2014 3Rs Sharing Conference

2014 3Rs Sharing Conference

Save the Date- February 27, 2014

3Rs
 Sharing
 Conference 
III- Paving
 the
 Path
 to
 Regulatory 
Acceptance of
 Alternative
 Methods
Facilitating
 the 
Integration
 of 
Alternative
 Methods 
Into
 the
 Regulatory
 Framework
The 
Palace 
at 
Somerset
 Park,
 Somerset,
 NJ 9:00
AM
 – 4:00
PM

Featured 
Keynote:

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

Topic:

The
 transformation
 of 
ICCVAM
 and 
the 
Growing
 Need
 for
 Obtaining
 Regulatory
 Acceptance of 
New
 Test
 Methods

Program Agenda

Morning Session

8:50 AM Opening Remarks
3Rs Committee Chair, Dale Martin, DVM, PhD, Global Head of Standards & Innovation, Animal Research & Welfare, DSAR, Sanofi

9:00 Stem Cells Applications
Kyle Kolaja, PhD, Vice President Business Development, Cellular Dynamics

9:50 New Direction & Transformation of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
Warren Casey, PhD, DABT, Senior Toxicologist & Acting Director
National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM)

10:40 Break

10:55 Panel Discussion: Key Issues and Challenges to the Implementation & Utilization of Alternative Methods
Moderator: Michael Kastello, DVM, PhD, Vice President and Global Deputy, Animal Research and Welfare, Sanofi-Aventis US, Chief Veterinary Officer, Sanofi Group
Panelists: Warren Casey, PhD, DABT, Senior Toxicologist & Acting Director NICEATM
Michael Graziano, PhD, DABT, VP Drug Safety Evaluation, Bristol-Myers Squibb
Abigal Jacobs, PhD, Associate Director of Pharmacology/Toxicology for the FDA, Center for Drug Evaluation & Research
Matt Martin, PhD, Research Biologist, USEPA, Office of Research & Development, National Center for Computational Toxicology

12:00 Lunch

Afternoon Session

1:00 – 3:00 PM Special Tracks
Toxicology Session
Facilitator: Lauren Hutchison, PhD, Senior Research Scientist, Product Safety, Colgate Palmolive
Regulator: Matt Martin, PhD, USEPA

• Getting more data from few animals: Innovative strategies for mammalian toxicity testing
Lynea Murphy, PhD, Associate Toxicology Manager, Mammalian Toxicology Group
Toxicology & Environmental Research and Consulting, The Dow Chemical Company

• Cardiac Stem Cells for Safety Pharmacology Application
Kyle Kolaja, Vice President, Business Development, Cellular Dynamics

• ToxCast Phase II Data & 3Rs Implications
Matt Martin, PhD, Research Biologist, USEPA, Office of Research & Development, NCCT

DMPK Session
Facilitator: Graham Lockwood, PhD, Associate Vice President, Disposition, Safety and Animal Research Sanofi
Regulators: Warren Casey, PhD, NICEATM & Abigail Jacobs, PhD, FDA CDER

• Microsampling – When less should have been more: One company’s experience bridging concept to execution
Alan Stokes, PhD, Interim Head of Toxicology, RTP, GlaxoSmithKline

• Development of approaches for efficient and animal-sparing cardiovascular risk assessment in early drug discovery
Charles Thompson, PhD, Merck

• Optimizing in vivo studies and determination of safe starting dose during drug development: Doing better with less
Arijit Chakravarty, Senior Scientist II, Head of Modeling and Simulation (DMPK) Takeda Pharmaceuticals
3:10 Session Summaries & Closing Remarks

Read About Our Distinguished Presenters-

Hosted 
by
 the
 New 
Jersey 
Association
 for 
Biomedical
 Research in
 partnership 
with 
the
 International
 Consortium
 for 
Quality 
&
 Innovation
 in 
Pharmaceutical
 Development
 (IQ) and
 
with 
the 
joint 
support 
of
 PSBR, 
MSMR,
 NCABR

For 
more 
information contact
 Eileen
 at 
609.392.0155
 or domanico@njabr.org

Register online for 3Rs Sharing Conference

© Copyright NJ Association of Biomedical Research 2014. All rights reserved.