This webinar will focus on the regulatory requirements and expectancies for the conduct of studies to support the scheduling of new chemical entities. A perspective will be provided on past approaches to scheduling as well as an overview of the three study types; dependence, drug discrimination, and self-administration. The process of selection of species for conducting these studies will also be discussed.
The results of abuse liability studies are used to make recommendations about scheduling in the form of an 8-factor document. The 8-factor document will include both clinical and preclinical data. Emphasis of this webinar will be on decision-making points and how to design these studies to meet the FDA and EMA requirements.
Mary Jeanne Kallman, Ph.D., Director of Nonclinical Global Neuroscience, Covance
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 advisor 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.Message Presenter
Who Should Attend?
This webinar is intended for Drug development scientists and decision makers with a focus on lead optimization pharmacology & toxicology
Covance, with headquarters in Princeton, New Jersey, is one of the world’s largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 11,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and Pharmaceutical clients’ toughest drug development challenges.
Covance Discovery and Translational Services more effectively and efficiently bridges research gaps by providing integrated solutions throughout preclinical and clinical phases of development. Only Covance drives innovative pipeline development—by integrating Lead Optimization safety and efficacy services with expert capabilities in Biomarkers, Genomics, Antibody Products & Immunology Services.