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BIO’s Coffee Chat focused on why we need PPRV reauthorization. Plus, a year-end readers’ survey. (821 words, 4 minutes, 6 seconds) Bio.News will take a holiday break. The next newsletter is scheduled for Jan. 12. Happy holidays! |
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Patient advocates explain urgency of PPRV action in BIO Coffee Chat
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Patient advocates said the Pediatric Patient Review Voucher (PPRV) saves children’s lives, because it drives decisions to develop rare disease drugs, and urged Senators to reauthorize the program in BIO’s last Coffee Chat for the year.
What happened: The Senate ultimately recessed for the year without reauthorization of the PPRV program. The program, which costs taxpayers nothing, expired a year ago. The reauthorization passed in the House Dec. 1.
What’s PPRV: The Food and Drug Administration (FDA) program provides vouchers to companies that gain approval for drugs to treat rare diseases primarily impacting children. Companies can use a voucher to expedite review of their next drug candidate, or they can sell the voucher to another company.
How well it works: Since the program’s 2012 launch, 63 vouchers were awarded for drugs targeting 47 different rare pediatric diseases, said a National Organization for Rare Disorders (NORD) report. Before the PPRV program, only four of these 47 rare pediatric diseases had any FDA-approved treatments.
Why it matters: “What’s at stake is a bunch of kids’ lives, including the lives of my daughters Belle and Abby,” Pam Crowley Andrews, Executive Director of the Firefly Fund told the Coffee Chat, BIO’s monthly policy discussions, featuring patient advocate experts. “Without the vouchers, it’s not realistic or viable for these drugs to make their way through the regulatory process.”
BIO’s view: “Families affected by rare pediatric diseases count on Congress to quickly renew the PPRV program. It enables development of drugs these families desperately need,” said Michele Oshman, BIO Chief Patient Advocate and Head, Patient Advocacy Center of Excellence.
What’s next: BIO continues leading the push for PPRV reauthorization, issuing a statement supporting House passage of reauthorization and closely tracking activity on Capitol Hill. Visit BIO’s PPRV advocacy toolkit for resources and powerful stories from rare disease patients and families.
Read more on Bio.News.
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BIO IP panel: Patent lawyers must understand ethics of AI |
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Patent lawyers can benefit from AI but they need to understand ethical issues or risk losing their cases, a panel told the BIO IP Conference.
Why it matters: AI distortions can hurt your case. “We’re all familiar with the fact that generative AI can hallucinate,” Joshua Rich, Partner at Lippes Mathias LLP, told the November . “It’s most apparent in our field in litigation, because there’s opposing counsel to call you out on it.”
When is AI OK? “You probably don’t want your summary section written by generative AI because of the need to precisely repeat the claim language. But you might use generative AI for a background section,” said Ann McCrackin, a law professor and founder of AI-Enabled Attorney LLC.
When patent lawyers use AI: Aaron Gin, Partner at McDonnell Boehnen Hulbert & Berghoff emphasized the need to give good prompts by defining: - the persona/role and objective;
- clear instructions, output format, and constraints;
- contextual information;
- success criteria.
Read more on Bio.News. |
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Feedback from our readership ensures that Bio.News continues to deliver trusted weekly industry coverage at the intersection of biotech innovation and policy. Thank you for your time and valuable input.
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CDC changes recommendation for hepatitis B vaccines. The Centers for Disease Control and Prevention (CDC) on Dec. 16 announced it has “adopted individual-based decision-making for hepatitis B immunization for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus. For those infants not receiving the birth dose, it is suggested that the initial dose be administered no earlier than two months of age.” A BIO statement objected to the original recommendation for this change made on Dec. 5 saying reduced vaccination “will result in increased rates of hepatitis B, causing liver disease and cancer.” Read more here. |
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“AI is accelerating drug discovery, improving protein modeling, and enabling the development of therapies with unprecedented precision,” Rep. John Joyce, MD (PA-R), told a Dec. 17 House Energy & Commerce Oversight and Investigations Subcommittee hearing on “Biosecurity at the Intersection of AI and Biology.” Rep. Lori Trahan (D-MA) expressed concerns that reductions in federal research funding weaken America’s biotech leadership and preparedness. She urged reauthorization of the Pandemic All Hazards Preparedness Act (PAHPA). “Congress has failed to reauthorize PAHPA in a meaningful way, leaving core preparedness programs in limbo," she said, mentioning programs like the strategic national stockpile.
Lawmakers head home for the year without passing legislation to extend Affordable Care Act subsidies beyond Dec. 31. Several other health-related bills await decisions in January. |
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