Name and Educational Degree: Larson, Jeffrey, Ph.D., D.A.B.T. Certifications DABT Education Ph.D. Toxicology/Pharmacology Washington State University Business Address: 2314 Acadiana Lane Seabrook, Texas 77586 USA Contact Information: Telephone: 713-294-2694 Fax: Mobile Number: Email Address: larson@paradyconsulting.com Web Site URL: http://www.paradyconsulting.com Specialties Development of biologics and drugs including study design, regulatory discussion, preparations of regulatory filings (IND, BLA, NDA, CTD, Annual Reports, Clinical Pharmacology sections of Clinical Protocols).   Offering development expertise in proof-of-concept pharmacology, GLP toxicology, clinical and non-clinical pharmacokinetics (including WinNonlin modeling).  Project Management from research to marketing approval.   Study conduct and monitoring in China.  Broad experience in primate toxicology. Experience 15 years experience in the pharmaceutical industry, including 8 years in biologics, with a special emphasis on monoclonal antibodies.  Board certified toxicologist and Study Director for repeated dose, reproductive, and carcinogenicity studies.  WinNonlin modeling experience.  Direct interaction with FDA from pre-IND through NDA filing.  Multiple IND and NDA filings.  Project leadership experience driving projects from research into the clinic.  Clinical experience including clinical research associate and clinical trials manager provides breadth of experience across disciplines.  Vivarium management and IACUC leadership. << Back to Index of Consultants