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5

NIBIB/AIMBE Fifth Workshop

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”

6:00-8:00 PM
AIMBE Sponsored Reception-Hyatt Regency Bethesda (above Bethesda Metro)