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Feb 18
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LONG
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Marty Makary
FDA Commissioner
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The FDA aims to cut the "pre-IND" approval timeline from 520 days down to competitive levels (China is ~200 days) to bring Phase 1 trials back to the US. Reducing regulatory red tape and startup time for clinical trials lowers cash burn for early-stage biotechs and encourages domestic innovation. LONG the US biotech ecosystem. Bureaucratic inertia may prevent meaningful process changes. |
CNBC
FDA's Marty Makary: Everything should be over...
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Feb 09
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AVOID
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Dr. Scott Gottlieb
Former FDA Commissioner; Board Member (Pfizer, Illumina, UnitedHealth); Partner at NEA (Venture Capital)
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Gottlieb warns that the environment for developing new vaccines has become toxic for investors. The regulatory bar at the FDA has risen, and the CDC's advisory committee has shown reluctance to recommend new vaccines even after approval. Consequently, venture capital firms are pulling funding from early-stage vaccine research because the path to commercialization is blocked by political and regulatory skepticism. Gottlieb notes that research money is actively leaving the space, specifically citing pulled funding for Epstein-Barr Virus (EBV) vaccines. A shift in public health policy or a new pandemic forcing a regulatory reversal. |
CNBC
Squawk Pod: Super Bowl ads & GLP-1 competitio...
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