Fourth AIMBE/NIH Workshop on Validation and Qualification of New In Vitro Tools

DATE CHANGE: March 6-7, 2014

NIH Campus, Lister Hill Auditorium (Breakout sessions in Natcher)

The American Institute for Medical and Biological Engineering (AIMBE) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) will be holding the fourth meeting in a series of Workshops addressing the topic of Validation and Qualification of New In Vitro Tools and Models for the Pre-clinical Drug Discovery Process on November 6-7, 2013 in Bethesda, MD. The overall goal of this series of workshops is to develop guidelines for investigators developing new tools for the pre-clinical drug development process on how to validate these new technologies so that they become useful, meaningful tools. The agenda and goals for the first three meetings, which covered current perspectives on validation as well as latest technologies for pre-clinical regulatory science, can be found at the following links:

March 19, 2012: Summit
September 18, 2012: Second Workshop
March 14-15, 2013: Third Workshop

This November’s workshop will build upon the results and recommendations of the previous workshops and will begin to develop guidelines for validation and qualification of new model systems. Specific emphasis will be on model systems that may augment or replace existing models, especially animal models, in the FDA drug approval process.

Day one of the workshop will review current perspectives on validation and qualification of new in vitro technologies from the perspective of the National Toxicology Program, ICCVAM, ECVAM, the European Medicines Agency, and the Food and Drug Administration (FDA). On day two of the Workshop, discussion of validation and qualification guidelines will begin with talks on five technologies chosen as examples for evaluation followed by a perspective on validation and qualification guidelines for these technologies by teams led by AIMBE fellows. Breakout session will follow with general audience participation for input on what guidelines would be necessary for each of the three chosen technologies. The results of the breakout groups will be presented, followed by a discussion to get feedback from the remainder of the participants and begin planning for the follow-on workshops.

Registration:
http://fourthnibibaimbewkshp.eventbrite.com

Event sponsors:
· American Institute for Medical and Biological Engineering
· National Institute of Biomedical Imaging and Bioengineering
· The University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI)

Chairs:

• James J Hickman, PhD
  AIMBE Board of Directors
  Professor of Nanoscience Technology, Chemistry, Biomolecular Science, and Electrical Engineering
  University of Central Florida
  jhickman@mail.ucf.edu

• Christine A. Kelley, PhD
  AIMBE Fellow
  Director
  Division of Discovery Science and Technology
  National Institute of Biomedical Imaging and Bioengineering
  NIH
  kelleyc@mail.nih.gov