Creating Biomedical Technologies to Improve Health

NEWS & EVENTS

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

Thursday, May 25, 2017 (All day) to Friday, May 26, 2017 (All day)
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 sixth 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 May 25-26, 2017 at NIH in Bethesda, MD. The overall goal of this series of workshops is to develop guidelines for investigators developing new microphysiological platform 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 and meaningful tools. The focus of the first four meetings was toxicological applications and the fifth addressed efficacy evaluation. The focus of the sixth meeting will be on an update on the current state of the technology and how these systems can be applied to rare disease applications as well as regulatory considerations. Information on previous meetings can be found at the following links: 

 

Registration is open until May 22, 2017

Poster registration is open until May 5, 2017 - Please e-mail the poster title, abstract, and full name of the presenter no later than May 5, 2017 in a pdf file to Seila Selimovic. Posters should be no larger than 4 feet x 4 feet.

Travel/Logistics:

Building: William H. Natcher Building/Building 45 on the NIH main campus in Bethesda, MD. The NIH main campus is accessible via the Metro Red Line (Medical Center Metro Station)

Room: Ruth L. Kirschstein Auditorium

Please allow adequate time to get to the NIH main campus and to get through security. You will need to obtain a visitor’s badge, so please bring a government-issued photo ID.

Access to NIH main campus from the Medical Center Metro Station through the NIH Visitors Center: The Visitors Center is located at the top of the escalators of the Medical Center Metro Station entrance, approximately 50 yards from the street and facing the entrance to the metro station. It is the building right in front of you as you exit the metro station. Enter at the blue Welcome sign and proceed to your right through security. All persons and bags will be screened. Lines to obtain your visitor’s badge will be on the other side of security; please remember to bring a government-issued photo ID. Maps of main campus are available in the Visitors Center.

Directions from the Visitors Center to the Natcher Conference Center and the Meeting: Once you obtain your visitor’s badge, proceed to your left, up the stairs or elevator to the upper level exit of the Visitors Center. Once outside, follow the signs down the hill to the Natcher Conference Center (Building 45). The curved, glass building should be straight ahead with the entrance at the end of the walkway. Proceed through the doors of the Natcher Conference Center and follow the signs to the registration desk.

Hotel Information
Hyatt Regency Bethesda
One Bethesda Metro Center
7400 Wisconsin Ave
Bethesda, Maryland, USA, 20814
Phone: +1 301 657 1234
Price: $242/night + taxes and fees
Hotel reservation link

AGENDA
Thursday, May 25  
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 Acting Associate Director, Extramural Science Programs, NIBIB/NIH
Dan Tagle, Ph.D., M.S., Associate Director for Special Initiatives, Office of the Director, NCATS/NIH
8:45-9:00 AM Welcome from AIMBE
  Gilda Barabino, Ph.D., AIMBE President, Dean and Daniel and Frances Berg Professor, The Grove School of Engineering, The City College of New York
9:00-9:15 AM Welcome from NIBIB and Perspective
  Krishna Kandarpa, M.D., Ph.D., Director, Research Sciences and Strategic Directions, NIBIB/NIH
9:15-9:40 AM NCATS Welcome and Perspective
  Dan Tagle, Ph.D., M.S., Associate Director for Special Initiatives, Office of the Director, NCATS/NIH
Session 1: Moderator: Khaled Bouri, PhD, MPH, Interdisciplinary Scientist, FDA/OC/ OCS/ORSI
9:40-10:10 AM FDA/CDRH-- In Vitro Devices for Efficacy
  Laura Koontz, Ph.D., Personalized Medicine Staff, Office of In Vitro Diagnostic and Radiological Health, Center for Devices and Radiological Health, FDA 
10:10-10:40 AM Drug Toxicity in Cardiomyocites from Patient-derived Induced Pluripotent Stem Cells: A Model for Orphan Disease Studies, FDA
  William Mattes, Ph.D., Director, Division of Systems Biology, National Center for Toxicological Research (NCTR), FDA
10:40-11:00 AM Break and Poster Viewing
11:00-11:30 AM Convergence of Tissue Models and Regenerative Medicine, NIST
  Anne Plant, Ph.D., Chief, Biosystems and Biomaterials Division, NIST
11:30-12:00 PM Patient Advocacy for Rare Diseases 
  Christopher Penland, Ph.D., Vice President of Research, Cyctic Fibrosis 
12:00-1:00 PM Lunch
Session 2: Moderator: William E. Bentley, Department of Bioengineering, University of Maryland
1:00-1:30 PM Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Overview and New Directions
  Warren Casey, Ph.D., DABT, Acting Director National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)
1:30-2:00 PM Emulate Company Perspective: An Organs-on-Chips Platform for Advancing Drug Discovery and Development
  Daniel Levner, Ph.D., Chief Technology Officer, Emulate, Inc.
2:00-2:30 PM Break and Poster Viewing
2:30-3:00 PM Hesperos, Inc. Company Perspective: Low-cost, Robust Multi-organ Microphysiological Systems for Pre-clinical Drug Development
  Michael L. Shuler, Ph.D., President/CEO, Hesperos, Inc. and Professor, Biomedical Engineering, Cornell University
3:00-3:30 PM TissUse Company Perspective: Applying Multi-organ-on-a-chip Technologies for Predictive Substance Testing
  Reyk Horland, Ph.D., VP Business Development, TissUse, GmbH.
3:30-4:00 PM Insphero Company Perspective: From Cell-based to Tissue-based Drug Testing: Qualification and Validation of 3D InSight Islet Microtissues
  Jens M. Kelm, Ph.D., Chief Technology Officer, Co-Founder & Member of the Management Team
4:00-4:40 PM Building Confidence: A Pharma Consortim Strategy for Egaging Novel in Vitro Technologies
  Brian R. Berridge, DVM, Ph.D., DACVP, Senior GSK Fellow, Head, WW Animal Research Strategy, Office of Animal Welfare, Ethics & Strategy, GlaxoSmithKline
4:40-4:50 PM Wrap-up of Day 1
6:00-8:00 PM

AIMBE Sponsored Reception
Share Wine Lounge in the DoubleTree Hotel
8120 Wisconsin Ave, Bethesda, MD 20814 

Friday, May 26  
8:00-8:30 AM Continental Breakfast and Check-In
8:30-8:45 AM Goals of the Second Day
  James Hickman, Ph.D., AIMBE Fellow and Professor, University of Central Florida
8:45-9:15 AM NCATS Rare Diseases Program
  Anne R. Pariser, MD, Deputy Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences, NIH 
9:15-9:45 AM FDA/CDER---Ideas on Efficacy for In Vitro Systems for Rare Diseases
  Paul Brown, Ph.D., OND IO, FDA
9:45-10:15 AM Surrogate BioMarkers and Rare Diseases
  Federico Goodsaid, Ph.D., Senior VP Clinical and Regulatory Affairs, TOMA Biosciences
10:15-10:45 AM Break and Poster Viewing
Session 3:                      

Preclinical Rare Disease Models - Moderator: Šeila Selimović, Ph.D., Program Director, Tissue Chips/Tissue Preservation Technologies/Sensors, NIBIB/NIH

10:45-11:15 AM European eRARE Initiative: A Decade of European Collaborative Programs for Rare Diseases Research Funding
  Daria Julkowska, Ph.D., Coordinator, Agence Nationale de la Recherche – ANR Health and Biology Department
11:15-11:45 AM A Brain Microphysiological Model of Disease and Toxicity
  Tom Hartung, M.D., Ph.D., Johns Hopkins University
11:45-12:15 PM Organs-on-chip: Recreating Organ Level Physiology and Function for Candidtae Drug Testing
  Monicah Otieno, Ph.D., East Coast Head of Molecular & Investigative Toxicology, Johnson & Johnson, Janssen Research and Development
12:15-1:15 PM Lunch
1:15-1:45 PM Adult-like Human Cardiac Tissue for Predictive Modleing of Rare Disease
  Gordana Vunjak-Novakovic, Ph.D., University Professor, Columbia University
1:45-2:15 PM Driven Assembly of Stem Cell Derived Human Tissues for Disease Modeling and Discovery
  William Murphy, Ph.D., Harvey D. Spangler Professor, Biomedical Engineering and Orthopedics, University of Wisconsin
2:15-2:30 PM Break
2:30-3:00 PM A Human Microphysiological Blood Vessel Model of Hutchinson-Gilford Progeria Syndrome
  George Truskey, Ph.D., R. Eugene and Susie E. Goodson Professor of Biomedical Engineering, Duke University
3:00-3:30 PM An Industry Perspective on Qualifying and Implementing 3D In Vitro Models for Assessing Hepatotoxicity Risk in Drug Delivery
  William Proctor, Ph.D., Senior Scientist, Head of Investigative Toxicology, Safety Assessment, Genentech, Inc.
3:30-4:00 PM Development of an In Vitro Drug Screening Platform for Vascular Malformations
  Christopher Hughes, Ph.D., Professor and Chair, Molecular Biology and Biochemistry, UCI
4:00-5:00 PM Panel Discussion on Paths for Rare Disease Validation and Qualification - Moderator: Šeila Selimović, Ph.D., Program Director, Tissue Chips/Tissue Preservation Technologies/Sensors, NIBIB/NIH
  Christopher Penland, Ph.D., Vice President of Research, Cystic Fibrosis Foundation
  Federico Goodsaid, PhD, Senior VP Clinical and Regulatory Affairs, TOMA Biosciences
  Anne R. Pariser, M.D., Deputy Director, Office of Rare Diseases Research, National Center for Advancing Translational Sciences, NIH
  Jonathan Goldsmith, Ph.D., Director of the Rare Disease Program in the Office of New Drugs
5:00-5:10 Wrap Up and Action Items Discussion

Click here to register.

Workshop Organizers:

  • James Hickman, Ph.D., University of Central Floria
  • Christine A. Kelley, NIBIB/NIH
  • Seila Selimovic, Ph.D., NIBIB/NIH
  • Dan Tagle, Ph.D., M.S., NCATS/NIH