Instem announced that its latest in silico solution offering known as Advance? is providing clients with a technology-enabled approach for assessing carcinogenicity based on the ICH S1B Weight of Evidence (WoE) Addendum. The ICH S1B guideline has introduced a WoE approach to assess human carcinogenic potential of small molecule pharmaceuticals and determine whether a 2-year rat carcinogenicity study would add value. Application of this integrated analysis supports the 3Rs principles, while promoting safe and ethical development of new small molecule pharmaceuticals. In early 2022, in response to the directive, Instem established a collaborative cross-industry working group to develop a protocol that could support the carcinogenicity WoE integrated assessment in a transparent, consistent, and defendable manner.
Since that time, Instem?s team of in silico experts have been instrumental in driving forward a solution to support the S1B guideline. In addition to leading the cross-industry working group, Instem has delivered numerous presentations, posters and workshops at key global industry conferences and events, as well as creating, developing, and delivering the Advance? technology-enabled service in consultation with key industry stakeholders.
The benefits of this revolutionary WoE approach are multi-fold. In addition to saving time, money and the need for animal experimentation, a literature and data-based reasoning provides scientists confidence in the experimental approach and prompt alerts to potential safety concerns. This ultimately enables pharmaceutical organizations to bring their life enhancing products to market faster.
The Advance? service is comprised of six areas, which mirror the six WoE factors. Instem can provide a full assessment of all six WoE factors, including database searches and in silico experimentation. Alternatively, a single WoE factor can be completed to complement an in-house workflow.

As the compound progresses through the pipeline, and more data or information becomes available, the WoE assessment can be updated and refreshed in real time.
Industry and regulators are increasingly recognizing the huge benefits of in silico approaches, which are driving forward this strong and sustained growth in the acceptance and adoption of alternative methods in drug discovery. The introduction of Advance? has further enabled organizations to replace, reduce or refine their efforts within animal research.