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Articles by Tom Popper
Floridians turn out to oppose changing school and daycare vaccine requirements
BIO voices concerns in statement for hearing about potential rule change. Reducing the number of vaccines required for school children risks the spread of dangerous, preventable diseases, concerned Floridians and public health advocates told a Florida Department of Health (FDOH) panel hearing on Oct. 8. The hearing allowed public input into FDOH’s proposed rule change to eliminate requirements for four of the current 11 vaccines students need to enter public schools and daycare.
Floridians and health advocates rally to oppose school, daycare vaccine changes
BIO voices concerns in statement for hearing about potential rule change. Reducing the number of vaccines required for school children risks the spread of dangerous, preventable diseases, concerned Floridians and public health advocates told a Florida Department of Health (FDOH) panel hearing on Oct. 8. The hearing allowed public input into FDOH’s proposed rule change to eliminate requirements for four of the current 11 vaccines students need to enter public schools and daycare.
Tariffs’ drag on innovation compounded by lack of guidance, experts say
Continuing confusion about compliance is exacerbating the harms that new pharmaceutical tariffs cause the biotech industry, especially small innovative firms, experts say. Tariffs of up to 100% on patented pharmaceuticals and their ingredients that went into effect Sept. 29 are expected to increase costs for innovators, discourage drug development and investment, and potentially reduce patient access to drugs they need.
BIO on the American Road visits pioneering NC biotech hub
Research Triangle Park resurgent with billions in investment in biotechnology manufacturing. With a famous biotech cluster in Research Triangle Park (RTP) established almost 70 years ago, North Carolina is already a powerhouse of pharmaceutical R&D and manufacturing, and recent expansion plans worth billions of dollars will continue growth into the future. A delegation from the Biotechnology Innovation Organization (BIO), led by BIO President & CEO John F.
BIO on the American Road visits pioneering NC biotech hub
Research Triangle Park resurgent with billions in investment in biotechnology manufacturing. With a famous biotech cluster in Research Triangle Park (RTP) established almost 70 years ago, North Carolina is already a powerhouse of pharmaceutical R&D and manufacturing, and recent expansion plans worth billions of dollars will continue growth into the future. A delegation from the Biotechnology Innovation Organization (BIO), led by BIO President & CEO John F.
iNFixion seeks NF1 treatment by enhancing what the body is doing right
The BIO 2026 Start-up Stadium winner targets a rare disease. As Herb Sarnoff sits in the hospital, waiting for a pain specialist to see his daughter, he describes how a mutation on just one side of the NF1 gene causes neurofibromatosis type 1 (NF1). “You have one good NF1 gene producing the neurofibromin protein your body needs, and one missing or mutant allele that isn’t, so every cell is not getting enough normal NF1 protein,” he explains.
A national security priority: BIO pushes PAHPA reauthorization in 2026
For decades, Congress has passed legislation to protect Americans from public health emergencies, ranging from national security threats to disease outbreaks and natural disasters, but that protection has lapsed. The Biotechnology Innovation Organization (BIO) is working to support Congress in ensuring our national health security by reauthorizing the Pandemic and All Hazards Preparedness Act (PAHPA) before year’s end.
With pharmaceutical tariffs looming, guidance on compliance is still lacking
With tariffs on patented pharmaceuticals and input materials set to take effect for all companies on Sept. 29, the lack of clarity about rules and exemptions is complicating business decisions and creating uncertainty for investors. What does seem certain is that pharmaceutical tariffs will reduce the funds biotechnology firms have to develop treatments, discourage investors, and threaten patients’ access to drugs.
PDUFA letter stresses stability, transparency, maturity, says BIO negotiator
An agreement designed to shape the future of drug approval recommends new efficiencies while leaning into the existing strengths of a system that makes America the world leader in biotech. The agreement, the Prescription Drug User Fee Act (PDUFA) VIII commitment letter, was released on Aug. 13. It was negotiated by the Food and Drug Administration (FDA) and representatives of the biopharmaceutical industry, including the industry’s association, the Biotechnology Innovation Organization (BIO).
BIO 2026: Generative genomics helps biotechs design better, not just faster
Generative genomics uses AI to analyze genetic sequences for innovative treatments. Every industry is racing to optimize AI in their operations. For many biotech research teams and investors that means “generative genomics.” Generative genomics is an emerging field of study using AI to analyze genetic sequences. Researchers hope that, with AI, they can efficiently assess the world’s collected stores of DNA/RNA data, discovering overlooked patterns that lead to new treatments.
Build patient access by strengthening innovation, BIO tells senators
BIO’s response to a request for information from the Drug Price Working Group explains why price setting won’t work. Improving patient access to new treatments requires policy that supports America’s innovation ecosystem—not price setting that discourages investment, BIO tells a Senate working group. Written comments by the Biotechnology Innovation Organization (BIO) advise against importing foreign pricing or increasing government setting of prescription drug prices.
Senators seek solutions for AMR, maintaining US biotech leadership
There was bipartisan support for the PASTEUR Act’s approach to addressing AMR and for NSCEB recommendations, both BIO priorities. A bipartisan Senate hearing sought strategic approaches to two related challenges facing U.S. security—maintaining American biotech leadership and tackling antimicrobial resistance (AMR). Lawmakers from both parties in the Aug.
BIO 2026: Industry PDUFA negotiators describe their agreement with FDA
Industry leaders at BIO 2026 discussed the proposed PDUFA VIII next steps.
BIO 2026: American biotech leadership protects patients and national security
U.S. biotech leadership is essential to ensure patients have access to the best medicines and America can maintain its national security. But that leadership is not guaranteed.
BIO 2026: American biotech leadership protects patients and national security
U.S. biotech leadership is essential to ensure patients have access to the best medicines and America can maintain its national security. But that leadership is not guaranteed.
BIO 2026: Gov. Tina Kotek on Oregon’s thriving bioscience sector
What will it take to build a stronger, more resilient U.S. life sciences industry? In a June 23 fireside chat at the 2026 BIO International Convention, Oregon Gov. Tina Kotek shared her perspective on her state’s thriving biosciences sector and advancing bold strategies to grow innovation, strengthen supply chains, and compete for the future. The following is an edited transcript of her remarks and interview with Bio.News.
BIO 2026: The business of biotech runs on partnerships
A $2.5 billion biotech AI deal announced at the beginning of the 2026 BIO International Convention grabbed headlines, but it’s only one of many partnership discussions that will begin, move forward, or culminate in a deal this week. Partnering is a major reason the Biotechnology Innovation Organization (BIO) hosts the BIO International Convention, the world’s largest gathering of the biotech industry, taking place in San Diego from June 22-25.
BIO 2026: The business of biotech runs on partnerships
A $2.5 billion biotech AI deal announced at the beginning of the 2026 BIO International Convention grabbed headlines, but it’s only one of many partnership discussions that will begin, move forward, or culminate in a deal this week. Partnering is a major reason the Biotechnology Innovation Organization (BIO) hosts the BIO International Convention, the world’s largest gathering of the biotech industry, taking place in San Diego from June 22-25.
BIO 2026 begins in San Diego, marking 50 years of biotech innovation
The Biotechnology Innovation Organization (BIO) International Convention kicks off in San Diego – and 2026 is a special year. “This is a special year for BIO, and to be back here at Convention in San Diego and in California, the state where biotech started 50 years ago,” said BIO President & CEO John F. Crowley.
BIO 2026 begins in San Diego, marking 50 years of biotech innovation
The Biotechnology Innovation Organization (BIO) International Convention kicks off in San Diego – and 2026 is a special year. “This is a special year for BIO, and to be back here at Convention in San Diego and in California, the state where biotech started 50 years ago,” said BIO President & CEO John F. Crowley.
BIO 2026: Partnering meetings fill up for industry’s biggest gathering
The last time the BIO International Convention was in San Diego, in 2024, Ram May-Ron of the non-dilutive funding specialists FreeMind Group began discussing a strategic partnership with a large pharma company. Discussion continued at BIO 2025 in Boston, where they signed a pre-agreement term sheet. “BIO is just an amazing opportunity to meet so many investors, partners, clients,” May-Ron said.
Lawmakers warn against weakening IP for medicines in House hearing
Lawmakers defended strong IP protections as essential to biotech innovation that saves lives in a June 4 Congressional hearing that also considered the role of generics and biosimilars.
House hearing to examine bill balancing data privacy and R&D needs
Researchers utilize health data to inform medical breakthroughs, but patients need to know their personal information stays confidential. The current patchwork of state laws regulating health data privacy does not provide American patients with consistent protection and creates a challenging environment for biotech innovators. Federal legislation to create a single regulatory framework that protects consumer privacy while enabling research will be examined in a June 3 Congressional hearing.
Experts explain how to drive business development with BIO 2026
The BIO International Convention, the world’s largest annual gathering of biotechnology stakeholders, provides an exceptional opportunity to make the connections that enable development of biotech innovations. In discussing plans for BIO 2026, running June 22-25 in San Diego, prospective licensees have said they hope to find companies with good data, while companies spoke of seeking investors who share their vision. Both groups said any partnership requires a strategic fit.
What is PDUFA—and why does it matter for biotech innovators, FDA & patients?
Key takeaway: PDUFA enables the FDA to collect user fees from the biopharmaceutical industry, allowing for efficient and more predictable reviews. This funding model provides essential stability for biotech companies of all sizes and ensures the FDA maintains its status as the global leader in bringing innovative new treatments to patients.
BIO on the American Road tours gene therapy hub in Ohio
Ohio’s diverse biotech sector provides the state with employment for 65,000 and provides the world with medical breakthroughs. Of the first eight gene therapies approved by the Food and Drug Administration, two—for Duchenne Muscular Dystrophy and Spinal Muscular Atrophy Type 1 (SMA1)—were developed by researchers at Nationwide Children’s Hospital in Columbus, a city that’s driving gene editing research and production.
BIO is expanding its work to defend IP
When a biotech firm sells investors on the promise of a new drug, what they are really selling is the intellectual property behind their innovation. That’s why biotech firms need a strong patent system to safeguard their IP. That’s also why the Biotechnology Innovation Organization (BIO) has always worked vigilantly to promote America’s patent system.
BIO kicks off ‘Fight of Our Lives,’ highlighting urgency of biotech progress at Axios event
As biotech celebrates its 50th year, we are locked in “the fight of our lives” to ensure patients get more of the medical innovations they need and America remains a leader in biotech, BIO President & CEO John F. Crowley told an Axios event.
BIO expert: Future of biotech depends on competing with China, updating FDA
Ensuring a brighter future for U.S. biotech requires modernizing the Food and Drug Administration (FDA) and addressing challenges from China, according to Kelly Seagraves, VP for National Security and International Affairs at the Biotechnology Innovation Organization (BIO). Seagraves explained these and other BIO priorities at an April 1 online panel on “the future of U.S. biotech” hosted by Research!America, a non-profit medical and health research advocacy alliance.
BIO CEO hails congressional report on threat of China dominating biotech
A year after a congressional commission urged strategic action to prevent China from replacing America as the world leader in biotechnology, we still have much to do in order to safeguard America’s health and security, BIO President & CEO John F. Crowley warned at a Washington event. Crowley’s message was echoed by Sen. Todd Young (R-IN), Rep. Chrissy Houlahan (D-PA), and Rep.
BIO Board member advises Congress on China’s clinical trial competition
China gains a huge advantage in biotech competition by speeding up clinical trials, and America must respond, a member of the Board of the Biotechnology Innovation Organization (BIO) testified in Congress. Speaking before the House Select Committee on China on March 18, Dr. Jacob Becraft, CEO of Strand Therapeutics and a BIO Board member, explained how China has enabled more rapid clinical trials, and recommended changes to keep America competitive.
BIO on the American Road in Puerto Rico: ‘Medicine Cabinet’ ready to reshore
Known as “America’s Medicine Cabinet,” Puerto Rico is working to maintain its leadership in U.S. biotech production by becoming a hub for reshoring pharmaceutical manufacturing. During a March 10-12 visit, BIO President & CEO John F. Crowley learned about the unique strengths and advantages of the biotech ecosystem of Puerto Rico, which already produces nearly a fifth of U.S. drug exports, more than any state in the Union.
BIO warns MFN models are illegal, ineffective, and a threat to innovation
Proposals to let decisions by other countries control American drug prices are illegal, would reduce the availability of innovative new treatments, and fail to help Medicare beneficiaries with their out-of-pocket costs, according to the Biotechnology Innovation Organization (BIO). Two models proposed by the Center for Medicare and Medicaid Innovation (CMMI) also threaten America’s biotech industry and Americans’ ability to obtain medicine, BIO explains in written comments.
Hearing highlights PBMs’ impact on prices as BIO CEO testifies in Congress
Pharmacy benefit managers (PBMs) were identified as a major driver behind higher prescription drug costs in a congressional hearing that featured testimony from BIO President & CEO John F. Crowley. Representing the membership of the Biotechnology Innovation Organization (BIO) in the House Energy & Commerce Health Subcommittee’s Feb. 11 hearing, Crowley explained how Congress can help make drugs more accessible while maintaining U.S. biotech leadership.
NIH Director says no studies link vaccines and autism
National Institutes of Health (NIH) Director Jay Bhattacharya acknowledged there are no studies indicating a link between any vaccine and autism as Senators pushed for a more science-forward approach to vaccines and research funding, in a Feb. 3 hearing. Bhattacharya, the lone witness for the hearing, took the opportunity to lay out his own plans for modernizing the NIH, which saw its budget increased by Congress that day, with the approval of a new spending package.
NIH Director says no studies link vaccines and autism
National Institutes of Health (NIH) Director Jay Bhattacharya acknowledged there are no studies indicating a link between any vaccine and autism as Senators pushed for a more science-forward approach to vaccines and research funding, in a Feb. 3 hearing.
BIO lauds passage of PPRV reauthorization and legislation on PBM reform
The Biotechnology Innovation Organization (BIO) hailed inclusion of a bill to encourage new treatments for children with rare diseases and measures targeting reform of pharmacy benefit managers (PBMs) in the package of legislation passed Feb. 3. The Mikaela Naylon Give Kids a Chance Act, reauthorizing the Pediatric Priority Review Voucher (PPRV) until 2029, was attached to the spending package that ended a partial government shutdown.
BIO warns of risks from change to CDC’s vaccine recommendations
The Biotechnology Innovation Organization (BIO) warned that new changes in federal recommendations for the childhood vaccination schedule are unscientific and put children’s health at risk. “The US vaccination schedule is the result of decades of a rigorous, public-facing, science-based process,” said a Jan. 5 statement from BIO.
Bayh-Dole at 45: Still an engine for innovation
A researcher working in a university lab makes a discovery that could lead to a new cure. Investors who see the potential of the discovery provide the staff and infrastructure needed to turn the one-off lab experiment into a marketable product. That’s been a typical model for innovation for decades. But there was a time when it was hard to make that model work if the university researcher, like many university researchers, received some government funding.
House passes BIO-backed legislation to increase access to capital
Legislation to free up capital for small innovative firms by removing regulatory barriers for both companies and investors passed the House Dec. 11—a move praised by the Biotechnology Innovation Organization (BIO). The Incentivizing New Ventures and Economic Strength Through Capital Formation (INVEST) Act was introduced by House Financial Services Committee Chair French Hill (R-AR) with Gregory Meeks (D-NY) and other co-sponsors from both parties.
Charlotte emerging as a global leader in health care innovation
Historically, Charlotte has been recognized as a major U.S. financial hub. Now, the city is making significant strides in another transformative sector: health care innovation. With a grand vision, strategic investments, and high-impact partnerships, Charlotte’s evolving role in health care innovation will be felt at a local, statewide and global level.
BIO-CSBA report explains why and how states seek to attract biotech
While U.S. biotech leadership is recognized as essential for national security, states also understand the industry’s local benefits and are implementing policies designed to attract and support their own biotech innovation ecosystems. State-level pro-biotech policies are detailed in a new report, The U.S. Bioscience Industry: A Powerful Engine for State Economies, released Dec.
BIO on the American Road: Indiana, a production powerhouse, is still expanding
At a time when the biopharma industry is seeking to increase U.S. manufacturing, Indiana is in the vanguard—and still expanding. During a Nov. 11 BIO on the American Road visit, BIO President & CEO John F. Crowley praised the state’s role in advancing biotech research and manufacturing. “Thriving ecosystems like Indiana’s don’t just happen.
Ahead of BIO IP Conference, research highlights why biotech needs strong patents
Venture capital funding for life sciences startups plummeted after legal changes weakened the patent system, according to new research that confirms the close relationship between intellectual property protections and biotech innovation. The importance of this relationship motivates the Biotechnology Innovation Organization (BIO) to hold an annual IP Conference, which this year runs Nov. 17-19 in Southern California.
PACE panel urges incentives for exciting new GTT drugs
Luke Rosen had hoped a new treatment would slow the progression of his daughter’s KIF1A Associated Neurological Disorder (KAND), but was amazed to see an apparent reversal of her rare disease symptoms. “She used to wake up and say my feet feel like they’re on fire inside,” but by the second dose of the new drug, her mornings had changed dramatically, Rosen, founder of KIF1A.ORG, told an Oct. 28 panel at the BIO 2025 Patient Advocacy Changemakers Event (PACE) in Washington, DC.
BIO CEO John Crowley tells Senate how to support biotech
Maintaining America’s biotechnology leadership requires Food and Drug Administration (FDA) modernization as well as Congressional action to reauthorize a program supporting rare disease research and incentivize domestic manufacturing, BIO President & CEO John F. Crowley told a receptive Senate hearing. “The United States has led the world in biotechnology for decades — not by chance, but by design,” Crowley’ testified Oct.
PACE: CDER director discusses faster approval, FDA morale with BIO CEO John F. Crowley
The FDA is hiring reviewers and finding ways to expedite drug approval, Dr. George Tidmarsh, Director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) told BIO President & CEO John F. Crowley in an Oct. 27 chat at BIO PACE 2025. The frank discussion covered a range of topics, including the need to boost morale and build staff at FDA, and a chance for easy wins by reforming the Investigational New Drug (IND) process.
BIO PACE 2025: Patients need to ensure state policies enable access to medicine
With Medicaid cuts expected, vaccine hesitancy getting politicized, and the continued challenge of Prescription Drug Affordability Boards (PDABs), state legislatures will drive many of the policies impacting patients’ access to drugs in the coming months. That’s why patients must be involved in advocacy on the state level, according to many of the speakers at the Biotechnology Innovation Organization (BIO) Patient Advocacy Changemakers Event (PACE) in Washington, D.C., from Oct. 26-28.
Senators seek patent clarity to support innovation
Legislation establishing clear rules about the kinds of ideas that can be patented would support innovation in biotech and other fields by eliminating ambiguities introduced through court decisions, lawmakers and witnesses said in an Oct. 8 Senate hearing. The Patent Eligibility Restoration Act (PERA) is essential to maintaining America’s leadership in innovation and intellectual property, Sen.
BIO on the American Road: Biotech innovation and job growth in Illinois
A concentration of scientific expertise, extensive manufacturing activity, and state support have helped make biotech one of the fastest-growing areas of employment in Illinois. “The life sciences industry in Illinois currently employs 93,402 workers earning an average of $153,000; these jobs are growing at 20 times the rate of Illinois’ overall private sector since 2019, at 7.5% annually,” according to a report by iBIO. But as an Oct.
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