Translational research encompasses a range of activities needed to develop and implement a new therapy for the clinic. This symposium will review new resources and diverse perspectives central to efficient and effective translational research. Specifically, the ILAE/AES Joint Translational Task Force will present updates from their efforts to accelerate preclinical translational research with preclinical common data elements, harmonization of EEG and other methods, choice of preclinical endpoints for translation to human studies, and multicenter preclinical trials. In addition, the pros and cons of drug discovery programs based on empiric observation versus known mechanism-of-action will be debated. The utility of preclinical translational research in humans will be discussed, with focus on neurotechnology and device-based therapeutics. Lastly, the expectations and requirements for successful translational programs will be reviewed from the perspective of both regulators and commercial developers.
Following participation in this activity, should be able to:
- Define translation and describe its constituent elements, sometimes referred to as T0-T6
- Review the work of the ILAE/AES joint task force, which addresses limitations in the traditional preclinical approaches that have impeded translation into human therapies
- Describe the areas identified by the ILAE/AES task force that should be addressed, including:
- Preclinical common data elements
- Harmonization of EEG and other methods
- Identifying preclinical endpoints that will be translatable to clinical endpoints in human studies
- Multicenter trials to expedite the progress of preclinical research projects and to demonstrate reproducibility of the findings
- Discuss the relative benefits of translational research that begins by establishing mechanism of action as contrasted to research that begins with screening or empiric observation
- Identify funding opportunities for each approach and critically assess research utilizing either approach
- Discuss current and soon-to-come therapies for epilepsy and comorbid conditions and be prepared for changes in practice that will occur as devices become a standard approach to epilepsy therapy
- Identify what is required to move a promising therapy from preclinical and early clinical work to late stage commercial development and consider these elements when developing a long-term translational plan
- Delineate the basic components of regulatory requirements for efficient translation of preclinical and clinical development
- Delineate the mechanisms by which FDA guidance can be obtained
- Identify NIH and FDA-harmonized clinical trial templates
- Restate the requirements for advancing a promising therapy from preclinical and early clinical work to late stage commercial development; incorporate these elements when developing a long-term translational plan
Neurologists, epileptologists, pediatric neurologists, researchers, nurses, psychologists/neuropsychologists, nurse practitioners/physician assistants, pharmacists
Chairs: Andrew J. Cole, M.D. and Martha Morrell, M.D.
Registered Attendees have free access to 2017 meeting recordings. Contact firstname.lastname@example.org if you need the coupon code.