The Ledger
Every statement that passed quotation and attribution checks. Mix any filter with any other: certainty 1/5, debate potential 5/5, or both at once.
why aren't all 29 resolved? a statement only gets an assessment when the public record can support or contradict it. opinions and what-ifs never can, and 1 checkable ones are still open, waiting for their date. predictions held up or didn't; assertions are supported or contradicted. on every card: ▮▮▮▮▮ certainty · ▮▮▮▮▮ debate potential. speakers are clickable
Nuzhna: China leads global development in in vivo CAR-T and gene editing
“They are now leading in, in VivoC RTs, they are leading in gene editing and gene therapy, and partially due to this ability to do those investigator-initiated trials.”
Nuzhna: AI will solve open biology questions before predicting drug efficacy
“Many big bio problems and open questions will be solved with AI way before we can predict efficacy for drugs.”
Nuzhna: AI virtual cell models are near realization with existing data
“Virtual cells is actually not that far out. I think we have all the necessary data to generate something like that.”
Nuzhna: New therapeutic modalities face a "better than the Beatles" bottleneck
“So I think many new modalities will be bottlenecked by the Beatles, better than the Beatles problem.”
Nuzhna: US multi-payer insurance system disincentivizes early preventive healthcare
“The payer that pays the most for diseases of aged population is Medicare which kicks in after 65. Before then we have a multi-payer system where patients Tend to rotate their insurance every few years. And so there's really not much incentive for someone to co…”
Nuzhna: Medicine will treat aging before understanding its underlying mechanisms
“I think we would be able to treat aging before we understand how to measure it or what it is or why it happens.”
Nuzhna: Modern medical stack can eliminate heart attacks for current generation
“And it does seem like we kind of hit a point where actually like our generation shouldn't die of heart attacks. It seems like we have everything to prevent high cholesterol in people from, like you can take antibodies sRNAs, small molecules, sun gene editors. …”
Nuzhna: Biotech companies should avoid being contrarian on novel biological mechanisms
“And I think biology is like one of the areas where you really don't want to be contrarian. You don't want to be the only company pursuing some obscure mechanism. Usually you want to have some literature validation, but in both of these cases, it was either a b…”
Nuzhna: FDA regulation has continuously increased except during the AIDS crisis
“Since the birth of this industry, we only had increasing regulation over time. I think there was like only one time in history of biotech where we made it easier to develop and approve new drugs. And that was during the ACE crisis where AIDS patients were just…”
Nuzhna: Investigator-initiated trials in China cut review timelines by 5x
“With investigator-initiated trials your view timelines are cut five to six X.”
Nuzhna: Biological breakthroughs stem from new modalities, not target discoveries
“Every time I think about where the biggest breakthroughs and successes in biology came from, it was always served from some type of technology or process or technique and rarely from like discovering a new target.”
Nuzhna: Treating aging with existing modalities is an uphill battle
“I think aging is in a somewhat similar space in that it's a massive multifactorial disease, and if we rely on existing modality approaches, it would just be an uphill battle to try and treat it.”
Nuzhna: Bullish on gene editing, epigenetic editing, and extrahepatic LNP targeting
“I think we are starting to see light at the end of the tunnel with gene editing, epigenetic editing more tailored targeting approaches where no longer do our LNPs just go to the liver. We can now target HCCs, we can target kidney, we can target potentially bra…”
Nuzhna: Biotech regulatory requirements have continuously increased since industry inception
“Since the birth of this industry, we only had increasing regulation over time.”
Nuzhna: Everyone in biotech will use AI within five years
“Everyone will be using AI and biotech industry five years from now.”
Nuzhna: One-fifth of public biotechs traded at or below cash balances
“Earlier this year we had something like one-fifths of public biotechs trading at or below their cash balances.”
Nuzhna: Biotech drug development uniquely combines engineering and scientific risk
“Approving drugs is really hard. It's probably one of the hardest areas of deep tech broadly, because it takes not only on engineering risk, but also on scientific risk.”
Nuzhna: Eli Lilly's Alzheimer's trial tests GLP-1s as broad aging treatments
“I think this month Lilly is reading out their semaglutide in Alzheimer's trial, which is to me is a real test of whether it's An aging drug or not because it's well outside of the metabolic spectrum of diseases.”
Nuzhna: Medicare refused coverage for GLP-1 drugs in obesity care
“Medicare refused to cover GLP-I ones for obesity care.”
Nuzhna: Lifespan-extending drugs in animals remain untested in humans
“I think regulation is lagging behind science. I think we have multiple drugs that extend lifespan in mice and monkeys that never been tested for lifespan indications in humans.”
Nuzhna: Caloric restriction is only proven lifespan extender in monkeys
“The only documented effect for lifespan that we have in monkeys is caloric restriction. We know that we can add about two and a half years to 25 year median lifespan in monkeys by calorically restricting them.”
Nuzhna: US will remain the primary exit market for biotech companies
“And even if Chinese population will continue to grow, US will still remain the biggest market for biotech companies to exit at.”
Nuzhna: 50% of FDA drug approvals in 2024 were orphan drugs
“And today, 50% of drugs approved in twenty-twenty-four were all orphan drugs.”
Nuzhna: A GLP-1-style race is emerging for muscle loss drugs
“I think muscle is in a similar space right now where for a while people weren't treating sarcopenia as a real indication because it's sort of muscle loss in elderly, but there is now a similar race to JLP wants to go and develop drugs for muscle.”
Nuzhna: Drug development costs exceed $2 billion per approval
“We now spend more than two billion dollars per approved drug.”
Nuzhna: Preclinical spending is a minor portion of drug development cost
“Most of it's spent is not in preclinical stage. It's spent in validating safety and efficacy in humans. It's spent on commercialization stage, which is what happens after phase three clinical trials.”
Nuzhna: Phase 2 efficacy trials have the highest drug development failure rate
“The highest failure rate right now is phase two, which is efficacy.”
Nuzhna: Humira succeeded as the first human monoclonal antibody, not first-to-market
“Humira was also not the first TNF-alpha antibody out there. It was like third to market, third TNF-alpha antibody to be approved, but it was the first human monoclonal antibody, one of the first ones to be approved. And all the previous ones were antibodies fr…”