Response to proposed rulemaking on Bayh Dole

Comment on: Doc # 2020-27581 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Proposed Rules Agency: National Institute of Standards and Technology (NIST), United States Department of Commerce Docket identification: 201207-0327 Notice of proposed rulemaking: Rights to Federally Funded Inventions and Licensing of Government Owned Inventions, 37 CFR 401 and 404 Respondent: Fred D. Ledley, M.D. Director, Center for Integration of Science and Industry; Professor, Departments of Natural & Applied Science, Management; Bentley University, Waltham, MA, 02452. Email: [email protected], Website: www.bentley.edu/sciindustr

Center for Integration of Science and Industry - Response to OSTP Bioeconomy RFI

RESPONSE TO: AGENCY: Office of Science and Technology Policy (OSTP). ACTION: Notice of request for information (RFI) for Bioeconomy Federal Register /Vol. 84, No. 175 /Tuesday, September 10, 2019 /Notices, page 47561 Transmitted electronically to [email protected] What specific actions could the U.S. Government take to reinforce a values-based ecosystem that will guide the transformation and expansion of the U.S. Bioeconomy, in both the shortand long-term? This response addresses specific actions the U.S. Government could take to ensure sustainable funding for the basic research that provides the foundation for the U.S. Bioeconomy. Empirical evidence demonstrates that a mature body of basic research is essential for the efficient discovery and development of new medicines, and recent studies have demonstrated the scale of the public sector (NIH) contribution to this research. This funding is, however, under threat. U.S. Government action is required to ensure sustainable funding for basic research. Specific actions by the U.S. Government could include: 1. Make a long-term commitment to sustained public funding of basic science by the NIH at levels at least equal to 2003 in constant dollars; 2. Ensure equitable returns to the public sector from the licensing of federally funded research for development in the biopharmaceutical industry; 3. Require accounting recognition of basic and applied research spending as a capital investment that produces a tangible asset (intellectual property); 4. Facilitate innovative investment instruments that provide long-term support for basic and applied research through tax exempt bonds

Could Human Genome Sciences have become Standard Oil?

Human Genome Sciences (HGS) was not a company with normal ambitions. At its inception, HGS aspired to dominate not only the field of genomic science, but also emerging markets for regenerative medicines designed to meet the needs of ageing populations. Fred Ledley asks whether HGS could have become the Standard Oil of our generation

How to lie with (FDA) statistics

The FDA approved 27 new drugs in 2013. Is this a downward trend? Is it an upward trend? Does it suggest that the pharmaceutical industry is failing, or that genomics is finally paying dividends? We revisit Darrell Huff’s 1954 classic How to Lie with Statistics for insights into these pressing questions

Biotech: Not just for geeks

Business students get high marks for scientific literac

Response to Department of Commerce, National Institute of Standards and Technology, Agency Information Collection Activities

This response supports the recommendations of the interagency working group for Bayh-Dole that the dataset collected and archived in iEdison “…be amended and expanded so that the agencies could get a clear picture of the commercialization plans for subject inventions, what the licensing landscape looked like, (and) what products were resulting, …” Our comments are informed by several recent studies describing the effectiveness and reach of the Bayh-Dole Act in promoting and protecting the public interest in practical applications of government-funded biomedical research to pharmaceutical innovations

Why does society support science? And how to meet the expectations?

Public support for science is related less to the wonder of scientific discovery than the expectation that scientific and technological advances will lead to new product, jobs, and economic growth. Recent evidence suggests that these outcomes are not certain. Fred Ledley argues that the public is often promised the benefits of scientific discoveries without adequate consideration of the business challenges inherent in translating science for public benefit

Statement Before the House of Representatives Subcommittee on Health of the Committee on Energy and Commerce

Statement of Fred David Ledley, M.D.Director, Center for Integration of Science and IndustryProfessor, Natural and Applied Sciences and ManagementBentley University, Waltham, MA Before the House of RepresentativesSubcommittee on Health of the Committee on Energy and Commerce Hearing: 21st Century Cures: Examining the Role of Incentives in Advancing Treatments and Cures for Patients June 11, 201

Comments Re: Draft Guidance Considering Exercise of March-In Rights - Docket No.: 230831-0207

This comment focuses on criterion #3 of the march-in provisions of the Bayh Dole Act, which pertains to “…action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the contractor, assignee, or licensees.” We recognize that the term “public use” in Bayh Dole refers not only to commercialization or availability of products representing practical applications of the inventions made with federal funding and licensed to industry under the terms of the Act, but also use of these inventions to achieve a series of socioeconomic goals (i.e., access to and affordability of medicines). As such, we suggest that assessment of the march-in provisions of the Act should address not only the contractor, assignee, or licensee actions to commercialize practical applications of the subject invention, but also their actions in relation to the articulated socioeconomic goals of the Bayh Dole Act