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BoB@JPM: Kasper Roet, Ph.D., QurAlis

Business Of Biotech

CHAPTER

Navigating Regulatory Challenges in Biotechnology

This chapter explores the formation of a consortium of 11 biotechnology companies aimed at tackling regulatory obstacles with the FDA, promoting a flexible risk-benefit approach for faster therapy approvals. It highlights the industry's collective push for systemic changes, the importance of early intervention in neurodegenerative diseases like ALS, and ongoing clinical trials for innovative therapies. The discussion also underscores the role of awareness initiatives and collaboration in advancing genetic medicine and RNA therapeutics.

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