Two meetings this summer, OpenTox USA and BioMed2, highlighted the important role of data sharing, data quality, and data management for implementing new approaches to toxicology. National Toxicology Program (NTP) scientists were organizers and key presenters at both events.
OpenTox USA: Toxicity data
The July 12-13 OpenTox USA 2017 conference focused on how data from novel model systems can be effectively generated, managed, and used in new approaches to predicting toxic effects. Nicole Kleinstreuer, Ph.D., deputy director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and NTP Biomolecular Screening Branch Acting Chief Richard Paules, Ph.D., chaired the conference. Presenters included NTP staff and contractors, NIEHS Clinical Research Unit scientists, and grantees.
Paules noted that people are exposed to chemicals every day, and have limited information about the toxicity of many of these chemicals. New toxicology procedures can address these information gaps, but implementing them presents challenges.
"We have to figure out the best approaches for designing these studies so that they'll give us human-relevant information, and also how to interpret the vast amounts of data these studies will produce," Paules said.
Kleinstreuer chaired a later session that focused on the adverse outcome pathway (AOP) tool. AOPs are models that describe how chemical exposures may cause a toxic effect or disease. They can provide a logical basis for designing and interpreting studies to assess a chemical’s likelihood to cause toxicity.
Presentations by Kleinstreuer and colleague Judy Strickland, Ph.D., who works for NICEATM contractor ILS, emphasized how the AOP tool has been used to identify and integrate appropriate data streams for classifying potential endocrine disruptors and skin sensitizers.
NTP scientists Scott Auerbach, Ph.D., and Steven Ferguson, Ph.D., also presented their work.
BioMed21: Drug development
The June 27-28 BioMed21 workshop focused on how data can be used to develop a better understanding of human biology. The information could lead to novel drug development techniques to identify new drugs as either effective or toxic before conducting expensive animal and human tests. NICEATM co-organized the workshop with the Human Toxicology Project Consortium, and NICEATM Director Warren Casey, Ph.D., served on the organizing committee.
Casey pointed out that major changes in the drug development process are needed to address the decline in new drug approval. "We need consensus goals driven by regulatory agencies, communication, and collaboration among all the players," he said. "Workshops like this can help facilitate both collaboration and goal-setting."
Although BioMed21 focused on drug development rather than chemical toxicity, its presenters, like those at OpenTox, discussed information gaps, study design, and data interpretation. Participants spent almost half of the 2-day workshop in breakout groups. In addition to experimental design and data sharing, the groups considered issues, such as institutional biases that discourage change, and the roles of basic researchers and funding agencies in the effort to implement new approaches.
(Catherine Sprankle is a communications specialist for ILS, the contractor supporting NICEATM.)