SBIR reauthorized: A BIO priority

SBIR reauthorization, a top BIO priority, is passed by Congress

Reauthorization of federal seed funding, a top priority for BIO’s work with Congress, passed the House March 17 and is set to become law by month’s end.

What happened: The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) seed-funding programs were reauthorized for five years. Federal grants from these programs help firms develop innovations for commercialization.

Why it matters: The SBIR/STTR programs have provided more than $77 billion in funding to 33,000 businesses, including many biotechs. SBIR/STTR funds helped support 12% of all FDA-approved drugs. The National Institutes of Health (NIH) operates the second-largest SBIR/STTR programs after the Department of Defense.

Bipartisan support: SBIR/STTR funding lapsed in October. The Senate voted unanimously on March 3 to reauthorize the funding, and the House approved the measure 345-41 on March 17.

BIO’s view: “The SBIR/STTR program has a long and proven track record of supporting and growing the most innovative American biotechnology companies,” said Brad Zakes, BIO SVP for Emerging Companies and Economic Affairs. “BIO applauds Congress for its leadership and for reauthorizing this important program.”

What’s next: The opening of applications for SBIR/STTR grants is anticipated soon and will be announced on the federal government’s Grants.gov website. BIO will be cooperating with federal agencies and biotech firms to facilitate this support for innovation.

Read more on Bio.News.

Competing with China requires clinical trial reform, BIO Board member tells Congress

China gains a huge advantage in biotech competition by speeding up clinical trials, and America must respond, BIO Board Member Dr. Jacob Becraft testified in the House on March 18.

The hearing by the House Select Committee on China on March 18 outlined several challenges created by China’s concerted efforts to dominate global biotech and the biotech supply chain, and sought to identify solutions.

The clinical trial challenge: Going from drug ideation to first-in-human trials usually takes 2-3 years in America and only one year in China, testified Becraft, CEO of Strand Therapeutics. This enabled China to become the world leader in clinical trials in 2025.

Why it matters: Other aspects of the biotech industry will follow. “Innovation ecosystems tend to influence where production happens and biotechnology companies will increasingly cluster around the locations where human clinical data can be generated most efficiently,” Becraft’s written testimony said.

How they do it: China, and Australia—another competitor in clinical trials—use local institutional review boards (IRBs) to decentralize clinical trial approval. While Food and Drug Administration (FDA) approval is important for many trials, running all trials through FDA creates a bottleneck, Becraft said.

What we can do per Becraft’s testimony:

• Use legislative and regulatory measures to accelerate first-in-human trials by establishing more flexible pathways.
• Better align manufacturing infrastructure with clinical trial systems.
• “The U.S. must align regulators, funders, clinical systems, and innovators around a shared objective: compressing the timeline from therapeutic discovery to first-in-human dosing.”

Read: Becraft’s full written testimony.

Watch: A video of Becraft’s opening statement.

What Else to Read

BIO Board Member John P. Butler testifies before the House Ways & Means Health Subcommittee on encouraging innovative kidney disease treatments. The Centers for Medicare & Medicaid Services (CMS) created the Transitional Drug Add-on Payment Adjustment (TDAPA) to encourage use of innovative treatments by easing payments—but only for two years, Butler, CEO of Akebia Therapeutics, testified. He said there are insufficient innovations in kidney treatments because the system does not support the use of new technologies for patients receiving kidney dialysis. Butler encouraged passage of the H.R. 6214, the Kidney Care Access Protection Act (KCAPA), which would extend TDAPA to three years and take other steps that begin to remedy the situation. Read John Butler’s full testimony.

Federal judge temporarily blocks changes to vaccine recommendations and changes to ACIP. A federal judge on March 16 granted a preliminary injunction against changes to the childhood vaccine schedule recommended early this year by the Centers for Disease Control and Prevention (CDC) and the remaking of CDC’s Advisory Committee on Immunization Practices (ACIP). The ACIP meeting set for last week was postponed. Next steps remain unclear as the situation is still developing. Read more here.

FDA releases new draft guidance on reducing animal testing. The Food and Drug Administration (FDA) is inviting comments on its draft guidance for the use of new approach methodologies (NAMs) as alternatives to animal testing in toxicology screening for drug development. “FDA's current regulatory framework permits and encourages the use of NAMs, as described in existing regulations and guidance,” and this new guidance would help “further encourage the submission of NAM data,” according to the Federal Register. Read more here.

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