Invite-Only Webinar: Scientific and Regulatory Considerations for the Design and Conduct of Human Abuse Potential Studies (HAP)

CNS-active new molecular entities (NMEs) are subject to an abuse potential evaluation and this evaluation may require a pivotal human abuse potential (HAP) study. An informed approach and expertly planned execution are critical to keep your clinical development program on-track toward a successful approval.

Hosted by Rho, Altreos, and Dr. Vince Clinical Research, join our experts as they discuss important aspects of designing and conducting HAP studies to satisfy regulatory requirements for abuse potential assessments.

This webinar will discuss:

  • When in the drug development process a sponsor should engage with the Controlled Substance Staff at FDA
  • Will a HAP study be required
  • Statistical considerations and powering of HAP studies
  • What other clinical data analyses is needed in a HAP study
  • Operational conduct of HAP studies

Webinar Available On-Demand Monday, September 26, 2022

Naama Levy-Cooperman, Ph.D.


Dr. Levy-Cooperman has extensive experience in CNS drug development, behavioral and neurocognitive assessment, and evaluation of abuse potential, including involvement in the design and analysis of over 70 clinical studies. Dr. Levy-Cooperman has presented her research internationally and has a number of peer-reviewed research papers. Dr. Levy-Cooperman completed her Ph.D. in Neuroscience from the University Of Toronto Institute Of Medical Science. Dr. Levy-Cooperman’s previous research interests were in cognitive neurology and neuroimaging in neurodegenerative disorders. Dr. Levy-Cooperman began her career in 2008 working as a research scientist for a clinical research company (INC Research). Dr. Levy-Cooperman has been involved in the design and critical review of abuse potential and other Phase 1 studies as well as in the design of Phase 2 and 3 clinical studies in a number of indications. She has expertise in selection and analysis of neurocognitive assessments, as well as regulatory and legal scientific support for the development of new drug products. As a founding partner of Altreos Research Partners, Dr. Levy-Cooperman continues her work in abuse potential by providing scientific and regulatory consulting, medical writing, and assessment of abuse potential of new molecular entities (NMEs) and novel formulations of existing products.


Kerri A. Schoedel, Ph.D.


Dr. Schoedel has extensive experience in clinical pharmacology, CNS drug development, and the assessment of abuse potential in preclinical and clinical studies, including the design and analysis of over 50 human abuse potential studies. Dr. Schoedel has contributed to over 100 research and review articles, book chapters, and national/international scientific presentations, primarily in abuse liability and CNS drug development. Dr. Schoedel is also a member of the College on Problems of Drug Dependence, and regularly organizes and participates in meetings with regulatory agencies to advance abuse liability methodology. Dr. Schoedel completed her Ph.D. in Pharmacology at the University of Toronto, with a specialization in nicotine addiction. Dr. Schoedel joined INC Research (formerly Ventana/DecisionLine CRC and Kendle) in 2004 as a research scientist, was promoted to Scientific Director in 2008 and Sr. Director, Clinical Pharmacology in 2013. At INC Research, Dr. Schoedel directed the Clinical Pharmacology group, lead strategic planning and was responsible for study design and support for scientific projects, including clinical studies (human abuse potential, safety/tolerability, pharmacokinetics, thorough ECG, and neurocognition). Dr. Schoedel has been involved in the preparation of numerous NDA and EMA drug abuse liability submissions, including those related to both NMEs and ADFs, and has interacted extensively with regulatory agencies.


Megan J. Shram, Ph.D.


Dr. Shram has over 20 years of experience in addiction research, and extensive knowledge in clinical pharmacology and abuse potential assessment. Dr. Shram has been involved in the design, management and analysis of over 80 clinical studies, primarily within the CNS area. Her preclinical experience also enables her to provide valuable input in the design and interpretation of animal abuse potential studies. She has assisted in developing comprehensive abuse potential programs for NMEs and abuse-deterrent formulations, and regularly prepares NDA drug abuse potential submissions. Dr. Shram is an adjunct professor of Pharmacology at the University of Toronto, has published numerous research articles in peer-reviewed journals and regularly presents at scientific meetings. Dr. Shram received her M.Sc. and Ph.D at the University of Toronto with specialization in Behavioral Pharmacology, during which she evaluated age and sex differences in response to various drugs of abuse.


Ben Vaughn, Chief Strategist, Biostatistics & Protocol Design


A proven leader in the industry for more than 20 years, Mr. Ben Vaughn serves as Rho’s Chief Strategist for Biostatistics and Protocol Design. In this role, he utilizes his extensive expertise to guide sponsors through marketing applications, regulatory interactions, and the design and analysis of analgesia trials. Mr. Vaughn has supported over 50 pain trials, over 30 marketing applications, and 5 FDA advisory committee meetings (both back room and bullpen) over the course of his career. In the past year alone, he has had speaking roles in 12 FDA Type A, B, and C meetings. His experience spans many therapeutic areas with emphasis on abuse liability trials, substance use disorders, as well as other psychiatric disorders and rare disease (orphan) products. Mr. Vaughn earned both his bachelor’s and master’s degrees in Biostatistics from UNC-Chapel Hill.