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Good Day BIO: WHO's global framework for regulating human genome editing
Good Day BIO Newsletter  •  July 26, 2021
Starting the last week of July with a look at a recent report on human genome editing from the WHO's Expert Committee, as well as what we know about how to combat vaccine hesitancy. (762 words, 3 minutes, 48 seconds)
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Good Day BIO: How we can end African swine fever
Good Day BIO Newsletter  •  July 23, 2021
ICYMI: African swine fever is making a comeback in Germany—this time in farm pigs. We explain how we could end this disease, as well as recap what BIO’s Dr. Michelle said during a Washington Post event about health equity. (770 words, 3 minutes, 51 seconds)
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BIO Promotes Sarah Gallo to Vice President, Agriculture and Environment
Press Release  •  July 22, 2021
The Biotechnology Innovation Organization (BIO) is pleased to announce today the promotion of Sarah Gallo to Vice President, Agriculture and Environment. In her new role, Sarah will lead the policy and market access strategies for BIO’s Agriculture and Environment Section, which is comprised of members from the former Food and Agriculture and Industrial and Environmental Sections. In this role, Sarah will also serve as the primary liaison between the organization and the section board of directors. “I could not be more thrilled to welcome Sarah to BIO’s leadership team,” said BIO’s President and CEO Dr. Michelle McMurry-Heath. “Throughout BIO’s restructure, Sarah’s leadership has been instrumental in uniting our agriculture and environment companies and distilling their priorities into BIO’s mission. These companies are creating breakthroughs that will be essential to the future of our society, and I look forward to watching BIO’s Agriculture and Environment Section grow under her leadership.” Sarah joined BIO in 2018 to lead market access strategy for BIO’s food and agriculture members. During that time, Sarah worked closely with BIO’s companies to spearhead initiatives on transparency and public awareness. “I am excited to be taking on this challenge during a transformational time at BIO,” said Sarah Gallo. “Our members are creating some of the most compelling breakthroughs of our generation, which will help to address global challenges like climate change and access to nutritious, healthy food. I want to thank Dr. Michelle and BIO’s leadership for the opportunity to lead this section and look forward to continuing to work closely with our members to showcase the many benefits of biotechnology across agriculture and the environment.” Prior to joining BIO, Gallo worked in government affairs and public policy for CHS, Inc. and the National Corn Growers Association. She also served as the Agriculture Counsel for the U.S. House of…
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BIO Comments on Cures 2.0 Discussion Draft
Human Health  •  Letters, Testimony & Comments  •  July 22, 2021
The Biotechnology Innovation Organization (BIO) is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. Our mission is to advance biotechnology innovation by promoting sound public policy and fostering collaboration, both locally and globally. Our members range from entrepreneurial companies developing a first product to Fortune 500 multinationals. BIO and our members appreciate the opportunity to provide comments to the 21st Century Cures 2.0 proposal discussion draft.
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Good Day BIO: COVAX Marketplace will boost global vaccine production
Good Day BIO Newsletter  •  July 22, 2021
Lots of newness today: the new COVAX Marketplace, BIO’s new VP for Agriculture and Environment, and more news from Washington. (888 words, 4 minutes, 26 seconds)
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BIO Comments on International Council for Harmonisation Q12: Implementation Considerations for FDA-Regulated Products
Letters, Testimony & Comments  •  July 21, 2021
BIO appreciates FDA’s commitment to harmonization of regulatory concepts across regional Health Authorities through the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Harmonization of critical regulatory concepts is an important part of ensuring a consistent and predictable regulatory environment and gives sponsors confidence that their drug development program will be generally accepted within different regions. BIO believes that the concepts in Q12 are important and warrant broad recognition across the globe. Even though implementation of Q12 is voluntary, this Draft Guidance explains FDA’s expectations on implementation of Q12 (e.g., format, eCTD locations for information) if an applicant so chooses to implement Q12 and thus is a helpful document. In BIO's comments, we requested additional clarity on how the Q12 draft guidance should be utilized by industry in conjunction with previously issued FDA guidances. We also noted the importance of globally aligned requirements for Established Conditions (ECs) and urged the Agency to carefully consider the terminology used throughout the draft guidance. Furthermore, we expressed concern about the potential introduction of new terms which are not internationally aligned. In line with this overarching feedback, a number of specific redline edits were provided.
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Good Day BIO: “COVID-19 won’t just go away.”
Good Day BIO Newsletter  •  July 21, 2021
Today, we have a quick recap of yesterday’s Senate hearing on the federal COVID-19 response, plus a look at a must-read long-read on how the tide is turning on GMOs and why it matters. (842 words, 4 minutes, 12 seconds)
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BIO Signs on to Letter in Support of Under Secretary for Farm Production and Conservation Robert Bonnie
Agriculture & Environment  •  Letters, Testimony & Comments  •  July 20, 2021
We write to express our support for the nomination of Robert Bonnie to serve as the U.S. Department of Agriculture’s Under Secretary for Farm Production and Conservation. The Under Secretary position is critical in overseeing the administration of a wide variety of USDA farm and conservation programs that directly serve farmers, ranchers, foresters, and landowners. Bonnie’s prior experiences show he is dedicated to serving U.S. agricultural producers, and improving the lands Americans depend on for food, fiber, water, recreation, and environmental enhancement. These experiences and his deep background knowledge make Bonnie uniquely qualified to serve as the USDA’s next Under Secretary for Farm Production and Conservation.
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Good Day BIO: Cancer deaths are down—but inequity remains
Good Day BIO Newsletter  •  July 20, 2021
Today, we look at a recent report that has both good and bad news on cancer deaths in the U.S., as well as how gene editing can make biryani ingredients more sustainable and resilient. (772 words, 3 minutes, 51 seconds)
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Good Day BIO: "A pandemic of the unvaccinated"
Good Day BIO Newsletter  •  July 19, 2021
We start a new week bearing bad news: COVID cases are rising across the U.S., and extreme climate events are increasing around the world. Fortunately, biotech can deliver solutions to both challenges—but we have some work to do to get them where they need to go. (766 words, 3 minutes, 49 seconds)
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