Creating Biomedical Technologies to Improve Health

Search form

NEWS & EVENTS

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

March 6, 2014 to March 7, 2014
Bethesda, Maryland

March 6-7, 2014

(Rescheduled from November 2013)

NIH Campus, Lister Hill Auditorium (Breakout sessions in Building 10, NIH Clinical Center)

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 March 6-7, 2014 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.  Information on previous 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 17-18, 2012: Second Workshop

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

This workshop, which was rescheduled due to the government shutdown, 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 Food and Drug Administration (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, Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), European Centre for the Validation of Alternative Methods (ECVAM), the European Medicines Agency, and the FDA.  On day two of the Workshop, discussion of validation and qualification guidelines will begin with talks on four 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 and input on what validation and quantification guidelines would be necessary for each of the chosen technologies from the talks. 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.  

Poster Session:

For the first time we will be accepting a limited number of abstracts to present at the poster session. Details can be found on the Registration Site.

Registration:

http://fourthnibibaimbewkshp.eventbrite.com/

AIMBE Page:

http://aimbe.org/events/fourth-aimbe-nih-workshop/

Event sponsor:

  • American Institute for Medical and Biological Engineering
  • National Institute of Biomedical Imaging and Bioengineering
  • University of Maryland's Center of Excellence in Regulatory Science (M-CERSI)

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

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

March 6-7, 2014

Lister Hill Auditorium, NIH Campus, Bethesda, MD

 

March 6             Day 1

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

8:45-9:00 AM

Welcome from the AIMBE

Ravi Bellamkonda, Ph.D., AIMBE President elect, Chair, Biomedical Engineering Georgia Tech

9:00-9:10 AM

Welcome from the NIBIB

William Heetderks, M.D., Ph.D. Associate Director for Science Programs, Extramural Science Programs, NIBIB/NIH

Session 1:

 

9:10-9:15 AM

Current Government Perspectives on Validation and Qualification for Toxicology

Moderator: Christine A. Kelley, Ph.D., AIMBE Fellow and Director, Division of Discovery Science & Technology, NIBIB/NIH

9:15-9:45 AM

FDA Regulatory Science Initiatives

Frank Weichold, M.D., Ph.D., Director, Critical Path and Regulatory Science Initiatives

9:45-10:15 AM

New Directions for Toxicology: The National Toxicology Program

John Bucher, Ph.D., Associate Director, National Toxicology Program, NIEHS/NIH

10:15-10:45 AM

Break and Poster Viewing

10:45-11:15 AM

Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Overview and New Directions

Warren Casey, PhD, DABT, Acting Director National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

11:15-11:45 AM

European Centre for the Validation of Alternative Methods (ECVAM) Overview

Maurice Whelan, Ph.D., Head of the Joint Research Center-Institute for Health and Consumer Protection, Systems Toxicology Unit and European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)

11:45-1:00 PM

Lunch and Poster Viewing Poster Session Abstracts

Session 2:

1:00-1:15 PM

Perspectives for Validation and Qualification from the Regulatory and Science Communities

Moderator: Khaled Bouri, Ph.D., MPH., Senior Science Advisor, HHS/FDA/OCS/ORSI

 

1:15-1:35 PM

Update on European Medicines Agency (EMA) and International Committee on Harmonization (ICH) Activities

Sonja Beken, PhD, Belgian Federal Agency for Medicines and Health and the European Medicines Agency

1:35-2:05 PM

FDA Evaluation Perspective on New In Vitro Toxicology Testing System

David Jacobson-Kram, Ph.D., DABT, Associate Director for Pharmacology & Toxicology, Center for Drug Evaluation and Research (CDER), FDA

2:05-2:35 PM

European Perspective: Changing the paradigm for safety testing of pharmaceuticals?

Beatriz Silva Lima, Ph.D., University of Lisboa, Portugal and Chair of the IMI Scientific Committee Belgium

2:35-3:05 PM

Break and Poster Viewing

3:05-3:35 PM

Validation of in vitro Devices: What Might That Look Like?

Anne Plant, Ph.D., Division Chief, Biosystems and Biomaterials Division, National Institute of Standards and Technology (NIST)

3:35-4:05 PM

Development and Integration of New Technologies in Review of Biologics by FDA Center for Biologics Evaluation and Review.

Richard McFarland, Ph.D., M.D., Assoc. Director for Policy, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research (CBER), FDA

4:05-4:25 PM

Topics and Speakers for Next Workshop on Efficacy.

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

4:25-4:55 PM

 Group Discussion and Plans for Day 2

5:30-7:30 PM

AIMBE Sponsored Reception 

Hyatt Regency Bethesda, One Bethesda Metro Center

 

March 7             Day 2

 

8:00-8:15 AM

Continental Breakfast

Session 3:

8:15-8:20 AM

Development of Draft Validation Guidelines

Moderator: Anne Plant, Ph.D., Division Chief, Biosystems and Biomaterials Division, National Institute of Standards and Technology (NIST)

8:20-9:00 AM

NCATS Perspective on Validation of In Vitro Microphysiological Systems and the Tox 21 Program

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

9:00-9:30 AM

Technologies Used by the FDA for Toxicology Research

Donna L. Mendrick, Ph.D., Associate Director of Regulatory Affairs, National Center for Toxicological Research (NCTR), FDA

9:30-10:00 AM

Technology Platform #1: Use of Regenerative Medicine and Bioprinting Techniques for Human Tissue Testing

Anthony Atala, M.D., Director, Wake Forest Institute for Regenerative Medicine   (presented by Shay Soker, Ph.D., Wake Forest)

10:00-10:30 AM

Break and Poster Viewing

10:30-11:00 AM

Technology Platform #2: Use of Stem Cell Derived Cardiomyocytes and Real-time Impedance-based Measurements to Accurately Predict Drug-Induced QT prolongation and arrhythmia

Kyle Kolaja, Ph.D., D.A.B.T., Fellow, A.T.S., Vice President, Business Development at Cellular Dynamics, International, consultant in vitro cardiac impedance measurements

11:00-11:30 AM

Technology Platform #3: Arrhythmogenic Liability in Stem Cell-Derived Cardiomyocytes Early in Drug Discovery via Kinetic Image Cytometry (KIC) 

Jeff Price, M.D., Ph.D., Founder, President and Chief Executive Officer, Vala Sciences, High-Content Imaging Systems; Adjunct Associate Professor, Sanford-Burnham Medical Research Institute, San Diego, CA

11:30-Noon

Technology Platform #4: An integrated in vitro model of perfused tumor and cardiac tissue

Steve George, M.D., Ph.D., Edwards Lifesciences Professor; Director, Edwards Lifesciences Center for Advanced Cardiovascular Technology, University of California, Irvine

12:00-1:00 PM

Lunch and Head to Bldg 10 (take down posters) 

Session 4:

1:00-3:00 PM

Parallel Breakout Sessions (Bldg 10 South FAES Rooms)

 

Discussion of Technology Platform #2 (Bldg 10 FAES Rm 3, B1C207)

Presentation Leader – Federico  Goodsaid, PhD, Vice President for Strategic Regulatory Intelligence, Vertex Pharmaceuticals Inc.

 

Discussion of Technology Platform #3 (Bldg 10 FAES Rm 6, B1C208)

Presentation Leader – James J Hickman, Ph.D., AIMBE Fellow and Professor, NanoScience Technology Center, University of Central Florida

 

Discussion of Technology Platform #4 (Bldg 10 FAES Rm 7, B1C206)

Presentation Leader – William Bentley, Ph.D., Robert E. Fischell Distinguished Professor, Department of Bioengineering, University of Maryland

3:00-3:30 PM

Break (move to Masur Auditorium in Bldg 10)

3:30-3:45 PM

Breakout Group 1 Report (Technology Group 2)

Presentation Leader – Federico  Goodsaid, PhD, Vice President for Strategic

Regulatory Intelligence, Vertex Pharmaceuticals Inc.

3:45-4:00 PM

Breakout Group 2 Report (Technology Group 3)

Presentation Leader – James J Hickman, Ph.D., AIMBE Fellow and Professor, NanoScience Technology Center, University of Central Florida

4:00-4:15 PM

Breakout Group 3 Report (Technology Group 4)

Presentation Leader – William Bentley, Ph.D., Robert E. Fischell Distinguished Professor, Department of Bioengineering, University of Maryland

4:15-5:00 PM

Final Discussion

Further development of validation and qualification guidelines for microphysiological systems. These guidelines will be used by the steering committee to meet with the FDA to determine next steps based on FDA requirements and to set the agenda for the next workshop. 

5:00 PM

Adjourn