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NEWS & EVENTS

Fifth AIMBE/NIH Workshop on Validation and Qualification of New In Vitro Tools and Models for the Pre-clinical Drug Discovery Process

Thursday, February 12, 2015 - 08:00 to 20:00
NIH Campus, Lister Hill Auditorium, Bethesda, MD

Fifth AIMBE/NIH Workshop on Validation and Qualification of New In Vitro Tools and Models for the Pre-clinical Drug Discovery Process

February 12, 2015

NIH Campus, Lister Hill Auditorium, Bethesda, MD

The American Institute for Medical and Biological Engineering (AIMBE), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the National Center for Advancing Translational Sciences (NCATS) will be holding the fifth 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 February 12, 2015 in Bethesda, MD. The overall goal of this series of workshops is to develop guidelines for investigators developing new tools for the pre-clinical, and possibly clinical, drug development process on how to validate and qualify these new technologies so that they become useful, meaningful tools.  The focus of previous meetings was on drug toxicity.  The focus of the February meeting will be on drug efficacy.  Information on previous meetings can be found at the following links:

            March 19, 2012: Summit

            September 17-18, 2012: Second Workshop

            March 14-15, 2013: Third Workshop  Final Report.pdf

            March 6-7, 2014: Fourth Workshop

The draft agenda for the 5th Workshop is posted below.

Registration:  Free but you must register here

Event sponsors:

  • American Institute for Medical and Biological Engineering
  • National Institute of Biomedical Imaging and Bioengineering
  • National Center for Advancing Translational Sciences

Chairs:

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

and

  • 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

Agenda

Fifth Workshop on Validation and Qualification of New In Vitro Tools and Models for the Pre-Clinical Drug Discovery Process

February 12, 2015

Lister Hill Auditorium, NIH Campus, Bethesda, MD

 Agenda-Thursday, February 12

 

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

Milan P. Yager, AIMBE Executive Director (confirmed)

 

8:55-9:05 AM

 

 

9:05-9:25 AM

 

 

Welcome from NIBIB

William Heetderks, M.D., Ph.D. Acting Deputy Director,  NIBIB/NIH (confirmed)

 

NCATS Welcome and Perspective

Christopher P. Austin, M.D., Director, National Center for Advancing Translational Sciences, NIH (confirmed)

 

Session 1:

 

9:25-10:00 AM

 

Moderator:  TBD

 

FDA/CDRH-- in vitro devices for efficacy

Alberto Gutierrez, Ph.D., Director Office of In Vitro Diagnostic Device Evaluation and Safety, FDA (confirmed)

 

10:00-10:15 AM

 

 

Break

 

10:15-10:50 AM

 

 

FDA/CDER---Ideas on efficacy for in vitro systems

Paul Brown, Ph.D., OND IO, FDA (confirmed)

 

10:50-11:25 PM

 

 

 

11:25-12:00 AM

 

 

 

12:00-1:00 PM

 

Session 2:

 

 

1:00-1:40 PM

 

 

1:40-2:20 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 (confirmed)

 

NCATS Rare Diseases

Pamela  McInnes, DDS., Deputy Director, NCATS, Acting Director, Office of Rare Diseases Research, NCATS, Office of Rare Disease Research (confirmed)

 

Lunch

 

Moderator: TBD

 

 

Vertex Pharmaceuticals’ program on predicting efficacy

Fred Van Goor, PhD, Vertex Pharmaceuticals (confirmed)

 

CIRM funded disease banking systems for induced pluripotent stem cells

Thomas J Novak, PhD, VP, Strategic Partnerships, Cellular Dynamics International

 speaker (confirmed)

 

 

2:20-3:00 PM

 

 

 

3:00-3:20 PM

 

Session 3:

 

3:20-4:00 PM

 

 

4:00-4:40 PM

 

Fit and form of the biomimetic MIMIC system to assess biologic function

William Warren, Ph.D., Head of VaxDesign Campus, Sanofi Pasteur

(confirmed)

 

Break

 

Moderator: TBD

 

Low cost multi organ in vitro systems for efficacy

Michael L. Shuler, PhD, CEO/President, Hesperos, LLC (confirmed)

 

Cardiac iPSCs for Disease Modeling and Drug Discovery

Joseph C. Wu, MD, PhD, Director, Stanford Cardiovascular Institute, Professor, Dept of Medicine/Cardiology & Radiology, Stanford University School of Medicine (confirmed)

 

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 (confirmed)

 

 

5:20-5:50 PM

 

6:00-8:00 PM

Group Discussion to plan next workshop on “Applications to Rare Neglected Diseases”

 

AIMBE Sponsored Reception - Share Wine Lounge

Doubletree Hotel at 8120 Wisconsin Avenue, Bethesda, Maryland 20814