Instem Enables Clients to Leverage ICH S1B Weight of Evidence Guideline
Advance™ technology-enabled solution enables R&D organizations to cut study timelines, deliver cost savings and reduce animal experimentation.
PHILADELPHIA, PA – (BUSINESS WIRE) - January 25, 2024 - Instem, a leading provider of IT solutions and services to the global life sciences market, announced today 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.
One of the global pharmaceutical organizations who collaborated with Instem on the development of the Advance™ solution said, “The Advance™ services are a living embodiment of more than a decade of effort from scientists and regulators across the globe. We now have an avenue for leveraging a scientific-based argument to reduce the emphasis on animal use in the post marketing space without compromising patient safety. It’s an opportunity for us to embrace innovation and to deliver medicines in a more efficient way”.
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.
Dr. Gordon Baxter, Chief Scientific Officer, Instem, commented: “The introduction of the Advance™ technology-enabled service is another important step for us all to recognize the ongoing demand for reliable alternatives to traditional testing methods. By reimagining the carcinogenicity assessment in this way, it will unlock numerous possibilities to progress the drug discovery and development journey for many organizations globally. The Advance™ assessment is robust enough to provide intelligent insights in the present, but can also be updated in the future when more research information becomes available.”
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.
A global provider of leading software solutions, technology enabled outsourced services and powerful scientific insights, Instem is helping clients to bring their life enhancing products to market faster.
We enable organizations in the life sciences to more efficiently collect, report and submit high quality regulatory data, while offering them the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Every day, across the entire drug development value chain, Instem solutions are meeting the rapidly expanding needs of life science organizations for data-driven decision making, leading to safer, more effective products.
Instem supports its global roster of clients through offices in the United States, United Kingdom, France, Switzerland, Japan, China, and India.
Julie Jones, Marketing Director
Pooja Pankhania, Marketing Manager – In Silico Solutions