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By Lynn L. Bergeson and Carla N. Hutton
 
On September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” On September 14, 2022, the White House will host a Summit on the National Biotechnology and Biomanufacturing Initiative during which cabinet agencies will announce a wide range of new investments and resources that will allow the United States to harness the full potential of biotechnology and biomanufacturing and advance the President’s Executive Order.
 
According to a White House fact sheet, the initiative will accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. It will “drive advances in biomanufacturing that substitute fragile supply chains from abroad with strong chains at home, anchored by well-paying jobs in communities all across America.” It will improve food and energy security, and promote agricultural innovation while mitigating the impacts of climate change.
 
Specifically, the initiative will:

  • Grow Domestic Biomanufacturing Capacity: The initiative will build, revitalize, and secure national infrastructure for biomanufacturing across America, including through investments in regional innovation and enhanced bio-education, while strengthening the U.S. supply chain that produces domestic fuels, chemicals, and materials.
     
  • Expand Market Opportunities for Biobased Products: The fact sheet notes that the U.S. Department of Agriculture’s (USDA) BioPreferred Program “is the standard for sustainable procurement by government agencies, both providing an alternative to petroleum-based products and supporting good-paying jobs for American workers.” The initiative will increase mandatory biobased purchasing by federal agencies and ensure that the Office of Management and Budget (OMB) and USDA regularly publish progress assessments. The fact sheet states that doing so “will provide specific directions to industry about gaps in biobased product options, leading to the creation of new products and new markets.” Together, the initiative will grow and strengthen the BioPreferred Program, increase the use of renewable agricultural materials, and “position American companies to continue to lead the world in bio-innovation.”
     
  • Drive Research and Development (R&D) to Solve Our Greatest Challenges: According to the fact sheet, focused government support for biotechnology can quickly produce solutions, “as seen with the first-of-their-kind mRNA vaccines during the COVID-19 pandemic.” This initiative directs federal agencies to identify priority R&D needs to translate bioscience and biotechnology discoveries into medical breakthroughs, climate change solutions, food and agricultural innovation, and stronger U.S. supply chains.
     
  • Improve Access to Quality Federal Data: Combining biotechnology with massive computing power and artificial intelligence can produce significant breakthroughs for health, energy, agriculture, and the environment. The Data for the Bioeconomy Initiative will ensure that biotechnology developers have streamlined access to high-quality, secure, and wide-ranging biological data sets that can drive solutions to urgent societal and global problems.
     
  • Train a Diverse Skilled Workforce: The United States is facing a shortage of relevant talent spanning all levels, from community college to graduate school. The initiative will expand training and education opportunities for all Americans in biotechnology and biomanufacturing, with a focus on advancing racial and gender equity and support for talent development in underserved communities.
     
  • Streamline Regulations for Products of Biotechnology: Advances in biotechnology are rapidly altering the agricultural, industrial, technological, and medical products landscape, which can create challenges for developers and innovators. The initiative will improve the clarity and efficiency of the regulatory process for products of biotechnology so that valuable inventions and products can come to market faster without sacrificing safety.
     
  • Advance Biosafety and Biosecurity to Reduce Risk: The initiative will prioritize investments in applied biosafety research and incentivize innovations in biosecurity to reduce risk throughout the biotechnology R&D lifecycles.
     
  • Protect the U.S. Biotechnology Ecosystem: The initiative will protect the U.S. biotechnology ecosystem by advancing privacy standards and practices for human biological data, cybersecurity practices for biological data, standards development for bio-related software, and mitigation measures for risks posed by foreign adversary involvement in the biomanufacturing supply chain.
     
  • Build a Thriving, Secure Global Bioeconomy with Partners and Allies: According to the fact sheet, the initiative advances international cooperation to leverage biotechnology and biomanufacturing to tackle the most urgent global challenges -- from climate change to health security -- and to work together to ensure that biotechnology product development and use aligns with our shared democratic ethics and values, and that biotechnology breakthroughs benefit all citizens.

The White House has posted a transcript of the press call announcing the Executive Order.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 1, 2022, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced the availability of two new resources to answer stakeholder questions regarding the revised biotechnology regulations under 7 C.F.R. Part 340:

These resources, along with other information on the revised biotechnology regulations, are available on the APHIS website. For additional questions regarding the regulation of modified microorganisms, contact APHIS at .(JavaScript must be enabled to view this email address). For questions regarding confirmation requests, contact APHIS at .(JavaScript must be enabled to view this email address).


 

By Lynn L. Bergeson

On May 12, 2021, from 3:30 p.m. to 5:00 p.m. (EDT), the European Commission (EC) Helpdesk will host a webinar on appropriate Intellectual Property (IP) rights for biotechnology inventions.  The 60-minute webinar will provide an overview of:

  • Relevant IP rights;
  • Product development IP context;
  • IP specifics in biotechnology;
  • IP portfolio development; and
  • IP portfolio management.

The webinar is free of charge, but registration is required.  Additional information is available here.


 

By Lynn L. Bergeson

On June 26, 2020, the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member, announced the winners of its 2020 Start-Up Stadium competition. The competition had 30 finalists that were evaluated during BIO Digital in June, by expert judges with backgrounds in investment, entrepreneurship, start-ups, economic development, capital formation, and academia. Five winners were chosen based on their commercially viable cutting-edge technologies and therapeutic solutions. Competition winners will receive:

  • A one-year membership in BIO;
  • Four hours of complimentary legal services;
  • One-hour advisory discussion with two venture capital firms; and
  • A “fast-track” accelerator application and nomination into the final selection phase for up to a $10,000 sequencing grant.

 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new terms and definitions to be added to the current standard and for revising existing terms and definitions as needed. The meanings and explanations of the technical terms have been written for both non-expert and expert users and is updated annually to include editorially any terms approved in the committees of technical standards. This standard, however, does not purport to address all of the safety concerns, if any, associated with the use of biotechnology products, materials, systems, or services. Interested parties should contact the sub-committee chair, .(JavaScript must be enabled to view this email address), or the E62 staff manager, .(JavaScript must be enabled to view this email address), directly.


 

By Lynn L. Bergeson

Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals. According to Penn State’s announcement, project proposals of up to $25,000 per project will be available. Favorable consideration will be given to grant proposals that: (1) leverage the capabilities in the CSL Behring Fermentation Facility; (2) provide matching funds to support new industry-funded collaborations; and (3) support graduate/undergraduate students in industrial biotechnology research or educational activities. The CSL Behring Fermentation Facility is a biotechnology pilot plant capable of research- and pilot-scale production of microbial cells, recombinant proteins, and other microbial products over a wide range of controlled conditions. Proposals should be submitted to CoEIB on or prior to 5:00 p.m. (EST) on February 7, 2020.


 

By Lynn L. Bergeson

On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his statement, the President assures Americans that his policies to encourage innovation and drive job growth will continue:

As we mark the start of National Biotechnology Month and a new decade of American ingenuity, we recognize the importance of American leadership in maintaining science- and risk-based review and regulation of biotechnology products, promoting and safeguarding critical biotechnology infrastructure and data, and preparing the next generation of biotechnology scientists, engineers, and innovators. Together, we can ensure this booming, innovative industry continues to foster economic growth and American innovation.


 

By Lynn L. Bergeson

On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO) on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The unified website also describes the federal review process for certain biotechnology products and allows users to submit questions to USDA, FDA, and/or EPA. Aiming to improve customer service to innovators and developers, the three agencies also wish to assure Americans about the safe use of biotechnology innovations. According to USDA Secretary of Agriculture, Sonny Purdue, all Americans deserve transparency and science-based regulations that foster innovation, conserve resources, and protect public health. BRAG will supplement this notice with more information next week.


 

By Lynn L. Bergeson

On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers, patients, and U.S. trading partners. In his published statement, Dr. Gottlieb emphasizes FDA’s ongoing implementation of the Action Plan, particularly on intentional genomic alterations in animals. Using genetic engineering and genome editing technologies, these innovations are providing additional clarity about how FDA’s regulatory framework works and should continue to work. A key part of the Action Plan’s implementation involves FDA’s Center for Veterinary Medicine’s Innovation Program, which provides sponsors with innovative products based on genomic alterations in animals to benefit from early feedback and guidance.
 
In the released statement, Abram further highlights the impacts of intentional genomic alterations in animals on human health. DNA editing not only benefits animals by halting animal-to-animal transmission of diseases, but also has the potential to benefit humans. According to Abram, FDA has already evaluated and approved several intentional genomic alterations in animals that produce drugs used to treat human diseases, advance the studies of new drugs, as well as human organ and tissue transplants.  The Commissioners state that by ensuring safety of intentional genomic alterations to animals and animal-derived foods, FDA will continue to evaluate the effectivity of these alterations based on the totality of evidence provided rather than from any one particular assessment or result.
 
On April 25, 2019, FDA’s Center for Veterinary Medicine and the Center for Biologics Evaluation and Research will host a live webinar to discuss policy changes that may improve the Action Plan framework.


 

By Lynn L. Bergeson

In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods used to introduce new traits or characteristics to a plant (e.g., plants resistant to insect pests, plants with reduced food waste, or plants with reduced levels of harmful elements, amongst others).  To assist developers in this field, FDA has a voluntary premarket Plant Biotechnology Consultation Program, which provides developers with the opportunity to engage with FDA to help navigate the appropriate regulatory pathways.  The program includes individualized advice from FDA’s biotechnology and food safety experts prior to a plant-based product being permitted to enter the market and allows for biotechnology developers to consult with these FDA experts throughout the entire development, data collection, and evaluation process.


 
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