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

March 19, 2012

Location: Lister Hill Auditorium, NIH Main Campus

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not only to be qualified by the FDA for use in drug discovery, but also to be considered for replacing existing, outdated technologies.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.

• Agenda
• Participant List

Event Presentations:

• Welcome and Goals of the Summit
  James Hickman, Ph.D., University of Central Florida, AIMBE BOD member
• Welcome from the AIMBE President
  Raphael Lee, MD, Sc.D., University of Chicago Medicine
• Address from the NIBIB Director
  Roderic I. Pettigrew, Ph.D., MD, Director, NIBIB/NIH
• Session I: Current Perspectives on Validation
  Moderator: Mohammed Heidaran, Ph.D., CBER/FDA
  • Introduction
    Mohammed Heidaran, Ph.D., CBER/FDA
  • Development and Validation of New Technologies for use in the Drug Discovery and Toxicology
    Christopher Austin, MD, NCATS/ NIH
  • Validation/Qualification Issues for Enabling Technologies for Drug Discovery
    David Stresser, Ph.D., BD Biosciences
  • From Engineering Validation to Qualification of Biomarkers, an FDA Success Story
    Federico Goodsaid, Ph.D., Vertex Pharmaceuticals
• Session II: Latest Technologies for Pre-clinical Regulatory Science
  Moderator: Rosemarie Hunziker, Ph.D., NIBIB/NIH
  • Introduction
    Rosemarie Hunziker, Ph.D., NIBIB/NIH
  • Experience using PBPK Models in Clinical Pharmacology Reviews
    Ping Zhao, Clinical Pharmacology CDER/FDA
  • Functional in vitro Systems for Drug Discovery
    Mike Shuler, Ph.D., Cornell University
  • Organs on Chips
    Donald Ingber, MD, Ph.D., Wyss Institute/Harvard
  • Liver Construct for Drug Screening and Toxicity
    Dawn Applegate, Ph.D., CEO RegeneMed
  • Stem Cell Technologies for Pre-clinical Drug Discovery
    Nick Thomas, Ph.D., GE Healthcare
  • Pre-clinical Imaging Technologies
    John Elliott Ph.D., NIST

Event sponsors:

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

This event was not recorded or archived.