Completed
Current data suggests that drug development, from the start of a research program to FDA approval, can take anywhere from 10 to 17 years. However, there is a need to speed up this lengthy drug development process. On April 8-9, 2013, the Forum on Neuroscience and Nervous System Disorders hosted a public workshop Accelerating Therapeutic Development for Nervous System Disorders towards First-in-Human Trials. This workshop explored opportunities to hasten the pathway from discovery to approval of the new therapeutics for nervous system disorders. Participants discussed the potential usefulness of new and emerging technologies in neuroscience research and potential challanges.
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Workshop
ยท2014
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop part...
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Description
An ad hoc planning committee will plan and host a two-day public workshop to explore opportunities to hasten the pathway from discovery to approval of new therapeutics for nervous system disorders. The workshop will feature invited presentations of new and emerging technologies and allow for interactive discussions around potential challenges.
Participants will be specifically invited to:
- Examine opportunities and challenges in neuroscience research for facilitating faster entry of potential treatments into first-in-human trials.
o Identify avenues for moving directly from cellular models to human trials minimizing the need for animal models to test efficacy
- Discuss the potential usefulness of new neuroscience technologies and techniques that would hasten the translation of research and facilitate the jump from cellular models to first-in-human trials (e.g. iPSCs, in vitro neuronal circuits, connectomics, brain imaging, etc.)
- Consider mechanisms of the regulatory review process which may facilitate faster entry of potential treatments into first-in-human trials.
o Explore the role of alternative tools, methods and approaches for validation (e.g. surrogate models)
- Consider mechanisms for integration and proliferation of new technologies and techniques to the broader neuroscience research community
An individually authored workshop summary will be prepared by a designated rapporteur based on the information gathered and the discussions held during the workshop in accordance with institutional policy and procedures.
Collaborators
Sponsors
Department of Health and Human Services
Private: For Profit
Private: Non Profit
Staff
Diana Pankevich
Lead
Major units and sub-units
Center for Health, People, and Places
Lead
Health and Medicine Division
Lead
Institute of Medicine
Lead
Board on Health Sciences Policy
Lead
Biomedical and Health Sciences Program Area
Lead