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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FDA Sets VMAC Meeting to Consider Genetically Engineered Salmon

The U.S. Food and Drug Administration (FDA) announced today it will convene its Veterinary Medicine Advisory Committee (VMAC) to consider a salmon that has been genetically engineered to reach its market weight in half the time of conventionally raised salmon. 

The VMAC meeting, part of a rigorous regulatory process required to assess such technologies before being approved for commercialization is scheduled for September 19-20.  At this meeting, the Committee will hear from independent experts about the product’s safety, effectiveness, and environmental benefits; it will also collect public testimony and examine 14 years of scientific evidence about the salmon before deciding whether or not to recommend regulatory approval.

The regulatory process for GE animals finalized by FDA in January 2009 ensures the products made available through genetic engineering go through a rigorous review process before being approved for the marketplace.

According to the FDA,

Genetic engineering is a targeted and powerful method of introducing desirable traits into animals using recombinant DNA (rDNA) technology. DNA is the chemical inside the nucleus of a cell that carries the genetic instructions for making living organisms.

In January, 2009, the Food and Drug Administration issued a final guidance for industry on the regulation of genetically engineered (GE) animals. The guidance explains the process by which FDA is regulating GE animals and provides a set of recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law. While the guidance is intended for industry, FDA believes it may also help the public gain a better understanding of this important and developing area.

The first U.S. approval for a GE animal product came in February 2009 when the FDA approved ATryn®, a therapeutic protein derived from the milk of goats genetically engineered to produce recombinant antithrombin.

As the FDA considers its first GE food animal this process may pave the way for new technologies currently in the pipeline.  Research with GE animals such as goats, pigs, sheep, chicken, fish and cattle has yielded a variety of products that can advance human health, mitigate environmental impact, optimize animal welfare, improve state-of-the-art industrial products and provide sustainable food sources in agriculture and aquaculture.

The Livestock Biotech Summit is Coming!

Don’t miss your chance to get the special early-bird registration rate for the 2010 Livestock Biotech SummitRegistration is now open, and our early-bird discounts will expire on Thursday, July 29, 2010 at 11:59 pm Eastern Daylight Time.

 The first-ever Summit of its kind, scheduled for September 28-30, in Sioux Falls, S.D., will provide participants three days of cross-cutting discussions among industry, academic and government leaders.

Program highlights include:

-A unique workshop tailored specifically to the care of agricultural animals in research as well as an interactive presentation on the newly revised Ag Guide.

– Lively sessions focused on genetically engineered animals and around such topics as real life case studies of products weaving their way through the regulatory process, food and biomedical applications, and funding opportunities for animal biotechnology research.

– W.R. Gomes, Ph.D., Vice President Emeritus of the University of California, will speak on developing global solutions through animal biotechnology.  Gomes recently retired from the University of California, where he served as Vice President of Agriculture and Natural Resources for the university-wide system, Director of the California Agricultural Experiment Station, and Director of California Cooperative Extension. 

Bruce Knight, Principal and Founder of Strategic Conservation Solutions, will give an overview of animal agriculture focusing on the increasing importance of animal care.  Formerly the Undersecretary for Marketing and Regulatory Programs at USDA and Chief of USDA’s Natural Resources Conservation Service, Knight is a nationally recognized expert on conservation, agriculture, and the environment.  He is currently a consultant focused on conservation and environmental issues related to agriculture.

– Dr. John McGlone of Texas Tech University will be coordinating the workshop on the care and use of livestock in biomedical and agricultural research.  Dr. McGlone speaks globally on topics of animal welfare, sustainable animal production, animal behavior, stress physiology and humane animal care.

– Panels of experts speaking on the “Case Study on the First Success Story on the U.S. Road to Regulatory Approval”, the “BIO GE Stewardship Program”, “New Products in the Pipeline”, “Funding Research on GE Animals”, and “Challenges for the Future”. 

BIO’s first-ever Livestock Biotech Summit is co-sponsored by: AAALAC International; Animal & Plant Health Inspection Service (APHIS), Animal Care – USDA; Exemplar Genetics, Hematech, Inc.; Sigma-Aldrich; South Dakota Biotech Association; South Dakota Governor’s Office of Economic Development; South Dakota State University; Trans Ova Genetics; University of Illinois; and ViaGen, Inc. 

For more information on the Livestock Biotech Summit – including updated program information and registration instructions – go to www.bio.org/livestockbiotechsummit, or contact David Edwards, BIO’s Director of Animal Biotechnology, at dedwards@bio.org.

Students Assess Future of Genetically Engineered (GE) Food

In a new paper, Student Response to Transgenic Meat: An Analysis of a Fort Valley State University Survey, to be presented at the Southern Agricultural Economics Association annual meeting on February 6-9, 2010 researchers surveyed college students’ acceptance of meat derived from livestock or fish that had been genetically engineered and found that more than half the respondents said they would purchase meat from GE animals if the price was the same as meat from conventionally raised animals.

The researchers surveyed 372 students to find out what they thought about meat from genetically engineered (GE) animals . The answer: they found that in addition to a willingness to purchase meat from GE animals, respondents who said they read labels when shopping were more likely to purchase meat from GE animals. The results also suggested that respondents who trust scientists to tell them the truth about biotechnology and meat production were more likely to purchase meat produced from biotech animals.

The researchers wrote,

“As food and fiber production continue be [sic] impacted by scientific advancement, the question continues to be whether consumers will accept those new or improved products. In this study we looked at students because they are the future consumers.”

That is the key, because students are our future, and genetic engineering is the future of food.

On GE Animals, Taking Initiative through Guidance on Stewardship

BIO hosted a successful special session on August 20th where the first public presentation was made of the BIO Guidance on Genetically Engineered (GE) Animal Stewardship with 100 international scientists and government officials in the audience of the 7th Transgenic Animal Conference, Tahoe, Calif.

Why is a stewardship program important to those working in research and development with GE animals? Stewardship is the initiative and processes undertaken by product developers in industry, academia and other groups, to increase their control over and responsibility for the conduct of practices.

Today’s landscape for GE animal technology includes many issues that drive public confidence and acceptance. These include the continuing “GMO” debates, the animal welfare concerns about GE technology, and concerns on ethics, social, religious issues. But the landscape also includes cutting edge science, strong regulatory processes, and best of all, the promise of compelling benefits of GE animals including advancing human health, enhancing food quality and safety, softer environmental footprint, enhanced animal health and welfare, and improving industrial products. By adopting a stewardship approach, we may minimize the negative issues and optimize the positive issues.

  • The mission of BIO’s Stewardship Initiative is to institute and promote guidelines for the development and use of GE animals, which promote good animal welfare and comply with current regulatory requirements. BIO Guidance is meant to be valuable to all who are conducting research and development of GE animals, ‘product developers’, including academia, industry and other organizations. The Guidance is meant to assist companies, universities, and the industry in developing and adopting their own stewardship principles. It will serve as a practical useful guidance; a one-stop shop.
  • The Guidance presents what is required to be done according to existing law and regulations, and it suggests other practices, dependent on animal species and application, that we should consider.
  • The Guidance addresses stewardship of GE animals through the life cycle of animals and animal products.
  • Module One, “Guidelines for Research and Development,” was presented.
  • Additional modules in the BIO Guidance will be developed in the future.

The feedback on BIO’s Guidance was excellent, with one leading expert in GE animal research stating, “it is timely and important to do this”. We had several positive compliments and constructive comments from domestic and international scientists and governments. Visit BIO’s web site soon to see the first Module.

The excitement at the Conference and the sophistication of the science (and the stewardship guidance!) being presented is terrific. This event serves as an excellent springboard for the new and novel BIO Livestock Biotech Summit to be held next year in late September, in Sioux Falls, South Dakota. It’s time to put that event on your calendar!

Tools in the 21st Century Tool Box: “Hot Science” on GE Animals

Today’s program at the 7th Transgenic Animal Research Conference in Tahoe, Calif., hit the “hot science”, as one researcher from Germany noted during lunch. The research on genetically engineered (GE) animals will reap huge dividends in societal benefits to solve the world’s most pressing challenges.

I was particularly impressed by the Chinese researchers from State Key Lab of Agrobiotechnology, China Agricultural University, Beijing. In 2001 they began studying six different genes in GE cattle which improve protein production in milk, including production of human lactoferrin, human lysozyme and a human antibody for cancer treatment. But they don’t stop there. Their GE pig research includes the study of four genes which also impact milk protein production.

Even more remarkable, I know you all have heard about the GE goats that produce spider silk proteins, used for body armor, suture material, or anywhere we need an industrial fiber with high strength. These GE goats are alive and well at the University of Wyoming.

Did you know that dragline silk, which is a protein produced by spiders, is the strongest fiber known to man? It is identical to Kevlar, used in bullet-proof vests, except that it has 35 percent elasticity, to Kevlar’s 5 percent. Researchers at the University of Wyoming are working in collaboration with AFMNet to study the attributes of spider silk proteins produced in the milk of GE goats. They discussed the capability to vary the ratio of two proteins that produce films and fibers with different mechanical properties.

Who’s interested? Good Year Tire is interested in this technology for producing tire cords. Eye sutures are another potential application, and the military has continuing needs to protect the armed forces. This is an exciting application with many benefits – indeed the new ‘tailor-to-task’ efforts in research by the University of Wyoming will continue. And the GE goats are so cute – normal and happy.

The scientific presentations are nearly outdone here in Tahoe along with the informal conversations and debate at coffee breaks. We have discussed the fact that this “hot science” on GE animals will not advance without a relevant and workable regulatory process to bring products to consumers. Tomorrow BIO gets the chance to discuss industry’s responsibility toward good stewardship in meeting (and in some cases exceeding) the regulatory requirements.

It all begins with “hot science” on GE animals, building the 21st century tool box. Stay tuned!

Scientists Enthusiastic About Potential for Genetically Engineered Animals

“We have the first approval in the United States – I see so many exciting things coming in the future from GE (genetically engineered) animals – now is our time” urged a scientist attending the 7th Transgenic Animal Research Conference in Tahoe, Calif., August 17-21. There are compelling benefits from the research and development of GE animals for society such as advancing human health, improving foods, enhancing animal welfare and reducing the environmental footprint of livestock production. What strikes me is that over 120 international scientists are convening to discuss the cutting edge science and research with GE animals. And there is tremendous enthusiasm that I witnessed last evening during the opening reception.

The field of GE animals scientifically is embraced and active world-wide. There are speakers here from all over the world: Australia, Brazil, Canada, China, Denmark, France, Germany, New Zealand, South Korea, Spain, United Kingdom and the United States.

BIO is excited to be sponsoring this meeting and to have a unique opportunity to bridge the alliance within the entire Industry. We want to seek unity of purpose and strength toward equivalency in science policy and regulations world-wide. BIO is presenting here in Tahoe for the first time its “BIO Guidance for Genetically Engineered Animal Stewardship.” The Guidance is meant to provide guidelines for all product developers of GE animals – in academia, government institutions and in academic institutions. We are thrilled with this opportunity to receive comment and feedback.

This conference with its focus on research is an excellent complement to BIO’s new “Livestock Biotech Summit” being planned for late September 2010 in Sioux Falls, South Dakota. More to come as the week unfolds!