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Success Factors for Technology Transfer Start-Up Companies
Webinars  •  September 14, 2023
With the majority of biological studies conducted in academic settings but nearly all innovative new drug clinical trials sponsored by industry, improving translational research success rates for commercialization is critical to bringing new treatments to patients. Surveys of academic tech transfer offices and the biopharma industry executives working on such alliances cite as obstacles two highly controllable factors: disagreement about alliance performance metrics and misalignment of deal terms priorities. This panel discusses best practices for removing such obstacles to accelerate more promising ideas into clinical development for patients. BIO's updated 2023 report, "U.S. Biotechnology Translational Research: Partnership Models, Management Principles, and Best Practices," is available for download at the link below.  The webinar also summarizes major findings from that BIO report as context for the panel discussion and audience Q&A.
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BIO Translation Research Report cover slide

BIO Regulatory Affairs Steering Committee (RASC) Meeting
September 13, 2023
The BIO Regulatory Affairs Steering Committee (RASC) acts as a steering committee for all staff-level science & regulatory committees and working groups. The RASC takes the lead or makes assignments to committees and working groups on implementation of user fee agreements, including continuous engagement activities with FDA. The RASC develops and implements strategic BIO responses to scientific and regulatory issues that affect the ability of BIO's human healthcare focused companies to research and develop new therapeutics, and to bring these products to market. The RASC responds to proposed regulations and draft guidance documents as necessary and holds liaison meetings with FDA to identify and discuss regulatory best practices. For more information and to join the Committee, please contact Surea Gainey (sgainey@bio.org).
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News on AMR, COVID shots, and more
Good Day BIO Newsletter  •  September 13, 2023
Busy Wednesday—but first, a look at PASTEUR Act advocacy yesterday from BIO (and Gronk), news on the new COVID vaccines, and BIO’s agriculture and environment awardees. (697 words, 3 minutes, 29 seconds)
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Understanding the Business Implications of Global Access and Benefit Sharing Policies
Webinars  •  September 13, 2023
View this important webinar for those invested in the broader biotech industry, "Understanding the Business Implications of Global Access and Benefit Sharing Policies." Tailored for members of BIO and a diverse community of stakeholders, this high-level session focuses on understanding the impact of recent developments in the global policy arena that will affect industry’s access to vital biologic materials and information. These policies have implications for the way industry will need to share the potential benefits that flow from their use of these physical and digital resources worldwide. Through interactive discussions led by seasoned experts across the Biotech ecosystem, explore the intricate relationship between national and global concerns, while uncovering the potential implications for your company. This webinar will equip you with the knowledge and insights essential to thriving in an ever-evolving global biotech landscape for an empowering dialogue that promises to shape the future of biotechnology.
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Global Access and Benefit Sharing webinar slide map

BIO Honors Biotech Leaders for Breakthroughs in Ag & Environment Biotech
Press Release  •  September 12, 2023
The Biotechnology Innovation Organization has honored two biotechnology leaders who are driving cutting-edge breakthroughs in agricultural, environmental and industrial biotechnology. Dr. Pam Marrone, Co-founder and Executive Chair of Invasive Species Corp., is the recipient of the Rosalind Franklin Award for Leadership in Industrial Biotechnology and Agriculture. Dr. Marrone has spent her 30-plus year career focused on biological products for pest management and plant health. She started and led three agricultural biotechnology companies―Entotech, AgraQuest and Marrone Bio Innovations, all of which were sold to larger companies. She is one of only 32 women to have founded a company and taken it public. Her fourth company, the Invasive Species Corp., and its corresponding Invasive Species Research Institute, is working to bring effective, environmentally friendly biological solutions to control destructive invasive species in water, forestry and farming. Hank Harris, DVM PhD, Co-founder of Genvax Technologies, and Professor Emeritus at Iowa State University, is the recipient of BIO’s George Washington Carver Award for Leadership in Agriculture and Environmental Biotechnology. Dr. Harris has worked to reduce the time it takes to produce animal vaccines. His company Harrisvaccines (acquired by Merck Animal Health) gained USDA licenses for vaccines against diseases in swine and poultry, including the first-ever vaccine against pandemic H1N1 in pigs and the first vaccine for porcine epidemic diarrhea virus which, at the time, caused more than 8 million piglet deaths in the first year of entering the U.S. pig population. His discoveries have shaped the way we raise livestock, combat animal disease threats, and protect the nation’s food supply. As co-founder of Genvax Technologies, Dr. Harris continues working to develop vaccine technology to aid in rapidly responding to foreign animal disease outbreaks. “The pace and impact of innovation in biotechnology is amazing…
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FDA approves updated COVID vaccines
Good Day BIO Newsletter  •  September 12, 2023
The FDA approved updated COVID vaccines as COVID is surging, and we’re marking the one-year anniversary of Biden’s biomanufacturing executive order with a look at what more needs to be done. (566 words, 2 minutes, 49 seconds)
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Coalition Letter Supporting Ag Research Funding
Agriculture & Environment  •  Letters, Testimony & Comments  •  September 11, 2023
BIO joined with other groups in writing House and Senate Agriculture Committee leaders in support of agricultural research (FFAR) funding in the farm bill. 
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BIO Federal Government Relations Committee Meeting
September 11, 2023
The Federal Government Relations Committee concentrates on educating and lobbying government officials regarding legislative proposals affecting the biotechnology industry. The committee reviews the BIO legislative and regulatory agenda as a whole to set priorities and strategies; initiates BIO policy discussions regarding legislation; and provides advice and recommendations to the Board. Committee members meet with various government officials and their staffs to gain information, offer insight and advice, and buttress BIO positions. The committee collaborates on substance and formulates legislative strategy for major BIO priorities. For more information and to join the Committee, please contact Amanda Galich (agalich@bio.org).
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What's new with COVID-19
Good Day BIO Newsletter  •  September 11, 2023
A new week begins with updates on COVID-19 (and possibly to the vaccines) and a boost for biofuels and biotech collaboration at the G20 in India. Plus, Congress is back to work with lots to do on a few BIO priorities. (498 words, 2 minutes, 29 seconds)
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Applied Digital Health Ethics
BIO Professional Development Courses  •  September 8, 2023
Ethics is foundational to a digital health industry that helps, not harms. Every one of us working in the field ╴must have the foundational knowledge of ethics to ensure that we realize the full promise of digitizing healthcare to improve lives for everyone. While this course is broadly applicable across any domains or subdomains, the following learners may find the course particularly valuable: Individuals developing or deploying digital health products  Subject matter experts within ethics/bioethics, privacy, security, and other related fields DE&I champions or SMEs focused on implementing DE&I in internal processes Students, professors, and academic researchers Topics include: We’re glad you’re here: Why ethics are the essential foundation to the new field of digital health Safeguarding data and information in the Digital Era of Health Ethics and equity: Avoiding disproportionate harm Ethical design for digital health products and programs Ethical approaches to earn public trust in digital health BIO Members receive a discounted rate for course registration. To request the discount code, BIO members should email courseshelp@bio.org with the following: The BIO Member Company's name, city, state/province, and country The Course Registrant's full name and email address The Course Title
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