Tuition:$450 if ONLY attending Clinical Trials Course
If attending ASENT Annual Meeting and the Course, add $200 to annual meeting registration
Requirements: Your CV or Biosketch (for the purposes of workshop assignments)
Included: Course materials provided onsite
Not Included: Travel and Hotel are NOT included
Credentials Provided: Certificate of Completion
About the Program
ASENT is pleased to offer our 2-day intensive course on Neurotherapeutics Clinical Trials. This year the course will be held March 15 - 16, 2027 at the Hyatt Regency Bethesda, in Bethesda, MD. The course is designed to introduce those interested in learning the principles of neurotherapeutics clinical trial development and implementation. The course is relevant to anyone interested in effectively conducting neurotherapeutics clinical trials.
The course covers the principles of clinical trials from pre-clinical programs to Phase III design and implementation, including necessary regulatory and IND enabling studies, IRB oversight, adverse event tracking and reporting. The course considers clinical trials in the neurotherapeutic space for both drugs and devices. The course addresses the unique challenges inherent in developing treatments for nervous system disorders.
Course Features
Didactic sessions
Interactive workshops where participants will work in teams on projects such as drafting protocols and addressing adverse events
Panel discussions with lively Q&A
Networking breaks with industry leaders
We are excited to have the opportunity to offer this course, which we believe will help to advance the availability of new drugs for patients with neurological conditions.
Participants
This course is designed for those interested in learning more about neurotherapeutic clinical trials. Here is a sense of who you might encounter at the course:
Academic Clinicians
Clinician-Investigators
Clinical Neurologists
Clinical Research Professionals
Drug Discovery Neuroscientists
Clinical Scientists
Clinical Trial Unit Directors
CROs
Industry Clinicians
Trainees (Basic, Clinical, Translational)
Learning Objectives
This 2-day course will introduce participants to the principles of neurotherapeutic clinical trial development and implementation. The course is relevant to anyone interested in effectively conducting neurotherapeutic clinical trials.
Students will learn:
The history of clinical trials
Present-day structure of clinical trials
Overview of preclinical and IND enabling studies
Best practices and processes for selecting sites and investigators
Steps required to ensure adequate assessment of safety and efficacy within Phase I and II
Design and implementation of multicenter trials in Phase III
Issues in drafting protocols and assessing adverse events
Practical aspects of managing Phase II and III data
Course Design
The course combines didactic lectures with active engagement activities in which the students will be challenged to utilize the lecture material during group workshops on protocol design and adverse events.
This course is designed to provide clinicians, scientists, and clinical research professionals with a knowledge base necessary to lead and conduct neurotherapeutic clinical trials.
Course Topics
Some of the topics covered in the course include:
Introduction and broad overview of the genesis of clinical trials and the protection of human participants
Present structure, with a focus on phases and types of trials, equipoise, oversight, and informed consent
Discovery, translation of novel mechanisms into a viable target for treatment, and toxicology studies
Process of obtaining investigational new drug and investigational device exemption status for clinical trials
Complexities of selecting sites and investigators
Phase I - safety, tolerability, pharmacokinetics, and pharmacodynamics
Phase II - demonstrating efficacy
Phase III - implementation of multicenter trials
Adverse Events - recognition, evaluation, and reporting
Critical elements of protocol design
Practical aspects of phase III data, including data capture and reporting
Faculty
The course faculty consists of leaders in the field of neurotherapeutics in industry, academia, and government, with combined decades of experience in clinical trials. Participating faculty include:
Debra Ehrlich, MD, MS, Director of the Parkinson's Disease Clinic, Intramural Research, Program Director for the Clinical Movement Disorders Fellowship Program, NINDS, NIH
Gail Farfel, PhD, Board Director of Neurvati Neurosciences and GRIN Therapeutics
W. Douglas Figg, Sr., PharmD, MBA, Senior Investigator, National Cancer Institute, NIH
Nichol McBee, MPH, Research Associate, Project Lead, Johns Hopkins University Trial Innovation Center, Johns Hopkins School of Medicine
W. Andrew Mould, MPH, Research Associate, Associate Director, BIOS Clinical Trials Coordinating CenterJohns Hopkins School of Medicine
Michael Rogawski, MD, PhD, Professor of Neurology, UC Davis
Continuing Engagement Activities Following the Course
Students will be encouraged to connect with faculty mentors following the course. In an effort to facilitate these connections both students and faculty will have several opportunities to network during the ASENT Annual Meeting immediately following the course. These networking opportunities will help foster these connections to ensure they are lasting relationships that course participants can access in the future.
Course Venue
The 2027 offering of ASENT’s Clinical Trials Course will be held Monday, March 15 - Tuesday, March 16, 2027 at the Hyatt Regency Bethesda in Bethesda, Maryland. The course will be held in person only - no virtual option is available at this time.
Course Location
Hyatt Regency Bethesda, Bethesda, MD
How to Register
See upcoming events below to register for the Clinical Trials Course in addition to or separate from the Annual Meeting registration.
American Society for Experimental Neurotherapeutics