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U.S. Department of Health and Human Services

Animal & Veterinary

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CVM Scientists Attend Conference on Transgenic Animals

by Wendelyn Warren, Ph.D. and Kevin Greenlees, Ph.D., DABT 
FDA Veterinarian Newsletter January/February 2002 Volume XVII, No 1

Seven scientists from the Office of New Animal Drug Evaluation and the Office of Surveillance and Compliance attended the Transgenic Animal Research Conference III. The conference was held from September 9 through September 13, 2001 at the Granlibakken Conference Center in Tahoe City, California and was hosted by the University of California at Davis. This was the third in a series of conferences since 1997 that uniquely focuses on genetic engineering in animal species used in agriculture. It was an international meeting intended to bring together researchers from the leading laboratories doing cutting edge research and development with transgenic animals.

The CVM attendees are all part of the Animal Biotechnology Working Group or the Biotechnology Process Group. These groups identify and resolve regulatory policy and scientific issues regarding transgenic animals. The presentations addressed cutting-edge methodology, technical improvements, and current progress towards producing transgenic animals for medical, agricultural, and even industrial applications. Information was provided on basic and applied research through presentations, posters, and informal discussions. CVM scientists were very interested in understanding the advances in genetic engineering and how they may impact considerations of safety and effectiveness, particularly in food animals.

The field of transgenic animal research is rapidly evolving towards practical applications for this technology. Presentations ranged from discussion on how to spin spider silk produced in the mammary gland of bioengineered goats to pharmaceutical production in the semen of transgenic pigs, to the production of low phosphorus manure in bioengineered pigs. Each of these very different applications of bioengineering technology share the key step of altering the structure and function of the bioengineered animal. Information about this conference is available through the University of California at Davis web site.

Altering the structure and function of an animal through the insertion of the transgenic material, and in some cases, the resulting expression product are considered to be subject to FDA's regulatory authority likely to require the submission of a new animal drug application to the Center for Veterinary Medicine (see Office of Science and Technology Policy, Center for Environmental Quality Case Studies of Environmental Regulation for Biotechnology, http://www.ostp.gov/html/012201.html). Other FDA Centers may have a role in the regulation of this new technology. The FDA's Center for Biologics, for example, regulates products such as human serum albumin or insulin intended for use in human medicine and harvested from the milk, semen, or other tissue of the bioengineered animal.

Because of the small size of the conference, the nature of the setting, and the collegial atmosphere some of the most important stakeholder outreach occurred over meals and coffee breaks. CVM scientists discussed the INAD and NADA process with sponsors and potential sponsors in this informal setting. There was also an opportunity for candid discussions with regulatory scientists from Health Canada and the Canadian Food Inspection Service. The conference allowed the CVM scientists to expand their breadth of knowledge in this fast-growing field and to interact with potential stakeholders and other government's agencies as the tools of genetic engineering find their way into commercial applications.

The 2001 Transgenic Animal Conference was impacted by the terrorist attacks on September 11, 2001. The shock and grief caused by these attacks was apparent in the discussions among the participants of the conference. Many attendees experienced considerable hardships in returning home. Travel arrangements were cancelled, rescheduled, and rescheduled again as airports struggled to cope with the events. Although thoughts were with all those who have been affected by this tragedy, it was clear that the conference solidified into a community of scientists that ignored national boundaries and brought together the individuals from academia, industry, and government. We thank the conference organizers and the Granlibakken Conference Center for their gracious understanding and support in a very difficult time. We would also like to acknowledge the remarkable support and solidarity expressed by the international attendees.

Dr. Warren is a Pharmacologist in the Residue Chemistry Team in CVM's Office of New Animal Drug Evaluation (ONADE). Dr. Greenlees is a Toxicologist in the Toxicology Team in ONADE.