About Mary Jeanne Kallman

Mary Jeanne Kallman has over 22 years of pharmaceutical industry experience in safety pharmacology and neuroscience. She spent 17 years at Eli Lilly in various roles including research adviser and group leader for safety pharmacology. She is a recognized leader in the development of abuse liability and risk assessment strategies and has served as President of the Safety Pharmacology Society as well as the Chair of the pHRMA/PSLC technical working group on abuse liability and she is currently co-Chair of the Cross Company Abuse Liability Consortium. In her present position as Director of Nonclinical Global Neuroscience at Covance Inc., she provides leadership for the neuroscience strategy across all Covance sites for delivering all central nervous system evaluations. She is engaged in the identification and development of preclinical models for evaluation of pharmaceutical compounds and specifically in the delivery of neuroscience strategies for drug abuse assessment.

Addressing the Challenges of Abuse Liability Testing – Meeting Regulatory Requirements and Study Design

Addressing the Challenges of Abuse Liability Testing – Meeting Regulatory Requirements and Study Design

Identifying clinically useful compounds and developing a novel drug treatment to improve human health has many rewards. But with increasing press about the growing abuse of prescription medications and potentials for physiological or physical dependence, regulatory agencies around the world have taken note.

Called abuse liability testing, this stage of drug development was first officially recognized in 1970 with the U.S. Controlled Substances Act. Since then, many iterations and guidelines have been developed to determine a compound’s potential for abuse.

Abuse liability studies are very important because they are required by the regulatory agencies in U.S., Europe, and even Asia for setting the scheduling of new chemical entities that come into the marketplace. Continue reading