Second AIMBE Workshop on
Validation and Qualification of New In Vitro Tools and Models for
The Pre-clinical Drug Discovery Process
September 17-18, 2012
Lister Hill Auditorium, NIH, Bethesda, MD
The American Institute for Medical and Biological Engineering (AIMBE) will be holding the second 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 September 17-18, 2012 in Bethesda. The agenda and goals for the first meeting, which covered current perspectives on validation as well as latest technologies for pre-clinical regulatory science can be found on AIMBE’s website (www.aimbe.wpengine.com). 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 September workshop will build upon the results and recommendations of the first workshop 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.
On day one of the workshop, the first session will review current perspectives on validation and qualification of new in vitro technologies from the perspective of the National Toxicology Program, the European Medicines Agency, and the National Institute for Standards and Technology (NIST). In the second session, an overview of new technologies that could be validated and qualified in the near future for use in pre-clinical drug discovery will be presented including “organ on a chip” grants recently funded by the NIH, a high content screening platform, the drug discovery industry, and a laboratory-developed immune system for vaccines, that will be one of the technical evaluations on the second day.
On day two of the Workshop, drafting of validation and qualification guidelines will begin with talks on the two remaining technologies chosen as examples for evaluation. Session three will also consist of brief overviews of the three example technologies followed by a perspective on validation and qualification guidelines for these technologies by teams led by AIMBE fellows. Each overview will be followed by general audience participation for input on drafting guidelines for each of the three chosen technologies. It is expected that there will emerge common guidelines for validation and qualification among the different technologies but also some uniqueness for each. The fourth session will present the results of the breakout groups followed by a discussion to get feedback from the remainder of the participants and begin planning for the follow-on workshops.
To register for this event, email Jason Hibner at email@example.com with your name, degrees, title, institute, and contact email.
Pre-Registration deadline is Friday, September 14, 2012, with on-site registration available during both days of the workshop.
Registration is free.
September 17 Day 1
|8:00-8:45 AM||Continental Breakfast and Check-In|
|8:45-9:00 AM||Welcome and Goals of the Workshop James Hickman, PhD, AIMBE BOD member and Professor, University of Central Florida|
|9:00-9:15 AM||Welcome from the AIMBE President Raphael Lee, MD, ScD, Professor, University of Chicago Medicine|
|Session 1:9:15-9:25 AM||Current Government Perspectives on Validation and Qualification Moderator: Christine A. Kelley, PhD, AIMBE Fellow and Director, Division of Discovery Science & Technology, NIBIB/NIH|
|9:25-10:10 AM||Validation of New Technology by NICEATM/ICCVAM William S. Stokes, DVM., DACLAM; Executive Director, Interagency Coordinating Committee on the Validation of Alternative Methods|
|10:35-11:20 AM||Validation of New Technology for Use in Drug Discovery in Europe Sonja Beken, PhD, Belgian Federal Agency for Medicines and Health and the European Medicines Agency|
|11:20-12:05 AM||Validation of New Technology from a NIST Point of ViewAnne Plant, PhD, Leader of the Cell Systems Science Group, NIST|
In Vitro Technologies for Draft Validation Guidelines Moderator:
Rosemarie Hunziker, PhD, Director of Tissue Engineering/Regenerative Medicine, Biomaterials and Medical Devices, NIBIB
NIH Technologies for Pre-clinical Regulatory Science
Dan Tagle, PhD, Associate Director for Special Initiatives, NCATS/NIH
|High Content Screening: Michael Jackson, PhD, V.P. of Drug Discovery and Development, Sanford Burnham Research Institute
Validation of New Technology from an Industry Perspective Jack Reynolds, PhD, Co-founder and CEO, AnaBios Corporation
|4:15-5:00 PM||Validation of New Technology from a Developer Viewpoint William Warren, PhD, AIMBE Fellow and VP, Head of VaxDesign Campus, Sanofi Pasteur|
|Group Discussion and plans for day 2
Reception-Lister Hill Lobby
September 18 Day 2
|8:00-9:00 AM||Continental Breakfast|
|Session 3:9:00-9:20 AM||Development of Draft Validation Guidelines Moderator: James Hickman, PhD, AIMBE BOD member and Professor, University of Central Florida,|
|9:20-10:00 AM||Experience using PBPK Models in Clinical Pharmacology Reviews Ping Zhao, PhD, Senior Clinical Pharmacologist CDER/FDA|
|10:00-10:40 AM||Human Body-on-a-Chip Systems Michael Shuler, PhD, AIMBE Fellow and Professor and Chair, Department of Biomedical Engineering, Cornell University|
|11:00-11:20 AM||Discussion of Sanofi-Pasteur’s MIMIC system. Presentation leader – Warren Grundfest, Ph.D., AIMBE BOD and Professor and Chair, Department of Biomedical Engineering, UCLA|
|Group discussions on validation guidelines for MIMIC system.
Discussion of Shuler’s Body-on-a-chip system. Presentation leader – Bill Bentley, Ph.D., AIMBE BOD and Professor and Chair, Department of Bioengineering, University of Maryland
Group discussion on validation guidelines for Body-on-a-chip system.
Discussion of Zhao’s in silico PBPK Model. Presentation leader – Michael Shuler, PhD, AIMBE Fellow and Professor and Chair, Department of Biomedical Engineering, Cornell University
Group discussion on in silico PBPK Model.
|Breakout Group 1 Report— Warren Grundfest, AIMBE