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We’re wrapping up a fantastic 2024 BIO International Convention with what FDA Commissioner Dr. Robert Califf said about supply chains (and more) and how you can get involved with ARPA-H—plus, a few headlines you might have missed. (703 words, 3 minutes, 30 seconds) |
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How to catch up Good Day BIO Live at BIO 2024 |
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We don't know about you, but the Good Day BIO Live Team had one of our best conventions ever – and there's much more BIO 2024 content to come! Here's how you can catch up on the week:
- Keep an eye on Bio.News for panel recaps, exclusive Q&As, and much more – it's not over yet.
- Join the conversation on X and LinkedIn, with hashtag #BIO2024. Watch for more exclusive video content and repost-worthy quotes.
- Watch your inbox for highlights right here at 10 AM ET/7 AM PT.
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FDA Commissioner on supply chains, clinical trial diversity, and more |
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BIO President & CEO John F. Crowley and FDA Commissioner Dr. Robert Califf in conversation at the 2024 BIO International Convention on June 5, 2024. |
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BIO President & CEO John F. Crowley spoke with Food and Drug Administration (FDA) Commissioner Dr. Robert Califf in a fireside chat at the BIO International Convention—here are the highlights.
On supply chains: “We saw what happens when we don’t have resilient supply chains in the United States during a pandemic,” said Crowley. “The BIOSECURE Act is more than anything a wake-up call on manufacturing.” Dr. Califf agreed: “If something goes wrong with the relationship with China, we’d be cut off completely.”
On regulatory coordination: “We just reached agreement with the Agriculture Department on genetically engineered animal issues and intentional genomic alterations,” Dr. Califf said.
On harmonization of international regulators: “If you’re producing a good data set for good stuff, there’s no reason to have to be submitting that to all the players in different ways, and if we could agree on the study design,” it can facilitate faster drug approval and access around the world, Dr. Califf said.
On clinical trial diversity: “We’re asking in the United States for a clinical trial system to overcome the health system, which is fundamentally inequitable,” Dr. Califf said.
On Accelerated Approval: “I don’t know of anybody in FDA who thinks that the basics of Accelerated Approval should be changed,” said Dr. Califf. But, he noted there may be improvements in post-market studies conducted to confirm the efficacy of drugs. Read more in Bio.News. |
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How to get involved with ARPA-H
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Speaking on June 6 in San Diego, Susan Monarez, Ph.D., Deputy Director of ARPA-H, explains how companies can get involved and get funding from ARPA-H. |
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Getting government support for a biotech startup no longer needs to be a slow and painful process, said staff and fundees of the Advanced Research Projects Agency for Health (ARPA-H) on Day 4 of BIO 2024. Launched just over a year ago,ARPA-H is small, agile, and flexible enough to accommodate diverse needs, panelists said. They work with early-stage innovations or help get late-stage ideas to market—quickly.
What they’re doing: ARPA-H has pushed out almost $1 billion in funding across an entire portfolio, including a recent $100 million sprint for women’s health.
What they’re saying: “My colleagues here from ARPA-H and I will tell you our agency is unique in our ability to work with public and private entities outside of government. The speed, the efficiency, the effectiveness—I’ve never seen anything like it in my time in government,” said Susan Monarez, Ph.D., Deputy Director of ARPA-H.
How to get started: The panelists provided tips on submitting an abstract and engaging with the right program manager—read more at Bio.News. |
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A few headlines you might have missed this week… |
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Yes, there was life outside of the San Diego Convention Center—here are a few headlines you might have missed.
A man in Mexico died in the first human case of the H5N2 bird flu variant. The 52-year-old died “after being infected with a bird flu subtype never before confirmed to have spread to humans,” reported The Washington Post. “This case marks the first time a human has been confirmed to be infected with this subtype, and the first time an avian H5 virus was confirmed in a person in Mexico.”
Fall COVID vaccines should target JN.1, say FDA advisors. The Vaccines and Related Biological Products Advisory Committee unanimously voted to recommend the updated COVID vaccines for fall target the JN.1 lineage of the virus, which overtook the XBB lineage in last year’s vaccines, explains USA Today.
BIO announced the winners of the 2024 Leadership in Agri-Biotechnology Awards: Dr. Annette Kleiser, CEO of Dalan Animal Health, as the recipient of the George Washington Carver Award, and Sylvia Wulf, President and CEO of AquaBounty Technologies, as the recipient of the Rosalind Franklin Award. The two awards recognize biotechnology leaders who are driving cutting-edge breakthroughs in agricultural, environmental, and industrial biotechnology. Read BIO’s press release. |
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