Workshop A: Deep Dive: Why Advanced Planning is Critical for a Successful Neuropsychiatric Patient Recruitment Strategy
Tuesday November 10, 10:00am – 13:00pm
A major cause of timetable delays and study failure is the failure to adequately plan to execute an effective recruitment campaign.
By attending this workshop, you will learn:
- How to effectively recruit the populations needed for the study by using epidemiological data of the incidence of the target population
- How inclusions and exclusion criteria as well as the design of the study will reduce the percentage of that population who will be interested in participating in the study
- How to determine how many sites in what regions are needed, weighing up the fact that more sites leads to greater costs and variance in the data
- To mitigate the dangers of relying on sites having a database of subjects eager to enroll in your study
Sheldon H. Preskorn
Professor, Department of
Psychiatry & Behavioral Sciences
University of Kansas School of Medicine (UKSM)
Workshop B: Exploring MDMA-assisted Psychotherapy for Neuro-psychiatric Drug Development
Tuesday November 10, 14:00 – 17:00pm
Excitingly, the FDA has granted a Breakthrough Therapy Designation to MDMA-assisted psychotherapy for PTSD.
This workshop aims to delve into this topic and explore how MDMA-assisted psychotherapy may be effective for other indications, like depression, social anxiety in autistic adults and eating disorders.
- Brief overview of the journey towards breakthrough
therapy designation and the history, mechanisms of
action of MDMA including fMRI data
- Diving into Phase 2 data and steps involved in interacting with the FDA to seek permission to move to Phase 3
- Managing Negotiations with the European Medicine Agency
- Introduction to the training programs in place for therapists registered to administer MDMA
- Risk evaluation mitigation strategies for post approval regulation
- How is the FDA going to regulate this?
- Further research and collaborations and the future vision of psychedelic assisted treatment centers worldwide
This workshop will equip you with the skills to understand the scientific basis for FDA’s Breakthrough Therapy Designation Status for MDMA-Assisted Psychotherapy for PTSD. Additionally, you will learn of the drug development strategies which are currently underway, that we anticipate may result in approval for prescription use in 2022.
Multidisciplinary Association for Psychedelic Studies (MAPS)