The FDA Animal Rule – Successful Submission of Animal Efficacy Studies

The presentation will include an overview of the FDA’s Animal Rule followed by an example end-user case study.

The format of the presentation is intended to be informative, keeping the audience abreast of key areas that need to be addressed when developing medical countermeasures (MCM) intended for FDA approval for diseases where human clinical trials are not feasible or ethical.

Critical success factors are addressed including choice of an appropriate animal model, developing a study design that will provide adequate data in the absence of a clinical trial, validation of in vitro biological assays, and key statistical analysis performed.

The case-study will highlight examples of application of the rule to both vaccine and compound efficacy studies in non-human primate and small animal efficacy studies conducted under FDA GLP regulations. Specifically, studies involving orthopoxvirus models, their development and use under the animal rule will be covered,  however these principles are applicable to other countermeasures as well. The speakers will address the complexity of study design, realistic timelines from direct experience, ways timelines can be compressed, factors influencing cost, and funding agency priority lists.

Technical, regulatory and management leaders at Biotech and Pharmaceutical companies as well as students, postdoctoral scientists and experienced subject matter experts from academia interested in submitting compounds, vaccines and biologics for FDA approval with the ultimate goal of supplying the national strategic stockpile with a medical countermeasure.

This webinar will also benefit individuals interested in hearing real-life examples of the application of the Animal rule to compound and vaccine efficacy studies from individuals with firsthand experience in the execution of primate and rodent studies under the FDA animal rule should.

Our presenters have study director and management responsibilities for GLP-studies funded by BARDA and work closely with their industry sponsors.

Dr. Silvera has over 20 years of experience in the development and utility animal models to evaluate preventive and therapeutic approaches for a variety of infectious agents including HIV, Smallpox, Tularemia, Plaque, Q-Fever and Venezuelan Equine Encephalomyelitis Virus. He has served as study director for Q-Fever, Tularemia and VEE vaccine qualification studies intended to lead to FDA licensure of these products by the U.S. military.

Recently, Dr. Silvera successfully managed a multimillion dollar NIAID-DAIDS contract “Simian Vaccine Evaluation Unit (SVEU)” which evaluated novel candidate vaccine approaches for HIV/AIDS in the Simian Immunodeficiency macaque model. He received an Excellent rating on the Contractor Performance Report from NIAID.

Dr. Silvera is responsible for the implementation of all research tasks, reporting data, preparing technical reports, and scientific and budgetary management of the work discussed today and is the Program Leader for the Animal Models and Vaccine Program at Southern Research.

As Director, Dr. Murray leads the operations and science direction of Southern Research’s Department of Infectious Disease within the Drug Development Division. He joined the Institute after twelve years experience in the pharmaceutical industry. Dr. Murray directs approximately $11 million of project revenue from contract and grant-based research for a client base that includes the U.S government, multinational pharmaceutical companies and the Biotech industry.

The department works with a diverse group of infectious agents and animal models of human disease. The major activities currently are vaccine and anti-viral development for HIV, Hepatitis viruses, influenza, and agents of Bioterrorism. Dr. Murray has overall responsibility for the facility containing well equipped high containment laboratories. The facility is fully accredited, and maintains active Certificate of Registration for CDC Select Agents.

Dr. Murray is trained in Quality Responsibilities of Management, and has testing facility management responsibility for studies conducted under Good Laboratory Practice Regulations.

Since 1941, the people of Southern Research have contributed to scientific advancements leading to life-saving drugs, safer space exploration, cleaner air and energy production, and enhanced national defense. Southern Research is a not-for-profit, 501(c)(3) organization conducting basic and applied research in Alabama, Maryland, and North Carolina in the areas of drug discovery, preclinical drug development, advanced engineering, and environmental protection.

Southern Research has a remarkable cancer-fighting track record, having discovered seven FDA-approved drugs used in the treatment or cancer and seven currently in preclinical development or clinical trials. As a leading contract research organization, Southern Research provides preclinical drug development services to pharmaceutical and biotechnology companies on an outsourced basis. Southern Research maintains capabilities in all phases of the early-stage drug discovery and development process and provides clients with comprehensive services and support to assist them in streamlining their custom drug discovery and development programs.