New In Vitro Tools and Models for the Pre-Clinical Drug Discovery Process
February 12, 2015 | Lister Hill Auditorium, NIH Campus | Bethesda, MD
Location and Registration
The workshop will be held in the Lister Hill Auditorium on the NIH campus in Bethesda, Maryland. Additional information, agenda, a link to registration, and information on previous workshops in this series can be found at: NIBIB’s Event Website
Program Schedule
8:00-8:30 AM
Continental Breakfast and Check-In
8:30-8:45 AM
Welcome from the Organizers and Goals of the Workshop James Hickman, Ph.D., AIMBE Fellow and Professor, University of Central Florida
Christine A. Kelley, Ph.D., AIMBE Fellow and Director, Division of Discovery Science & Technology, NIBIB/NIH
8:45-8:55 AM
Welcome from AIMBE Ravi Bellamkonda, Ph.D., AIMBE President, Chair, Biomedical Engineering Georgia Tech
8:55-9:05 AM
Welcome from NIBIB William Heetderks, M.D., Ph.D. Acting Deputy Director, NIBIB/NIH
8:55-9:05 AM
NCATS Welcome and Perspective Christopher P. Austin, M.D., Director, National Center for Advancing Translational Sciences, NIH
Session 1:
Moderator: TBD
9:25-10:00 AM
FDA/CDRH-- in vitro devices for efficacy Alberto Gutierrez, Ph.D., Director Office of In Vitro Diagnostic Device Evaluation and Safety, FDA
10:00-10:15 AM
Breaks
10:15-10:50 AM
FDA/CDER---Ideas on efficacy for in vitro systems Timothy McGovern, Ph.D., Center for Drug Evaluation and Research (CDER), FDA
10:50-11:25 PM
European Innovative Medicines Initiative (IMI) on in vitro prediction of efficacy Beatriz Silva Lima, Ph.D., iMED.UL Universidade de Lisboa, IMI Scientific Committee Chair
11:25-12:00 AM
NCATS Rare Diseases Pamela McInnes, DDS., Deputy Director, NCATS, Acting Director, Office of Rare Diseases Research,
NCATS, Office of Rare Disease Research
12:00-1:00 PM
Lunch
Session 2:
Moderator: TBD
1:00-1:40 PM
Vertex Pharmaceuticals’ program on predicting efficacy Fred Van Goor, PhD, Vertex Pharmaceuticals
1:40-2:20 PM
CIRM funded disease banking systems for induced pluripotent stem cells Thomas J Novak, PhD, VP, Strategic Partnerships, Cellular Dynamics International speaker
2:20-3:00 PM
Fit and of the biomimetic MIMIC system to assess biologic function William Warren, Ph.D., Head of VaxDesign Campus, Sanofi Pasteur
3:00-3:20 AM
Breaks
Session 3:
Moderator: TBD
3:20-4:00 PM
Low cost multi organ in vitro systems for efficacy Michael L. Shuler, PhD, CEO/President, Hesperos, LLC
4:00-4:40 PM
Title TBD Joseph C. Wu, MD, PhD, Director, Stanford Cardiovascular Institute, Professor,
Dept of Medicine/Cardiology & Radiology, Stanford University School of Medicine
4:40-5:20 PM
Induced pluripotent stem cell models of diseases Stephen M. W. Chang, PhD, Vice President, Research and Development, The New York Stem Cell Foundation Lab
5:20-5:50 PM
Group Discussion to plan next workshop on “Applications to Rare Neglected Diseases”