Leffel Consulting Group provides translational medicine services to pharmaceutical and biotechnology companies desiring external assistance in preclinical and nonclinical programs. We provide expertise in the area of developing vaccines and therapeutics for emerging infectious diseases as well as medical countermeasures (MCMs) for biological, chemical or radiation/nuclear disasters. Scientific and regulatory guidance is provided in the areas of: FDA Animal Rule navigation including model development, inhalation routes of exposure, appropriate designs for successful efficacy studies, interpretation of data, and preparing documents suitable for both government and investor audiences.