AIMBE/NIH Summit on Validation and Qualification of New In Vitro Tools for the Pre-Clinical Drug Discovery Process

Lister Hill Auditorium, NIH Main Campus

Program Area
Meeting summaries and reports

This Summit focused on understanding the process necessary for getting new technologies validated, before being submitted to the FDA, that could be used in evaluating small molecules and biologics in the drug development process. Specific emphasis was on in vitro technologies that will augment or replace existing models, especially animal models. Qualification of validated technologies was also discussed in context of the new Regulatory Science and Engineering Initiative. This Summit was held by the American Institute for Medical and Biological Engineering (AIMBE) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH.

The first session of the Summit attempted to define what validation means to the FDA, NIH and the drug discovery community in a series of presentations and also addressed what are the barriers for broad validation of NIH developed technologies. There were also presentations describing how the FDA qualifies new technologies for use by the general community as well as a case study on validation/qualification of biomarkers.

The second session gave an overview of new technologies that are at the cutting edge of Regulatory Science and Engineering or technologies that could be validated and qualified in the near term future for use in pre-clinical drug discovery, such as platforms, devices, imaging and computational models.

The third session will build upon events of the previous two sessions to discuss these technologies in terms of what it would take to have them validated, not only to be qualified by the FDA for use in drug discovery, but also to be considered for replacing existing, outdated technologies.

This was the first in a series of meetings sponsored by AIMBE and NIH. It is envisioned that the second meeting, held September 17-18, 2012, will be a workshop focusing on validation/qualification issues small molecules as well as for biologics.

Event Presentations:


Event sponsors:

  • American Institute for Medical and Biological Engineering
  • University of Virginia

This event was not recorded or archived.