Developers of drugs with central nervous system (CNS) activity rightly focus on physical safety and efficacy first, particularly in the case of products intended for rare disorders or diagnoses often unresponsive to existing therapeutic options. These products may have little if any apparent CNS mediated effects but crossing the blood-brain barrier is sufficient to trigger the FDA requirement for an abuse potential assessment. This webinar is the second part of a 2-part series.
Part 1 on June 28, discusses the following:
- FDA Guidance on Assessment of Abuse Potential of Drugs: What drug development timelines need to avoid delays and unexpected costs
- Assessment needed to characterize a drug’s potential as part of the safety evaluation of the substance
- Non-clinical safety assessments and human data
- Assessments to provide early indication of the potential need for risk management programs
This second webinar in a two-part series will provide a complementary overview of the requirements for conduct of Human Abuse Potential assessment and clinical abuse potential data integration into the regulatory framework of an 8-Factor Analysis. The session will include a discussion of recent experience and regulatory interactions with the FDA, along with information on submitting an abuse potential assessment and the needed components of a full development plan, details on design, analysis and interpretation of human abuse liability studies. Featured speakers will outline the principals and issues involved in the design, analysis and interpretation of clinical abuse potential studies and discuss the potential for the Take Drug Again subjective response to serve as a primary endpoint in HAP studies.
The webinar will have the following learning objectives:
- Outlining the principles and issues involved in the design, analysis and interpretation of clinical abuse potential studies
- Consider timing and strategy of the assessment of human abuse potential in order to satisfy regulatory requirements/expectations
- Understand the integration of clinical data in the 8-Factor Analysis/Modular Abuse Potential submission to FDA
Topics will include:
- Determining a drug’s abuse potential
- When Should an Abuse Potential Assessment be submitted to FDA?
- What should be included in an Abuse Potential Submission?
- Human laboratory studies
- Human abuse potential study in recreational drug users
- Related pharmacology studies
- Clinical trial data relative to Abuse Potential Assessments
- Labeling and drug scheduling
- Discuss the potential of the Take Drug Again endpoint as a primary endpoint in Human Abuse Potential
- FDA 8-Factor Analysis/Modular Abuse Potential Submission to FDA in NDA
This webinar is the second of a 2-part series. Click here for information about Part 1.
Lynn R. Webster, MD, Vice President of Scientific Affairs, Neurosciences, PRA Health Sciences
Dr. Webster is Vice President of Scientific Affairs for PRA Health Sciences, a clinical research organization that operates in more than 80 countries. He is a past president of the American Academy of Pain Medicine (AAPM). Dr. Webster is the author of the award-winning book, The Painful Truth (Oxford University Press). He is also co-producer of a critically acclaimed television documentary also called The Painful Truth that has been nationally distributed on public television. He earned his Doctor of Medicine from the University of Nebraska and completed his residency in the University of Utah’s Department of Anesthesiology. He is board certified in anesthesiology, pain medicine, and addiction medicine. He has authored more than 300 scientific publications and abstracts. Dr. Webster is a senior editor of the journal Pain Medicine and is a regular contributor to The HillMessage Presenter
Ryan Turncliff, PhD, Sr. Director, Scientific Affairs – Clinical Pharmacology, PRA Health Sciences
Ryan Turncliff, PhD. is a clinical pharmacologist with 15+ years of pharmaceutical drug discovery and development experience. He has developed CNS therapeutic development expertise in pain, addiction, schizophrenia, depression, and multiple sclerosis. He is a past recipient of NIDA funding for research in addiction medicine and is the author of more than 50 publications and presentations. Dr. Turncliff earned a Bachelor of Arts degree in Biochemistry from Skidmore College and completed his doctoral training in pharmaceutics at the University of North Carolina Chapel Hill, Eshelman School of Pharmacy.Message Presenter
Jack Henningfield, PhD, Vice President, Research, Health Policy, and Abuse Liability at PinneyAssociates
Jack E. Henningfield, Ph.D., Vice President, Research, Health Policy and Abuse Liability, PinneyAssociates, and Professor, Adjunct, Behavioral Biology, Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine.
Dr. Henningfield was trained in abuse liability assessment and related sciences in the Psychopharmacology Program at the University of Minnesota and the Behavioral Biology Program of The Johns Hopkins University in the 1970s. In 1980, he joined the National Institute on Drug Abuse (NIDA), which contributes to Controlled Substances Act drug scheduling, where he served as Chief of the Clinical Pharmacology Branch, and the Abuse Potential Assessment Section, and contributed to NIDA’s drug scheduling recommendations. In 1996 he left NIDA and joined PinneyAssociates to provide guidance on the clinical and nonclinical assessment of abuse potential and the development of abuse potential submissions including 8-factor assessments to guide drug scheduling recommendations to FDA and regulatory agencies outside of the US.
Dr. Henningfield has published more than 400 articles and books and contributed to abuse potential assessment monographs from NIDA in the 1980s, FDA’s first draft guidance in 1990, and expert reviews and special conferences on abuse potential involving FDA in the 2000s leading to FDA’s guidances for assessing the abuse potential of drugs and abuse deterrence of opioids.
Who Should Attend?
Mid- and senior-level professionals responsible for regulatory affairs and the clinical development of CNS-active drug products.
Relevant areas of expertise include:
- Regulatory Affairs
- Drug Safety/Pharmacovigilance
- Risk Management
- Project Management
- Clinical Research
- Medical Affairs
- Clinical Affairs
- Research and Development
- Clinical Pharmacology
- Clinical Operations
- Project Management
What You Will Learn
- Abuse potential assessment in the context of drug products for products that cross the blood-brain barrier, but not typically considered as having abuse potential
- The Final FDA Guidance to Industry on Assessment of Abuse Potential of Drugs
- The role of abuse potential assessment and the 8-factor analysis in drug scheduling and control
- Studies to assess abuse potential of CNS-active products during the development cycle
- How to leverage assessment results to support appropriate scheduling and patient access
- Overall development planning for and timing of human abuse potential studies
- Design of abuse potential studies and logistical considerations including timelines
- Appropriate selection of comparators based on compound characterization
- Understanding dose selection and route of administration
- Examples and case studies of Controlled Substance Staff (CSS) feedback and interactions
- 8-Factor Analyses: Labeling and drug scheduling
- Interpretation and analysis of results to support regulatory objectives, appropriate scheduling and label considerations
PRA Health Sciences’ early phase professionals live and breathe clinical pharmacology. As the most comprehensive high-end Phase I CRO in the world, PRA Early Development Services provide a unique scientific environment required for complex compound development in both healthy volunteers and special patient populations. Committed to the highest standards of clinical excellence and scientific expertise, we operate state-of-the-art facilities in North America and The Netherlands and as well as an innovative patient pharmacology model in Central and Eastern Europe. Our fully harmonized, GLP-compliant laboratories are located close to our clinical units, enabling us to quickly analyze time-critical samples.
PinneyAssociates helps our pharmaceutical and consumer healthcare clients to reduce their regulatory risk and enhance the commercial and public health value of their life sciences products. During the past 40 years, PinneyAssociates experts have advised and served with pharmaceutical companies, the National Institute on Drug Abuse, College on Problems of Drug Dependence, the FDA, and others in the development of comprehensive abuse potential assessment, tamper testing of abuse deterrent formulations, and risk management for CNS drugs.