On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report:Preparing for Future Products of Biotechnology.Pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, Modernizing the Regulatory System for Biotechnology Products, NAS was tasked with looking into the future and describing the possible future products of biotechnology that will arise over the next five to ten years, as well as providing some insights that can help shape the capabilities within the agencies as they move forward.
Via an ad hoc committee, the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System, NAS developed this report through several months of gathering and synthesizing information from several sources, including: 74 speakers over the course of three in-person meetings and eight webinars, including one presented by Lynn L. Bergeson; responses to its request for information from a dozen federal agencies; statements solicited from members of the public at its in-person meetings; written comments through the duration of the study; and recent NAS studies related to future products of biotechnology.
The report presents conclusions concerning the future biotechnology products themselves, as well the challenges that federal agencies will face in regulating them, which include:
The bioeconomy is growing rapidly and the U.S. regulatory system needs to provide a balanced approach for consideration of the many competing interests in the face of this expansion;
The profusion of biotechnology products over the next five to ten years has the potential to overwhelm the U.S. regulatory system, which may be exacerbated by a disconnect between research in regulatory science and expected uses of future biotechnology products;
Regulators will face difficult challenges as they grapple with a broad array of new types of bio-technology products -- for example, cosmetics, toys, pets, and office supplies -- that go beyond contained industrial uses and traditional environmental release;
The safe use of new biotechnology products requires rigorous, predictable, and transparent risk-analysis processes whose comprehensiveness, depth, and throughput mirror the scope, scale, complexity, and tempo of future biotechnology applications.
The report provides three recommendations for federal agencies in responding to these challenges, which it states should be taken to enhance the ability of the biotechnology regulatory system to oversee the consumer safety and environmental protection required for future biotechnology products:
The U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and other agencies involved in regulation of future bio-technology products should increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural, regulatory, and social sciences.
EPA, FDA, and USDA should increase their use of pilot projects to advance understanding and use of ecological risk assessments and benefit analyses for future biotechnology products that are unfamiliar and complex and to prototype new approaches for iterative risk analyses that incorporate external peer review and public participation.
The National Science Foundation, the Department of Defense, the Department of Energy, the National Institute of Standards and Technology, and other agencies that fund bio-technology research with the potential to lead to new biotechnology products should increase their investments in regulatory science and link research and education activities to regulatory-science activities.
The report is well-written and contains an impressive amount of new, relevant, and important information. The Committee participants are to be commended for an important new piece of scholarship in this area.
The reports conclusions are also significant, but not entirely unexpected.For those of us working in this space, we have recognized for years the lack of clarity regarding jurisdictional boundaries, the paucity of government resources, and the urgent need for regulatory clarity and significantly enhanced funding. Unfortunately, given current Trump Administration efforts to diminish government funding for EPA, FDA, and elsewhere, the well-crafted and spot-on recommendations may tragically fall on deaf ears.Shareholders should carefully review the report and work hard to ensure the recommendations are implemented. The consequences of failing to increase scientific capabilities, tools, expertise, and horizon scanning in key areas of expected growth of biotechnology, including natural regulatory, and social sciences -- the number one recommendation in the report -- are too great to ignore.
2017 Bergeson & Campbell, P.C.
Link:
NAS Issues Report on Preparing for Future Products of ... - The National Law Review
- What's Going On With Liver Disease Focused Vir Biotechnology Stock Is Friday? - Yahoo Finance - November 16th, 2024
- Department of Biotechnology Launches Webinar Series on Biomanufacturing and Biofoundry Initiative - IBG NEWS - November 16th, 2024
- Multimodal scanning of genetic variants with base and prime editing - Nature.com - November 16th, 2024
- NEW INITIATIVE BY THE ITALIAN EMBASSY IN WASHINGTON ON BIOTECHNOLOGY WITH THE MILKEN INSTITUTE AND LEADING RESEARCHERS AND INDUSTRY EXPERTS -... - November 16th, 2024
- Vir Biotechnology Announces Positive End-of-Treatment Results for Tobevibart and Elebsiran Combinations in Chronic Hepatitis B from the MARCH Study at... - November 16th, 2024
- Albany State offers new Master of Science in Integrated Biotechnology program - The Albany Herald - November 16th, 2024
- What's Going On With Liver Disease Focused Vir Biotechnology Stock Is Friday? - Benzinga - November 16th, 2024
- iNtRON Biotechnology (KOSDAQ:048530) Is In A Strong Position To Grow Its Business - Simply Wall St - November 16th, 2024
- PDS Biotechnology Highlights Clinical Progress and Q3 Results - TipRanks - November 16th, 2024
- We Think Puma Biotechnology's (NASDAQ:PBYI) Robust Earnings Are Conservative - Yahoo Finance - November 16th, 2024
- Puma Biotechnology's (NASDAQ:PBYI) Performance Is Even Better Than Its Earnings Suggest - Simply Wall St - November 16th, 2024
- APHIS Announces Final Notice on Additional Exemptions for the Movement of Organisms Modified or Produced Through Genetic Engineering - USDA APHIS - November 16th, 2024
- Adaptimmune nears second approval for TCR-T therapy - European Biotechnology News - November 16th, 2024
- Lundbeck reports 18% revenue growth in third quarter - The Pharma Letter - November 16th, 2024
- BioNTech to boost oncology offering with buy of Biotheus - The Pharma Letter - November 16th, 2024
- Puma Biotechnology Third Quarter 2024 Earnings: Beats Expectations - Yahoo Finance - November 16th, 2024
- WPI Receives Federal Funding to Address Anticipated Demand for Biology and Biotechnology Professionals and Educators - WPI News - November 3rd, 2024
- Jonathan Dinman to Direct the Institute for Bioscience and Biotechnology Research - College of Computer, Mathematical, and Natural Sciences - November 3rd, 2024
- PDS Biotechnology Co. (NASDAQ:PDSB) Given Average Recommendation of "Buy" by Analysts - MarketBeat - November 3rd, 2024
- COP16, DSI mechanism for benefit sharing from the use of digital sequence information approved - Renewable Matter - November 3rd, 2024
- Artificial Intelligence in Biotechnology Market to Hit USD 7.75 Billion by 2029 with 19.1% CAGR | MarketsandMarkets - PR Newswire - November 3rd, 2024
- Axonis Therapeutics raises $115 million in Series A financing - The Pharma Letter - November 3rd, 2024
- Regeneron third-quarter 2024 earnings top expectations - The Pharma Letter - November 3rd, 2024
- AbbVie inks up to $1.4 billion deal with EvolveImmune - The Pharma Letter - November 3rd, 2024
- CEO and Chairman of the Executive Board - European Biotechnology News - November 3rd, 2024
- The transformative potential of biotechnology and AI in healthcare - The Armchair Trader - November 3rd, 2024
- U.S. Biotechnology And Pharmaceutical Services Outsourcing Market Size to Reach USD 16.68 Billion By 2033 - BioSpace - October 6th, 2024
- Vir Biotechnology, Inc. (NASDAQ:VIR) is largely controlled by institutional shareholders who own 53% of the company - Yahoo Finance - October 6th, 2024
- Resolution Therapeutics scores 63.5 million in series B round - The Pharma Letter - October 6th, 2024
- Wiregrass Institute for Biotechnology welcomes local military veteran from Southeast Health as its first computational biologist - AOL - October 6th, 2024
- Generating and characterizing a comprehensive panel of CHO cells glycosylation mutants for advancing glycobiology and biotechnology research -... - October 6th, 2024
- Sapience Therapeutics Announces Participation at the 4th Annual Needham Private Biotech Company Virtual 1x1 Forum - PR Newswire - October 6th, 2024
- Spyre Therapeutics lures Abivax exec to be its CMO - The Pharma Letter - October 6th, 2024
- Convergence is AIxBio: AI and the Bioeconomy - OODA Loop - October 6th, 2024
- Congress targets Chinese influence in health tech. It could come with tradeoffs - ABC News - September 13th, 2024
- Researchers, media engage to educate farmers on biotechnology - University World News - September 13th, 2024
- Congress targets Chinese influence in health tech. It could come with tradeoffs - The Associated Press - September 13th, 2024
- Comer Delivers Remarks in Support of Bipartisan BIOSECURE Act - House Committee on Oversight and Reform | - September 13th, 2024
- Announcement of $2 Million for the University of Delaware to Advance Biotechnology - WGMD Radio - September 13th, 2024
- Thailand's Competitiveness Enhanced Through Advanced Biotechnology at Thailand LAB INTERNATIONAL 2024 - BSA bureau - September 13th, 2024
- Biotechnology company Amgen expands global reach with technology innovation center in Hyderabad, India - BioProcess Insider - September 13th, 2024
- Adam's Biotech Scorecard: Can iTeos and GSK solve TIGIT's troubles? - STAT - September 13th, 2024
- Cizzle Biotechnology Advancing Lung Cancer Detection from R&D to Application with Moffitt Cancer Centre (VIDEO) - DirectorsTalk Interviews - September 13th, 2024
- MAIA Biotechnology Announces Positive Survival Updates in Phase 2 Study of THIO in Non-Small Cell Lung Cancer - Business Wire - September 13th, 2024
- MAIA Biotechnology Advances with Clinical Trials and Partnerships - TipRanks - September 13th, 2024
- Viridian Therapeutics reports positive results for veligrotug - The Pharma Letter - September 13th, 2024
- Chinese biotech firms refute US bill, stressing they have no access to Americans personal data - Global Times - September 13th, 2024
- Vir Biotechnology Enhances Portfolio with Sanofi Deal and Executive Appointments - TipRanks - September 13th, 2024
- Tesla BioHealing and Cell Biotechnology Partner to Advance Stem Cell Therapies - Vancity Buzz - September 13th, 2024
- Time to leverage intellectual property to drive innovation in seed and biotechnology sectors: Experts - The Times of India - May 5th, 2024
- Where Does Capricor Therapeutics Inc (CAPR) Stock Fall in the Biotechnology Field After It Has Risen 24.73% This Week? - InvestorsObserver - March 10th, 2024
- Where Does SpringWorks Therapeutics Inc (SWTX) Stock Fall in the Biotechnology Field After It Has Gained 12.41% This Week? - InvestorsObserver - February 18th, 2024
- Should Biotechnology Stock Axsome Therapeutics Inc (AXSM) Be in Your Portfolio Wednesday? - InvestorsObserver - February 18th, 2024
- Where Does Candel Therapeutics Inc (CADL) Stock Fall in the Biotechnology Field After It Has Gained 22.38% This Week? - InvestorsObserver - February 18th, 2024
- What is Biotechnology? Types and Applications - Iberdrola - January 25th, 2024
- Where Does Immunitybio Inc (IBRX) Stock Fall in the Biotechnology Field After It Is Lower By -9.32% This Week? - InvestorsObserver - January 25th, 2024
- Can Sana Biotechnology Inc (SANA) Stock Rise to the Top of Healthcare Sector Monday? - InvestorsObserver - January 25th, 2024
- Should You Buy Sana Biotechnology Inc (SANA) Stock After it Has Fallen 15.41% in a Week? - InvestorsObserver - January 25th, 2024
- Where Does Tscan Therapeutics Inc (TCRX) Stock Fall in the Biotechnology Field After It Is Lower By -9.81% This Week? - InvestorsObserver - January 25th, 2024
- Should Biotechnology Stock Mink Therapeutics Inc (INKT) Be in Your Portfolio Monday? - InvestorsObserver - May 9th, 2023
- Where Does Ambrx Biopharma Inc - ADR (AMAM) Stock Fall in the Biotechnology Field After It Has Risen 22.18% This Week? - InvestorsObserver - May 9th, 2023
- Should Biotechnology Stock Dermata Therapeutics Inc (DRMA) Be in Your Portfolio Thursday? - InvestorsObserver - May 9th, 2023
- Should Biotechnology Stock Tempest Therapeutics Inc (TPST) Be in Your Portfolio Wednesday? - InvestorsObserver - May 9th, 2023
- Biotechnology - Applications of biotechnology | Britannica - May 1st, 2023
- Where Does BioLine RX Ltd - ADR (BLRX) Stock Fall in the Biotechnology Field After It Is Down -3.67% This Week? - InvestorsObserver - May 1st, 2023
- Where Does Apellis Pharmaceuticals Inc (APLS) Stock Fall in the Biotechnology Field After It Is Higher By 4.17% This Week? - InvestorsObserver - May 1st, 2023
- Where Does Aldeyra Therapeutics Inc (ALDX) Stock Fall in the Biotechnology Field After It Is Lower By -11.45% This Week? - InvestorsObserver - May 1st, 2023
- Is Rain Oncology Inc (RAIN) Stock at the Top of the Biotechnology Industry? - InvestorsObserver - April 7th, 2023
- Does Sana Biotechnology Inc (SANA) Have What it Takes to be in Your Portfolio Tuesday? - InvestorsObserver - April 7th, 2023
- Where Does Ambrx Biopharma Inc - ADR (AMAM) Stock Fall in the Biotechnology Field After It Is Lower By -15.43% This Week? - InvestorsObserver - April 7th, 2023
- Where Does Protagonist Therapeutics Inc (PTGX) Stock Fall in the Biotechnology Field After It Has Risen 3.62% This Week? - InvestorsObserver - April 7th, 2023
- What is Biotechnology? Definition, Types and Applications | TechTarget - March 21st, 2023
- Where Does Novavax Inc (NVAX) Stock Fall in the Biotechnology Field After It Is Lower By -12.99% This Week? - InvestorsObserver - March 21st, 2023
- Should Biotechnology Stock Outlook Therapeutics Inc (OTLK) Be in Your Portfolio Thursday? - InvestorsObserver - March 21st, 2023
- SANA BIOTECHNOLOGY, INC. : Results of Operations and Financial Condition, Financial Statements and Exhibits (form 8-K) - Marketscreener.com - March 21st, 2023
- Where Does Revance Therapeutics Inc (RVNC) Stock Fall in the Biotechnology Field After It Is Lower By -2.17% This Week? - InvestorsObserver - March 5th, 2023
- Is TG Therapeutics Inc common stock (TGTX) Stock at the Top of the Biotechnology Industry? - InvestorsObserver - March 5th, 2023
- Where Does GT Biopharma Inc (GTBP) Stock Fall in the Biotechnology Field After It Is Down -20.73% This Week? - InvestorsObserver - March 5th, 2023
- Where Does Dyne Therapeutics Inc (DYN) Stock Fall in the Biotechnology Field After It Is Lower By -2.35% This Week? - InvestorsObserver - March 5th, 2023
- Is CytomX Therapeutics Inc (CTMX) Stock at the Top of the Biotechnology Industry? - InvestorsObserver - November 17th, 2022