|David J. Glass,
Summary of Experience and Accomplishments
Over 30 years of diverse management experience in several fields of biotechnology, including industrial, medical, agricultural and environmental applications.
Longstanding expertise in industrial, environmental and agricultural biotechnology regulatory affairs. Currently offering consulting services in industrial biotechnology, after directing regulatory affairs for a leading renewable fuels company. Earlier in career, obtained several of the earliest approvals for field tests of genetically modified agricultural microorganisms and transgenic plants. Advised companies on the impact of biotechnology regulation on the uses of engineered microbes in hazardous waste treatment and biofuel production.
Leadership roles in technology transfer at Harvard Medical School-affiliated institutions, including a senior management role in a large, active tech transfer office (Massachusetts General Hospital); and originating and directing in-house tech transfer functions at two smaller Harvard affiliates (McLean Hospital and Joslin Diabetes Center). Currently directing tech transfer at the Dartmouth and Boston campuses of the University of Massachusetts.
Technology transfer experience includes negotiation of sponsored research and license agreements for biomedical technologies; successful environmental biotechnology partnering projects; liaison to corporate research sponsors and licensees, including companies in Japan and Europe; other international business experience. Awarded the Certified Licensing Professional (CLPTM) certification in July 2008 and the Registered Technology Transfer Professional (RTTP) certification in November 2013.
Managed intellectual property programs both in industry and academia, including responsibility for a portfolio of over 300 biomedical patent applications.
Excellent communications skills, including over 70 speaking appearances, testimony before congressional and state legislative committees, and extensive media interactions. Authored over twenty professional articles and ten market reports on various topics in biotechnology, bioremediation and phytoremediation.
D. Glass Associates, Inc., Needham,
Beginning in October 1990, David Glass has pursued a variety of consulting activities through D. Glass Associates, Inc., encompassing two areas of expertise: industrial, environmental and agricultural biotechnology, focusing on regulatory affairs, market assessments and general management consulting; and licensing, strategic patent management, and academic technology transfer. Full-time 2001-2011 and 2014-present; part-time at all other times.
Industrial and Environmental Biotechnology. Recent activities are concentrated in renewable fuels and industrial biotechnology. Experience includes advising companies on the impact of EPA biotechnology regulations on the development of biofuels such as cellulosic ethanol and bio-based chemicals, and preparation of Microbial Commercial Activity Notices (MCANs) and TSCA Experimental Release Applications (TERAs) for filing with the U.S. EPA. Other recent experience in compliance with U.S. Renewable Fuel Standard, California Low Carbon Fuel Standard, and EU Renewable Energy Directive (click here for representative list of recent clients). Early activities focused primarily on projects involving regulatory affairs and market analyses in environmental and agricultural biotechnology. Advised Envirogen, Inc., Energy Biosystems, Inc., and other companies on regulation of environmental and industrial biotechnology, helped a multinational company identify potential European partners for a bioremediation product, advised several companies in the U.S. and Europe on the structure of bioremediation markets. Authored seven market reports for Decision Resources, Inc., authored and published two market reports on phytoremediation, and wrote numerous other articles and reports. Presented keynote speech at Third International Bioreclamation Symposium, April 1995, on international bioremediation activities, and numerous presentations (many invited) on U.S. and international phytoremediation markets at conferences sponsored by International Business Communications (IBC), the Association for the Environmental Health of Soils (AEHS), Battelle, and others.
Licensing, Patent Management and Technology Transfer. Dr. Glass maintains expertise in strategic patent management, technology transfer and licensing, in biotechnology and other biomedical fields, and continues to offer consulting services in these fields. Dr. Glass is currently consulting within the University of Massachusetts system: he is handling all tech transfer functions at UMass Dartmouth 1-2 days a week (August 2014 to present) and at UMass Boston (February 2018 to present). Other projects (2013-present) include conducting technology and market assessments as Senior Consultant for Foresight Science and Technology (December 2015 to present), served as Interim Licensing Manager for Partners Healthcare Innovation during an employee’s extended maternity leave (July 2016 to June 2017), assisting the tech transfer offices at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center (2018-2020), invention evaluation and other tech transfer support to Western New England University (July 2017 to present), select tech transfer tasks for Western Michigan School of Medicine, assisting a medical device company in negotiating research agreements with academic medical centers, and helping a small engineering firm draft several provisional patent applications. Dr. Glass's previous experience in licensing, tech transfer and patent management is described below.
Regulatory Affairs Consultant, Joule
Unlimited Technologies, Inc.,
Bedford, Massachusetts. 2014-2016
Director of Regulatory Affairs, Joule Unlimited Technologies, Inc., Bedford, Massachusetts. 2011-2013
Responsible for all matters of regulatory compliance for the commercial activities of Joule Unlimited, a company developing genome modified photosynthetic microorganisms for the production of fuels and chemicals from sunlight, carbon dioxide and water. Responsibilities include compliance with biotechnology regulations, fuel certification regulations, and other biofuel-related government regulations and programs, in the United States and elsewhere in the world.
D. Glass Associates, Inc.,
Licensing, Technology Transfer and Patent Management, 2001-2011
In addition to Dr. Glass's activities in industrial and environmental biotechnology, during the period from April 2001 to October 2011, a significant portion of his effort was devoted to licensing and technology transfer in the fields of biotechnology, biomedicine and medical devices. During this time, Dr. Glass assisted academic institutions with technology transfer and their intellectual property programs, and he advised several small companies on academic relations, strategic patent management, and other matters. Clients and assignments during this period included:
University of Louisville, Louisville, Kenturcky (May 2006 to September 2009). Conducted technology assessments of new invention disclosures in the fields of biotechnology and medical devices.
Chief Executive Officer, Applied
PhytoGenetics, Inc., Athens, Georgia. 2001-2005
Recruited by founders to become first CEO of a small company pursuing phytoremediation – the use of trees and plants to remove hazardous contaminants from the environment. Initial responsibilities include redrafting business plan, raising initial rounds of funding, supervising the growth of company from founders-stage to early-stage development, lead and participate in business development efforts, in-licensing from founding academic institution, and other general management responsibilities. Part-time position.
Associate Director, Corporate
Sponsored Research and Licensing, Massachusetts General Hospital,
Boston, Massachusetts. 1998-2001
Technology transfer responsibilities for an internationally-known teaching hospital with a large professional research staff, and its affiliated psychiatric hospital the McLean Hospital. Responsibility, along with a staff of three Ph.D.-level tech transfer professionals, for managing the hospital's invention and patent program, and carrying out much of its non-software technology licensing. Drafted and negotiated technology licenses and other industry-academia agreements.
Associate Director for Patents,
Office of Technology Affairs, Massachusetts General Hospital, Boston,
Technology transfer responsibilities for an internationally-known teaching hospital with a large professional research staff, and its affiliated psychiatric hospital the McLean Hospital. Managed the hospital's patent portfolio, including evaluation of new disclosures, strategic direction of patent prosecution and liaison to U.S. and foreign licensees. Drafted and negotiated legal agreements for patent licenses and industry-sponsored research.
Vice President, Government and
Regulatory Affairs, BioTechnica Agriculture, Cambridge, Massachusetts.
Responsible for all matters of regulatory compliance, community relations and government relations for the agricultural subsidiary of BioTechnica International, with supervision over intellectual property protection and regulatory affairs for the parent company. Obtained regulatory approval for several field tests of transgenic plants and microbes. Recognized as an industry spokesman for agricultural and food biotechnology public policy issues.
Director, Patents and Regulatory
Affairs, BioTechnica International, Cambridge, Massachusetts.
Responsibilities included development and implementation of the company's program of intellectual property protection, regulatory compliance in a variety of product areas and liaison to trade associations. The primary regulatory project was an application to conduct a field test of a genetically engineered agricultural microorganism, which involved a program of community relations and media relations at the test site.
Executive Assistant and Research
Scientist, BioTechnica International, Cambridge, Massachusetts.
Responsibilities included biosafety, radiation safety, technical writing, and other administrative duties.
Freelance Science Writer, 1981, with publications in Science Digest, BioScience.
Princeton University, Princeton, New
Department of Biochemical Sciences
M.A., 1978, Ph.D., 1981
Cornell University, Ithaca, New York
Major: Biological Sciences
Congressional Testimony and Government Workshops and Committees
Subcommittee on Department Operations, Research and Foreign Agriculture, U.S. House Committee on Agriculture, Testimony on proposed bill H.R. 5312, Washington, D.C., October 2, 1990.
Subcommittee on Hazardous Wastes and Toxic Substances, U.S. Senate Committee on the Environment and Public Works, Testimony on adequacy of federal regulatory framework, Washington, D.C., November 5, 1987.
Office of Technology Assessment, Workshop on Factors Affecting Commercialization and Innovation in Biotechnology, Washington, D.C., June 11, 1987.
Subcommittees on Natural Resources, Agriculture Research and Environment; and on Science, Research and Technology, U.S. House of Representatives, Testimony on proposed bill H.R. 4452, Washington, D.C., June 5, 1986.
Member, Wisconsin State Assembly, Subcommittee on Genetic Engineering, 1987-1988.
Member, Minnesota State Government, Advisory Committee on Biotechnology Regulations, 1989 to 1990.
Memberships and Certifications
Awarded Certified Licensing Professional (CLPTM) certification in July 2008 and the Registered Technology Transfer Professional (RTTP) certification in November 2013.
Massachusetts Biotechnology Council; President, April 1988 to April 1990. Vice President, April 1987 to March 1988. Secretary, March 1985 to March 1987. Member, Board of Directors, March 1985 to March 1991. Chairman, Regulatory Affairs Committee, 1985 to 1987.
Industrial Biotechnology Association; various committee memberships, 1983 to 1990. Chairman, EPA Relations Committee, November 1988 to October 1990. Chairman, Food Biotechnology Public Relations Subcommittee, May 1988 to January 1990.
International Food Biotechnology Council, Member of Executive Committee and Board of Directors, February 1988 to February 1991.
Member, Board of Directors, Massachusetts Medical Device Industry Council (MassMEDIC), May 1997 to April 2001.
Member, Editorial Board, International Journal of Phytoremediation, June 1998 to December 2008.
Member, Editorial Board, Journal of Soils and Sediments, January 2001 to December 2007.
Individual Member, Applied Biotreatment Association, 1990 to 1992. Corporate Member, Environmental Business Council, March 1991 to March 1992; January 1993 to March 1994.
Chair, Needham, Mass. Biotechnology Advisory Committee, October 1995 to May 1996.
Member, Licensing Executives Society. Member, Association of University Technology Managers.
Individual Member, Algae Biomass Organization.
Bureau of National Affairs, Member, Advisory Board for Special Report Series on Biotechnology, 1989, 1990. Member, Biotechnology Working Group, Kennedy School of Government, 1991 to 1995.
American Society for Testing and Materials, Committee E-48 on Biotechnology; Secretary, Subcommittee E-48.04 on Environmental Issues; Chair, task group E-48.04.1 on Monitoring and Detection, 1985-1987.
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