Field notes on life sciences, biotech, and the people moving the industry forward. Written for the operators, not the headlines.
The FDA spent 75 years becoming the world's gold-standard regulator. Prashant Yadav on why that confidence is eroding, and why it crosses party lines.
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When war hits, clinical trials stop and patients lose the treatment they depend on. Anna Titkova on what happened in Ukraine, and what it means for...
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A lot of US drug ingredients trace back to one or two locations in China. A former Marine intelligence officer on the concentration risk regulators are...
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The BIOSECURE Act names five companies and binds federal contractors. A former Marine intelligence officer explains why the rules are likely to widen.
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Intellectual property rarely leaves the way people think. A former Marine intelligence officer breaks down the three ways IP is stolen in China.
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The COINS Act would put US investment, licensing, and JVs in Chinese biotech under government review. A former Marine intel officer explains what's coming.
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Why won't insurance cover gene therapy? Two industry leaders on the employment-linked insurance problem that stalls one-time cures in the US.
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Why don't eligible patients get cell therapy? Only 20% in the US do. Hewitt and Holder on referral, capacity, and the commercial fix.
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Are there alternatives to Chinese biotech suppliers? A counterintelligence expert on why the "China is the only option" assumption is worth testing.
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Charles River's Matthew Hewitt and L.E.K.'s Jeff Holder on how to pay for one-time cell therapy when US insurance is built for monthly refills.
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How to map sub-tier supply chain risk: a former Marine Corps intelligence officer on why third-party checks miss the danger hiding in tiers 3 to 5.
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Does the BIOSECURE Act apply to private companies? A former Marine Corps intelligence officer explains the commercial-channel gap the law leaves open.
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