Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

The administration’s Office of Science and Technology Policy received 134 submissions.

President Barack Obama’s administration has begun reviewing suggestions for a National Bioeconomy Blueprint detailing measures by which the Obama administration intends to apply biological research innovations toward national challenges that include health, food, energy, and the environment.

The administration’s Office of Science and Technology Policy (OSTP) posted on its website that it received 134 submissions to a formal Request for Information (RFI) between October 7 and the December 6 deadline. In announcing the plan on September 16, the administration said the Blueprint would be developed by January 2012. A spokesman was unavailable Wednesday to confirm if that timeframe was still in effect.

OSTP sought comment on 17 questions, some of which asked respondents to identify “grand” challenges, suggest options for surmounting technical hurdles to accelerating research, improve the regulatory system and training programs, define roles for community colleges and the private sector, and explore new business-led models for funding commercialization.

Grand Challenges

Bruce W. Stillman, Ph.D., president of Cold Spring Harbor Laboratory, urged the administration to peer review its Bioeconomy initiatives and to avoid creating permanent institutions in pursuit of the grand challenges. He offered several suggestions for grand challenges the blueprint could support: A national cancer therapeutics initiative, more funding for basic plant science, continued funding for scientist training and basic research, and a major commitment to funding basic science research in neuroscience.

The American Society for Biochemistry and Molecular Biology (ASBMB) suggestions ranged from providing healthcare for the nation’s graying population to combating obesity to supporting interdisciplinary research toward diagnostics and preventive medicine.

Beyond grand challenges, the greatest challenge, ASBMB underlined for emphasis, was staying competitive and ending years of yo-yo budgets for federal agencies: “The instability of federal funding for scientific research has placed our research enterprise and innovation engine at great risk. Other countries such as China and Singapore are investing very heavily in basic science and are successfully recruiting U.S. faculty and research trainees.”

The grand challenge approach drew criticism, however, from Pharmaceutical Researchers and Manufacturers of America (PhRMA), which noted that most biomedical advances stem from cumulative steps. “A construct that would value only the rare and obvious paradigm-changing breakthroughs and discount other advances would cut off a common route to highly valuable advances and create very significant disincentives for innovation,” Richard I. Smith, evp, policy and research, wrote.

Credits and Incentives

PhRMA called for boosting R&D tax credits and reviewing long-term innovation strategies of other nations, singling out the U.K.’s Life Sciences Blueprint of 2009. In addition to setting aside £25 million (about $38.7 million) to dispense innovative medicines through the NHS, the U.K. blueprint created an £18 million (roughly $27.8 million) commercial R&D investment program. It also set aside £1 million (about $1.55 million) to form a U.K. Life Sciences Super Cluster to coordinate work across industry, higher education, and the NHS as well as build international recognition of the U.K. in the life sciences.

The Biotechnology Industry Organization (BIO) submitted its 90-page five-year policy agenda. “Unleashing the Promise of Biotechnology” calls for promoting more investment by small businesses, in part through tax incentives; granting FDA the authority to make independent budget, management, and operational decisions while creating a new external management review board for the agency; creating a new FDA chief innovation officer and linking agency staff to external scientific and medical expertise, in part through new chief medical officers in each center.

“Biotechnology companies are working every day to solve the greatest challenges facing our society—whether it’s finding a cure for cancer, protecting against bioterror threats, or creating renewable energy sources,” James C. Greenwood, BIO’s president and CEO, wrote. “Yet despite the urgent need for scientific breakthroughs in these areas, some current government policies are holding back the potential and promise of biotechnology.”

Tech Transfer

To advance research from universities and institutes, the Association of University Technology Managers (AUTM) urged the administration to reject the “free agency” recommendation by the President’s Council on Jobs and Competitiveness—namely that research funded with federal dollars be presented to any university tech transfer office rather than the one where research took place.

“The Free Agency approach to commercialization will create more risk in the eyes of companies that would normally invest in the technologies because untangling title and ownership would be more complicated and fraught with potential legal burdens,” AUTM argued. “It is imperative the Administration opposes any proposed policy or legislation that would enact a Free Agency model.”

AUTM also pressed OSTP to ease up on rules it said discouraged federal agency staffers from using the group’s services, including a proposal by the Office of Government Ethics to bar those staffers from attending the association’s conferences for free.

New Science

Three policy analysts, two from the J. Craig Venter Institute (JCVI), the other from the University of Virginia, said the Bioeconomy Blueprint should address the challenge posed by new technologies such as synthetic biology considering the pace of technological change post the 1986 Coordinated Framework for the Regulation of Biotechnology. The three are investigators on a Department of Energy-funded study on the topic, with a full report expected in late 2012.

They envision another assessment of the Framework along the lines of reviews in 2001 by OSTP and the White House Council on Environmental Quality. “While there are strong arguments for maintaining the basic structure of the Framework, there will be a need to review regulatory authorities to meet the challenges of new technologies, including synthetic biology,” wrote Robert Friedman, Ph.D., JCVI’s director for California and leader of its policy group; JCVI policy analyst Sarah R. Carter, Ph.D.; and policy analyst Michael Rodemeyer from University of Virginia.

“Such a reassessment inevitably involves making difficult but extremely important judgments about striking the appropriate balance between regulation intended to prevent harm to public health and the environment and the desire to bring beneficial and safe products to market,” the three added.

Synthetic biology was among two biotechnology research priorities that Life Technologies president and COO Mark Stevenson urged the administration to identify; the other was genomics and public health. To advance synthetic biology, Stevenson suggested a cross-agency, coordinated research agenda in consultation with the private sector, with government supporting increased computational abilities; naming conventions aimed at forming a metagenomic catalogue of tools; identification and characterization of novel hosts and properties; and development, validation, and categorization of tools for scaled DNA construction and engineering.

As for genomics, Stevenson recommended two broad applications aimed at addressing the impact of microbes on human health and disease: Use of next-generation sequencing for food safety and epidemiological outbreaks and validation and standardization of instruments and methods.

Stevenson added that the Obama administration must also remove bioeconomy barriers by developing a regulatory pathway for next-gen sequencing, relying on manufacturers’ quality systems to keep nonconforming products from the market. It should also revise the draft FDA guidance concerning the labeling of in vitro diagnostic products marked research use only and investigational use only to address industry concerns that the proposed rules would, if adopted, disrupt the operations of clinical molecular labs.

Small Businesses

Several RFI respondents seek changes to the Small Business Innovation Research (SBIR) program. While its funding is being resolved through FY 2019 through a six-year reauthorization announced earlier this week, the respondents urged the administration to refocus SBIR on helping commercialize discoveries as much as funding R&D and to widen access to the program.

“Special consideration should be given to federally funded bioeconomy-related research that can be commercialized in the near future in order to generate sales and jobs in the United States as quickly as possible,” Phyllis B. Siegel, CEO of Biomedical Development, said.

Randall Legeai, director, institutional program development at Tulane University’s Office of Government Affairs, urged the administration to establish “additional support mechanisms, including workshops and other outreach,” to bolster SBIR/STTR, specifically in states served by NSF’s EPSCoR program.

North Carolina Biotechnology Center (NCBC) advised the administration to boost life science funding, especially for academic-industry collaborations and transitions between the two and for bridge funding programs such as SBIR’s Phase II Bridge awards designed to accelerate commercial development of technologies past Phase II. With commercial development in mind, NCBC president and CEO E. Norris Tolson also recommended that industry join with consumers and FDA staff in a task force to develop ideas for “streamlining FDA approval processes while maintaining reasonable safety standards.”

Alex Philippidis is senior news editor at Genetic Engineering & Biotechnology News.

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