BIO survey reveals dependence on Chinese biomanufacturing

Breaking: BIO has released the results of a survey revealing companies’ dependence on Chinese biomanufacturing. Yesterday, a busy day on Capitol Hill featured testimony from a BIO Board member and a reception celebrating the 20th anniversary of Project BioShield. (839 words, 4 minutes, 11 seconds)

BIO survey reveals dependence on Chinese biomanufacturing, indicating up to 8 years needed to change partners

A BIO survey of 124 biopharma companies finds 79% have at least one contract or product with a China-based or China-owned CDMO/CMO, and they’ll need up to eight years to switch manufacturing partners—or millions of patients could be affected.

What’s happening: The proposed BIOSECURE Act would effectively prohibit Chinese biotech companies from doing business in the U.S.. An updated version is expected to be marked up in the House Oversight & Accountability Committee in the coming weeks. 

The key takeaway: The survey indicates that companies will need as many as eight years if they are required to change manufacturing partners. The more advanced the research program, the longer it will take—and already-approved medicines will take the longest.

Why it matters: Without a pathway to ensure continued access and thoughtfully decouple from China, millions of patients could be impacted by the potential loss of access to approved medicines or stalled R&D, the results indicate.

The survey covers a broad cross-section of the industry:124 unique biopharma and biotech companies—large, medium, and small, as well as pre-clinical companies and companies with products in clinical development. More than two-thirds (68%) of these companies are small, emerging companies with fewer than 250 employees. The vast majority (79%) have at least one contract/product with a China-based or China-owned CDMO/CMO.

BIO’s take: “We must continue to advance biotechnology as a national security asset for the United States. The survey results show the current state of the industry’s reliance on China-based and/or China-owned contract biomanufacturing organizations,” said BIO President & CEO John F. Crowley. “As we advance toward strengthening the resilience of our biomanufacturing industry in the United States, we need as well to ensure an uninterrupted pathway to patient access to life-saving therapies for the millions of patients impacted. As we redomicile manufacturing in this country, we will work closely with Congress to pursue a comprehensive set of policies and long-term commitments to increase state-of-the-art domestic biomanufacturing capacity and capabilities nationwide and retain our position as the medicine chest to the world.”

Sutro CEO tells Congress what innovative small biotechs need

Emerging biotechs working on future cures need modernized regulation, policy to preserve and incentivize investment, and good IP protection, Sutro Biopharma CEO Bill Newell told Congress yesterday.

What happened: Testifying before a House Small Business Committee hearing, BIO Board member Newell called for improved legislation and regulation in areas like:

• fixing the R&D tax deductions and improving access to capital,
• ensuring strong intellectual property protections,
• streamlining Food and Drug Administration (FDA) regulation, and
• changing the disincentives in the Inflation Reduction Act (IRA).

Why it matters: “Small biotech companies and their investors are particularly sensitive to the U.S. policy environment in which we operate,” he testified.

His company’s experience: Raising $1.6 billion in two decades of researching cancer treatments, Sutro is a few years away from an approved drug. “That eyebrow-raising figure and our over 20-year company journey is, unfortunately, very typical of the small biotech experience,” he said.

The impact of taxing research: The loss of long-standing R&D deductions meant Sutro—which has no sales revenue—paid $15 million in taxes, “the equivalent of two phase-one clinical trials to study new medicines in patients,” Newell said in response to Rep. Dan Meuser (R-PA).

The bottom line: “It is critical that we implement and support policies that encourage our development and reexamine policies that deter investment and delay treatments,” Newell testified. 

Read more in Bio.News.

BIO, Members of Congress celebrate Project BioShield, call for reauthorization

BIO joined current and former policymakers for an early celebration of the 20^th anniversary of Project BioShield—and call for the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA).

Signed into law on July 21, 2004, Project BioShield provides funding for private companies to develop medical countermeasures like vaccines, therapeutics, and diagnostics against biological, chemical, radiological, and nuclear (CBRN) threats. 

Project BioShield “created new market incentives for pharmaceutical and biotech companies to engage in the development of CBRN medical countermeasures and transformed the partnership between the federal government and industry into a shared responsibility for increasing preparedness,” says BIO’s new report on the law’s legacy.

A bipartisan celebration: Former Sen. Richard Burr (one of the law’s architects), Rep. Richard Hudson (R-NC), and Assistant Secretary for Preparedness and Response Dawn O’Connell joined BIO and industry leaders at the May 8 reception on Capitol Hill to mark the anniversary of Project BioShield, which Sen. Burr said was key to advancing innovations like the COVID-19 vaccines.

The big picture: Biotechnology is key to national security because it can advance pandemic preparedness and “protection against acts of bioterrorism,” and because “having a healthy, prosperous society is a strategic imperative for the United States...an instrument of national power,” said BIO President & CEO John F. Crowley in his opening remarks.

The next steps: Reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA), which expired in September 2023.

President Biden’s Thursday: Celebrating WNBA champion Las Vegas Aces before traveling to San Francisco. BIO is currently reviewing the Biden Administration’s plan to coordinate regulation of plants, animals and microorganisms by the Environmental Protection Agency, Food and Drug Administration, and U.S. Department of Agriculture, released yesterday.

What’s Happening on Capitol Hill: A quiet day.