Animal Biotechnology Industry Update Barb Glenn, Ph.D. Managing Director, Animal Biotech Food & Agriculture Section FASS Symposium May 14, 2007
Industry Status Goal Snapshot, Priorities, Members Technology Sectors Genomics, cloning and transgenics Challenges Future collaboration
A Little About BIO We are the world s largest biotechnology o ogy trade association, representing more than 1,100 companies, academic centers, state and regional affiliates and related entities. Our perspective is broad: The top 10 biotechs and top 10 pharmas are members. But 88% of corporate members are small firms. We represent the big tent biomedical, food & agriculture, and industrial & environmental biotech.
Biotech Overview: Food & Agriculture Genetic, other technologies can also be used to improve crops and animals. First ag biotech products: Bovine somatropin (1993) and Flavr Savr tomato t (1994). Major staple crops (corn, soybeans, cotton) introduced in 1996; more than 1 billion acres planted since then. Enhanced animal health; improving meat, milk, eggs; new medicines for human health using cloning and transgenesis in farm animals.
2007 Snapshot: Food & Agriculture Most recent biotech crop statistics (2006 growing season): 252 million acres planted in 22 countries worldwide. Double-digit acreage growth translating into strong financials at biotech leaders. 90% of farmers using the crops are in the developing world. Biotech crops increase yields, farmer income; reduce pesticide use and tillage. Pipeline includes drought- and salt-resistant t t crops; more-nutritious crops; safer, healthier meat and milk; improved animal vaccines.
U. S. the World Leader- Future of Animal Biotechnology? U. S. accounts for 75% of biotech products 78% of public biotech company revenues 75% of biotech R&D investment
February 1997 Dolly - Hello Dolly!
Animal Biotechnology Industry Priorities Enhance public confidence Need strong regulation Sell products Build a unified voice
Industry Mission Provides industry leadership on science and regulatory issues for the ethical application of biotechnology used to improve animal and human health for the public good. Scientifically strong Relatively small
Amazing Future! Industry Scope Improve animal health Develop more nutritious food Conserve environment & animals Advance human health
Industry s Focus: Consumer Improve foods: Benefits nutrient content, fatty acid composition, tenderness, shelf life, color Differentiate products Increases production efficiency Benefits environment
Timeline of Technologies in Animal Agriculture Artificial Insemination 1950 s Embryo Transfer early 1980 s Embryo Splitting and Cloning late 1980 s In Vitro Fertilization i i early 1990 s Genetic Preservation late 1990 s Somatic Cell Nuclear Transfer early 2000 s Transgenic technology In research
Livestock Industry Trends Company Chicken Swine Beef #1 #2 #1 #1 #4 #4 #2
Animal Biotechnology Technology Segments Genomics Cloning Areas of biotechnology that currently and will continue to improve foods Transgenics Research and development only
Status - Technology Segments Genomes have been sequenced for the 3 major livestock species (cattle, swine and chicken) Bovine and chicken genome sequencing projects completed Developing genetic markers for selection purposes. Cattle, swine and sheep have been cloned. Single nucleotide polymorphism (SNP) technology
Status- Regulatory Draft risk assessment on cloning is published. There are no products from transgenic animals approved by federal government (There are over 100 biotech vaccines, biologics and diagnostics approved for use to improve animal health )
Application of Genomics in Livestock Production Systems In the future, every production animal will be genotyped and a DNA sample will be stored in long-term archive Enhanced Breeding and Selection Targeted to economically important traits Disease Surveillance and Food Safety Source verification and animal traceback Improve Animal Production Efficiency i Management systems based on genetic potential Enhance End Product Quality and Consistency Certification of branded meat programs
Application of Genomics to Companion Animals Understanding companion animal genomics will lead to refined models of disease mechanisms and new approaches to health care research. Polygenic Diseases Hip Dysplasia Diabetes Autoimmune Disorders Kidney Disease Complex Traits Energy Metabolism Aging Breed-specific Traits Phenotype SNP Markers Predictive Diagnostics Microsatellites Genes Nutrition Personalized Wellness
What is Cloning? Cloning is simply an assisted reproductive technology which allows us to produce offspring that are genetically identical to the single donor animal (identical twins separated in time). Progeny, which are not animal clones, will provide most of the food from the cloning process.
Why Clone? Disseminate best genotypes Reduce genetic lag Utilize broadly and directly Amplify impact of superior animals Increase breeding progress Females Overcome death, infertility Increase impact of outliers
FDA Draft Risk Assessment Among the most exhaustive food safety studies ever conducted. Public comment period closes April 2, 2007. Final RA released by end of 2007? The FDA asks that t industry continue to refrain from selling these foods pending conclusion of this process.
Proposed Risk Management Plan and Guidance for Industry FDA to continue to monitor the science Open and informal channels of communications Liaisons with professional, scientific, and veterinary organizations, including development of a public database of health and production data care standards for surrogate dams and clones
Cloning for Show Ring Cloning already being used for show
Challenges on Cloning Labeling debate BIO does not support mandatory labeling National Organic Program BIO does not support exclusion of animal clones and their progeny Food retailers Dean Foods, grocery store chains- No- clone supply chain Industry dialogue Supply chain management Consumer education International trade BIO supports USG dialogue toward adoption of US regulatory steps Codex, OIE, France, Japan, NZ risk assessments European Commission
Supply Chain Management On-going industry discussions Enable meat and milk companies to meet marketing requirements of their customers NOT a safety or health issue Enable labeling li by exclusion Compatible with NAIS Cloned animals only Not progeny
Communication and Education Extensive media outreach What cloning is What it is not Provide information for consumers, industry www.clonesafety.org BIO, ViaGen, other cloning companies Processor and retailer meetings Appropriate p consumer outreach
Cloning from a Carcass Cell It s like duplicating Michael Jordan until you have five Michael Jordans on a team Donald Brown, Throckmorton, TX (Ft. Worth Star Telegram) ViaGen produced this calf, Elvis, in 2005 by cloning a Prime Yield Grade 1 Angus crossbred steer using a cell taken from its carcass.
Application of Transgenics Increase rate and quality of milk and meat production Rate of gain, milk proteins, muscling Increase disease resistance Mastitis, BSE, AI Produce human medicines Animal-made pharmaceuticals Produce organs which are less likely to be rejected Xenotransplantation
Timeline of Transgenic Technologies First tg sheep and pigs (DNA microinj) 1985 Tg sheep by nuclear transfer 1997 Tg cattle from fetal fibroblasts and Nuclear transfer 1998 Gene targeting gin sheep 2000 Trans-chromosomal cattle 2002 Heterozygous KO pigs 2002 Homozygous gene KO in pigs 2003 Tg pig via lentiviral injection 2003
Advent of Aqua Biotechnology AquAdvantage Salmon: An Atlantic salmon broodstock that is genetically-engineered engineered to grow more rapidly Non-transgenic salmon Siblings at ca. 12-1515 months after first-feeding feeding AquAdvantage Salmon
Transgenic Cows Resistant to Mastitis
Human Antibody-producing Calves Calves carrying human antibody genes. Calves produce specific human antibody after immunization Microchromosome with human antibody genes in cow cell
European Commission Approves First Protein Produced d by a Transgenic Animal A milestone ATryn, a human anti-clotting protein Produced by transgenic goats in their milk
Platform Technology Introduce target protein construct into embryo Transfer into recipient female Breeding of founder Transgenic milk production herd Purified Drug
U. S. Regulatory Framework for Transgenic Animals FDA is currently the lead agency USDA, Animal Plant Health Inspection Service is working on their authority also to regulate. APHIS also has jurisdiction over animal care and biotech vaccines
U. S. Regulatory Framework BIO supports regulation of transgenic animals by FDA using the New Animal Drug process according to the FFDCA. The NAD is the transgene construct, article intended to affect the structure or function Working toward publication of guidance
U.S. Regulatory Framework BIO supports a coordinated framework for regulation that includes FDA and USDA. APHIS, Biotechnology Regulatory Services, according to the PPA, AHPA, is working on processes to regulate.
Challenges on Transgenics Office of Science Technology and Policy IWG on Regulation of Transgenic Animals No guidances have been developed to date regarding safety criteria International standard setting bodies Codex, OIE, BSP
Future Challenges Scientific discovery Safety and product approvals through a science-based regulatory process Building gpublic confidence
Conclusions Animal biotechnology will impact the future of food production The animal biotech industry seeks to work in partnership with the scientific community, livestock and food industries Finalize the regulatory processes Meet food chain demands for consumer benefits Public understanding and confidence with fact-based information
Piglet Clones, 6-7 weeks old
Latest Information BIO 2008, San Diego www.clonesafety.org http://www.bio.org/foodag/animals Dr. Barb Glenn, bglenn@bio.org Phone: 202 962 6697