Beth Leffel

Background

About Beth Leffel

Life science executive with 25 years of experience in leading preclinical and nonclinical drug development programs including translational medicine services to accompany product development and regulatory strategies. Assistance is provided in the development and characterization of animal models, advancement of aerosol research of biothreat and infectious agents and progressing medical countermeasures for licensure by the FDA Animal Rule, New Drug Applications and Biologics License Applications. Primary specialization is in vaccine/therapeutic development for emerging infectious disease indications and biological/radiological/chemical protection. Accomplished in strategic portfolio management; translational medicine; FDA Animal Rule; aerobiology; directing research, development and commercialization programs; Good Laboratory Practices; and promoting responsible science in all stages of product development for corporate and government programs. Specialties: biodefense; animal models of infectious disease and radiation-induced syndromes; medical countermeasure (MCM) development; pre-IND packages; government contracting; contract research organization oversight; liaison between company and customer.