David J. Glass, Ph.D. Qualifications and Experience

Summary of Qualifications and Experience 

• Biotechnology regulatory experience dating back to the early 1980s, including nine years at BioTechnica International, an early U.S. agricultural biotechnology company; over 20 years as a consultant in industrial, agricultural and environmental applications of biotechnology; and over 2 years serving as director of regulatory affairs for a leading U.S. renewable fuels company. 

• Pioneering role in environmental biotechnology regulation, during the early days of the agricultural biotechnology industry. At BioTechnica International, obtained federal and state approvals for five of the earliest field tests of genetically engineered microorganisms in the United States and field tests of transgenic plants; also participated in early public policy debates over the scope of biotechnology regulation. 

• As a consultant, advised several companies on EPA regulation of the use of biotreatment reactors with genetically engineered microorganisms, and assisted two companies obtain formal notification from EPA that a biotreatment reactor would qualify for reduced oversight if used with engineered organisms.
• Recent experience consulting on industrial biotechnology regulations and markets, including advising companies on the impact of EPA biotechnology regulations on the development of biofuels and bio-based chemicals; coordinating preparation of MCANs for filing with the U.S. EPA for biofuel production microorganisms; advising companies on other regulatory matters including FDA regulation of animal feed ingredients; and assessing potential markets for industrial biotechnology products.
• Prepared and submitted a new fuel pathway petition under the U.S. EPA Renewable Fuel Standard, and obtained a Medium Alcohol Fuel Producer Permit for a commercial bioethanol facility.   

• Author of five reports on U.S. and international bioremediation markets and several publications on bioremediation, including several joint publications with Dr. Thomas Raphael.
  
  
• Author of numerous publications on phytoremediation, and the market reports "U.S. and International Markets for Phytoremediation, 1999-2000", published July 1999 and "The 1998 U.S. Market for Phytoremediation", published April 1998.
  
  

• Over 25 years experience with intellectual property protection, and 20 years licensing and tech transfer experience. Awarded the Certified Licensing Professional (CLP^TM) certification in July 2008 and the Registered Technology Transfer Professional (RTTP) certification in November 2013.

• 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 University of Massachusetts Dartmouth, and recently served as Interim Licensing Manager at Partners Healthcare Innovation.
  

• Managed intellectual property programs both in industry and academia, including responsibility for a portfolio of over 300 biomedical patent applications.

• Technology transfer accomplishments include successful negotiation of a large number of license, option and sponsored research agreements for biomedical technologies, including formation of biotechnology and medical device start-ups.

• Extensive experience in managing corporate relationships, including liaison to corporate research sponsors and licensees, particularly companies in Japan, Australia and Europe; successful international partnering efforts.

Professional Experience

Education

Princeton University, Ph.D., Biochemical Sciences, 1981.

Cornell University, B.S., Biological Sciences, 1975.

[Curriculum Vitae]

[List of Publications]

[Published Market Reports]

[Selected Speaking Appearances]