Field notes on life sciences, biotech, and the people moving the industry forward. Written for the operators, not the headlines.
Why is anonymized data a national security risk? Because state actors want population-level data, and current rules protect the individual instead.
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Why are small biotechs a cyber target? Because they hold the newest R&D. An IP trial lawyer and a pharma security VP on the size-versus-technology mistake.
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What are the risks of unproven stem cell therapy? ISCT's Bambi Grilley on the desperation economy sending families abroad, and the financial ruin.
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How far away is in vivo gene therapy? ISCT's Jaap Jan Boelens on why in vivo gene therapy for genetic disease is likely more than a...
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Why does gene therapy reimbursement take so long? ISCT's Bambi Grilley on the million-dollar float when an insurer says yes but pays a year later.
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What is a single-case agreement in gene therapy? ISCT's Jaap Jan Boelens on why sickle cell patients walk away from a cure when the paperwork drags.
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Approval isn't availability. ISCT's Bambi Grilley on why approved gene therapies aren't available to patients: manufacturing scale and reimbursement.
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Is a Chinese medical device a security risk? Christian Espinosa argues country of origin is a signal, not a control, and points to the CMS8000 backdoor.
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Reimbursement strategy has to start at product design, not after FDA clearance. Edwin Lindsay on the mistake that cost one medtech startup six years.
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A USB port, Bluetooth, or NFC can make your product an FDA cyber device. Christian Espinosa explains the any-way-to-connect test and its misuse cases.
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Can you vibe code a medical device? Christian Espinosa on why AI-generated code fails FDA scrutiny and where it belongs in a regulated build.
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An FDA cybersecurity deficiency letter can run 37 pages and starts a 180-day clock. Christian Espinosa explains what it means and how to respond.
Read article →Get the free quarterly briefing: every guest from the quarter, in one sitting. What decides whether a therapy reaches a patient, gets funded, and can be trusted.
Robert Califf and Vid Desai on what FDA staff turnover costs sponsors: guidance you cannot bank on, lost precedent, and re-litigated study designs.
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Vid Desai, the FDA's first CIO, on why Elsa and programs like it stall: temporary funding, operating costs, and the question most executives ask wrong.
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Vid Desai and Robert Califf on China's research funding passing the US, why phase one trials run cheaper there, and what a US strategy needs.
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Operation TrialBlazer aims at the FDA. Robert Califf, twice its Commissioner, says the real delay sits with research sites that are slow and expensive.
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As US and European funding frays, China is expanding its health diplomacy. Prashant Yadav on why the model is different, and what it leaves out.
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The US is still the largest funder of global health. Prashant Yadav on why other wealthy and emerging economies haven't raised their share, and what fills...
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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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Cell and gene therapies can cure diseases that were recently untreatable. They are also among the most expensive medicines ever made, which is why “why is...
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