Field notes on life sciences, biotech, and the people moving the industry forward. Written for the operators, not the headlines.
Due diligence for licensing drugs from China: a local bilingual team, site visits, IP review, partner ownership checks and global trial standards.
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Why big pharma is licensing drugs from China: patent cliffs, 4,000 Chinese biotechs needing capital, and assets often already tested in patients.
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Foreign investor due diligence often stops at four checks. Two former intelligence officers on board ties, hiring patterns and where to start.
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Why are trade secret lawsuits hard to win? Two former intelligence officers on weak evidence, sensitive proof and why small biotechs absorb the loss.
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How to detect insider threats in biotech: two former intelligence officers on vetting, digital patterns of behavior and early foreign patent filings.
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What is ambient listening in healthcare? A former health system legal chief explains how AI drafts the clinical note and why it stuck with clinicians.
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Why do hospital AI pilots fail to scale? A former health system legal chief and an AI founder on rollout plans, real priorities and aligned incentives.
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How is AI changing doctor-patient conversations? Patients now arrive with LLM-shaped questions and plans. A healthcare lawyer and an AI founder explain.
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Is health data in ChatGPT protected by HIPAA? A healthcare lawyer explains why records in consumer AI apps fall outside it and what governs them.
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What is the CMS TEAM model? The founder of Rainfall Health explains Medicare’s mandatory model for the 30 days after surgery and where AI fits.
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A former Sequoia partner found early round size inversely correlated with success. Should biotech startups raise less money early? Two investors answer.
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Two biotech investors on whether warm introductions still matter in venture capital, and what actually counts as a connection when you do not have one.
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.
AbbVie Ventures reviewed more than 660 biotech opportunities and made five investments. Christian Schubert and Mike Goguen on where the rest fall out.
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How do biotech companies prioritize their pipeline? A board chair and investment banker on choosing between assets and cutting a program that works.
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How long do biotech M&A deals take? An investment banker on why a deal announced at JPM usually started nine months earlier, and what founders can...
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When should a biotech plan for reimbursement? An investment banker and ISCT’s commercialization chief on payers and the aducanumab lesson.
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What is CMC in cell and gene therapy? An investment banker and ISCT’s commercialization chief on why manufacturing sinks startups and how to plan for it.
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What is a target product profile? An investment banker and ISCT’s commercialization chief explain why founders should write the label first.
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What is crown jewel analysis? A retired Air Force general explains how to identify the data that matters most to a company and protect it first.
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Who is responsible for cybersecurity in a biotech with no CISO? A retired Air Force general explains why the CEO owns the risk and what to...
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A venture firm's diligence files map a whole sector. A retired Air Force general explains what a VC due diligence data breach gives an adversary.
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Amgen, Boston Scientific and McKesson all disclosed cyber incidents in summer 2026. A retired Air Force general explains why he reads them as a pattern.
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Why is biology hard for AI? Paul Agapow and Nindhana Paranthaman on discovered versus invented data, and why models trained elsewhere break in the clinic.
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How to reduce protocol amendments in clinical trials: two drug development leaders on the unglamorous work with the clearest return on offer.
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Why do biotechs chase the same drug target? Nindhana Paranthaman and Paul Agapow on target herding, me-too drugs, and what investors should look for.
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Can a digital twin replace a patient in a clinical trial? Paul Agapow and Nindhana Paranthaman on why the objection is logical, and where twins do...
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A biotech CEO on cutting good programs at a company that is not out of money, and why placing the people through the network is part...
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A biotech co-founder describes the obligation that outlives the company: patients on therapy stay on therapy, which turns a wind-down into logistics.
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A biotech co-founder reduces the pivot-or-close decision to three questions about hypothesis, cash and time, and explains what two answers of no means.
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Two biotech leaders on the signals that appear months before a cash crunch, why they arrive unlabeled, and how to tell which ones change the plan.
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Should startups put AI in their pitch deck? A biotech CEO raising money right now left it out entirely, and explains why.
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How to prompt AI for scientific research: build checkpoints into the request instead of accepting whatever arrives at the end.
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Why is AI so expensive for companies to run? A biotech CEO on the roughly ninety percent of the real cost that providers are still absorbing.
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Who is liable for AI mistakes in drug development? Two biotech CEOs on where the responsibility for AI-generated data actually lands.
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Why do AI errors in biotech take months to find? A cell line takes nine months to build, and a bad input does not fail until...
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Jeremy Levin's management team voted against buying Medarex. He wrote his resignation on a napkin to force it through. The deal brought Bristol-Myers Squibb ipilimumab.
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Boston and San Francisco are no longer the only options. Jeremy Levin and Sara Jane Demy on the biotech hubs forming in Miami, Houston and the...
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Family offices once handed their money to venture funds. Jeremy Levin and Sara Jane Demy on why they now deploy directly, and what founders should do...
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Biotech CEOs once doubted Chinese science. Sara Jane Demy of Demy-Colton on what changed and why her members now treat the data as reproducible.
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Jeremy Levin, former CEO of Teva, on China's 25-year biotech strategy, its 2035 target, and why he says the real question is when China leads, not...
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Venture philanthropy funds drugs a VC cannot yet touch, then hands them off. An ADDF executive and a seed investor on where the two models meet...
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Two brain health investors on how they read a founder, the red flags that end a deal, and the diligence test one firm runs without telling...
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Fifty years of failures made investors cautious about neuroscience. Two brain health investors on what earned that caution and what has actually changed.
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NIH, DARPA, ARPA-H and the Department of War all fund brain health. A seed investor on why nearly every company in his portfolio has a dual-use...
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Anthem now covers blood-based Alzheimer's biomarker testing, and a broader policy lands October 1. What the shift means for patients and diagnostics developers.
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What should a biotech vendor contract require? Right to audit, breach notification, and a real off-boarding process. A pharma security VP walks the lifecycle.
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Who owns the data in a collaboration agreement? Most biotech contracts barely say. An IP trial lawyer on the four-sentence clause that gives it away.
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What do nation state hackers want from biotech? Not ransom. A pharma security VP and an IP trial lawyer on the roadmap they are really after.
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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.
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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 is 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 wealthy and emerging economies haven't raised their share, and what fills the...
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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 treatment they depend on. Anna Titkova on what happened in Ukraine and what it means for research.
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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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What is the COINS Act? The 2025 law screens US investment in some Chinese tech. A House bill would add biotech; a former Marine intel officer...
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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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