Insights / Function
Posts carrying the Clinical development tag.
7 May 2026 · 3 min read
Most AI-first techbios are modeling clinical costs that are roughly half of what they will actually face — and the capital required to put an AI-derived molecule in front of a patient has roughly doubled within the lifespan of one mRNA company. Discovery cost reductions are real and welcome, but the binding constraint sits elsewhere.
30 Apr 2026 · 3 min read
The FDA's first real-time clinical trials don't just promise faster reviews — they insert a new infrastructure layer between sponsors and the agency. I break down what that architectural shift means for clinical development.
28 Apr 2026 · 4 min read
OpenEvidence has withdrawn from the EU and UK citing regulatory uncertainty around the EU AI Act, making the geography of clinical AI access officially American. I break down what this means for US and European pharma, and why the AI Act's first observable market effect may be pushing physicians toward less-grounded AI alternatives.
2 Apr 2026 · 3 min read
CRO stocks dropped sharply on AI fears: IQVIA, Medpace, Charles River. The market may be right that AI changes trial economics. It’s wrong about where the disruption lands. CROs are infrastructure companies, and AI should make them more valuable, not less — if they can break free from the cost-plus model.
5 Mar 2026 · 3 min read
The FDA quietly granted Breakthrough Device Designation to a generative AI chatbot — not a diagnostic, not a scoring tool. An LLM that talks to post-surgical patients twice daily and escalates red flags. No GenAI device has ever received FDA authorization. This becomes the test case.
29 Jan 2026 · 3 min read
Hologen, Eric Schmidt’s stealth biotech-AI venture, is raising $150M at an $850M pre-money on a promise of 100% returns in 12 months. The pitch is closer to financial underwriting than AI product development. Here’s what would convince me it’s more than narrative.
5 Jan 2026 · 2 min read
I'm sharing my 5 bets for AI in Healthcare and TechBio in 2026 — from ambient scribes becoming table stakes to a TechBio Series B shakeout accelerating. If one of these is wrong, I want to know which one and what would change your mind.
13 Nov 2025 · 1 min read
AbbVie is quietly unwinding its 11-year longevity bet with Google's (Alphabet's) Calico Life Sciences — a $1.5B collaboration started in 2014 around aging and age-related disease. I don't think this particular setback signals something more fundamental, but it raises real questions about where dedicated drug development in longevity is headed.
25 Sept 2025 · 1 min read
The NHS is building AIR-SP, a national AI screening cloud that lets every trust plug into shared, real-world trials — starting with a breast-cancer study involving nearly 700,000 women. I think the overall approach makes sense, and I'd love to see other countries adopt something similar.
18 Jun 2025 · 1 min read
I joined an interesting discussion on AI in drug discovery and development at HLTHEurope2025 with panelists from Novartis, Roche, and OWKIN. From real-world evidence generation to biomarker development and regulatory considerations, the conversation covered both the opportunities and challenges of bringing AI into pharma.
3 Jun 2025 · 1 min read
The FDA is now using GenAI to review regulatory dossiers — and I think that's a good thing. Pharma companies have already been using generative AI to craft submissions, so it makes perfect sense for regulators to leverage the same technology on their end.
13 May 2025 · 1 min read
Last week at the AI in Clinical Development Summit 2025 in NYC, I joined a panel tackling the timeless build-or-buy question for pharma AI in clinical development. Our consensus: a "build with" strategy — co-developing with selected strategic AI startup partners — strikes the right balance between speed, fit, and long-term value.
6 Mar 2025 · 1 min read
I attended a very insightful panel at the EPA conference in Amsterdam on how global healthcare reforms are impacting local market access strategy. Modeling demands are becoming more challenging, joined Health Technology Assessments are increasingly the rule, and — as Gavin Lewis of Novartis put it — your access strategy is becoming your entire enterprise strategy.
5 Dec 2024 · 1 min read
Interesting insights on the use of GenAI in Healthcare, from Bayer's Guido Mathews, Medtronic's Irina Evstifeeva and Karista's Amine Benmoussa at Health Tech Forward in Barcelona. From drug discovery and digital twins to medical imaging and workflow efficiency, the panel surfaced where GenAI is maturing — and where it still has a long way to go.
4 Dec 2024 · 1 min read
I attended a fascinating panel at Health Tech Forward on Automation in Clinical Trials featuring in-silico trials and digital twins. Speakers from QuantHealth, a leading VC, and United Therapeutics shared how AI is cutting trial lengths, replacing animal models, and opening new doors for orphan disease research.
18 Nov 2024 · 1 min read
Formation Bio, in collaboration with Sanofi and OpenAI, has introduced Muse, an AI-powered tool designed to optimize patient recruitment in clinical trials. I think it will be fascinating to watch how this three-party collaboration — Big Pharma, Health Tech, and Large Tech — evolves, and I wouldn't be surprised to see more of these partnerships emerge in the coming year.
9 Oct 2024 · 1 min read
A great talk from Gilead's Jeremy Zhang at BiotechX on scaling LLMs like OpenAI and Claude to the clinical portfolio — covering key use cases from protocol design to automated document generation, and the real hurdles of stakeholder skepticism and regulatory clarity.