Navigating Industry Challenges with Renewed Optimism
Despite current hurdles facing biopharma and biotech companies, the recent BIO International Convention event saw innovation take center stage and provided a sentiment of optimism for the future, so long as industry does not rest on its laurels.
So far, 2025 has been financially challenging for the biopharmaceutical and biotech sectors — with limited access to capital and lean financing on offer — further complicated by macroeconomic uncertainty (1). However, despite these obstacles, stakeholders from biopharma and biotech have been voicing optimism about innovation that can help to drive forward success and ensure patients gain access to life-saving therapies.
At the recent BIO International conference, which was held in Boston, Mass. between June 16–19, biotechnology and biopharmaceutical leaders came together under the theme of “the world can’t wait,” reveals Nirupama Pike, PhD, Global Head of Strategic Alliances for Cell Therapy at Catalent. “We cannot wait, the advancements cannot wait, for one reason, because the patients cannot wait! So, in spite of the geopolitical climate, unstable economies, funding challenges that we talk about and read about, [at this year’s BIO event] I sensed a renewed energy and excitement.”
A Comprehensive Gathering
“BIO International is the world’s largest and most comprehensive gathering of biotechnology and biopharmaceutical leaders,” specifies Sarah Alspach, Executive Vice President and Chief Communications Officer at BIO. “The Convention unites industry executives, policymakers, investors, and scientists to explore the latest innovations and opportunities in biotech, with a shared commitment to improving the lives of patients worldwide.”
For the 2025 event, there were more than 20,000 registrants, 1,600 exhibitors, representation from 72 countries, over 1,100 speakers across more than 180 sessions, and more than 60,000 partnering meetings with 10,000+ partnering delegates, Alspach highlights. “The lineup of notable speakers included President George W. Bush; FDA Commissioner Marty Makary; Massachusetts Governor Maura Healey; Pennsylvania Governor Josh Shapiro; Olivér Várhelyi, European Commissioner for Health and Animal Welfare; Lord Patrick Vallance, UK Minister of State for Science, Research and Innovation; H.E. Prof. Dr. Hisham Saad Aljadhey, CEO, Saudi Food and Drug Authority; Dr. Angela Belcher and Dr. Michele Rozo from the National Security Commission on Emerging Biotechnology; and Pro Football Hall of Famer, broadcaster, and entrepreneur, Michael Strahan,” she says.
A Time of Choosing
During the second day of BIO 2025 (Tuesday June 17), John F. Crowley, President and CEO at BIO, discussed the current state of the industry, highlighting an important message for all stakeholders to keep in mind:
“We are at a crossroads in our industry and we’re at a time of choosing. We must recognize that if any nation, whether the United States or elsewhere, fails to support science and innovation they will fail in the race to support their citizens, communities, and our collective global society,” Crowley said. “Health, prosperity, and security all hang in the balance. Will we stop? Will we move backwards? Or will we launch forward with urgency? Those are our choices today. And history again here teaches us a great lesson. A lesson taught many times that no country, no civilization, no industry can rest on its laurels.”
Among the many standout moments from BIO 2025 was President Bush’s compelling conversation with John F. Crowley, President and CEO — the headline discussion on the main stage at the event — emphasizes Alspach. “During their wide-ranging discussion, the former president reflected on his leadership launching global HIV/AIDS initiatives that have saved millions of lives,” she notes.
For Alspach, other memorable happenings from the event included Maura Healey, Governor for Massachusetts, being honored with the 2025 BIO Governor of the Year Award for her administration’s strong support of the state’s biotech sector and the landmark USD 1 billion Mass Leads Act, and the discussion between FDA Commissioner Marty Makary, M.D., M.P.H, and Crowley where Makary shared his vision for the FDA’s future, emphasizing efficiency, safety, and regulatory clarity.
“Michael Strahan, Pro Football Hall of Famer and broadcaster, shared an emotional story about his daughter’s successful battle with cancer,” continues Alspach. “The session culminated with moving testimonials from more than 10 patient advocates sharing why biotech gives them hope, including Megan Crowley, John Crowley’s daughter, whose journey continues to inspire her father’s life’s work in biotechnology. That was probably the pinnacle of the convention for me.”
Spotlight on the Need for Innovation
Reviewing the sessions from BIO 2025, Alspach points out that there were many talks focused on drug development and how the industry can get new medications to the patients that need them faster. “At the top of the list was the main stage conversation with Commissioner Makary in which he discussed his vision for the FDA and the recently announced Commissioner’s National Priority Voucher (CNPV) pilot program,” she says. “This new program allows qualifying drug developers to participate in a priority review process, shortening review times from approximately 10–12 months to 1–2 months. Commissioner Makary said the program essentially allows the ‘lion’s share’ to be submitted before the final New Drug Application (NDA) or Biologics License Application (BLA) ‘to take advantage of the time that is spent watching a clinical trial reach its end points.’ We look forward to learning more about the implementation of the program and were appreciative of the Commissioner joining us in Boston.”
Alspach herself took part in several of the conference sessions, during one, she moderated the breakout session ‘Policy Outlook: All Eyes on Intellectual Property Rights’, which included a panel of IP policy and biotechnology experts (2). “I was particularly pleased to moderate a policy discussion on intellectual property, where we spoke about the role of IP in ensuring a strong and thriving biotech ecosystem in the US,” she confirms.
“One area of particularly high interest this year was the application of AI [artificial intelligence] tools to accelerate all aspects of drug discovery, clinical development, and scaling biomanufacturing, with BIO 2025 including more than 20 AI-related sessions,” Alspach adds. These sessions featured perspectives from tech leader NVIDIA, in addition to Big Pharma, small biotechs, investors, and research institutes on panels (3,4), she reveals.
AI-driven platforms and technologies were noted as big talking points at BIO 2025 by Pike as well. “[These platforms and technologies] are now set to completely transform the industry,” she says. “What I noticed is that they’re not just buzzwords, but they become an operational element. The use of AI, everybody believes, will help us achieve shorter timelines, more accurate data, faster approvals, and safer drugs.”
Incorporation of machine learning and robotics is increasing within industry as well, Pike continues. “There is also a big push of using AI in the regulatory space, to streamline the regulatory process and compress timelines,” she confirms.
Other pivotal discussions took place around areas of “high growth potential for therapeutic development where there are significant unmet patient needs and clear reimbursement paths,” Alspach states (6,7). Additionally, a session focusing on early development challenges provided attendees with an overview of the trends impacting the drug development pipeline, offered strategies to overcome resource constraints, and demonstrated the growing role of smaller companies in driving forward innovation (8), she notes.
A new roadmap is being implemented by venture capitalists (VCs) and investors, which should be considered by innovators within biopharma, asserts Pike. “While VC partners value innovation, they have made it very clear that they will fund the companies that have made progress beyond the early-stage discovery or innovation,” she confirms. “[VCs] are interested in companies that have proven some translational merits off their discoveries in terms of either getting ready for a GMP-compliant process or treating a handful of patients.”
In relation to this new funding roadmap, companies are shifting their efforts to become more attractive, Pike continues. “[Companies] are putting their efforts into de-risking the manufacturing process,” she remarks.
A standout session in the biomanufacturing space for Alspach was ‘Beyond Innovation: Supercharging America’s Biomanufacturing Infrastructure’ (5). “[This session] examined critical considerations for expanding the U.S. biomanufacturing infrastructure to support the production of pharmaceuticals, chemicals, and other bio-based products,” she specifies.
Building on Momentum
“All the conversations [from the conference] reflected the sector’s momentum and the urgency around innovation in biomanufacturing to meet global health demands,” Alspach asserts. “We look forward to building on the momentum from BIO 2025 as we plan another great BIO International, which takes place in San Diego, Calif., June 22–25, 2026,” she remarks.
“BIO 2026 will feature important sessions on breakthrough technologies, great speakers on the forefront of biotechnology, and many more opportunities for networking and partnering,” Alspach confirms.
References
Ernst & Young. Focus on Fundamentals to Bounce Back: EY Biotech Beyond Borders Report 2025. EY Insights, June 18, 2025.
BIO. Policy Outlook: All Eyes on Intellectual Property Rights. Breakout Session at BIO International Convention 2025, June 17, 2025.
BIO. AI in Biologics Drug Discovery: Analyzing the Competitive Landscape, Technical Approaches, and the Industry’s Role. Breakout Session at BIO International Convention 2025, June 16, 2025.
BIO. Patient Diversity and Access to New Medicines — Can AI Improve Access in Disadvantaged Patient Populations and Optimize the Economics of Medical Innovation? Breakout Session at BIO International Convention 2025, June 17, 2025.
BIO. Beyond Innovation: Supercharging America’s Biomanufacturing Infrastructure. Breakout Session at BIO International Convention 2025, June 16, 2025.
BIO. Unlocking Investment for Women’s Health. Breakout Session at BIO International Convention 2025, June 17, 2025.
BIO. The Rare Disease Promise of Externally Led Scientific Focused Drug Development Meetings. Breakout Session at BIO International Convention 2025, June 17, 2025.
BIO. Breaking Through: Overcoming Early Development Challenges. Breakout Session at BIO International Convention 2025, June 16, 2025.
Photo by Ali Alauda on Unsplash