FDA's Regulation of Veterinary Regenerative Medicine: What Industry Needs to Know to Market and Sell a Stem Cell Product for Use in Dogs, Cats, Horses and other Animals

Why Should You Attend:

The rapid development of cell-based and related biological therapies for use in veterinary medicine has provided exciting new options for the safe and effective treatment of common veterinary diseases and conditions such as osteoarthritis, tendon strain injuries, suspensory desmitis, congestive heart failure and other commonly diagnosed diseases and injuries.

FDA’s Center for Veterinary Medicine (“CVM”) asserts primary and exclusive regulatory jurisdiction over veterinary regenerative products and their future commercialization in the U.S. Under CVM’s proposed regulatory approach, a veterinary regenerative product exceeding a hypothetical veterinary equivalent standard will be treated as a drug requiring FDA review and approval prior to marketing and sale.

This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlights the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S. It will provide an introduction to veterinary stem cell therapy, an overview of the veterinary drug approval product, a summary of FDA’s potential reliance on human cellular regulations to regulate such products, and recommendations for industry on strategies for mitigating FDA enforcement risks.

Learning Objectives:

• Provide an introduction to the veterinary regenerative medicine and stem cell therapy market.
• Gain a basic understanding of FDA's regulatory oversight of cellular and other complex biotech products for use in animals.
• Provide attendees with an overview of how stem cells products are currently regulated by FDA.
• Describe the criteria used by FDA for distinguishing between a stem cell product regulated as a drug and one that is not, and how a similar standard may be applied to veterinary stem cell products.
• Learn how FDA is currently regulating drug products for veterinary use.
• Highlight known FDA regulatory activity in the market.
• Discuss what FDA looks for when is reviews labeling and identify some of the biggest mistakes made when it comes to marketing and advertising.
• Provide recommendations for mitigating the risk of FDA enforcement action.

Areas Covered in the Seminar:

• Who regulates veterinary cellular and tissue products; and biotherapeutic products intended for commercialization.
• FDA's regulation of veterinary regenerative medicine including stem cells and other biotherapeutics.
• FDA's currently regulation of human cellular and tissue products; and how those same regulatory policies may be applied to veterinary products.
• Discussion of the new animal drug approval process.
• The potential for a drug / non-drug distinction to be made between products based on the amount of processing applied to the product.
• What are the requirements for labeling, marketing and advertising such a product.
• Strategies for mitigating FDA enforcement risks.

Who Will Benefit:

• Regulatory Affairs Professionals
• Professors
• Managers
• Consultants
• Scientists
• Research Analysts
• State Policy Officials
• Insurers focusing on Representations & Warranties Insurance
• Investment Analysts
• Venture Capitalists
• Stem Cell Companies, Biotech, Animal Drug Companies, Pharmaceutical Companies, Veterinarians, Veterinary Hospitals and Clinics
• Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to domestic and international pharmaceutical, medical device and biotech companies on issues related to the U.S. Food and Drug Administration’s regulation of human and veterinary drugs, devices and biologics. He regularly assists clients with determining the regulatory status of proposed products and how such product may be regulated by FDA. He also specifically helps companies with the development of strategies for the marketing and sale of regenerative medicine products include cellular, tissue and gene therapies. He frequently presents and has published on such topics.

Topic Background:

The rapid development of cell-based and related biological therapies in veterinary medicine has provided additional options for safe and effective alternatives to traditional drug products. Scientific evidence and study data show positive results for the treatment of tendon strain injuries, suspensory desmitis, arthritis, congestive heart failure and other commonly diagnosed diseases and injuries. In addition to the potential for a more functionally optimal repair, biological therapies are particularly attractive for use in performance horses because there are currently no applicable withholding requirements that might restrict subsequent participation in competitions. Biological therapies are also increasingly used for the treatment of musculoskeletal injuries in human athletes with several high-profile successes being covered by the mainstream media.

FDA’s Center for Veterinary Medicine (“CVM”) asserts primary and exclusive regulatory jurisdiction over veterinary regenerative products and their future commercialization in the U.S. Despite asserting such authority, CVM has neither adopted regulations nor published official guidance articulating its regulatory position on such products. However, the FDA is currently working on a document for publication that will publicly articulate its regulatory position on veterinary regenerative products. The Agency has yet to say however when it will be published.

All indications suggest that FDA will create a regulatory scheme modeled after its approach to the regulation of human cellular and tissue products. FDA’s position on the use of cell- and tissue-based therapeutic agents, including stem cells, in human medicine was released in 2006, and in the absence of regulatory guidance specific to veterinary products, this position can be used to predict FDA’s potential position on veterinary biologic and regenerative therapies, if and when regulatory oversight is applied to veterinary use. In human medicine, cell- and tissue-based therapies are termed “human cells, tissues, and cellular and tissue-based products”, or HCT/Ps, and are defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient”. This definition covers allografts of bone, ligament, skin, and dura mater, as well as stem cell therapies.

Under CVM’s current regulatory approach, a veterinary regenerative product exceeding a hypothetical veterinary equivalent Minimal Manipulation Standard will generally be treated as a new animal drug product requiring FDA approval prior to marketing and sale. Under that proposed regulatory approach, a drug v. non-drug distinction will be made on the level of processing used to manufacture the proposed product. There is however an argument that such therapies fall under the regulation of the practice of veterinary medicine, because of their autologous nature, and that product approval should not be required. It is unlikely however that the final regulatory approach will triumph in the end.

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