CLSA Wire

Bioeconomy Blueprint Can Unleash Promise of Biotechnology

While members of BayBio were visiting Washington, D.C. for the annual BIO Fly-In in April, the White House released its National Bioeconomy Blueprint. The content of the document is overwhelmingly positive for biotechnology, its role in the economy and in improving health. The document can help clear the path for innovation and the possibility to unleash the promise of biotechnology.

The two stated purposes of the document are to lay out strategic objectives that will help realize the full potential of the U.S. bioeconomy and to highlight early achievements toward those objectives.  In addition, the document describes five strategic objectives:

  1. Support R&D investments that will provide the foundation for the future U.S. bioeconomy.
  2. Facilitate the transition of bioinventions from research lab to market, including an increased focus on translational and regulatory sciences.
  3. Develop and reform regulations to reduce barriers, increase the speed and predictability of regulatory processes, and reduce costs while protecting human and environmental health.
  4. Update training programs and align academic institution incentives with student training for national workforce needs.
  5. Identify and support opportunities for the development of public-private partnerships and precompetitive collaborations — where competitors pool resources, knowledge, and expertise to learn from successes and failures.

The document defines the bioeconomy as “economic activity that is fueled by research and innovation in the biological sciences” and identifies the bioeconomy as a priority for the Obama Administration.  It notes the tremendous potential of the bioeconomy for fostering economic growth as well as for providing critical societal benefits:  “It can allow Americans to live longer, healthier lives, reduce our dependence on oil, address key environmental challenges, transform manu¬¨facturing processes, and increase the productivity and scope of the agricultural sector while growing new jobs and industries.”  The report also notes that a growing U.S. population requires “increased health services and more resources such as food, animal feed, fiber for clothing and housing, and sources of energy and chemicals for manufacturing.  In short, it needs a new and more potent bioeconomy fueled by innovative ideas and practices that can help address these needs in new, more powerful ways.”

The document concludes that “by strategically shaping future R&D investments, improving commercialization of bioinventions, updating workforce training programs for new bioeconomy careers, reforming regulatory processes, and building new bioeconomy public-private partnerships, the Administration will help stimulate the growth of a high-wage, high-skill sector while improving the lives of all Americans.”

The document mostly describes initiatives already taken or underway by various federal agencies to support the bioeconomy and the above-listed strategic objectives.  It does not set forth any major new initiatives, but promises on behalf of the Administration to continue to expand these existing areas of focus.  BIO will continue to push the Administration to adopt more specific policies and reforms to advance biotechnology innovation.  And we will challenge the Administration when it’s policies are inconsistent with this established Blueprint.

BIO’s press release on the report, which includes a link to the Blueprint itself, can be found athttp://www.bio.org/media/press-release/new-national-bioeconomy-blueprint-can-help-unleash-promise-biotech-drive-america.

Below, we have listed specific items of potential interest to our members from the Administration’s Blueprint:

Emerging Companies/Capital Formation

The report includes the following programs aimed at enhancing technology transfer and capital formation:

  • Streamlining the Licensing of Intramural Research Inventions to Start-up Companies:  Supports short-term, exclusive license agreements between NIH and companies that are less than five years old, with fewer than 50 employees and less than $5 million in capital raised.  The new licenses will be offered to companies developing drugs, vaccines, or therapeutics from NIH-patented or patent-pending technologies.
  • Improving the Transfer of Technology from Federal Research Laboratories:  Instructs agencies to design “lab to market” plans with goals and metrics to streamline partnership processes, engage in public-private partnerships, and share federal laboratory facilities with high-tech start-up companies.
  • Facilitating Commercialization of Biomedical Discoveries through Improvements to the Small Business Grant Program:  Supports enhancements to the SBIR program, including the NIH SBIR Technology Transfer Program, an assistance program for companies navigating the approval process at FDA, and additional modifications to accelerate the translation of biomedical discoveries to commercial markets.
  • Driving Innovation to Encourage Entrepreneurship:  Highlights the Administration’s support for the R&D Tax Credit, including expanding the credit and making it permanent.  Also touts the White House’s Start-up America initiative.
  • Using the Power of Prizes to Drive Innovation:  Supports the use of prizes at federal agencies to support innovative development.
  • Driving Interdisciplinary Ventures with New Funding Mechanisms:  Supports a new National Science Foundation grant mechanism, CREATIV, which will provide funding to unusually creative high-risk/high-reward interdisciplinary proposals.

Food and Agriculture

The report recognizes the contribution of genetically-engineered crops to the U.S. economy and environment.  In addition, it notes the progress to date made through the use of biotechnology in crop yield gains and reduced pesticide and water use, and emphasizes the future contribution of biotechnology to healthier foods and a healthier environment.  The specific item highlighted that is consistent with Food and Ag priorities is:

  • Recognition of the need for agencies to reform regulations to increase the speed and predictability of the regulatory processes and ensure agency coordination.

In this regard, the Food & Agriculture Section will continue to encourage the Administration to embrace a regulatory approach to agriculture consistent with these needs, across agencies.  These regulatory improvements are critical to continued agricultural investment, innovation and timely commercialization, upon which future advancements will depend.

Health

The report notes that increased investment in research has not resulted in a concomitant increase in approved drugs.  It identifies the following as potential solutions:  “Advances in translational and regulatory sciences, improvements in the transfer of technology from the public to the private sector, regulatory process improvements, Federal workforce enhancements, and innovative public-private partnerships.”  The following are a few select activities described in the report:

  • Transforming the FDA Archives into a Driver of Discovery and Development: Integrating and analyzing FDA’s repository of clinical data to allow researchers to address fundamental scientific questions about how different patients respond to a therapy, while maintaining proprietary information and reducing costs to drug and medical device developers.
  • Transforming Biomedical Translational Sciences: The National Center for Advancing Translational Sciences (NCATS) will identify barriers to the discovery and development of drugs and diagnostics for a wide range of human diseases and conditions, and provide science-based solutions to reduce costs and time required to bring products to market.
  • Accelerating Progress to Market through a New Regulatory Science Initiative: NIH-FDA collaboration to support regulatory science research.
  • Removing Barriers of Innovation in Biomedical Industries: FDA reforms to increase transparency, consistency, and predictability of the regulatory processes and help drive medical product innovation forward; strengthening the agency’s relationship with the small business community; facilitating drug development; and harnessing the potential of information sharing and data mining.
  • Expanding the Coverage with Evidence Development (CED) Program to Drive Innovation: The Centers for Medicare & Medicaid Services (CMS) will better define the parameters and guidance for CED so it can be “used more widely and effectively as a driver of innovation.”
  • Reducing the Time to Market by Implementing Parallel Regulatory Reviews for Medical Products:By engaging CMS earlier in the process, the parallel review program is expected to limit the duplication of effort on the part of product sponsors and agency reviewers and reduce the time it takes new products to enter the market and receive payments from Medicare and other providers.
  • Supporting Public-Private Partnerships to Find New Uses for Known Drug Compounds: The NIH plans to fund efforts to bring together industry and academic researchers to accelerate the “rescue” of abandoned pharmaceutical compounds and “repurposing” of approved products for novel therapeutic uses.
  • Building Collaborations for Smarter Drug Design: NIH is organizing a joint NIH-Industry Target Validation Consortium, which will use DNA and genome sequence data from diverse populations to better understand health and disease and provide high-value drug targets that companies can use for discovery and development of new diagnostics and therapeutics.
  • Collaborating to Combat Alzheimer’s Disease: A team of researchers from the NIH, FDA, aca¬¨demia and pharmaceutical companies are collaborating to expedite the diagnosis and treatment of Alzheimer’s disease using biomarker panels in both plasma and cerebrospinal fluid samples from patients.

Industrial and Environmental

The report notes the contributions industrial biotechnology can make to energy security and a cleaner, healthier environment.  Specific items highlighted in the report that match suggestions made by BIO’s I&E Section include:

  • Increasing Availability of Renewable Fuels, Intermediate Chemicals, and Bio-based Products: R&D funding that so far has provided $30 million in grants, including to BIO members companies.
  • Improving of Biofuel and Bioenergy Crops: Funding for biomass research at USDA.
  • Unlocking the Promise of Synthetic Biology: Department of Energy (DOE) funding for R&D.
  • Inspiring New Commercial Products and Technologies through Fundamental Biological Research:National Science Foundation funding of fundamental biological research, which supported BIO members’ research on artemisinin and BDO (a polyester precursor).
  • Advancing Biofuels for Military and Commercial Transportation: Supports funding of the Navy, USDA and DOE memorandum of understanding for development of aviation biofuels.
  • Driving Innovation and Creating Jobs in Rural America through Bio-based and Sustainable Product Procurement: Expands and provides guidance on federal BioPreferred procurement of bio-based products to include products made with renewable intermediate chemicals. Enhances and enforces reporting requirements on procurement.
  • Improving the Regulation of Emerging Technologies: Recognizes synthetic biology as an evolution of biotechnology, which has a long record of safety.
  • Expanding and Enhancing the Biomanufacturing Workforce: Expands workforce training program through community colleges.