BIO on the American Road in Puerto Rico

BIO on the American Road visits Puerto Rico, the top pharma manufacturer

Puerto Rico, which hosts more biotech manufacturing than any state in the Union, is positioning itself to lead in reshoring, a BIO delegation learned last week.

What happened: BIO President & CEO John F. Crowley led a March 11-12 BIO on the American Road tour of Puerto Rico’s biotech ecosystem.

Why it matters: “We have the greatest density of pharmaceutical and medical device companies in the world,” said Ivan Lugo, ED of INDUNIV, BIO’s affiliate in Puerto Rico. The territory leads U.S. pharma exports, at $54+ billion annually.

Reshoring: Puerto Rico is “playing aggressively” to reshore manufacturing, said PR Development Secretary Sebastián Negrón Reichard. Recently, Eli Lilly announced a $1.2 billion expansion in their Carolina, PR facility, and Amgen announced a $650 million expansion at their Juncos, PR pharma plant, the largest on the island.

Amgen's investment reflects “the company’s long-standing commitment to U.S. biomanufacturing and global supply chain resilience, and underscores confidence in Puerto Rico’s skilled workforce and infrastructure,” said Thomas Seewoester, Amgen VP and Site Head.

Academia and research: University of Puerto Rico “is proud to contribute to the advancement of biotechnology” with a research center and skilled workers, said UPR President Zayira Jordán-Conde. The PR Science, Technology & Research Trust presented its biotech incubator and clinical trial center. “Patients are at the center of our clinical research strategy,” said Luz A. Crespo, CEO.

BIO’s view: “Through sustained investments in workforce development, cutting-edge research infrastructure, and strong partnerships between industry, academia, and government, Puerto Rico is positioning itself as one of the most dynamic biotech ecosystems in the United States,” Crowley said.

Read more on Bio.News.

BIG Summit themes: Resilient investment, MFN threat, patients in the center

The inaugural BIO Investment and Growth (BIG) Summit helped biotech leaders understand policy trends and market developments—and build partnerships that will drive future innovation.

Big themes coming out of BIG, held March 2-3 in Miami, included:

The resilience of biotech markets: Despite headwinds, venture capital managed to rebound from its lows in 2023, and robust 2025 M&A activity should continue at a good pace this year.

Most favored nation (MFN) pricing: “With MFN, they’re looking at the list price of the drugs in other countries,” Carl Schmid, of HIV+Hepatitis Policy Institute told a Washington policy panel. “It just doesn’t make any sense. We don’t price our hospital bills based on other countries.” Read more on Bio.News.

Patients first: Panelists consistently said patients must drive innovation and policy—and decisions about M&A and investments. “How does effective science translate into something that truly reaches patients?” asked panelist Nicole Schwerbrock, a venture philanthropy expert at IBD Ventures.

Read more on Bio.News.

BIO CEO John Crowley writes about American biotech leadership in STAT

The founding of Genentech 50 years ago “birthed an industry that has saved tens of millions of lives” making America the leader in biotech, but America’s position is threatened, BIO President & CEO John F. Crowley writes in STAT on March 12.

Why it matters: While biotech leadership brings Americans more treatments—and economic benefits, China seeks to surpass us. “If they succeed, it’ll have dire consequences for our economic and national security,” Crowley writes. “Keeping the lead depends on fixing what’s broken about the policy status quo—and not breaking what works.”

What to do: “We must ensure that other countries stop free riding off the United States. … Other nations use price controls to artificially suppress their own spending,” Crowley writes. “Washington can also crack down on the middlemen who currently drive up the price of medicines.”

What not to do: “Federal officials will need to resist the temptation (and public pressure) to simply mimic other countries’ price controls.”

Read the full story here.

What Else to Read

The hidden layer of PBMs: What a recent investigation reveals. With health care affordability a top concern for many Americans, pharmacy benefit managers (PBMs) are at the center of the debate. Working with insurance companies, these intermediaries decide what medicines patients can get and what is paid at the pharmacy. What’s more, an investigation by Hunterbrook Media uncovers an invisible layer of the PBM ecosystem—PBM-affiliated group purchasing organizations (PBM GPOs)—that raises more questions about how these entities operate and their impact on health care affordability. Read more on Bio.News.

The Advisory Committee on Immunization Practices (ACIP) meets March 18-19. “The agenda will include updates on ACIP Workgroups and discussions on COVID-19 vaccine injuries and Long-COVID and ACIP recommendation methodology,” according to the Federal Registry. “Recommendation votes may be scheduled for COVID-19 vaccine injuries and Long-COVID and ACIP recommendation methodology.” Read more here.

BIO’s Chief Legal and Policy Officer Joe Franklin discusses AI drug development and FDA’s support in Axios. The Food and Drug Administration (FDA) is encouraging use of AI in drug development and seeking to incorporate AI in its own processes, according to Axios. “FDA has been very supportive in public statements over the last couple of years,” says Franklin. “AI is developing so quickly that ongoing policy development by FDA will be important, including in areas like AI in clinical research and drug manufacturing.” Read more here.

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