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BIO Submits Comments on WHO Guideline: Nonclinical and Clinical Evaluation of Monoclonal Antibodies and Related Biological Products Intended for the Prevention or Treatment of Human Infectious Diseases
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Letters, Testimony & Comments  •  October 28, 2022
On October 28th, BIO submitted comments to the World Health Organization on its new draft guideline containing regulatory considerations and requirements for the marketing authorization of monoclonal antibodies (mAbs) and related products based on an immunoglobulin framework. In the comments submitted, BIO stated strong support for WHO’s mission to ensure the equitable and widespread availability of safe, effective, and quality health products. With this objective in mind, BIO also provided several overarching recommendations. First, BIO encouraged further incorporation of the 3Rs principles (replacement, reduction, and refinement of animal use) throughout the guideline. While nonclinical in vivo studies continue to provide critical information to sponsors and regulators on the safety and efficacy of products, BIO urged WHO to reconsider when such studies are truly necessary in the context of this guideline as in vitro technologies and computational models (e.g., physiological based pharmacokinetic models) can be leveraged to inform nonclinical assessments. BIO also suggested that WHO refine the guideline broadly to ensure consistency with existing international guidelines, such as the ICH S6 Guideline. Furthermore, BIO stated that the acknowledgement and incorporation of current regional guidances where possible and applicable, especially those that have been issued since the COVID-19 pandemic, would be beneficial.
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BIO Submits Comments on ICH Guideline: E11A Pediatric Extrapolation
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Letters, Testimony & Comments  •  October 28, 2022
On October 28th, BIO submitted comments on the ICH E11A Pediatric Extrapolation Guideline as published by the Food & Drug Administration (FDA). In the comments submitted, BIO voiced appreciation for the guideline’s clear explanation for how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations. BIO also noted agreement with the guideline’s stance that extrapolation decision-making is complex, that knowledge evolves over time, and that gaps in information at the time of the initial pediatric development plan may be addressed during the execution phase of such a plan. In addition to requesting more clarity on the types of products and modalities the recommendations contained within the guideline could apply to, BIO suggested that a discussion section regarding endpoint considerations and data presentations be added. Lastly, BIO noted that a glossary with more precise definitions would be beneficial for sponsors interpreting its recommendations.
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Good Day BIO: How the IP waiver harms SMEs – plus, takeaways from BIO's patient summit
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Good Day BIO Newsletter  •  October 28, 2022
Every member of the Council of State Bioscience Associations (CSBA) joined a letter expressing concerns about expanding the COVID IP waiver, and Mexico’s Deputy Ag Minister confirmed the corn ban is happening. Plus, three takeaways from Day 1 of the Patient and Health Advocacy Summit and how to follow the conversations today. (894 words, 4 minutes, 28 seconds)
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Good Day BIO: Patient advocacy, explained
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Good Day BIO Newsletter  •  October 27, 2022
We’re at the BIO Patient and Health Advocacy Summit in Washington, D.C., this week, where our team will bring you news and highlights right here and at Bio.News—keep reading to learn how you can follow along and why the patient voice matters, plus, some almost positive news on climate. (543 words, 2 minutes, 42 seconds)
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Biotech Sector Thrives, Generating Nearly $3 Trillion Economic Impact – New Report Shows
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Biotechnology Jobs Report, Industry Analysis Reports, Council for State Biotechnology Associations (CSBA)  •  Press Release  •  October 26, 2022
The Biotechnology Innovation Organization (BIO) and the Council of State Bioscience Associations (CSBA) today released new data on the bioscience industry in the United States.The new report, The U.S. Bioscience Industry: Fostering Innovation and Driving America’s Economy Forward, examines the bioscience industry’s economic performance and its footprint across the nation and individual states during the COVID-19 pandemic.Some key takeaways:The nation’s bioscience industry employed 2.1 million employees across more than 127,000 U.S. business establishments in 2021.As the overall economy shed 1.5% of it’s job base, the biosciences industry increased employment by 11% since 2018.In total, the bioscience industry’s economic impact on the U.S. economy amounted to $2.9 trillion dollars in 2021, as measured by overall output.Biotech companies – especially small – and mid-sized – undertook a monumental effort to develop COVID-19 vaccines and therapeutics; there are 747 novel compounds in development currently.“This data highlights the vital role U.S. bioscience companies have in creating jobs and stimulating the economy. The report further shows the industry’s enormous role in navigating the COVID-19 pandemic, both in terms of getting life-saving therapies and vaccines to patients, as well as economic recovery,” said Pete Pellerito, BIO Senior Policy Adviser for Federal and State Economic Development and Technology Transfer Initiatives.“Even during the pandemic, bioscience employment grew as other industrial sectors faltered. Looking forward, the industry will continue to play a critical role, not only in addressing global health challenges but in helping to grow the U.S. economy by generating high-quality jobs,” said Ryan Helwig, Principal and Project Director with TEConomy Partners.The state-by-state industry assessment is the tenth in a biennial series, developed in partnership by TEConomy Partners and BIO, and studies the state of the U.S. bioscience…
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Good Day BIO: Biotech's booming (and so are fungi)
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Good Day BIO Newsletter  •  October 26, 2022
Two reports you need to know about today. First, a new report released by BIO and CSBA with TEConomy finds the U.S. biotech industry is a major economic driver in all 50 states and explores why investment is booming. Second, WHO released the first-ever list of fungal priority pathogens, with 19 fungi we need to pay attention to. (552 words, 2 minutes, 45 seconds)
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Good Day BIO: Vaccine equity & bad bird flu
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Good Day BIO Newsletter  •  October 25, 2022
BIO joined with the international industry to offer a practical solution for global vaccine access that doesn’t hurt innovation. Also, it’s not even Halloween and we’re already excited for Thanksgiving—or we would be, if the price of turkey wasn’t skyrocketing. Biotech has a solution. (596 words, 2 minutes, 58 seconds)
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Good Day BIO: House leaders speak out on IP waiver expansion
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Good Day BIO Newsletter  •  October 24, 2022
More congressional leaders are speaking out against expanding the waiver of IP protections for COVID technology. Plus, USAID’s Samantha Power visited BIO member Corteva and spoke about the need for innovation to “break the cycle” of food crises. (621 words, 3 minutes, 6 seconds)
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Good Day BIO: SAF could soon be the same price as fossil-based fuel
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Good Day BIO Newsletter  •  October 21, 2022
A busy Friday, with a look at a big boost for SAF, why you should get an Omicron booster, and a lot more news. (756 words, 3 minutes, 46 seconds)
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Good Day BIO: Biodefense, COVID IP waiver concerns, and World CRISPR Day
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Good Day BIO Newsletter  •  October 20, 2022
A busy week for the bioeconomy in D.C., with President Biden launching the National Biodefense Strategy and bipartisan U.S. Senators expressing serious concerns about the expansion of the WTO’s COVID-19 IP waiver. Also, it’s World CRISPR Day—we look at recent developments. (856 words, 4 minutes, 16 seconds)
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