FDA Approval Process Costs $25 Million and 18 Months Before Human Trials Even Begin
"Right now, in order to do a clinical trial of what we call a first-in-human, the first time you give a drug to a human, a new drug, in order to do that in the United States right now, you need to write an IND, which is called an initial new drug application, to the FDA. It's very long. I think ours for our first trial was 22,000 pages long. Just to write it, it costs millions of dollars. The manufacturing of your drug and the associated analytics of your drug in order to be correct in the document costs millions of dollars. And all of a sudden this application costs you $25 million."
About this episode
Tim Ferriss hosted Jake Becraft, CEO and co-founder of Strand Therapeutics, in an experimental two-part format tracking an actual policy influence campaign from initial brainstorming to presidential-level impact. The episode documented how a dinner conversation in Boston led to refined messaging, a Washington Post op-ed, congressional testimony, and ultimately the president's legislative priorities—all within two months. Becraft presented clinical data showing a stage 4 melanoma patient with widespread organ metastases achieving complete cancer clearance using Strand's programmable genetic medicine platform, remaining cancer-free 18 months later after exhausting all standard treatments. The conversation revealed that Strand has solved what Becraft called the "holy grail" of genetic medicine: intravenous delivery of genetic medicines to organs throughout the body, not just the liver. Becraft made the case that burdensome FDA regulations requiring $25 million and 18 months just to file paperwork for first-in-human trials are pushing American biotech companies to China, where industrialized clinical trial infrastructure enables faster, cheaper drug development. He proposed eliminating FDA pre-approval for Phase 1 trials, instead using a notification system like Australia's that relies on hospital review boards. The episode explored platform therapeutics as analogous to SpaceX's reusable rocket architecture—creating delivery systems that dramatically reduce time and cost for each successive "payload" or drug candidate. Becraft argued that biotech has become trapped in a real estate development mindset of single-asset exits rather than building generational companies, contrasting this with how Bezos built Amazon and Musk built SpaceX through patient capital and long-term vision. The conversation included detailed discussion of split-testing headlines, refining policy messaging for maximum impact, and the importance of storytelling that leads with solutions rather than problems. Becraft positioned the moment as biotechnology's potential "SpaceX moment" if policy reforms unlock rapid innovation before China dominates the biomedical industrial base.
Key takeaways
- Becraft's op-ed on FDA reform reached the president's legislative priorities within two months of publication, an exceptionally fast policy turnaround.
- Strand demonstrated complete cancer clearance in a stage 4 melanoma patient with widespread organ metastases who remained disease-free for 18 months.
- FDA requires $25 million and 18 months just to file paperwork before first-in-human trials, compared to notification systems in Australia and China.
- China has built industrialized clinical trial infrastructure causing American biotech companies to offshore drug development and threatening US competitiveness.
- Strand's platform enables intravenous genetic medicines to reach organs throughout the body, solving the 30-year "holy grail" problem of delivery beyond the liver.
- Becraft proposed eliminating FDA pre-approval for Phase 1 trials, shifting safety oversight to hospital review boards as in Australia's CTN system.
- The biotech industry has become trapped in a real estate development model of single-asset exits rather than building platform companies like SpaceX or Amazon.