The International Society of Regulatory Toxicology and Pharmacology

 

ISRTP Workshop
Progress and Barriers To Incorporating Alternative Toxicological Methods
in the U.S.

November 17 & 18, 2005
Marriott Waterfront Hotel
Baltimore, MD
 

Workshop Objective

The objective of this workshop is to explore progress to date in implementing new, revised and alternative toxicological test methods across regulatory evaluation frameworks and decision-making programs in the U.S., identify barriers to progress and explore potential bridges to facilitate overcoming such barriers. These barriers may be technical, regulatory, economic or societal.

Workshop Work Products

The workshop work products will include PowerPoint presentations to be posted on the ISRTP website as well as a written summary (to be published in Regulatory Toxicology and Pharmacology) that will include the recommendations of the panel discussions.

Workshop Outcomes

• Better understanding of current alternatives research and validation efforts in the U.S. (who, what, objectives of research; availability of resources);

• Enhanced understanding of the environment stimulating alternatives research and how this is or is not linked with the regulatory communities who rely on test methods;

• Identification and understanding of barriers that impede progress;

• Recommendations to overcome these barriers.

Sponsors

 View Sponsors for this Program

 
Program                                                                    
November 17, 2005
7:30 – 8:30 am Continental Breakfast
8:30 am

Welcome & Workshop Objectives: Goals & objectives of the workshop
Christopher J. Borgert (Treasurer, ISRTP) View Slides

8:45 am Opening Address: The Future is Now - Developing Partnerships to Advance the Development, Validation and Acceptance of New, Revised and Alternative Methods
Christopher Portier (NTP/NIEHS) View Slides / Speaker Bullets
9:30 am
 
Session 1: Research, Development & Validation of Alternative Methods within the US Federal Government
This session will cover current efforts in US to develop, validate and incorporate new, revised and alternative toxicological methods into regulatory evaluation frameworks and decision-making programs.

Session Chairs:
Sara Amundson
(Doris Day Animal League)
Rick Becker
(American Chemistry Council)

9:30 am Session Introduction, Session Chairs
9:35 am EPA’s Computational Toxicology Program
David Dix (US EPA) View Slides / Speaker Bullets
10:00 am NTP’s Vision of High Throughput Screening and Other Alternative Methods
Christopher Portier (NIEHS/NTP) View Slides / Speaker Bullets
10:25 – 10:35 am Break
10:35 am Perspective on Standardization, Validation, and Use of Alternative Methods Within FDA CDER
Abigail Jacobs (FDA, CDER) View Slides / Speaker Bullets
11:00 am The Roles of NICEATM and ICCVAM
William Stokes (NIEHS/NICEATM) View Slides / Speaker Bullets
11:25 am Panel Discussion and Audience Dialogue Session 1 Panel .pdf
12:00-1:30 pm Lunch
1:30 pm Session 2: Emerging Alternative Methodologies with Potential Applicable to a Broad Spectrum of Toxicity Evaluation Strategies
Speakers will be asked to cover some of the scientific, technical, and sociological challenges that need to be met before the new methods can be effectively applied.

Session Chair: William Stott (Dow Chemicals)

1:30 pm Session Introduction, William Stott View Slides / Speaker Bullets
1:35 pm The Future of SAR and Predictive Toxicology in a Flattening World
Ann Richard (US EPA/NCCT) View Slides / Speaker Bullets
2:00 pm Computational Approach to Systems Toxicology – a Common Path to Mechanism and Biomarkers
Pieter Muntendam (BG Medicine) View Slides / Speaker Bullets
2:25–2:55 pm Break
2:55 pm An Overview of High-Throughput Screening
William Janzen (Amphora) View Slides / Speaker Bullets
3:20 pm Organ on a Chip
Albert Li (The ADMET Group) View Slides / Speaker Bullets
3:45 pm Panel Discussion and Audience Dialogue Session 2 Panel .pdf
4:30 pm Adjourn
November 18, 2005
7:00 – 8:00 am Continental Breakfast
8:00 am Session 3: Tiered Evaluation Strategies
Speakers will be asked to address the current status of tiered strategies and where their use is envisioned in the future; what are some of the key barriers to wider use?

Session Chairs:
Jay Ansell (Yves Rocher North America, Inc.)
Simon Webb (Procter & Gamble)

8:00 am Session Introduction, Jay Ansell/Simon Webb
8:10 am Tiered Evaluation Strategies: Experiences from HPV Programs
Larry Rampy (American Chemistry Council) View Slides / Speaker Bullets
8:40 am ILSI Agricultural Chemical Safety Assessment (ACSA) Project: A Tiered Testing Approach?
Ann Blacker (Bayer Crop Science) View Slides / Speaker Bullets
9:10 am Intelligent Testing Under REACH
David Owen (Shell Chemicals) View Slides / Speaker Bullets
9:40 – 9:50 am Break
9:50 am Canadian Experiences Under CEPA/DSL
Bette Meek (Health Canada) View Slides / Speaker Bullets
10:20 am Tiered Evaluation Strategies: An Animal Protection Perspective
Martin Stephens (Humane Society of the United States) View Slides / Speaker Bullets
10:50 am Panel Discussion and Audience Dialogue Session 3 Panel .pdf
11:30 am -
12:30 pm
Lunch
12:30 pm Session 4: Roundtable Discussion
Discussion will identify: 1) What are the critical (4-5) barriers and 2) What are the key recommendations for overcoming these barriers?
A rapporteur will capture dialog & recommendations.
View Slides / Session 4 Panel .pdf

Facilitated Discussion Leader: Leon Bruner (Gillette)

Stakeholders:

Academic
Alan Goldberg (JHU) View Slides / Speaker Bullets

Government
William Stokes (NIEHS/NICEATM) View Slides / Speaker Bullets

Animal Welfare
Andrew Rowan (HSUS) View Slides / Speaker Bullets

Industry
William Stott (Dow Chemicals) View Slides / Speaker Bullets

Private Sector/Contract Research
Rodger Curren (IIVS) View Slides / Speaker Bullets

1:45 – 2:15 pm Break
3:00 pm Adjourn View Slides
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