Co-Sponsored with
Who Should Attend
Industrial, government, and academic professionals involved in the research, development or regulation of veterinary pharmaceuticals.
Goals and Objectives
This two-day workshop serves the animal health community with rare programming specifically tailored to this field. This workshop will bring together an international, cross-disciplinary audience to examine contemporary challenges and new advances impacting the global animal health industry. Specific objectives are to
- review and discuss current Veterinary ICH regulations/regulatory guidances and industry practices related to the globalization of the animal health pharmaceuticals industry,
- review and discuss current & emerging tools / models used to characterize and predict the clinical performance of animal health drugs,
- review and discuss opportunities and barriers to the expansion of therapeutic options in animal medicine including the introduction of novel dosage forms and use of opiates.
Background
Meeting the global demand for animal health products requires increased efficiency, smart use of resources and predictive tools, and an expansion of our therapeutic options. Economic considerations have forced the animal health industry to increase dependence on contract research and manufacturing organizations, as well as “in-house” resources located offshore. In order to make the best use of resources and bring innovative products to market as quickly as possible, it is essential to understand worldwide regulatory requirements and guidances. This workshop will highlight regulations and contemporary industry practices that will help the audience better identify opportunities and navigate pitfalls for successful global product registrations. For example, presentations will address the progress of global harmonization under the Veterinary ICH guidelines, leveraging clinical data for worldwide market applications, and impediments to achieving one set of global product specifications.
Tools for predicting drug performance are of critical importance to animal health, and also in human health because of the role animal studies play in the early screening and development of human drug candidates. Meeting the demand for fast, efficient ways of screening & evaluating drug candidates requires tools such as validated biomarkers, PK-PD modeling, and an understanding of metabolic differences across species. These and other important tools will be discussed at this workshop.
The final workshop topic, Expanding Our Therapeutic Options, includes presentations on improved utilization of existing available drugs such as opiates, advances in biotherapeutics for animal health, as well as the opportunities and impediments to bringing truly novel drugs and delivery technologies to market.
Programming Committee
Jay C. Brumfield, Ph.D., Intervet/Schering-Plough Animal Health, Co-Chair
Krishan Kumar, Ph.D., Pharmaceutical Development Solutions, Co-Chair
Robert Albright, Ph.D., Pfizer Animal Health
Carleton J. Barbour, Ph.D., Intervet/Schering-Plough Animal Health
Pamela Boner, Ph.D., Pfizer Animal Health
Terrence P. Clark, D.V.M., Ph.D., Procyon Pharmaceuticals
Carol A. Davis, Ph.D., University of Illinois
Raafat Fahmy, Ph.D., U.S. Food and Drug Administration
Todd P. Foster, Ph.D., Pfizer Animal Health
Grace Gowda, Ph.D., Merial
Marilyn N. Martinez, Ph.D., U.S. Food and Drug Administration
Sunil Narishetty, Ph.D., Pfizer Animal Health
