Advanced Animal Biologics Workshop

This workshop is designed for people tasked with developing and maintaining an animal health company’s product portfolio and involved with a company’s regulatory strategies. This includes individuals involved with regulatory affairs, veterinary product development, conducting due diligence for product or company acquisitions, those tasked with ensuring corporate compliance, and members of investment companies working to learn about the industry. Among others, this includes:

• Personnel new to the Industry
• Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) employees
• Entrepreneurs
• Regulatory agents
• U.S. agents of foreign corporations
• Process owners
• Record retention specialists
• Legal professionals
• Financial advisors and institutional investors
• Consultants, inspectors and cGxP experts

Upon completing this course on veterinary biologics regulations participants will have learned:

• Terminology, definitions and the history of veterinary biologic laws and regulations
• How it is determined whether USDA or FDA has jurisdiction over the products
• How submissions are made to the agency
• Overview of the registration and licensing process
• Overview of the types of products licensed by the CVB (Autogenous, Antibody, Platform, Prescription, Diagnostic Test Kits, etc.)
• Master seed and cell concepts
• Risk assessment documents
• Immunogenicity study requirements
• Assay development and validation
• Other required studies for licensure (Reversion to virulence, safety, efficacy, etc.)
• Labeling and packaging requirements
• Requirements for an Outline of Production
• Requirements for USDA production, quality facilities, and quality systems
• Compliance following licensure
• Review of the items that the agency will review during an audit
• Facility documents, 2007 forms and 2008 forms
• Review of appropriate Advertising and Promotional Materials

Norm Brown
Norm Brown has 35 years of veterinary vaccine regulatory and quality experience with companies including Boehringer-Ingelheim Animal Health, Merck Animal Health, Diamond Animal Health and Mallinckrodt Veterinary. Mr. Brown is an experienced leader with a diverse background and a customer-oriented approach. His background specifically includes regulatory and compliance resolution, new product registration, product complaint resolution, international registration, system critique, and continuous improvement implementation. Mr. Brown graduated from University of Nebraska with an B.S. in Microbiology and an M.S. in Veterinary Services.

Terrie Jo Hamtak
Terrie Jo Hamtak started her career in human health as a microbiologist from California State University- Long Beach, before entering the animal health world at the Veterinary Medical Diagnostic, University of Missouri, Columbia. From the veterinary diagnostic arena, she moved into the animal health industry working for several large firms in various departments from Quality, Virus Production, Regulatory Affairs, R&D, Quality Technical Support and most recently Compliance Programs. Mrs. Hamtak is currently the director of Large Molecules Compliance Programs for Intervet Inc. d/b/a Merck Animal Health with a major focus on regulatory and quality management compliance. She also actively pursues activities in animal health organizations, including but not limited to, the Animal Health Institute (AHI) and the Association of Veterinary Biologics Companies (AVBC). One never stops learning, even after 40 years in the industry. She notes that she learn something new and exciting about the world of animal health and compliance every day. On a personal note, Terrie Jo keeps very busy with training her puppy training as a service dog for her husband, as well as being a gardener with a love of roses.

Helen Smith
Helen Smith received her Bachelor of Science and Master of Science degrees from the University of Guelph. Following graduation in 1992, she joined Langford Laboratories, then a division of Cyanamid Canada, supervising the Viral Quality Control group and developing a Viral Research and Development team. Following a company takeover and then a subsequent move to Fort Dodge, Helen continued work in Bovine Viral R&D. After a brief interlude in Assay Development, Helen started her career in Biological Regulatory Affairs in 1998 with Fort Dodge Animal Health. Through changes in companies and mergers Helen continued her career in Biological Regulatory Affairs at Schering-Plough Animal Health, which became part of Merck Animal Health, and worked at Boehringer Ingelheim as the Head of U.S. Biological Regulatory Affairs for Livestock and Equine. Helen is currently the Director of Regulatory Affairs at Ceva Animal Health.