Drug Use Liability Assessment - NDA
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Abuse Liability Assessment of New Drugs from Candidate Selection to New Drug Application
Prescription drug abuse is a growing global challenge that underlines the importance of assessing the abuse potential of pharmaceutical products and implementing measures designed to control their non-medical use. New drug applications (NDA) for medications that could affect the central nervous system must include an assessment of their potential for abuse.
This webinar will explain what pharmaceutical drug abuse liability assessment implies and which factors must be taken into consideration when approaching these studies in light of the regulatory requirements. Given the complexity of the scheduling process, and the experimental subtleties that can impact on preclinical and clinical studies used to support a drug’s schedule, it is essential that abuse liability investigations are designed with the utmost care. An integrated approach in the earliest stages of development can provide valuable benefits in terms of timelines and likelihood of success.
Key discussion points of the webinar:
- Regulatory environment of abuse potential of CNS active compounds under development
- Scheduling process and implications
- Critical steps and decision points for the assessment of abuse potential of CNS active compounds
- Tiered approach: overview of core preclinical studies
About the Speakers
Mary Jeanne Kallman PhD, DSP
Mary Jeanne was an Associate Professor and Director of the PhD Experimental Graduate Program at the University of Mississippi for 9 years. She worked for Lilly Research Labs for 17 years as the Group Leader for Safety Pharmacology in their Toxicology Group where she provided drug develop solutions in rodents, primates and dogs as needed. She also worked for Covance Laboratories, a large CRO, as the Global Director of Neuroscience and she is currently managing a consulting business which provides input on CNS issue resolution and abuse liability strategies for drugs in development.
- Mary Jeanne earned a PhD from the University of Georgia in Neuroscience and completed a postdoctoral fellowship in pharmacology and toxicology at Virginia Commonwealth University
- Mary Jeanne holds diplomate status in the Safety Pharmacology Society and she has held several professional leadership positions including President of the Safety Pharmacology Society, Leader of the Scientific Liaison Coalition (SLC) of SOT, and co-leader of the Cross Company Abuse Liability Council (CCALC)
Mary Jeanne frequently publishes scientific papers, book chapters, and presents on various CNS issues. She received EPA and NIH funding for her research and support of her academic laboratory.
Michela Tessari, Research Leader, Abuse Liability, Global Preclinical Development, Evotec
Michela is an experienced pharmaceutical scientist with a strong expertise in the drug dependence field. She has contributed to many programs as an in-vivo pharmacologist responsible for the behavioral assays (pharmacodynamic and disease) in rodents with relevance for multiple CNS disease areas. She has led the implementation of GLP regulations in the conduction of behavioral studies for the investigation of abuse potential.
- Michela has a degree in Biology from the University of Padua (Italy) and a postgraduate master degree in Experimental Pharmacology from the University of Milan (Italy)
- She is currently responsible for abuse liability assessment studies within Preclinical Development at Evotec
Michela is a member of the Safety Pharmacology Society.
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