51st Annual Meeting & ToxExpo - Society of Toxicology

San Francisco, California
The Thematic Track information can be found on pages 8–9.
in these disease areas have been identified. While pharmaceutical
inhibitors of epigenetic targets such as histone deacetylases and DNA
methyltransferases have recently gained regulatory approval, the field
of pharmacoepigenetics is still relatively young. As greater understanding
of the epigenome is evolving, previously approved drugs
are now serendipitously being found to have epigenetic modulatory
properties and are currently under evaluation for new indications.
With the rapid emergence of multiple novel epigenetic targets for
pharmacological inhibition, new considerations for the field of toxicoepigenetics
are becoming apparent as well. In order to address the
potential toxicological consequences associated with pharmacological
inhibition of potential therapeutic epigenetic targets, toxicologists are
addressing the need for new models and endpoints to be considered
in the safety assessment of epigenetic targets. These important toxicological
issues, which may be unique to epigenetic targets, will be
addressed.
• Epigenetics Meets Toxicology: An Integrated View of
Mechanisms Controlling Transcription That Are Superimposed
on DNA Base Sequence. Jay Goodman, Michigan State University,
East Lansing, MI.
• Evaluation of Potential Safety Risks of Pharmacological
Inhibitors of Epigenetic Targets in Discovery Toxicology.
Brandon Jeffy, Celgene, San Diego, CA.
• Epigenomics—Impact for Drug Safety Sciences. Jonathan Moggs,
Novartis, Basel, Switzerland.
• Investigation of Transgenerational Epigenetic Inheritance in
Product Safety Assessment. Reza Rasoulpour, The Dow Chemical
Company, Midland, MI.
• Current and Future Epigenetic Therapies. Nessa Carey, Pfizer,
Cambridge, United Kingdom.
Regulatory Science: Bridging the
Gap between Discovery and Product
Availability
21st Century Validation Strategies—One Size No
Longer Fits All
Symposia
drugs are tested for their risk to humans. This new vision of toxicology
testing will be based upon human rather than animal biology and
will involve a strong commitment to the 3Rs—replacement, reduction,
and refinement of animal use in research and testing. There are
many challenges to fully implementing this vision. Current formal
approaches to validation involve lengthy and expensive processes that
require validating in vitro data against in vivo data. This approach may
not be relevant or even feasible for the new pathways and endpoints
being measured. Consequently, applying a one size fits all approach
to validation is not conducive to the rapid incorporation of emerging
science or technology into the regulatory decision-making framework.
As new safety testing evolves, new approaches to demonstrating
that a test is reliable and relevant for a particular purpose must also
evolve. Such approaches may differ for different tests and be based
on their intended use (e.g., as part of screening or other algorithmic
approaches versus intended replacement of existing tests). To meet
this challenge will require an active dialogue and early collaboration
among all stakeholders, including federal regulatory agencies, other
regulators, NGOs, academia, and industry scientists. This session
offers an opportunity for such a dialogue about what could constitute
a more flexible approach to demonstrating that these new toxicology
testing methods are scientifically valid and address the fundamental
questions of human safety and efficacy.
• Challenges to Incorporating New Technologies into the
Toxicology Regulatory Testing Paradigm. Wallace Hayes, Harvard
University, Andover, MA.
• Biomarker Qualification—A Pathway for Acceptance of
Alternative Toxicology Test Methods by Regulatory Agencies.
Marc Walton, US FDA, Silver Spring, MD.
• Developing Scientific Confidence in Computational Approaches
for Hazard Evaluation. Richard A. Becker, American Chemical
Council, Washington, DC.
• Toxicity Test Validation in the 21st Century. Vicki Dellarco,
US EPA, Washington, DC.
• In Vitro/In Silico/Exploratory Assessment of Pharmaceuticals.
Abigail Jacobs, US FDA, Silver Spring, MD.
• An Evolving Example of Integrating In Vitro Risk Signals.
Robert Chapin, Pfizer, Inc., Groton, CT.
Scientific
Monday, March 12, 2:00 PM to 4:45 PM
Chairperson(s): Suzanne C. Fitzpatrick, US FDA, Silver Spring, MD,
and Richard A. Becker, American Chemical Council, Washington, DC.
Sponsor:
In Vitro and Alternative Methods Specialty Section
Endorsed by:
Regulatory Safety Evaluation Specialty Section
Risk Assessment Specialty Section
Recent advances in systems biology and related scientific fields offer
the potential to fundamentally change the way that chemicals and
up-to-date information at www.toxicology.org 71
Thematic Session