The NGTX Task Force was set up in 2019 following an initial meeting in London, attended by interested CORESTA members with the intention of creating a working group to assess the potential of these novel approaches for NGP assessment. A symposium was held in 2019 at the annual CORESTA Smoke Science and Product Technology Conference in Hamburg, looking at various novel in vitro assays being used by the members of the group and introducing the new Task Force. The Task Force was set about to explore the opportunity offered with the recent advancement of in vitro toxicology and biology, also known as 21^st century toxicology, or NAMs, which seeks to harness innovation in cellular and molecular biology including computational approaches, robotics and human in vitro tissue systems, improving the evaluation of the safety and health risks of novel consumer products,

Current Activities

1. An objective of NGTX is to generate or provide guidance documents to support assay application for NGP testing using relevant approaches, and an easy place to start is to see what already exists for other sectors and if this can this be translated to tobacco and nicotine products. Members of the NGTX Task Force have compiled a general review of emerging technologies and the application of new approach methodologies to assess NGPs. Currently this is undergoing peer-review following publication in a peer-review journal.
2. The OECD has a guidance document on the principles good in vitro method practices (GIVIMP), which testing laboratories can acquire accreditation to, and is being recognised by a number of in vitro alternative authorities, including FDA, ICVAAM and ECVAMM. This guidance document is currently being reviewed by the NGTX members to see if the principles have application for NGP in vitro testing; The aims of GIVIMP as stated by the OECD are to increase confidence in in vitro animal alternatives testing, the test methods and rigorous and reproductible conditions under which data are generated. GIVIMP provides guidance for method developers and end users of the resulting data on key elements of in vitro methods. The GIVIMP guidance document and  the summary of GIVIMP as applied to NGP testing using non-regulatory in vitro assays, will be shared on the NGTX TF webpage.
3. To develop guidance on the use of High Content Screening (HCS) for those new to NGP testing and to look at method harmonisation for those CORESTA members that currently use HCS. HCS is a cell biology approach using automated cell imaging and quantitative data analysis in a high-throughput format. HCS is primarily a fluorescence imaging method, using multiple fluorescent markers of cell health typically measuring multiple markers in the same cell. It is used to provide amongst other additional mechanistic information on cell toxicity. A working group is looking at HCS measurement using inhouse methods and normal human bronchial epithelial cells (NHBE) for three agreed end points and with standardised positive controls. The next stage is to further standardise methodology across the companies and use a human cell line, to see if this leads to decreased variability across laboratories. Another aim is to produce guidance for those new to HCS to facilitate the wider adoption of this methodology.
4. Organisation of two NAM sessions at CORESTA Smoke Science and Product Technology Conferences 2021 and 2023. The first symposium focused on the use on NAMs by invited industry speakers with a series of presentations (Lee et al., 2022). The second NAMs session was focussed on the use of NAMs for evaluating NGPs (Lee et al., 2023).
   • Lee K.M., Corley R., Jarabek A.M., Kleinstreuer N., Paini A., Stucki A.O., and Bell S. (2022). Advancing New Approach Methodologies (NAMs) for Tobacco Harm Reduction: Synopsis from the 2021 CORESTA SSPT-NAMs Symposium. Toxics 10, 760
   • Lee K.M., Leverette R., Zhang J., Simms L., Keyser B., Talikka M., and Ito S. (2023). New Approach Methods (NAMs) Symposium-II: Applications in Tobacco Regulatory Sciences, the 2023 CORESTA SSPT Symposium

Other projects are either at the ideation stage or at an early stage but are highlighted in the annual reports.

Scientists who wish to participate in the NGTX Task Force can register their interest with the CORESTA Secretariat.

March 2024