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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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Good Day BIO: Biden to boost biomanufacturing
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Good Day BIO Newsletter  •  September 12, 2022
President Biden’s set to announce an executive order today that will provide more funding for biomanufacturing, and also announce a BIO member company scientist to lead ARPA-H. Plus, the HHS Secretary expressed support for addressing AMR during last week’s World AMR Congress. (768 words, 3 minutes, 50 seconds)
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BIO Comments on WHO White Paper: Regulation of Cell and Gene Therapy Products
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Human Health  •  Letters, Testimony & Comments  •  September 9, 2022
Today, BIO submitted comments to the World Health Organization (WHO) regarding its revised, draft white paper on the regulation of Cell and Gene Therapy Products (CGTPs). As stated previously, BIO emphasized that this paper represents a major milestone and will be the first global regulatory guidance on these innovative therapeutics. In response to the new and extensively revised draft, BIO expressed appreciation and support for this very important and thoughtful document. In particular, the paper provides valuable terminology, which is important given the current global inconsistencies in nomenclature and definitions. BIO also stated support the utilization of a risk-based approach for the proper regulatory oversight of ATMPs and HCT, as is described in the paper. However, BIO suggested there could be challenges when determining the level of regulatory oversight commensurate with product risk, given the paper’s recommendations for basing this assessment on the extent to which cells and tissues are manipulated, as this measure could be somewhat subjective. Therefore, BIO recommended that the paper maintain clarity for when the therapeutic will be for heterologous use, so as to avoid ambiguity. Furthermore, BIO requested additional clarity on how the regulatory reliance mechanisms laid out in the paper will address the challenges that are discussed. Lastly, BIO stated that as the ATMP space continues to rapidly change, it will be crucial for regulators to assess when new issues which need regulatory guidance arise and to quickly provide guidance to ensure clear recommendations.
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Good Day BIO: IRA climate investments and long COVID
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Good Day BIO Newsletter  •  September 9, 2022
Ending the week with BIO’s letter to President Biden explaining what needs to be done to bolster the Inflation Reduction Act’s historic climate investments, plus what we know—and don’t—about long COVID. (697 words, 3 minutes, 29 seconds)
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BIO Calls for Actions to Bolster IRA's Climate Investments by Advancing Biotech
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Press Release  •  September 8, 2022
As the Biden Administration begins implementation of the Inflation Reduction Act, the Biotechnology Innovation Organization today called on the administration to take additional steps to foster the development and deployment of pioneering technologies that are critical to meeting the nation’s greenhouse gas reduction targets.   “By proactively advancing biotechnology, we can take bold and drastic action to tackle the climate crisis, bolster the climate investments made in IRA, and ensure the U.S. meets its emissions reduction goals,” wrote BIO President and CEO Dr. Michelle McMurry-Heath in a letter to President Biden.   From swift implementation of tax credits for sustainable fuels and actions to increase federal procurement of biobased products, to leveraging the regulatory system to quickly deploy climate-positive biotechnologies and incentivize their use, BIO outlined several steps that federal agencies should take to complement the climate investments made by IRA and realize the full climate-positive potential of biotechnologies and bioproducts.   BIO staunchly opposed passage of IRA due to its damaging and counterproductive provision establishing government price controls on prescription drugs, which will erect barriers to developing much-needed new therapeutics and combating future pandemics. However, BIO also has acknowledged that the historic investments to tackle climate change will advance environmental and public health goals and encourage investment in the biotech industry’s agriculture and environment sector.   “Biotechnology is enabling a dramatic paradigm shift in the production of fuels and chemicals,” BIO wrote the president. “More biorefineries are converting domestic sources of renewable biomass, wastes, and residues into sustainable low carbon fuels, chemicals, and products.”   Actions the administration could take, according to BIO, to deploy biobased technologies and create more sustainable supply chains…
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BIO Letter on Inflation Reduction Act Implementation, Climate & Biotechnology
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Climate Change, Rare Diseases  •  Letters, Testimony & Comments  •  September 8, 2022
As the federal government begins to implement IRA, BIO urges the administration to take additional steps to foster the development and deployment of pioneering technologies that will further reduce greenhouse gas emissions in manufacturing, transportation, and agricultural supply chains to build a stronger, more resilient, and environmentally sustainable economy. 
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Good Day BIO: Athletes fight rare disease – plus, a new high-protein soybean advances
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Good Day BIO Newsletter  •  September 8, 2022
Football season starts today—and college athletes are kicking off a contest to support rare disease R&D. BIO member Benson Hill recently announced a new partnership to advance high-protein soybeans—with AI, data science, genomics, and biology. Plus, news from D.C. on a key USTR nominee and EUA for monkeypox tests. (729 words, 3 minutes, 38 seconds)
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Good Day BIO: Mental health and America's kids
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Good Day BIO Newsletter  •  September 7, 2022
Back to work, back to school—and back to mental health challenges. Mental Health America has insights on the mental health of America’s kids, and resources to help. Plus, the White House is planning for a major food security summit—and we hope biotech is on the menu. (595 words, 2 minutes, 58 seconds)
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