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The government wants you to weigh in on how to streamline biotech regulation and the value of the bioeconomy—we tell you how. Plus, BIO’s been working with international partners on global regulatory harmonization of pharmaceutical regulations, which could help us prepare for the next pandemic. (613 words, 3 minutes, 3 seconds) |
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Biden administration seeks your input on how to support biotech |
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The federal government today issued two requests for public input on how to advance and support biotech development in ways that benefit the industry while furthering societal goals.
What’s happening: As part of the Biden administration’s National Biotechnology and Biomanufacturing Initiative, the U.S. Office of Science and Technology Policy seeks feedback from “interested individuals and organizations” to inform federal policy on biotech.
Two Requests for Information (RFIs) focus on: - Efforts to clarify and streamline regulation of biotechnology by the FDA, EPA, and USDA; this is managed by USDA, but all three agencies will consider comments.
- The bioeconomy, including how biotech can help society, data, and metrics for the bioeconomy, domestic biomanufacturing and its workforce, bio-product procurement, safety and security, and international engagement.
BIO concerns taken onboard: The second RFI on the bioeconomy features questions raised by BIO in September, when we asked the Biden administration for further action on climate provisions in the Inflation Reduction Act (IRA). Questions cover procurement, quantification of the bioeconomy, and revisions to official industry and product classification systems.
Make yourself heard! The RFIs can reduce regulatory obstacles and ensure we have the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. Click here to help shape policy that impacts our industry: More Agriculture and Environment News: Press Release: Rolls-Royce and Gulfstream give wings to sustainable business aviation
“Rolls-Royce and Gulfstream Aerospace Corp. conducted “the first original equipment manufacturer test flight of an ultralong-range business jet powered by 100% Sustainable Aviation Fuel (SAF)… The SAF that was used in the test consists of two components: HEFA (Hydroprocessed Esters and Fatty Acids), produced from waste fat and waste plant oils by low-carbon fuel specialist World Energy in Paramount, California, and (SAK) Synthesised Aromatic Kerosene made from waste plant-based sugars by Wisconsin-based Virent Inc.” |
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Online Auction Featuring Rubius Therapeutics’ State-of-the-Art Lab Equipment
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Looking to save on late-model lab equipment in the new year? American Laboratory Trading (ALT), BIO’s preferred provider of refurbished lab equipment, is hosting the auction of Rubius Therapeutics’ equipment from their Cambridge, Massachusetts, lab. Assets include bioreactors, purification systems, freezers, and more. The bidding period opens on January 9 and closes on January 11.
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Why we need global regulatory harmonization for pharmaceuticals |
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By standardizing regulations, it will be easier for drugmakers that gain FDA approval to reach patients around the world. BIO and its members are part of an international effort to make it happen. Working in harmony: Industry and regulators cooperate via the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) to agree on common regulations. A drugmaker that meets an ICH-approved standard in one country will be in compliance in several others.
The latest ICH conference in Incheon, Korea, in November, worked toward common regulations in areas like continuous manufacturing, collection of clinical trial safety data, safety of biotechnology products developed with viruses, and more, Bio.News reports.
How it works: The expertise of industry members helps ICH working groups deal with the newest technologies, so BIO members play a vital role in writing the rules. “Having a BIO expert at the table means they’re representing BIO’s membership as a whole,” says BIO’s Science & Regulatory Director Alex May.
The process helps small firms, which make up 90% of BIO’s membership and lack the legal resources necessary to navigate international regulatory processes, says Nancy Travis, BIO’s VP for International Affairs.
Key to pandemic preparedness: Harmonization received attention after COVID-19 showed how streamlined regulation could speed new drugs to patients.
What they’re saying: “To the extent that countries can agree ahead of time on a harmonized set of requirements, that’s just going to make it easier and quicker for patients to get access to these new therapies,” explains Travis. |
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President Biden’s Tuesday: No official activities scheduled today. What’s Happening on Capitol Hill: Details of the Senate’s Omnibus Spending Bill to fund the federal government through September were rolled out late yesterday, and are said to include the Growing Climate Solutions Act, which BIO supports. |
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