Welcome back to the YourCareerEdge Blog. Here’s another contribution from Dr. Rob Hunter, animal health lead instructor and advisor on the topic of animal health regulatory affairs. Rob shares his perspective on the Regulatory 101 workshop he co-teaches with Norm Brown.
“Animal Health Regulatory 101” was first held at K-State Olathe in November of 2019. This two-day workshop covered FDA/CVM (Food and Drug Administration/Center for Veterinary Medicine), USDA/CVB (United States Department of Agriculture/Center for Veterinary Biologics), and a bit on EPA (U.S. Environmental Protection Agency) product approvals at a high level (+30,000 ft). It has been offered two additional times with more than 90 people participating so far from across the US and five international countries. The fourth offering will be April 7-8, 2021.
This workshop provides an animal health industry perspective of how the government agencies regulate different veterinary products, as well as the development and approval processes associated with each agency. The workshop is not intended to be a comprehensive, in-depth regulatory resource, but rather provide attendees with a general overview of the industry’s processes and data needs. As with the human pharmaceutical industry, both innovative products and generic products are essential to the existence of animal health companies. It typically takes 5 to 15 years (shorter time for generics and companion animal products; on the longer end for food animal products) and more than $100 million to advance an animal health drug from initial concept to market. The company has a minimum of 20 years from the time a patent is issued to recoup its development costs. The company may be able to extend that patent time by patenting novel formulations, uses or production processes in addition to strategic approvals to add to the products’ market exclusivity.
This workshop is designed for people who are tasked with developing and maintaining an animal health company’s product portfolio and involved with a company’s regulatory strategies, but may be relatively new to the animal health industry, the species they are developing products for or unfamiliar with the regulatory agency that regulates their company’s product or products. This includes individuals involved with regulatory affairs, product development, conducting due diligence for product or company acquisitions, tasked with ensuring corporate compliance and members of investment companies working to learn about the industry and its regulatory obligations. Previous attendees have had diverse backgrounds including CEOs of human health start-ups interested in the animal health applications of their products, lawyers responsible for compliance of animal health companies, academics interested in the veterinary approval process and seasoned industry veterans looking to stay on top of the latest information.
The workshop provides the following:
- Basic overview of which regulatory body has jurisdiction for the different types of various products.
- For FDA/CVM, review of the 7 technical sections, including the types of studies and data needed to complete each of those technical sections for CVM/FDA. As well as the differences between pioneer and generic requirements and the associated user fees.
- For USDA/CVB, explanation of the CVB’s role in the development, approval and maintenance of veterinary vaccines and biologics, including the documentation requirements, inspection process and post approval maintenance.
- For EPA, a brief discussion of the EPA process, with emphasis on similarities and differences compared to CVM and CVB.
I hope you will attend or refer some of your colleagues to this workshop as it has been both fun and educational for all involved. More information and registration can be found here https://olathe.k-state.edu/professional-dev/workshops-topic/animal-health/. Please don’t hesitate to contact me at firstname.lastname@example.org or Angela Buzard at email@example.com if you have questions or comments. We look forward to working with you!