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Good Day BIO: Ways & Means wants info on IP waiver – plus, the new podcast season launches today
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Good Day BIO Newsletter  •  September 20, 2022
The House Ways & Means Committee is marking up a resolution that asks questions about the Biden administration’s policy regarding the WTO TRIPS waiver, and we launch the new season of the I am BIO Podcast with a fascinating episode about data storage with synthetic DNA. (793 words, 3 minutes, 57 seconds)
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Data Storage Crisis: DNA to the Rescue
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I am BIO Podcast  •  September 20, 2022
You might be surprised to learn that data storage currently requires huge amounts of land and energy, and we're running out of both. In this episode, we speak with a small group of researchers who are working to revolutionize the way we store the massive amounts of data we produce every day. Their solution: use DNA.
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Good Day BIO: Why we're talking about 340B
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Good Day BIO Newsletter  •  September 19, 2022
We take a deep dive on 340B programs—plus, look at the largest ever outbreak of bird flu in the UK and what Biden said yesterday about COVID-19. (724 words, 3 minutes, 37 seconds)
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Good Day BIO: Monkeypox update and a big purple tomato
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Good Day BIO Newsletter  •  September 16, 2022
Federal officials discussed the state of the monkeypox outbreak and USDA greenlights a big purple tomato—plus, lawmakers are expected to work on FDA user fee reauthorization through the weekend. (713 words, 3 minutes, 33 seconds)
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Good Day BIO: Recap of White House biotech summit
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Good Day BIO Newsletter  •  September 15, 2022
We recap yesterday’s biotechnology summit at the White House, and look at what’s ahead for COVID-19 IP protections at the WTO. Plus, today marks the start of Hispanic Heritage Month. (745 words, 3 minutes, 43 seconds)
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Good Day BIO: USDA triples Climate-Smart grant program
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Good Day BIO Newsletter  •  September 14, 2022
USDA announced the awardees of the climate-smart grant program and we’re taking action to renew the SBIR/STTR seed-funding programs before they expire on Sept. 30. Meanwhile, a busy day in D.C. with the White House Summit on the National Biotechnology and Biomanufacturing Initiative and hearings on monkeypox and soil health. (590 words, 2 minutes, 57 seconds)
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BIO Comments on FDA Guidance: Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies
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Letters, Testimony & Comments  •  September 13, 2022
On Tuesday, September 13th, BIO submitted comments in response to the FDA’s recent draft guidance on voluntary consensus standards (VCS) for regenerative medicine therapies. In the comment letter, BIO expressed appreciation to FDA for issuing a guidance on this topic along with support for VCS, as they are a necessity for ensuring product quality and patient safety. Furthermore, BIO stated that VCS will accelerate the development of regenerative medicine, which encompasses a set of complex and rapidly evolving technologies, by making it easier for developers to comply with FDA regulations and enabling them to better compare different strategies for manufacturing cell and gene therapy (CGT) products. BIO additionally noted that CDRH’s long running VCS program is widely considered a success and demonstrates the feasibility and advantages of this approach. BIO additionally presented several recommendations for how the Agency could further strengthen the program. For example, ensuring that standards evolve with emerging science, manufacturing, and clinical experience (in the RMT field). Additionally, modality-specific considerations (e.g., AAV vectors versus CAR-T cells) should be considered when developing VCS that apply across all RMTs.
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Good Day BIO: Biden's EO on biotech and biomanufacturing
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Good Day BIO Newsletter  •  September 13, 2022
We have more details on Biden’s biotech executive order (and how BIO’s long called for something like it) and new technology to turn food waste into fuel. Don’t forget to join today’s webinar on the importance of SBIR/STTR reauthorization—register here! (624 words, 3 minutes, 7 seconds)
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Biden's Executive Order to Advance Biotechnology, Biomanufacturing Prioritizes Science to Solve Global Challenges
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Press Release  •  September 13, 2022
Dr. Michelle McMurry-Heath, president & CEO of the Biotechnology Innovation Organization, released the following statement in response to the Biden Administration’s “Advancing Biotechnology and Biomanufacturing” Executive Order: “BIO welcomes the Biden Administration’s directives to strengthen our domestic biotechnology and biomanufacturing industry. This Executive Order the president signed today acknowledges the ‘power of biotechnology’ and its benefits to the U.S. economy, work force and quality of life, as well its potential to boost food and agriculture innovation and address the climate crisis. We commend the administration for launching this initiative, particularly the actions to streamline regulatory regulations for biotechnology products, expand market opportunities for biobased products, work for international alignment of regulatory standards, and invest in training and education pathways to ensure an adequate, diverse biotech workforce. “From the onset of the Biden administration, BIO has called on the administration to proactively advance biotechnology to foster resiliency and sustainability throughout the agricultural value chain and build a stronger, more resilient, and environmentally sustainable economy. This executive order will help the U.S. and the world meet our environmental and public health goals.” Background The following are examples of BIO’s calls to advance biotechnology and biomanufacturing: BIO Calls for Actions to Bolster IRA’s Climate Investments by Advancing Biotech, Sept. 8, 2022 100 Days of Innovation Blueprint, Jan. 27, 2021 BIO letter to Pres. Biden on Advancing Biotech to Address Climate Crisis, Jan. 25, 2021 BIO Briefing Paper on Flighting Climate Change Through Biotech Innovation ###
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SBIR/STTR Reauthorization Webinar
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Webinars  •  September 13, 2022
BIO, CSBA, and AdvaMed hosted a special briefing to discuss the success of SBIR/STTR programs, their economic impact, and the important next steps to Federal reauthorization. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are highly competitive award-based programs that encourage domestic small businesses to engage in Federal Research/Research and Development with the potential for commercialization. Federal funding for the SBIR/STTR Program will expire on September 30, 2022, and we need your support to ensure timely reauthorization! Hear from successful SBIR/STTR grantees and technical experts on these vital programs. After this webinar, you will be able to effectively advocate for Federal SBIR/STTR program reauthorization. Make Your Voice Heard by Congress: https://action.bio.org/X8gCA7U https://www.advamed.org/takeaction/?vvsrc=%2fcampaigns%2f96142%2frespond%3futm
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