Show notes
In part one, we explored why drug development costs are exploding and how better software could fix it. In part two, we get practical: what’s actually stopping Britain from becoming a biotech superpower, and what would it take to get there?Meri pulls no punches. The single hardest thing about building Lindus Health in the UK? Three-month notice periods. Want to staff up for new trials? Wait three months for people to work out their notice—during which they’re not exactly doing their best work. “It’s incredibly ineffective. It acts as a transfer from the most productive companies to the less productive companies people are resigning from.” Meanwhile, US contracts have no notice period or a couple of weeks max.But notice periods are just the start. The real bottleneck is that Britain produces excellent early-stage research but can’t capture the value because we’ve made ourselves an unattractive market for drug sales. NICE’s role has become “get the lowest price possible, even if that means greatly delaying when the drug is distributed in the UK.” We’ll spend five years negotiating a thousand pounds off a course of treatment while people literally die. The solution? Turn the NHS into a pharma company—have it fund and run trials like the RECOVERY trial that discovered dexamethasone, then earn royalties by selling the drugs to America.From ethics committees run by religious volunteers who delay STI trials to promote abstinence, to why Brexit was actually good for medical devices (FDA approval now automatically carries over to UK), to the limits of in-silico trials and why randomised control trials are “literally magic,” Meri lays out a vision for fully automated luxury NHS—and explains why everything comes down to clinical trials, even in the age of AI.Tom, Calum, and Meri discuss:* Why Meri’s company had to go transatlantic: “We haven’t moved to the US—we’re transatlantic. About 150 people, half still in UK. But look, I’m not going to deny there are strong forces pulling us to the US.” Not capital availability—European investors funded them to Series B. It’s the market. “Markets aren’t big enough in Europe to sustain global category dominant companies. If you want to build category defining companies in the UK, you need to grow the economy.”,* Three-month notice periods are killing British startups: “The single hardest thing about building the company so far in the UK has been notice periods. We’ve won new trials, need to staff up, hire good people—takes time. Then they have three months between resigning and joining us. It’s incredibly ineffective because once you’ve resigned, you’re not doing your best work.” US contracts: no notice period or couple weeks. “Even a couple weeks is enough to fully hand over even a senior productive person’s work.”,* What Lindus Health actually does: Design overall study, find sites, train them, oversee operations through software that integrates with health records and labs. Monitor for errors and patient safety risks in real time. For home-based trials like ME/CFS: “We employ nurses directly to visit patients in their home or have video calls. We do pretty much everything.”,* Adaptive trials that analyze data in real time: “Clinical trials today are very waterfall. Design, run, analyze months after it’s wrapped up. Our software runs every trial adaptively. We don’t know how many patients we’ll enroll or what ratio between control and treatment. Software automatically randomises patients in a way that boosts statistical power and stops enrolling as soon as we’ve enrolled enough to show statistical effect.” Not p-hacking—stays blinded,* Testing multiple variations in parallel: “Should be testing multiple in parallel. One control arm of 100 people, indeterminate number of arms with slight variation of dose or patient population. For the same time and massive cost saving, get way richer data.” Already doing this today,* Why in-silico trials are limited: “RCTs are literally magic. By randomizing participants fairly, you control for all possible variables without needing to know what they are. To run effective in-silico experiments, you need to know what all possible variables are, which is essentially impossible because humans are incredibly complex.” Where they work: late-phase cancer (unethical to give placebo) and psychedelics (you immediately know if you got ketamine),* Brexit was actually good for medical devices: “If you get FDA approval for a medical device, you automatically get approval in UK—been a big triumph post-Brexit. What would be amazing is to have it both ways.” For drugs, you still need slightly varying requirements for each country but one expensive phase three gets approval in Europe, Japan, US, South Korea,* Ethics committees run by unhinged volunteers: “Someone delayed phase two oncology trial—so people were going to die—because they felt the font was too small in documents. Delays by at least four weeks because the committee only meets every four weeks.” One person delayed STI test trial because of religious conviction, insisted on promoting abstinence,* Just pay for private ethics committees: “In US you can pay private regulated company to convene ethics committee. Costs five or ten grand but we get quick good feedback and can start in a week. That’s a no-brainer—same centralised system but pay the people, implement rigorous standards, make it self-funding.”,* The COVID trials that worked: Recovery trial—Martin Landray ran very fast pragmatic trial testing different COVID treatments. Discovered dexamethasone was effective at reducing mortality. “Extremely cheap in drug trial terms.” Their VP of clinical operations was key person behind panoramic and principle trials, both fully remote. “By really tight integration with health system, you can run trials so much faster and cheaper in a way that’s not possible unless you are the health system.”,* Turn the NHS into a pharma company: “Have NHS run trials for free or very low cost like RECOVERY. In return they own a share of the drug. We’ve run phases 1-3 on NHS very quickly—now we’re the distributor or we sell license to pharma and earn significant royalty. British patients get access sooner and it would be incredibly profitable because you run these trials so much cheaper than on US healthcare systems.” Would require fundamentally re-architecting NHS around for-profit model,* Why speed matters more than people think: “Because of how patents work in life sciences, every day that ticks by is literally on average worth hundreds of thousands for the average drug. That’s less revenue you could be earning before the patent cliff when drug goes off patent and becomes generic.” Speed should be incredibly important—and they reinvest that revenue into fundamental R&D,* The vision for 50 years from now: “If we can crack opening this bottleneck—safely test 10x, 100x as many iterations of potential drugs at scale—you inevitably get healthcare bioabundance. This has to happen to cure cancer, cure Alzheimer’s, live to 200. Everything comes down to clinical trials. Until AGI can completely simulate the human body, you literally cannot objectively claim you’ve cured cancer until you’ve tested it in enough humans.”,Plus: Why lipids massaged into mouse hair could cure Tom’s Norwood 2, the meeting rooms named after James Lind’s original trial arms (cider, seawater, oranges, lemons, barley water, garlic paste), and why they randomised people onto different drinks at their early parties.Your clinical trial success depends on notice periods—who knew? This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.anglofuturism.co/subscribe