Presenting a regulatory case study at BIO Pacific Rim Conference

Next week, I’ll be speaking and moderating a panel at the BIO Pacific Rim Conference on Industrial Biotechnology and Bioenergy in San Diego.  The panel is entitled “Overcoming Challenges in Regulation and Intellectual Property”, and I’ll be presenting an overview of U.S. and international regulations affecting industrial biotechnology along with a case study of my work for Joule Unlimited in its recent successful interactions with the EPA for review of a Microbial Commercial Activity Notice (MCAN) for a modified cyanobacterium for ethanol production.

The other speakers on the panel will be Kevin Wenger of Mascoma, speaking about his company’s experience in gaining regulatory approval for genetically modified yeast strains for ethanol production and use as animal feed ingredients, Konrad Sechley, of the Canadian patent law firm Gowling Lafleur Henderson, LLP, who will discuss the scope of patent protection available for biotechnology in view of recent legal developments, and Kathleen Roberts, of Bergeson & Campbell Consortia Management, LLC, who will discuss the impact of the Toxic Substances Control Act on the manufacture of bio-based chemicals.

The conference is taking place December 8-11, 2013, and you can find more information on the conference website. This is the 8th annual Pacific Rim Summit organized by the Biotechnology Industry Organization, and is the original conference dedicated solely to the growth of the industrial biotechnology and bioenergy sectors in North America and the Asia-Pacific region. In addition to four plenary sessions, the meeting will feature 30 breakout panels covering topics including algae, advanced biofuels, bioplastics, dedicated energy crops, renewable chemicals, marine bio-resources and synthetic biology.

Please let me know if you’re attending the conference and would like to meet, or if you’d like a copy of my presentation, which I expect to make available after the meeting. I also hope to blog about the conference and some of the sessions I attend, time permitting.

D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. Dr. Glass also serves as director of regulatory affairs for Joule Unlimited Technologies, Inc. More information on D. Glass Associates’ regulatory affairs consulting capabilities, and copies of some of Dr. Glass’s prior presentations on biofuels and biotechnology regulation, are available at and at The views expressed in this blog are those of Dr. Glass and D. Glass Associates and do not represent the views of Joule Unlimited Technologies, Inc. or any other organization with which Dr. Glass is affiliated. Please visit our other blog, Biofuel Policy Watch.


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