Physicians Committee Promotes Modern Test Methods

Read more below about our events and activities to engage and train toxicologists and regulatory scientists on New Approach Methodologies; links to presentations are provided.

Monday, March 11th

Nonclinical Innovation and Patient Safety Initiative (NIPSI)
The Physicians Committee and AxoSim Technologies hosted a luncheon for the Nonclinical Innovation and Patient Safety Initiative (NIPSI). We shared recent efforts, including our Drug Discovery Today Publication, and discussed next steps for our work to support and gain regulatory acceptance of innovative nonclinical approaches. Contact ebaker [at] pcrm.org (ebaker[at]pcrm[dot]org) for more information.

Tuesday, March 12th

INFORMATIONAL SESSION
TSCA Implementation: A Focus on New Approach Methodologies
Presenter: Kristie Sullivan, MPH

With a requirement for EPA and submitters to consider and use testing approaches not reliant on vertebrate animals whenever requesting or generating new information, the revisions to TSCA provide a framework for implementation of the National Academy of Sciences report Toxicity Testing in the 21st Century: A vision and a strategy. This presentation offered a look at how policies and guidance enacted so far relate to New Approach Methodologies implementation, highlighted opportunities for stakeholder involvement and international cooperation, and suggested key recommendations for continued momentum in implementing 21st-century regulatory toxicology.

Increasing the Availability and Quality of Human Tissue for Research 

Human tissues and cells from healthy and diseased donors have become a critical part of research; they are invaluable resources for medical research, disease modeling, diagnostic tests, biomarker discovery, drug development, product testing, chemical exposure, and much more. As interest grows in using more human tissues for numerous applications, policies and guidelines are needed to ensure an uninterrupted supply of a variety of quality human tissues. This luncheon discussed the current state of human tissue research and provided a platform for researchers to share their experiences and input.

Read more about our work in human tissue research or contact jmccarthy [at] pcrm.org (jmccarthy[at]pcrm[dot]org). 

Wednesday, March 13th

POSTER
The Nonclinical Innovation and Patient Safety Initiative (NIPSI): Supporting Human-Based Nonclinical Approaches Through Advances in Regulation, Policy, Science, Education and Training
Presenting Author: Elizabeth Baker, Esq.

POSTER
California law first in North America to require non-animal safety substantiation of cosmetic ingredients
Presenting Author: Kristie Sullivan, MPH

ROUNDTABLE SESSION
The Necessity of Uncertainty: Quantifying Uncertainty for Regulatory Application of New Approach Methodologies
Chair: Esther Haugabrooks, PhD

The face of regulatory toxicology is undergoing a makeover in the 21st century with the encouragement of new approach methodologies. This roundtable will discussed how uncertainty has historically been quantified, how it differs between methods (in vivo/in vitro/in silico), and how it has been addressed and should be addressed in order to facilitate development and implementation of new approach methodologies. We dared to broach the cultural barriers to accepting new approach methodologies in safety and risk assessment. We also encouraged dialogue to address what types and subsequent levels of uncertainty are likely or tolerable in 21st-century.

• References and Resources

AOP Hands-on Training: Building the Foundation for Predictive Toxicology

The Human Toxicology Project Consortium and the Physicians Committee for Responsible Medicine co-sponsored an event to help attendees deepen their understanding of the AOP Wiki and gain experience entering an Adverse Outcome Pathway in a structured, hands-on seminar. Contact ksullivan [at] pcrm.org (ksullivan[at]pcrm[dot]org) for more information.

Presentations can be found below.

• Introduction and overview of the OECD AOP framework; Catherine Willett, HTPC/Humane Society International
• Approaches and tools for AOP assembly and an example of a Bayesian network approach to predicting steatosis; Natalia Reyero, US Army Corps of Engineers
• Application of the AOP framework to make regulatory decisions: Early case studies; Kristie Sullivan, Physicians Committee