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BIO Comments to FTC
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Letters, Testimony & Comments  •  March 31, 2023
BIO response to Federal Trade Commission request for comment on the agency's Guides for the Use of Environmental Marketing Claims (Green Guides)
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What went wrong with PBMs?
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Good Day BIO Newsletter  •  March 31, 2023
A busy week in Washington wraps with a Senate hearing on PBMs, House hearings on agriculture, and the final day of the USITC’s hearing on the expansion of the COVID IP waiver. (748 words, 3 minutes, 44 seconds)
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CSBA Letter to Congressional Leaders urging for passage of S. 866, the American Innovation & Jobs Act of 2023 (March 28, 2023)
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Council for State Biotechnology Associations (CSBA)  •  Letters, Testimony & Comments  •  March 30, 2023

Majority of American Voters Want Congress to Prioritize and Fund Public Health Preparedness, Poll Reveals
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Press Release  •  March 30, 2023
Healthcare Ready, Biotechnology Innovation Organization, and Wakefield Research release data Washington (March 30, 2023) -- The last several years have shown that preparing for a public health emergency is vital to protect the public, our national security, and the economy. As policymakers in Congress reflect on ways to strengthen our public health preparedness efforts, the Biotechnology Innovation Organization (BIO) and Healthcare Ready, in conjunction with Wakefield Research, have released new survey data that show American voters -- on both sides of the aisle -- believe their congressional representatives should prioritize funding for public health preparedness to ensure the United States isn't vulnerable during future public health crises.   In summary, the polling data show:  There is overwhelming bipartisan support for the federal government to act on a variety of fronts:95% of respondents believe that "The federal government should prepare for a wide variety of potential public health emergencies." 92% of respondents agree that "The lessons learned from the last pandemic should be incorporated into our national preparedness efforts for the next public health emergency." 90% of respondents agree that "The federal government should expand long-term preventive measures to help avoid any future pandemics."   More than 8-in-10 voters believe it is 'extremely' or 'very' important for the federal government to prioritize funding for public health emergency preparedness:More than two-thirds (71%) of voters want the federal government to increase funding for public health preparedness rather than maintain or decrease it because current spending levels are too low (50% say the federal government is spending too little, 17% say too much, 33% say about right).Nearly 8 in 10 voters (77%) say they would be more likely to vote for a candidate who supports funding for public health preparedness.  Voters also…
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Actions matter to investors – and voters want pan prep
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Good Day BIO Newsletter  •  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
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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
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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
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Letters, Testimony & Comments  •  March 29, 2023

HHS on price controls, PBMs, and more
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Good Day BIO Newsletter  •  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
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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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