2021 Course Offering
Due to the ongoing global pandemic, the 2021 course will be held virtually by videoconference. The application process is unchanged from previous years. We hope to provide students the same rich, intensive experience as in years when the course was offered in person.
This training program in neurotherapeutics discovery and development is an intensive 3½ -day course that will provide trainees with the various knowledge elements required to discover and advance a neurotherapeutic agent to Investigational New Drug (IND) Application. Following the course, the training program will continue for a two-year period during which students will have individualized mentoring.
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 neurotherapeutics drug discovery and development process.
Students will learn:
- How to identify a good drug discovery target
- How to construct an assay
- The elements of medicinal chemistry
- How to conduct animal efficacy testing
- The principals of ADME studies and safety/toxicology testing
- The steps required to prepare an IND document
In sum, students will be equipped with the skills to develop and coordinate a drug discovery and development effort and work collaboratively with subject experts in each of the component areas.
The course combines didactic lectures with active engagement activities in which the students will be challenged to utilize the lecture material to work through their own drug discovery project plan with the guidance of the faculty.
Why This Course Is Needed
Because industry engagement in CNS drug discovery has diminished in recent years there is an increased need for university researchers to participate in the development of new therapies for disorders of the nervous system. NIH and other granting agencies have created new mechanisms to support academic drug discovery and development. However, many academic researchers are not equipped with the knowledge base and skills to lead a drug discovery and development project. This course is designed to provide academic researchers with the skills to compete successfully for translational drug discovery and development grant opportunities and to lead an academic drug discovery and development effort.
The course faculty is made up of the pre-eminent practitioners in drug discovery and development. They are drawn from academia, industry and government and have deep subject expertise and an enormous base of experience.
Some of the topics to be covered in the course include:
- Overview of the Neurotherapeutics Discovery and Development Process
- Generating Lead Compounds (Target and Pathway Identification, Biology Basics for Identifying Hits, Medicinal Chemistry, Moving from Hit to Lead to Clinical Candidate, Alternative Approaches to Lead Generation
- ADME, Formulation and Non-Clinical Proof-of-Concept
- Preclinical Proof-of-Concept/Target Engagement Studies
- Principles of Biological Therapies and the Discovery and Development of Specific Biological Therapies for Neuroscience, Including Antibody-Based Therapies, Cell-Based Therapies, and Gene-Based Therapies
- Toxicology, IND Enabling Studies, Preparation of the IND
- Interacting with the FDA
- Intellectual Property
- Funding Academic Drug Discovery Research
Continuing Engagement Activities Following the Course
Students will make contact with a faculty mentor at least once a quarter during the 2-year period following the course, so that they have a continuing source of guidance and mentorship.
The course syllabus and video recordings of the lectures will be available for viewing after the course ends.
This course is designed for advanced post-doctoral researchers and faculty members who are engaged, or would like to become engaged, in neurotherapeutics discovery and development. Occasionally advanced graduate students are accepted. Senior academic professionals are particularly invited to apply if they are considering a career transition to drug discovery and development. Applicants will generally have a doctoral degree in a relevant subject area (Ph.D., M.D., M.D./Ph.D., D.O., D.V.M., Pharm.D. or equivalent). Students interested in applying should contact the course organizers to request a determination of eligibility. NIH policy provides that research education programs should be used primarily for the education of U.S. citizens and permanent residents. Individuals primarily employed in industry are not eligible for this training program.
Individuals from racial and ethnic groups underrepresented in biomedical research, individuals with disabilities and women are particularly encouraged to apply.
Course Venue and Schedule
The course will be held virtually by videoconference. Students are required to participate in the entire course.
Michael A. Rogawski, MD, PhD
Departments of Neurology and Pharmacology
School of Medicine
University of California, Davis
Barbara S. Slusher, PhD, MAS
Department of Neurology
Director, Johns Hopkins Drug Discovery
Johns Hopkins School of Medicine
Karl A. Scheidt, PhD
Department of Chemistry
Weinberg College of Arts & Sciences
About the American Society for Experimental NeuroTherapeutics
Logistical support for the course will be provided by the American Society for Experimental NeuroTherapeutics (ASENT), a 20-year-old non-profit professional organization founded on the belief that bringing new treatments for disorders of the nervous system to patients will be accelerated by communication between the various groups of professionals who contribute to the effort — academic clinicians and researchers, industrial scientists, government regulators, and patient advocates. ASENT publishes the journal Neurotherapeutics. Further information on ASENT is available from the society web site.