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  • Clinical Trials Course

2026 Training in Neurotherapeutic Clinical Trials:
Development and Implementation

 Download Course Brochure Register to Participate

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



    Upcoming events

    • 2026 Abstract Submissions

      • September 23, 2025
      • October 27, 2025
      • 11:59 PM
      • Hyatt Regency Bethesda, Bethesda MD
      Register

      Submitting an Abstract to ASENT

      Deadline: October 27, 2025 at 11:59PM ET

      The Abstract Review Committee is committed to presenting the best in neurotherapeutic research at the ASENT Annual Meeting. All abstracts are evaluated by experts in neurotherapeutics according to the following criteria and overall merit:

      1. Scientific or clinical impact
      2. Quality of data, analysis, and presentation
      3. Relevance to the discovery and/or development of neurotherapeutics and inclusion of novel targets or new initiatives.
      4. Abstracts must be submitted, presented, and cited in English.

      The abstract should describe original research broadly relevant to the goal of ASENT, which is to encourage and advance the development of improved therapies for diseases and disorders of the nervous system. Please check your abstract carefully for typographical errors, misspellings, etc. Be sure to include data results.

      FAQs on Eligibility

      • ASENT welcomes Encore Abstracts, or those abstracts that have been previously presented at other recent scientific meetings, or submitted for consideration to other scientific meetings.
      • Trainees and early career researchers are encouraged to submit
      • All sectors (academic, industry, government, etc.) are welcome to submit
      • Trial Designs or Trials in Progress are welcome and considered 
      • Case Studies or Case Reports will not be considered

      If Accepted

      One presenting author must be designated to attend the Annual Meeting in person. All attendees must register to attend the meeting via asent.org separate from this form. 

      Poster Presentations
      If your abstract is selected for a poster, you will need to be available to participate in our poster presentation at the annual meeting. This is scheduled to take place on Wednesday, March 4, 2026 at 5pm.

      Oral Presentations
      Submitted abstracts that most closely conform to the above criteria, and the ASENT goals, may also be selected for a 10-minute oral presentation (including 2 minute Q&A) at our Oral  Presentation session. ASENT encourages abstracts from private, public and startup companies and government or academic labs that contain neurotherapeutic research results.

      About the Meeting
      The ASENT Annual Meeting attracts a broad spectrum of researchers, clinicians, investors, and other leaders in neurotherapeutics from all over the world, in all neurologic disease states. Oral presentations increase exposure to strategic partners in life sciences who have supported novel approaches through partnerships or strategic investments.

      For questions regarding abstracts, please email jessica@asent.org.

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    • ASENT 2026 Annual Meeting and Clinical Trials Course

      • March 02, 2026
      • 8:00 AM
      • March 06, 2026
      • 1:00 PM
      • Hyatt Regency Bethesda, Bethesda, MD
      Register

      ABOUT the MEeting

      Neurotherapeutic Clinical Trials Course: March 2-3, 2026
      ASENT 2026 Annual Meeting: March 4-6, 2026

      The ASENT 2026 Annual Meeting and Clinical Trials Course, the premier neurotherapeutics conference will take place March 2 - 6, 2026 at the Hyatt Regency Bethesda in Bethesda, MD. This scientific meeting is where senior leaders from leading payers, providers, employers, investors, fast-growing startups, pharma, policymakers, funders and innovation centers gather with one central focus, improving the process of bringing neurotherapeutics to market.

      Advance Program Submit an Abstract Register Clinical Trials Course Exhibit Opportunities


      ASENT's popular Neurotherapeutic Clinical Trials Course runs March 2-3. Followed by the ASENT 2026 Annual Meeting, which runs March 4-6, all in one location.

      Attendees interested in participating in both the Clinical Trials Course and Annual Meeting are encouraged to select the appropriate registration level and then add on the clinical trials course during the registration process for an additional $150.

      The plenary sessions, panel discussions, outstanding pipeline presentations and poster sessions focus on the latest science in neurotherapeutics. The conference content will focus on the latest science in neurotherapeutics including innovations across disease states, novel delivery systems, gene therapy and biomarkers, and of course the latest drug therapies and devices. The event features plenary sessions, panel discussions, satellite luncheons, networking meetings, pipeline presentations and poster sessions.

      WHO ATTENDS

      Chief Medical Officers | Chief Scientific Officers | Clinician-Investigators | Clinical Research Professionals | Clinical Scientists Clinical Trial Unit Directors | CROs | Drug Discovery Neuroscientists  Founders | Funders | Innovation Centers | Investors / Venture Capital | Journal Editors | Medical Directors | MSLs | Patient Advocates | Regulatory Science Professionals | Research Scientists | Trainees (Basic, Clinical, Translational)

      Show details
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