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Good Day BIO: Veterans Day and regenerative farming
Good Day BIO Newsletter  •  November 11, 2022
We’re honoring America’s veterans and thinking about how biotech can support them, especially the growing population of women vets. Also, a report says the uptake of regenerative farming practices needs to triple to address food sustainability and climate change. (682 words, 3 minutes, 24 seconds)
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Good Day BIO: USDA seeks input on blight-resistant tree – plus, has biotech found the fountain of youth?
Good Day BIO Newsletter  •  November 10, 2022
USDA is seeking input on a gene-edited American chestnut tree, which has been awaiting regulatory approval. Plus, scientists are closing in on the “fountain of rejuvenation,” thanks to biotech. (631 words, 3 minutes, 9 seconds)
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Good Day BIO: What we know so far
Good Day BIO Newsletter  •  November 9, 2022
Here’s what we know so far about the election results, and what it means for biotech. Plus, Twist Bioscience CEO Emily Leproust explains how DNA could be the answer to data-storage problems. (867 words, 4 minutes, 19 seconds)
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Good Day BIO: Midterms preview - plus, R&D tax changes and OOP 'smoothing'
Good Day BIO Newsletter  •  November 8, 2022
It’s Election Day—we got expert insights on which races are worth staying up late to watch tonight. Plus, BIO joined a letter on an R&D tax change and Avalere released a new report (with support from BIO) on the need for out-of-pocket “smoothing.” (793 words, 3 minutes, 57 seconds)
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Good Day BIO: Why you should care about COP27
Good Day BIO Newsletter  •  November 7, 2022
Before all of our attention turns to tomorrow’s midterms, let’s take a moment for the planet—here’s what you need to know about COP27, and why even the health care sector needs to care about climate change. (728 words, 3 minutes, 38 seconds)
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Good Day BIO: Biotech leaders and 340B
Good Day BIO Newsletter  •  November 4, 2022
We have the winners of BIO’s Impact Awards and California Life Sciences’ Pantheon Awards. Plus, today’s the 30th anniversary of the 340B program, so we look at how the program has ballooned beyond its original intent. (558 words, 2 minutes, 47 seconds)
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BIO Announces 2022 Impact Awards
Press Release  •  November 3, 2022
Awards Recognize Innovators in Agricultural, Environmental and Industrial Biotechnology   The Biotechnology Innovation Organization today announced Dr. Annie Tsong, chief strategy & product officer at Amyris, as the winner of this year’s Rosalind Franklin Award for Leadership in Industrial Biotechnology and Agriculture, and announced Dr. Robert Kennedy, chief scientific officer at Vestaron, as the winner of the 2022 George Washington Carver Award for Innovation in Industrial Biotechnology and Agriculture. Collectively known as the Impact awards, the awards honor leaders who are driving cutting-edge, sustainable breakthroughs in agricultural, environmental and industrial biotechnology.   BIO presents the Rosalind Franklin Award to a pioneering woman who is leading today’s innovations in agriculture, food systems, sustainable energy and biobased manufacturing. The George Washington Carver Award recognizes individuals who have advanced biotech innovation to make supply chains greener and have worked successfully toward that goal in the private sector, government or academia. The George Washington Carver Award is sponsored by the Iowa Biotechnology Association (IowaBio).   “BIO Impact award winners are leaders in advancing the bioeconomy,” said Rachel King, interim president and CEO of BIO. “Both Dr. Annie Tsong and Dr. Robert Kennedy are doing groundbreaking work that demonstrates biotechnology’s revolutionary potential to meet the challenges of today and tomorrow. BIO is proud to recognize these two game-changers in biotechnology, and we thank IowaBio for sponsoring this year’s George Washington Carver Award.”   Under Dr. Tsong’s leadership, Amyris has developed a biotech-based fermentation technology to efficiently convert feedstocks into products and ingredients from vitamin E and squalene to flavors and fragrances. Her work helps the planet by developing biotech-based alternatives to ingredients from limited or vulnerable natural…
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Good Day BIO: The IP waiver was always political
Good Day BIO Newsletter  •  November 3, 2022
The IP waiver for COVID-19 technology was never about access to vaccines, says one BIO expert. Plus, with genetics and digital technology, Bayer is making corn with shorter stalks—we tell you why that’s a good thing. (595 words, 2 minutes, 58 seconds)
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Good Day BIO: How value assessments can exacerbate inequity
Good Day BIO Newsletter  •  November 2, 2022
A study identifies the potential for systemic racism in health technology assessments. Plus, one BIO member company is expanding its beauty empire with a synbio beauty secret. (507 words, 2 minutes, 32 seconds)
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BIO Submits Comments on Quality Management Maturity (QMM) Program and Knowledge-Aided Assessment and Structured Application (KASA)
Letters, Testimony & Comments  •  November 1, 2022
On November 1st, BIO submitted comments in response to the Food & Drug Administration’s (FDA) recent Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. The meeting was primarily focused on two topics: the future of the Quality Management Maturity (QMM) program and the next stages of Knowledge-Aided Assessment and Structured Application (KASA). In particular, FDA requested feedback from stakeholders on the development of a CDER QMM program to incentivize investments in mature quality management practices. On this topic, BIO provided three primary recommendations: (1) A QMM program should be voluntary and industry-driven if implemented; (2) Any QMM assessment model should be standardized and well-integrated with related programs; and (3) Details about the proposed implementation of a QMM program should be clarified. During the Advisory Committee meeting, FDA also requested feedback on its vision and plan to expand KASA over the next five years to include drug substances, all generic dosage forms, new drug and biologics applications, and post-approval changes. Regarding KASA, BIO stressed the importance of utilizing the system to build upon international harmonization efforts and to support interoperability of data standards, in contrast to its potential for introducing further integration challenges and regulatory discrepancies. BIO also suggested that a pilot program conducted in partnership with industry would provide valuable insight on the potential benefits, challenges, gaps, and best practices associated with the implementation of KASA.
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