Chairs: Darren Kidd & Amer Jamalpoor
New Approach Methodologies (NAMs) are rapidly becoming a realistic option for safety testing within multiple industry sectors. NAMs are utilized in the early discovery and/or hazard screening stages as well as for mechanistic understanding (at any stage in product development). A strong 3Rs focus is driving industries and regulatory agencies to explore wider use and adoption of NAMs as important legislative changes (e.g.: FDA Modernisation Act 2.0 and REACH annexe updates) have occurred. Even still, the questions of validation / fit for purpose / context of use remain.
The OECD Test Guideline assays for local tolerance assays (skin corrosion, irritation and sensitization plus ocular hazard identification) are early successes but NAMs for the more complex biological concerns such as systemic toxicity and developmental and reproductive toxicity are still being developed. Stemina Biomarker Discovery Inc’s devTOX quick predict assay and Toxys’s ReproTracker assay are two human in vitro assays that have been developed to provide in vitro data on developmental toxicity risk potential. These assays lead the way for NAMs to predict toxicological concerns in complex human biology systems and obtaining confidence at the Regulatory level is the next goal.
This session will present the current landscape from the regulatory level (covering in vitro NAMs and routes to acceptance – e.g. EMA’s Innovation Task Force (ITF), FDA’s iSTAND program and their Biomarker Qualification Program), the developer level (Toxys’s ReproTracker and their work as part of the UK NC3Rs CRACK-It challenge “Cross-DART”) and the end-user level (experiences of using the devTOXqp assay and subsequent in-house decision-making processes).
This will provide an insight to the current frameworks for progressing in vitro NAMs into Regulatory submissions and driving international acceptance as well as hands-on experiences from two of the best defined in vitro methods currently available for the complex biological concern of developmental and reprotoxicity.
Speakers
- Matthew Burbank – A DEFINED APPROACH BASED ON NAMS FOR ASSESSING TERATOGENICITY
- Andy Gibbs – Application of NAMs in a regulatory context: the pursuit of confidence
- Amer Jamalpoor – Validation and application of NAMs for developmental toxicity testing to predict human safety
- Additional presentations will be selected from poster submissions