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Actions matter to investors – and voters want pan prep
Bio.News  •  March 30, 2023
We’ve packed a lot in today’s issue: BIO’s testimony on the TRIPS waiver at the USITC, a new poll that shows support from voters in both parties for pandemic preparedness, and a recap of CSBA’s Capitol Hill fly-in—plus, a few things you missed on the Hill. (599 words, 2 minutes, 59 seconds)
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Short and Long Read Sequencing for AAV Characterization
Webinars  •  March 30, 2023
Cell + Gene Therapy Science Series   An ASGCT collaboration with BIO and FDA The Cell and Gene Therapy (CGT) Science Series is a quarterly seminar series focused on scientific topics related to cell and gene therapy products. The CGT Science Series is intended to foster scientific exchange between the Biotechnology Innovation Organization (BIO), American Society of Gene & Cell Therapy (ASGCT), and FDA's Center for Biologics Evaluation and Research (CBER) review staff on a variety of topics that span the CGT product lifecycle. The seminars are planned as 60-minute virtual webinars featuring a speaker from one of the three organizations. The CGT Science Series will enable a deep dive into a specific technical and/or scientific area.  Topics in the series may include, but are not limited to, nonclinical, CMC, clinical, or post-market phases of development related to CGT product lifecycle.    Short and Long Read Sequencing for AAV Characterization   The inaugural CGT Science Series seminar  focused on NGS characterization of AAV and was presented by Dr. Lauriel Earley.  Dr. Earley is a Senior Scientist with Shape Therapeutics who has been studying the basic biology of adeno-associated virus for over decade. During her graduate studies at Oregon Health & Science University, she examined the role of assembly-activating protein under the mentorship of Dr. Hiroyuki Nakai. After receiving her PhD, she joined Dr. Jude Samulski's laboratory at the University of North Carolina, Chapel Hill and took on a project to characterize the intrinsic promoter ability of the inverted terminal repeat sequences from various AAV serotypes. Dr. Earley joined Shape Therapeutics in 2019 and is currently leading their vector platform development team. In addition, Dr. Earley has been an active member of ASGCT since 2012 and is currently serving on the Patient Outreach Committee.
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ASGCT-BIO AAV Sequencing webinar title card

BIO Office Hours: Grant Applications with PSC Biotech
March 29, 2023
BIO Office Hours is a resource for BIO members to meet one-on-one with subject matter experts on business services. Are you applying for a government grant? Don't know where to start or how to best allocate your time and resources to complete the grant proposal and subsequent work? Not sure if your application satisfies all requirements? Schedule an office hour with a PSC Biotech Subject Matter Expert.   Schedule Office Hour
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BIO Statement to the U.S. International Trade Commission on COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities
Letters, Testimony & Comments  •  March 29, 2023

HHS on price controls, PBMs, and more
Bio.News  •  March 29, 2023
We recap what HHS Secretary Becerra said yesterday about everything from drug pricing to PBMs, and get ready for more hearings today, including the USITC’s hearing on the COVID IP waiver. (674 words, 3 minutes, 22 seconds)
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BIO Files Amicus Brief in U.S. ex rel. Scutte v. SuperValu Inc. at the Supreme Court of the United States
Amicus Brief  •  March 28, 2023
BIO has filed an amicus brief in U.S. ex rel. Scutte v. SuperValu Inc., which addresses the issue of the intent requirement under the False Claims Act (FCA). Specifically, BIO urges the Court to uphold the view that a firm does not have the requisite intent to violate the FCA when its interpretation of a statute or regulation: (1) is “objectively reasonable,” and (2) no authoritative guidance cautions against it. A carefully calibrated FCA intent requirement is important to biotech companies, which operate in an environment of extreme regulatory complexity. Federal agencies frequently manage this complexity by pursuing a strategy of deliberate regulatory ambiguity (i.e., relying on non-binding guidance rather than statutory language or rulemaking). Ths approach has a number of advantages, but when coupled with a overly broad FCA intent requirement risks chilling beneficial conduct. In the absence of a sensible intent requirement, biotech companies will tend to adopt only the most conservative regulatory interpretations, resulting in innovation- and investment-stifling overdeterrence, with corresponding implications for access and patient health. BIO was joined in the brief by AdvaMed and the Medical Information Working Group.
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How Accelerated Approval works
Bio.News  •  March 28, 2023
In the lull before the hearing storm, listen to the new episode of the I am BIO Podcast, which explains why Accelerated Approval is so important for patients. Plus, we look at legislation that would increase tax breaks for R&D. (729 words, 3 minutes, 38 seconds)
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Accelerating Hope: The Pathway for Cures
I am BIO Podcast  •  March 28, 2023
When people were dying from AIDS in the 1980s and 90s, Congress found a way to expedite the drug approval process and saved countless lives. Established in 1992, the Accelerated Approval Program allows the FDA to speed approval of drugs for patients with serious and life-threatening conditions. In this episode we talk with the father of children with a rare disease, a company CEO working to treat rare diseases and two policy experts on Accelerated Approval.
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podcast

Why we need new antifungals – fast
Bio.News  •  March 27, 2023
We’re gearing up for another busy week in Washington—but first, what USTR said about biotech corn on Friday and why we need to act on a rapidly spreading fungus. (450 words, 2 minutes, 15 seconds)
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340B Backgrounder
Human Health, Government Price Setting  •  Toolkit  •  March 27, 2023
In 1992, with the support of the biopharmaceutical industry, Congress created the 340B Drug Pricing Program to help uninsured and vulnerable patients. As part of the law, drug manufacturers provide significant discounts on outpatient medicines and treatments to select eligible health care “covered entities” — often referred to as safety- net providers.
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