Biography

Jeffrey L Larson, Ph.D., DABT is a board certified toxicologist with 14 years of experience within the pharmaceutical industry, including 8 years in development of biologics. He has held a number of positions within the industry, with his most recent position being as Senior Director of Drug Development at Tanox, Inc. in Houston, TX, a monoclonal antibody-based biotech pharmaceutical company. Dr. Larson has held positions within large pharma (Rhone-Poulenc Rorer, now Sanofi Aventis), mid-size pharma (Allergan) and small start-up pharma (Aronex Pharmaceuticals). His breadth of clinical therapeutic areas is broad, encompassing oncology, anti-viral, anti-fungal, anti-inflammatory, respiratory, dermatology and ophthalmic indications.

Dr. Larson began his career as a drug safety toxicologist and has been a Study Director for dozens of studies to support all phases of drug development, including acute to chronic toxicology studies, carcinogenicity studies, reproductive toxicology studies, and in vitro safety studies. He has overseen studies across species including rhesus and cynomolgus monkeys, baboons, and chimpanzees. He has also traveled to China to investigate the use of contract facilities in that country for primate proof-of-concept and toxicology studies and has established relationships with several contract research organizations.

In addition to his specialization in toxicology, Dr. Larson has had oversight in all realms of preclinical drug development including in vivo proof-of-concept pharmacology studies. He has been involved in numerous tumor xenograft studies in mice and has conducted efficacy studies in primates. His expertise further includes pharmacokinetics studies in animals, modeling of the data, and predictive simulations. He had responsibility for all clinical pharmacology activities while at Tanox and authored multiple clinical trial protocols and reports of clinical pharmacology data. Dr. Larson offers pharmacokinetic modeling services using WinNonlin (Pharsight® Corporation) software. His clinical experience also includes clinical research associate responsibilities, clinical trials management, and clinical operations activities. This clinical experience has proved very valuable in the overall design of drug development and clinical trials strategies and provides him with a unique perspective in preclinical development.

As the majority of his experience has been in a small company environment, his experiences have been an amalgamation of activities spanning the research bench to New Drug Application filing. His leadership skills were recognized within Tanox where he led multiple project teams and was a key participant in company objective and goal setting. Dr. Larson has had oversight for Institutional Animal Care and Use Committees and vivarium management. In terms of extramural activities, Dr. Larson has had numerous interactions with FDA regarding IND submissions and preclinical and clinical protocol designs. He has authored a number of INDs including submissions for asthma, oncology, and inflammation programs.

Dr. Larson received his Ph.D. in Toxicology/Pharmacology from Washington State University in 1990. He held a postdoctoral fellowship from 1991-1993 at the Chemical Industry Institute of Toxicology (CIIT) in Research Triangle Park, NC. During his fellowship at CIIT, Dr. Larson received the Frank Blood Award for the Best Paper in Fundamental and Applied Pharmacology (1995). Dr. Larson accepted a position within the Drug Safety Department at Rhone-Poulenc Rorer (now Sanofi-Aventis) where he was a staff toxicologist (1993-1997). Dr. Larson has held toxicology positions at Allergan (1997-1998) and Aronex Pharmaceuticals (1998-1999). During his tenure at Aronex, he also gained valuable experience as a Clinical Research Associate (CRA) and Clinical Trials Manager. Dr. Larson joined Sierra Biomedical Inc. in San Diego in 1999 and was Director of Toxicology until the closure of the department in 2001. He joined Tanox, Inc. in 2001 as the Director of Toxicology and Pharmacokinetics in 2001 and was the Senior Director of Drug Development at the time the company was acquired by Genentech in 2007. Dr. Larson is a full member of the Society of Toxicology (SOT) and the American College of Toxicology (ACT) and has been a Diplomate of the American Board of Toxicology (DABT) since 1994.