BioCentury This Week Ep. 320 - U.K. Biotech, U.S.-China, Insmed
Sep 16, 2025
Merck's decision to relocate its R&D from the U.K. sparks debate about the nation's life sciences policies. The discussion delves into MHRA's aspirations to enhance regulatory standards. Meanwhile, a new law passed in the U.S. threatens to cut academic research collaborations with China. On a positive note, Insmed celebrates a remarkable success after years of reinvention, highlighted by a recent Phase III triumph. The political implications of vaccine endorsements also add an intriguing layer to the conversation.
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MHRA To Lean Into UK Strengths
- Lawrence Tallon plans to position MHRA by focusing on UK strengths like cell and gene therapies, rare diseases, vaccines and mRNA.
- He aims to speed trial starts to U.S.-like timelines and expand mutual recognition with other regulators to amplify UK approvals.
Speeding Trial Starts Is Crucial
- Shortening the time to start clinical trials is a top regulatory priority to make the UK more competitive for early-stage R&D.
- Steve Osden says matching U.S. timelines (even if not China-fast) will address a major inhibitor to running UK trials.
Regulatory Reliance Multiplies Market Reach
- Mutual recognition could make MHRA approvals unlock broader markets beyond the UK's 60 million population.
- Steve Osden suggests reliance agreements would increase the value of UK regulatory decisions.