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The Future of Cell and Gene Therapy: Navigating Innovation, Regulation, and Manufacturing Challenges
An interview with Philip Vanek, chief commercialization officer of the International Society for Cell & Gene Therapy (ISCT), reveals both promising developments and significant concerns shaping the advanced therapies sector’s trajectory through 2025 and beyond. This interview was conducted with support from Tozaro.
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Looking at licensing deals struck in the past 10 years, Jefferies found that many Big Pharmas do not ultimately follow through with M&A after earning a right of first negotiation. Sanofi, on the other hand, almost always does, as it did with Vigil recently.
Gene therapies have ridden investor mania to huge valuations but commercialization challenges have pushed market caps to the floor. At a roundtable last week, FDA leaders promised faster approvals and broad support to the industry.
As multiple companies vie to expand on Alnylam’s success in commercializing RNAi therapeutics, the pioneering company has set a goal of targeting small interfering RNA to any tissue by 2030.
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Omega Therapeutics, Inc., a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, announced the appointment of Kaan Certel, Ph.D., as Chief Business Officer.
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BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the agency’s decision to issue a complete response letter for Replimune’s viral treatment RP1 for advanced melanomas. Shares of the company tumbled 75% on Tuesday.
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