Field notes on life sciences, biotech, and the people moving the industry forward. Written for the operators, not the headlines.
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...
Read article →
A biotech co-founder describes the obligation that outlives the company: patients on therapy stay on therapy, which turns a wind-down into logistics.
Read article →
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.
Read article →
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.
Read article →
Should startups put AI in their pitch deck? A biotech CEO raising money right now left it out entirely, and explains why.
Read article →
How to prompt AI for scientific research: build checkpoints into the request instead of accepting whatever arrives at the end.
Read article →
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.
Read article →
Who is liable for AI mistakes in drug development? Two biotech CEOs on where the responsibility for AI-generated data actually lands.
Read article →
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...
Read article →
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.
Read article →
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...
Read article →
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...
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.
Biotech CEOs once doubted the veracity of Chinese science. Sara Jane Demy of Demy-Colton on what changed, and why her members now treat the data as...
Read article →
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...
Read article →
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...
Read article →
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...
Read article →
Fifty years of failures made investors cautious about neuroscience. Two brain health investors on what earned that caution and what has actually changed.
Read article →
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...
Read article →
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.
Read article →
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.
Read article →
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.
Read article →
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.
Read article →
Why is anonymized data a national security risk? Because state actors want population-level data, and current rules protect the individual instead.
Read article →
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.
Read article →
What are the risks of unproven stem cell therapy? ISCT's Bambi Grilley on the desperation economy sending families abroad, and the financial ruin.
Read article →
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...
Read article →
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.
Read article →
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.
Read article →
Approval isn't availability. ISCT's Bambi Grilley on why approved gene therapies aren't available to patients: manufacturing scale and reimbursement.
Read article →
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.
Read article →
Reimbursement strategy has to start at product design, not after FDA clearance. Edwin Lindsay on the mistake that cost one medtech startup six years.
Read article →
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.
Read article →
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.
Read article →
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 →
Robert Califf and Vid Desai on what FDA staff turnover costs sponsors: guidance you cannot bank on, lost precedent, and re-litigated study designs.
Read article →
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.
Read article →
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.
Read article →
Operation TrialBlazer aims at the FDA. Robert Califf, twice its Commissioner, says the real delay is research sites that are slow and expensive.
Read article →
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.
Read article →
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...
Read article →
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.
Read article →
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...
Read article →
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...
Read article →
The BIOSECURE Act names five companies and binds federal contractors. A former Marine intelligence officer explains why the rules are likely to widen.
Read article →
Intellectual property rarely leaves the way people think. A former Marine intelligence officer breaks down the three ways IP is stolen in China.
Read article →
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.
Read article →
Why won't insurance cover gene therapy? Two industry leaders on the employment-linked insurance problem that stalls one-time cures in the US.
Read article →
Why don't eligible patients get cell therapy? Only 20% in the US do. Hewitt and Holder on referral, capacity, and the commercial fix.
Read article →
Are there alternatives to Chinese biotech suppliers? A counterintelligence expert on why the "China is the only option" assumption is worth testing.
Read article →
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.
Read article →
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.
Read article →
Does the BIOSECURE Act apply to private companies? A former Marine Corps intelligence officer explains the commercial-channel gap the law leaves open.
Read article →
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...
Read article →