2026 Training in Neurotherapeutic Clinical Trials:
Development and Implementation

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FAQs

Format: In Person at Hyatt Regency Bethesda, MD

Tuition: $350 if ONLY attending Clinical Trials Course
If attending ASENT Annual Meeting + Course add $150 to annual meeting registration 

Requirements: You will be asked to complete informational form and share 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 This Training Program

ASENT is pleased to offer our 2-day intensive course on Neurotherapeutics Clinical Trials. This year the course will be held March 2 - 3, 2026 at the Hyatt Regency Bethesda, in Bethesda, MD. The course is designed to introduce those interested in learning the principles of neurotherapeutic clinical trial development and implementation. The course is relevant to those interested in effectively conducting neurotherapeutic clinical trials.

The course covers the principles of clinical trials from pre-clinical programs to Phase IV 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 that go in depth into a wide range of topics

• 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 dinners 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 those interested in effectively conducting neurotherapeutic clinical trials.

The course covers the principles of clinical trials from pre-clinical programs to Phase IV design and implementation, including necessary regulatory conversations 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.

Students will learn:

• The genesis of clinical trials

• Present structure of clinical trials 

• About preclinical and IND enabling studies

• The process complexity of selecting sites and investigators

• Steps required to ensure safety and efficacy within Phase I and II

• About the design and implementation of multicenter trials in Phase III

• How to address issues in drafting protocols and assessing adverse events

• The practical aspects of Phase III data

In sum, participants will be provided with the skills to effectively conduct neurotherapeutic clinical trials.

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 with the practical skills necessary to successfully lead neurotherapeutic clinical trial sites. ASENT has created this new mechanism to support the education and development of clinicians to become high quality trialists. 

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

• The elements involved in Protocol design

• Practical aspects of Phase III data, including data concerns, capture and reporting
  
  

Faculty

The course faculty is made up of leaders in the field of Neurotherapeutics throughout industry, academia, and government, and offer a depth of expertise in clinical trials that is unparalleled. Each presenter has a deep subject matter expertise and an enormous base of experience so as to benefit participants both during the course and in the years following. Below you will find a list of our esteemed faculty:

• Debra Ehrlich, MD, MS, Director of the Parkinson's Disease Clinic, Intramural Research, NINDS, Program Director for the Clinical Movement Disorders Fellowship Program, NIH
• Gail Farfel, PhD, Consultant
• W. Douglas Figg, Sr., PharmD, Senior Investigator, 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
• Svetlana Shore, PhD, Director, Clinical Development, Neurocrine Biosciences
• Kenneth Sommerville, MD, Consultant, Sommerville Consulting
• Lauren Reoma, MD, Deputy Clinical Director, and Director, Clinical Trials Unit, Office of the Clinical DirectorNIH
  
• Michael Rogawski, MD, PhD, Professor, Neurology, UC Davis
• Robert Wechsler, MD, PHD, FAES, FAAN, Consultants in Epilepsy & Neurology PLLC

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 2026 offering of ASENT’s Clinical Trials Course will be held Monday, March 2 - Tuesday, March 3, 2025 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

Register

Download Course Brochure Register to Participate