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Day 2 brought current and former lawmakers at the federal and state levels to discuss how policy can advance progress. On Day 3, it's all about the patients. (804 words, 4 minutes, 1 seconds) |
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Day 3: Patients can't wait.
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Commissioner Martin Makary, M.D., M.P.H., discusses his vision for the FDA |
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Food and Drug Administration (FDA) Commissioner Martin Makary, M.D., M.P.H., emphasized his commitment to working with the industry and outlined his vision for the agency. On changes at FDA: “I came in just after the DOGE [Department of Government Efficiency] cuts at the agency, and it was a challenge,” Dr. Makary said. “I’m proud to report that we’re on track to meet all our different targets, and that morale is good and improving.” He reiterated that the FDA is focused on efficiency and reducing redundancy in non-scientific areas: “The most important thing is that no corners are cut on the scientific evaluation process.” On AI: Dr. Makary highlighted the FDA’s new AI tool, ELSA, aimed at increasing efficiency for FDA staff, noting how one reviewer said the tool reduced a process that would normally take 2-3 days to just 6 minutes. On the CNPV pilot program: He spoke just hours after the FDA announced the Commissioner’s National Priority Voucher (CNPV) pilot program, which he said would allow 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.” On industry partnership: Dr. Makary emphasized the importance of collaboration between the FDA and the biotech industry, underscoring how the FDA wants “to stand before you and listen.” Read more on Bio.News. |
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How do we talk about vaccines now? |
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Public health advocates are reevaluating vaccine communication in the post-pandemic world, including how to rebuild trust. A key takeaway: “I think one of the biggest mistakes that everyone on both sides of the aisle made was politicizing vaccinations,” said former Member of Congress Larry Bucshon, M.D. “I think it was a dangerous precedent to use public health as a political tool on both sides of the aisle to try to win elections.” “The best messengers on public health can be local people, local officials, and local physicians,” he continued. “Even overseas during the Ebola outbreaks, the U.S. government spent a lot of time building those connections to make sure that the public was informed at the local level,” echoed Luciana Borio, M.D., Senior Fellow for Global Health at the Council on Foreign Relations. “I don’t think the attitudes have shifted dramatically amongst individual lawmakers,” said Dr. Bucshon. “I think what has shifted is the view of what the government’s role should be in the implementation of vaccination.” What’s next: “We have to learn how to invest in the health of this country in a way that’s not political and that is sustainable, so that we don’t have to start over every administration,” said Sherri Berger, who spent three decades at the Centers for Disease Control and Prevention (CDC). Read more on Bio.News. Watch our interview with Dr. Bucshon: |
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ICYMI: Govs. Healey, Shapiro visit BIO 2025 |
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Day 2 was a big day for the states – with remarks from Massachusetts Gov. Maura Healey and Pennsylvania Gov. Josh Shapiro, plus an exciting workforce announcement.
Massachusetts Gov. Maura Healey was presented with the 2025 BIO Governor of the Year Award, in recognition of her administration’s support for the state’s biotech sector. Under her leadership, and with a record of “leading by actions, not just words,” the state passed the Mass Leads Act, which dedicated $1 billion to the Massachusetts life-sciences sector over 10 years. Read our exclusive profile with Gov. Healey – and watch what she says we can learn from Massachusetts: |
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Pennsylvania Gov. Josh Shapiro talks PA biotech, importance of vaccines. "Jonas Salk invented the polio vaccine in Pittsburgh and more recently in the last 5-6 years, Drew Weissman and his team at the University of Pennsylvania saved millions of lives when they developed the mRNA vaccine that helped get people out of their homes during COVID,” he said during a fireside chat. He also discussed the state's current bioeconomy – and the fact that 75% of vaccines administered in the U.S. come from a GSK plant in Marietta, PA. Watch our interview: |
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Life Sciences Workforce Collaborative (LSWC) officially launches to strengthen talent pipeline across the U.S. Formerly known as the Coalition of State Bioscience Institutes (CSBI), the LSWC brings together more than 50 state and regional life sciences associations and workforce leaders to scale industry-led solutions to talent development across the U.S. "State associations and institutes have long led the way in workforce innovation. LSWC gives us a shared platform to amplify that work nationally, foster collaboration, and position the U.S. life sciences industry for sustained growth," said John Conrad, Chair of the Council of State Bioscience Associations (CSBA) and President & CEO of iBIO. Read more. |
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On Day 2, Ted W. Love, M.D., passed the BIO chairmanship to Fritz Bittenbender, Senior Vice President and Head of Genentech Public Affairs and Access.
"Fritz is an extraordinary leader. He understands policy. He understands BIO," said Dr. Love. "Fritz really is the person incredibly well-equipped to diagnose, come up with plans, and implement those solutions."
"BIO is at such a critical inflection point for our industry, and BIO is going to be the key catalyst that assures we continue to grow the biotech industry and make it stronger than it ever has been," said Bittenbender.
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