a year based on an assessment of the current pipeline and the clinical success rates of these products.”

On the subject of CAR-T the FDA stated: “Our new guidance will recommend parameters for how innovators can introduce advances in manufacturing that promote the more efficient development and application of CAR-T therapies without necessarily requiring costly new clinical investigations. We intend to propose ways to help ensure the safety and effectiveness of the resulting products through available technologies and examinations, and when limited clinical bridging studies may be needed prior to approval of a change, possibly followed by the submission of additional clinical information supplied by real-world data after the change is introduced.”

“We welcome this supportive statement from the FDA regarding new policies to advance development of safe and effective cell and gene therapies. To date, we believe our optimized CryoStor® and HypoThermosol® proprietary biopreservation media products have been used in more than 300 customer clinical applications. The new FDA guidance could help accelerate adoption of our products specifically with later-phase companies that still use non-optimized, generic ‘home-brew’ preservation media cocktails. We see the potential to convert these trial sponsors to our products. Oftentimes these companies perceived the risk of having to conduct new clinical studies as an obstacle to switching to our best-in-class biopreservation media.” – Mike Rice, BioLife CEO