For Jake Becraft, Ph.D., the future of America’s biomedical innovation isn’t just playing out in the lab—it's being shaped by industrial policy. In a recent interview with Fierce Biotech, the Strand Therapeutics CEO and co-founder warned that the U.S. faces a critical choice: either modernize its regulatory framework for early-stage clinical trials or risk losing the capabilities permanently.
“We need to have a concerted industry-government effort [to] come together to actually understand, what are the risks of building the drugs in a certain way? What do we need to know about them? What is acceptable? What is necessary?” Becraft, who also sits on the board of the Biotechnology Innovation Organization, said.
Becraft was referring to what he describes as cumbersome FDA requirements for Investigational New Drug (IND) filings and lagging industry support as prohibitive factors for small biotechs planning to start first-in-human clinical trials in the U.S. During March testimony before the U.S. House of Representatives’ Select Committee on China, Becraft outlined the damage that the harsh environment for early-stage trials could inflict on the overall health of the U.S. biotech industry.
“The defining competitive metric in modern biotechnology is no longer who discovers a promising therapy first,” Becraft testified. “It is who can turn that discovery into first-in-human clinical data the fastest.”
It’s no secret that the U.S. is losing early-stage clinical trials to China and Australia, where first-in-human studies are cheaper and faster to start thanks to more streamlined regulatory pathways.
“This matters because early clinical data creates what I describe as a ‘flywheel effect,’” he continued in the testimony. “When a therapy produces early human results, that program becomes derisked, investors step in, partnerships form, companies grow, and manufacturing capacity expands, clinical centers gain experience running more clinical trials, and the cycle repeats.”
The $20M barrier to entry
The primary hurdle to running a first-in-human study in the U.S., according to Becraft, is a regulatory framework that has become increasingly disconnected from the scientific and operational realities today.
Becraft started Strand in 2017 and spun it out of the Massachusetts Institute of Technology to focus on mRNA therapeutics. At that time, financial models projected phase 1 costs at roughly $50,000 to $100,000 per patient, with an entire IND costing around $9 million.
By the time that Strand submitted its first IND and entered the clinic about two years ago, the cost per patient was over $400,000, Becraft said. The total cost to reach the clinical starting line, including manufacturing and preclinical studies, exceeded $20 million.
To Becraft, a big problem centers on how current FDA regulations around chemistry, manufacturing and controls (CMC) treat phase 1 drugs almost as if they are ready for a full commercial launch. These include multiyear stability and “hardcore, full” good manufacturing practice (GMP) requirements for raw materials, some of which Becraft doesn’t think are necessary.
GMP facilities are very expensive for small companies.
“It’s such a liability,” Becraft said. “Even if someone gave us the money to build one [….] the ongoing cost of operating one is often too high for a company like ours.”
That means many small biotechs have to rely on a small number of contractors. But the problem is, because the manufacturing suites are so expensive, larger-scale projects are often given priority to use them, while early-stage projects wait in line.
“We need to re-industrialize a small-scale manufacturing base for novel pharmaceuticals,” Becraft said. “We have to be able to rapidly produce them. We need to reform FDA regulations around CMC requirements for early-stage advanced biologics.”
Becraft himself doesn’t have the perfect solution. That’s why he’s calling for an industry-government initiative to try to tackle the pain points.
He raised the example of what’s known as qualified assays. Assays are developed to analyze a drug’s pharmacological effects and attributes, and they must be verified at qualified labs as part of the IND package. On multiple occasions, the lab Strand used would return irrelevant results on “very simple assays,” according to Becraft, leading to back-and-forth between the biotech and the vendor.
“Is it necessary from the standpoint of an early-stage trial? Or is that [for] something if you’re going to go into hundreds of patients?” Becraft said. “They take time, they take money, they lead to longer timelines, higher amounts of pieces, all because the FDA might not want to trust us running the assay and reporting it at the early stages. So, how do you solve for that? I don’t have 100% of an answer.”
To Becraft, the U.S. needs to find “common-sense regulation in the middle that keeps patients safe but enables folks to get revolutionary treatments into patients faster.”
“If the answer is that, the only way to start a trial is 19,000 pages of a regulatory document that’s going to convince you that you should give a medicine to very sick people who are desperately in search of something or anything, I just fundamentally don’t think that’s the case,” he said.
Multiple arbiters
The FDA is already aware that some of its IND regulations are outdated. In his fiscal year 2027 budget request to Congress, FDA Commissioner Marty Makary, M.D., asked Congress’ permission to create a new “Expedited IND” pathway, noting that greater barriers to clinical entry in the U.S. have “fueled the increase in early-stage preclinical and Phase 1 activity in China and Australia.”
From a pre-IND request, an IND go-ahead takes about 380 days on average with the FDA, versus 220 days in China, Makary noted during an internal speech.
“Can we reduce the requirements of the IND? They really have not been updated in decades,” Makary said. “We have to be efficient. We should not be requiring things that are not central to safety or efficacy.”
China and Australia are able to move faster partly because their authorities have placed trust in local Institutional Review Boards (IRBs) to act as safeguards for patient health in first-in-human studies, whereas the U.S. operates under what Becraft laments as “multiple different arbiters of the same process.”
RELATED: FDA lays out policy wish list, including new trial pathway and new enforcement powers
Besides making efforts to accelerate IND green lights, China has also opened up investigator-initiated trials (IITs), run by researchers at major medical institutions and requiring only approvals by IRBs rather than drug regulators. IITs can weed out bad candidates and validate promising ones at a relatively low cost and could inform the design of INDs.
In Australia, an explosion of clinical trial initiations can be credited to the nation’s twin approval pathways. For most early-phase studies, the Clinical Trial Notification (CTN) scheme requires ethics approval by the local IRB, followed by a simple notification to the drug regulatory body. Only high-risk trials need to go through the Clinical Trial Approval process to undergo a more rigorous review by drug authorities.
For both China and Australia, the responsibility for early clinical research was entrusted to healthcare facilities, which are closer to clinical practice and have a reputation to maintain themselves, thereby circumventing complex and lengthy IND processes.
In the U.S., both IRBs and the FDA must sign off before a trial could begin. And as Makary noted during a recent internal speech, U.S. IRBs are not always efficient, either.
Becraft saw firsthand how the different approaches play out, as Strand ran a hybrid trial in both Australia and the U.S.
“I just started saying, ‘why can’t we do this?’” he recalled. “The loudest I’ve been about it is this year, and the reaction has been, ‘maybe we’ll do it.’”
To Becraft, it would be a serious ethical concern if the Chinese and Australian pathways put people’s lives at risk. But “if that lower safety standard is not putting people’s lives at risk, but it’s actually just a more efficient pathway, then there’s no reason that it can’t be done in the United States.”
Becraft hopes that the FDA’s IND reform could incentivize both domestic small-scale manufacturing setups and “centralization and professionalization” of IRBs, eventually leading to more first-in-human participation in the U.S.
“First-in-human clinical trials are often a last line of hope for a lot of patients,” Becraft said. “We should want Americans on those trials.”
So, what if China wins over phase 1s?
As Becraft noted, the FDA’s IND reform is only one component of a complex ecosystem. And even Makary’s “Expedited IND” proposal does not remove FDA oversight the way Australia’s CTN and China’s IIT pathways do.
“Will we be able to fully move as fast as China? I don’t know, but we certainly can move drastically faster than we can right now,” Becraft said.
So, what if China does win over phase 1s? Is it truly a net loss for U.S. patients if China and Australia can cut costs and expedite early-stage development and therefore shave years off a drug’s timeline to market? After all, only about 10% of all drugs that enter small in-human clinical trials can eventually obtain commercial approval to benefit a much larger population. And because the U.S. remains the largest commercial pharmaceutical market, drugmakers prioritize U.S. launches for their major products.
Becraft sees a bigger problem—the U.S. could lose its “industrial capacity” in biomedicine if the current trend continues and the U.S. keeps relying on other countries to run faster first-in-human trials rather than improving its own system.
“If you do all of that over and over again, then you will lose the ability to ever do it here in the United States,” he said.
And with China specifically, a geopolitical risk exists.
Becraft draws a direct parallel between the current state of U.S. biotechnology and the historical shift in the automobile industry. He calls it the “rare earth playbook,” where China subsidized the domestic refining of rare earth materials when Western countries found it environmentally messy. Once China captured that stage of the supply chain for lithium-ion batteries used in electric vehicles, it gained a leverage point over Western competitors.
“China’s industrial policy has nothing about wanting to be the winner of first-in-human trials,” Becraft said. “This is the rare earth playbook that happened in electronic vehicles over and over again. If people in biotechnology and pharma want to see what this looks like, fast forward in seven years, they should just look at the difference in market cap between American automakers and European automakers over the last three years.”
The U.S. has the Advanced Technology Vehicles Manufacturing loan program to support domestic battery manufacturing and has increasingly recognized the role of rare earth materials as critical minerals to national security, allowing more government subsidies and support for domestic mines.
“America did something about the rare earth and lithium-ion battery market […] and Europe waited,” Becraft said, noting that European automobile giants are now “teetering on the verge of bankruptcy.”
“I don’t believe in protection and isolationism. But I do believe that if a nation state is conspiring economically to undermine the ability of your industry to operate in a capital market, then you should at least compete and not just see defeat,” he said.
On April 16, the day that Fierce interviewed Becraft, The Wall Street Journal reported that the Ford Motor Company plans to expand its partnership with Chinese manufacturers, as CEO Jim Farley said a tie-up with Chinese companies is necessary for the U.S. automaker to maintain a global edge.
“They’re really leading the world in many ways when you look at the technology and the cost and the speed of what they’re doing,” Farley said, as quoted by WSJ.
Meanwhile, total cross-border licensing deals of Chinese biotech products increased by 120% from 42 in 2022 to 93 in 2025, while the total upfront value of those transactions increased about 400%, from $1.1 billion in 2022 to $5.6 billion last year, according to Evaluate.