Jerry Pommer: Livestock Biotech Conference Preview

BIOtech Now visited with Jerry Pommer, Director of Animal Regulatory Compliance and Quality Assurance for Hematech, Inc. in Sioux Falls, South Dakota. Jerry is a member of the program steering committee for BIO’s first-ever Livestock Biotech Summit, which  will provide participants with three days of cross-cutting discussions among industry, academic and government leaders on the care and use of animals in research and the many possibilities in the realm of GE animal research, regulation, and funding within the biotechnology industry. Jerry discusses the unique draw and expectations for the conference, in addition to the GE animals that will be spotlighted – including:

• Pigs that have been genetically engineered to produce human compatible donor tissues, cells and organs;

• Cattle that have been genetically engineered to produce human antibodies that can help prevent and/or treat a wide variety of human health conditions and diseases;

• Cattle that have been genetically engineered to be “prion-free” and therefore resistant to bovine spongiform encephalopathy (BSE, or “mad cow disease”); and

• Goats that have been genetically engineered to produce a spider silk fiber in its milk.  With its strength and elasticity, the spider silk has a variety of applications such as providing artificial ligaments and tendons, eye sutures, and for jaw repair. The silk could also have industrial applications in bulletproof vests and improved automobile airbags.

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Biotech Livestock Come of Age at BIO’s Livestock Biotech Summit

The genetic engineering of animals can produce animals that are resistant to deadly diseases, reduce their carbon footprint, and produce proteins used in human pharmaceuticals and other health therapies.  The field, still in its early stages a few years ago, has undergone some dramatic changes in the last several years.

For example, in June 2008, BIO released a report at its International Convention.  The report, Genetically Engineered Animals and Public Health – Compelling Benefits for Health Care, Nutrition, the Environment and Animal Welfare, discusses how GE animals enhance human health, food production, environmental protection, animal health and provide cutting-edge industrial applications.  Specifically it addressed the regulatory environment at the end of its executive summary stating,

“Today, there are more than two dozen drugs in development derived through the genetic engineering of farm animals, and numerous agricultural animal applications with beneficial environmental and husbandry attributes suitable for commercialization. But so far, the practical benefits of this technology have not reached American patients and consumers, owing to regulatory and political obstacles rather than scientific limitations. The public health benefits can only be realized when we create the regulatory framework for governing how these animals can provide human health, environmental and food and agricultural benefits. Establishing a predictable, rigorous, science-based regulatory pathway is essential if this technology is going to be allowed to deliver practical benefits in the areas that the science of genetic engineering of agricultural animals is now enabling.”

Then in September 2008 FDA released its draft regulatory guidance for genetically engineered animals and their products —a sign that the industry was maturing.  The final guidance was issued in January 2009.

“The publication of FDA’s regulatory guidance was a huge milestone,” says Dr. David Edwards, Director of Animal Biotechnology at BIO.

Now, to keep human health researchers, animal health researchers, regulators, drug and vaccine developers, biomedical device makers, animal disease model developers, and xenotransplantation specialists all on the same page, BIO is launching its first-ever Livestock Biotech Summit to be held September 28-30 at the Sioux Falls Convention Center in South Dakota.

The program will include a day and a half on the “Care of Livestock in Biomedical and Agricultural  Research” and another day and a half on “Genetic Engineering of Ag Animals-Bridging to New Technologies,” which will include expert panels discussing topics such as biopharming, animal stewardship, products in the pipeline, research funding, and the regulatory process.

“We are very excited about the experts speaking at this meeting,” said Dr. Edwards, “We think that the attendees will find the program exciting and the opportunities to network excellent.”

To register for the conference visit the Livestock Biotech Summit website.



New Era in Animal Biotechnology: FDA Approves Therapy Produced with Genetically Engineered Goats

As an animal scientist, today is an exciting day in my career. I know first-hand the dedication and scientific expertise needed to work towards developing technologies that use animals to improve the human condition. Animals have a long history of serving humankind, and today marks another contribution. It is a landmark day for us, and it hails the efforts of animal scientists everywhere.

The U.S. Food and Drug Administration granted the first-ever U.S. approval of a product derived from a genetically engineered animal. The product is a protein, developed to treat hereditary antithrombin deficiency, a rare clotting disorder associated with severe complications for which there are few treatment options. To give you more specifics, I’ll quote from the news release that we issued today:

“ATryn®, a recombinant form of human antithrombin developed by GTC Biotherapeutics, was approved by the FDA for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients. ATryn® is the first ever transgenically produced therapeutic protein and the first recombinant antithrombin approved in the United States. Along with the approval of ATryn®, the FDA’s Center for Veterinary Medicine also approved GTC’s New Animal Drug Application, the first of its kind to regulate genetically engineered animals. This is now required for a recombinant technology used to develop transgenic animals, such as the goats that produce recombinant antithrombin. GTC has granted OVATION the right to market ATryn® in the United States and pursue further clinical development.”

This has been a long road, and I am thrilled because this product will make a difference in the lives of these patients. It also means that the U.S. government regulatory process for genetically engineered animals is effective. The regulatory process was clarified in final guidance released by FDA on January 15, 2009 (link to BIO’s press release) The process ensures the products made available through various applications of genetic engineering will go through a rigorous and transparent review process before being approved for the marketplace. In short, there’s nowhere to go, but up! Biotechnology does indeed heal the world.

Learn about hereditary antithrombin deficiency:
GTC-Biotherapeutics resource page
Wikipedia’s entry
National Alliance for Thrombosis & Thrombophilia