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2025 Training in Neurotherapeutic Clinical Trials:
Development and Implementation

Course Overview

 CLINICAL TRIALS COURSE APPLICATION 

APPLICATION DEADLINE EXTENDED: November 19, 2024

Format: In Person
Application: Free
Tuition: $450 for Accepted Applicants (includes access to Annual Meeting)
Requirements: Completed Application
Credentials: Certificate of Completion

Not Included: Travel and Hotel is not included for all participants

About This Training Program

ASENT is pleased to offer a 2-day course March 10-11, 2025 at the Hyatt Regency Bethesda, in Bethesda, MD to introduce clinicians interested in clinical research to the principles of neurotherapeutic clinical trial development and implementation. The course will be especially relevant if you are a neurologist with clinical experience interested in conducting neurotherapeutic clinical trials.

The course covers the principles of clinical trials from pre-clinical programs to Phase III design and implementation, including necessary regulatory conversations and IND enabling studies, IRB oversight and adverse event tracking and reporting. The course considers clinical trials in the neurotherapeutic space for both drugs and devices. The faculty will also address the unique challenges inherent in developing treatments for nervous system disorders.

This year, we have expanded on those features of the course that proved to bring participants the most immediate value.

Course Will Feature

  • 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. If your work would benefit from an understanding of neurologic clinical trials you are encouraged to apply.

Eligibility

This course is designed for those interested in conducting neurotherapeutic clinical trials. Applicants should have some familiarity with clinical research; however, any clinical investigator who would benefit from the course is invited to apply. Those in academia, industry and in private practice are encouraged welcome to apply. As the course will be held in person at the Hyatt Regency Bethesda, in Bethesda, MD, applicants must be available to attend the entire course in person. (Virtual option is not available at this time.)

Apply

All applicants must apply using the online process, which can be initiated using the link below or at the top of the page. Upon entering your information you will be sent an email providing you with a link to complete the application. All that is required is basic information and your CV.

 CLINICAL TRIALS COURSE APPLICATION 

Selection Process

Applicants will be evaluated based on the strength of their CV and likelihood to implement the learnings from the course. Applicants will be notified of their acceptance in November, 2024. Enrollment will be limited to a maximum of 50 students for the 2025 course. 

Learning Objectives

This 2-day course will introduce researchers and clinicians to the principles of neurotherapeutic clinical trial development and implementation and will provide participants with knowledge elements required to successfully conduct a neurotherapeutic clinical trial as a site lead or team member.

The training, which is designed to be applicable to diverse diseases of the nervous system, will equip students with a broad understanding of the various component steps in the clinical trial process.

 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, students will be equipped with the skills to conduct a neurotherapeutic clinical trial as a site lead or team member, and work collaboratively with subject experts in each of the component areas.

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 2025 offering of ASENT’s Clinical Trials Course will be held Monday, March 10 - Tuesday, March 11, 2024 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

    Contact
    Please direct all application questions to caroline@asent.org

     CLINICAL TRIALS COURSE APPLICATION 


    Upcoming events

    • 2025 Abstract Submissions

      • August 15, 2024
      • November 19, 2024
      • 11:59 PM
      • Hyatt Regency Bethesda, Bethesda MD
      Register

      Submitting an Abstract to ASENT

      DEADLINE EXTENDED: Nov 19, 2024 11:59PM ET

      The Abstract Review Committee is committed to presenting the best in neurotherapeutic research at the ASENT Annual Meeting.

      Abstracts selected for presentation by our esteemed review committee will be presented as either a poster or a pipeline presentation at the ASENT 2024 Annual Meeting which will take place at the Hyatt Regency Bethesda in Bethesda, MD, March 12-14, 2024. 

      All abstracts selected for presentation will be listed in the program and will be published in the society's high impact journal Neurotherapeutics, which is published by Elsevier and led by Editor in Chief, M. Maral Mouradian, MD. 

      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.

      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.

      Upon registering and paying the abstract fee, you will be sent a confirmation email with a link to the Abstract Submission System. If you have not used our partner, Oxford Abstracts, you will be asked to create an account. This will allow you to edit your submission as needed.

      Below you will find details regarding Posters, Pipeline, Guidelines, Eligibility and the benefits of submitting.

      GUIDELINES

      Title: Sentence Case (Max 50 Words)
      Abstract Body: One Paragraph with no subheadings and no tables or graphs (Max 250 Words) Include a sentence on study's purpose, brief description of methods, summary of results, and statement of conclusions reached.
      Authors: Sentence Case

      ELIGIBILITY FAQs 

      - Encore Abstracts, those that have been previously presented at other recent scientific meetings, or submitted for consideration to other scientific meetings, are welcome.

       - International and traditionally underrepresented submissions are welcome.

       - Private, Public and Startup Companies are welcome to submit.

       - Academic researchers and trainees are welcome to submit.

      NOTE: Case studies are NOT considered whereas, Trials in Progress ARE accepted if they can show a novel trial design or new development.

      POSTER PRESENTATIONS
      If your abstract is selected for a poster, you will need to be available to participate in a poster presentation at the annual meeting. This is scheduled to take place on Thursday, March 13 at 5pm.

      PIPELINE 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 one of our Pipeline Presentation sessions. ASENT encourages abstracts from private, public and startup companies and government or academic labs that contain neurotherapeutic research results.

      The ASENT Annual Meeting attracts leaders in neurotherapeutics from all over the world, in all disease states. Pipeline presentations increase exposure to strategic partners in life sciences who have supported novel approaches through partnerships or strategic investments.  

      Past presenters have reported the following results:

      • increase in stock values in the days following the presentation
      • financially beneficial partnerships as a result of presentation
      • development of new companies as a result of participation in meeting

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

      Show details

    • ASENT 2025 Clinical Trials Course

      • March 10, 2025
      • March 11, 2025
      • Hyatt Regency Bethesda, Bethesda MD

      Training in Neurotherapeutic Clinical Trials: Development and Implementation Course

      APPLICATION DEADLINE EXTENDED: NOVEMBER 19, 2024

      APPLY TODAY

      DOWNLOAD THE BROCHURE

      About the Course

      • Format: In Person 
      • Application: Free 
      • Tuition: $450 for Accepted Applicants 
      • Requirements: Completed Application 
      • Credentials Provided: Certificate of Completion 
      • Included: Course materials, Discounted Registration for ASENT Annual Meeting, Discounted fee to Submit Abstract to ASENT. 
      • Not Included: Travel and Hotel is not included for all participants

      ASENT is pleased to offer a 2-day course March 10-11, 2025 at the Hyatt Regency Bethesda, in Bethesda, MD to introduce researchers and clinicians to the principles of neurotherapeutic clinical trial development and implementation. The course will be especially relevant if you are interested in conducting neurotherapeutic clinical trials.

      The course covers the principles of clinical trials from pre-clinical programs to Phase III design and implementation, including necessary regulatory conversations and IND enabling studies, IRB oversight and adverse event tracking and reporting. The course considers clinical trials in the neurotherapeutic space for both drugs and devices. The course will also address the unique challenges inherent in developing treatments for nervous system disorders. 

      The course will feature a mix of:

      • 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 

      • Discounted access to the ASENT Annual Meeting

      APPLY TODAY

      DOWNLOAD THE BROCHURE


      Participants who attend the course will have ongoing access to senior faculty in attendance in a mentoring capacity. We anticipate that most applicants will have some familiarity with clinical research however, any clinical investigator who would benefit from the course is invited to apply. Those in industry and in private practice are also welcome to apply. The course will be offered annually and participants have discounted access to the ASENT Annual Meeting.

      You will be asked to provide:

      • Name
      • Contact Information
      • CV
      • A one page letter of interest

      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. If your work would benefit from an understanding of neurologic clinical trials you are encouraged to apply.

      APPLY TODAY

      DOWNLOAD THE BROCHURE


      Show details

    • ASENT 2025 Annual Meeting

      • March 12, 2025
      • 8:00 AM
      • March 14, 2025
      • 1:00 PM
      • Hyatt Regency Bethesda, Bethesda, MD
      Register

      ABOUT ASENT 2025 Annual Meeting

      The ASENT 2025 Annual Meeting, which will take place March 12 - 14, 2025 at the Hyatt Regency Bethesda in Bethesda, MD, is the premier neuroscience and neurotherapeutics conference 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.

      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

      Physician-Scientists | Neurologists | Neuroscientists | Trainees | Drug and Device Companies | CROs | Fellows | Post-docs | Founders | Funders | Industry Leaders | Nonprofit Organizations and Advocacy Groups | Journal Editors | Representatives from NIH, NIA, NIDA, NINDS and FDA


      Show details
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