Discover this groundbreaking webinar delving into the latest insights from the Cross-Company Abuse Liability Council (CCALC) and The Food and Drug Administration (FDA) in drug development and clinical evaluation of human drug abuse and dependence potential. This webinar aims to discuss current knowledge and recent updates on the clinical evaluation of the abuse and dependence potential of drugs. In September 2023, the CCALC, a group of representatives from the industry, held its first face-to-face meeting with members of the Controlled Substances Staff of The FDA since 2018. At this meeting, key opinion leaders discussed nonclinical and clinical assessments, current issues in the design and analysis of these studies and pertinent topics that have emerged based on recent trends in drug development (e.g., hallucinogens). The clinical portion of the meeting discussed a broad range of topics; however, the current webinar will focus on updating attendees on:
1) Discussions relating to the design and statistical analysis of human abuse potential (HAP) studies
2) Challenges related to recording and documenting abuse-related adverse events
3) Regulatory requirements for assessing physical dependence and withdrawal within a clinical program
HAP studies are randomized crossovers evaluating multiple dose levels of the new chemical entity (NME), positive control(s) with known abuse potential and placebo, using a range of subjective effects measures administered at multiple time points. Their designs include an enriched sample of “experienced recreational drug users”, as well as highly sensitive endpoints (“canary in the coalmine” approach). These safety studies are often geared towards excluding false negatives (i.e., concluding no abuse potential, when it exists), usually at the expense of false positive results (concluding abuse potential when there isn’t any).
Non-linear dose responses (inverted U-shape) associated with drugs of abuse can present challenges in interpretation, as can the variability and “distributional” violations associated with the subjective measures. These factors can make the analysis and interpretation of these data difficult.
Join this webinar to gain valuable knowledge from the recent CCALC meeting, FDA guidelines, and discussions on advancements in drug development.
Dr. Lynn Webster, MD, Executive Vice President, Scientific Affairs, Dr. Vince Clinical Research
Dr. Lynn Webster is an internationally recognized clinical research expert in pain and addiction medicine. He has participated as an Investigator in hundreds of clinical trials and has authored more than 300 peer-reviewed articles. He is board-certified in anesthesiology, pain medicine and addiction medicine. He is the former Co-Founder of Lifetree Medical as well as an Editor of Pain Medicine. Dr. Webster also serves as a Peer Reviewer of several professional journals and is a National Institute of Health Grant Reviewer. He has significant expertise in clinical research with a focus on experimental pain models, human abuse potential studies as well as assessing drugs’ effects on respiratory depression.
Dr. Naama Levy-Cooperman, PhD, Director, Altreos Research Partners
Dr. Naama Levy-Cooperman completed her Doctorate in Neuroscience from the University of Toronto Institute of Medical Science. Dr. Levy-Cooperman has over 15 years of experience in CNS drug development, behavioral and neurocognitive assessment and critical review and evaluation of abuse potential, including involvement in the design and analysis of over 75 Phase I clinical studies. Dr. Levy-Cooperman has presented her research internationally and has many peer-reviewed research papers. Dr. Levy-Cooperman has extensive experience in the design, critical review and evaluation of abuse liability and Phase I clinical studies and review of neurocognitive aspects of clinical trials.
Dr. Kerri Schoedel, PhD, Director, Altreos Research Partners
Dr. Kerri Schoedel completed her PhD in Pharmacology at the University of Toronto, with a specialization in nicotine pharmacokinetics and addiction. Dr. Schoedel has extensive experience in neuro- and clinical pharmacology, CNS drug development and the assessment of abuse potential in pre-clinical and clinical studies, including contribution to the design and analysis of over 80 human abuse potential studies and over 100 research and review articles, book chapters and national/international scientific presentations. Dr. Schoedel has also been involved in the preparation of numerous NDA and EMA drug abuse potential submissions, including those related to both new molecular entities and abuse-deterrent formulations, and has interacted extensively with regulatory agencies.
Who Should Attend?
This webinar is designed for mid- and senior-level professionals responsible for the clinical development and regulatory submissions of central nervous system (CNS)-active drug products, especially those in the areas of psychiatry, substance abuse and dependence and pain. Relevant areas of expertise include:
- Clinical pharmacology
- Clinical research and development
- Clinical operations
- Clinical affairs
- Drug development
- Medical affairs
- Project management
- Regulatory affairs
- Translational medicine
- Experimental medicine
What You Will Learn
Attendees will gain insights into:
- Key topics on clinical evaluation of abuse and dependence potential discussed at the recent CCALC meeting (September 2023)
- Up-to-date recommendations on the design and analysis of human abuse potential studies
- Update on the collection and documentation of abuse-related adverse events
- Guidelines on what the FDA requires/expects with respect to measuring physical dependence and withdrawal in human subjects
Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a world-class early phase CRO (Contract Research Organization) with a custom-built, green-designed headquarters and research complex encompassing three buildings in Overland Park, KS. DVCR’s complex includes a 90-bed clinical pharmacology unit featuring a combination of luxurious and private research suites and a cGMP compliant pharmacy. DVCR specializes in conducting clinical trials for both healthy normal volunteers and patient populations in a wide variety of early phase trials. Support services include project management, data management, biostatistics, monitoring and medical writing. By leveraging both technology and one of the country’s most experienced leadership teams, DVCR provides Smarter, Faster Data to their biopharmaceutical clients.
Vice President, Business Development
Dr. Vince Clinical Research