Instem, a leading provider of IT solutions to the global life sciences market, announced today that it has acquired Leadscope, Inc. as part of its mission to further consolidate and harmonize key application areas that are helping customers streamline and accelerate their research and development processes.
Founded in 1997 and based in Columbus, Ohio, Leadscope is a well-respected name within the scientific community. Leadscope is known for its advanced informatics and prediction technology, along with database solutions, that help organizations effectively unlock valuable knowledge contained in both public and proprietary sources of research data.
Leadscope accelerates the drug discovery and development process through intuitive tools that are used by their international clients to predict toxicity and perform expert reviews for genetic toxicity, skin sensitization, carcinogenicity, acute toxicity, reproductive and developmental toxicity, organ toxicity and environmental toxicity.
“On behalf of our clients and staff, we couldn’t be happier to be part of the Instem group and the transformation they are leading in health and life sciences,” comments Dr. Glenn Myatt, CEO at Leadscope. “The Instem brand is synonymous with innovation and market leadership, and they have managed to balance their growth while maintaining excellent service to their clients – something that is highly important for us here at Leadscope. As a leading provider of in silico safety assessment solutions, having the resources and global reach of Instem will help us further meet the growing need of industry and regulators for adaptable and flexible workflows that embed comprehensive and ethically acceptable safety assessments.”
Leadscope are renowned leaders in computational toxicology and their clients include pharmaceutical, chemical and consumer products organizations, as well as international regulatory agencies. Leadscope’s innovative solutions allow researchers to combine their own proprietary data with publicly-curated toxicity databases. Clients searching Leadscope’s toxicity databases can access well over 500,000 toxicology studies for more than 200,000 chemicals, enabling fast, accurate, defendable and regulatory accepted predictions.
“This acquisition is a great fit for us, and the synergies created will further help us enable clients to make better informed decisions,” states Phil Reason, CEO at Instem. “We have been in regular dialogue with Glenn and the Leadscope team for over 10 years, and with the increasing needs of the market for in silico tools, both in regulatory submissions and in safety profile screening, the timing is perfect. They have built a deep relationship with the regulatory authorities, a fantastic client base and have an excellent reputation in the market as true collaborators.”
Leadscope provides scientific leadership in computational toxicology enabled through several Research Collaboration Agreements with the FDA and through the management of consortia to develop protocols and position papers to help further drive market adoption. This includes an in silico toxicology protocol project funded by an NIH grant where Leadscope is managing a consortium of over 60 members, including international regulatory agencies, pharmaceutical, chemical and consumer products organizations, academics and toxicity consultants.
Increased Demand for Model Based Drug Development
The acceptability and use of alternative approaches, and more specifically in silico methods, are being driven by the need to maximize the relevance and credibility of safety assessments. The industry continues to evaluate the practicality of high-cost animal testing combined with the need to assess the safety of substances in a limited timeframe amidst a competitive environment; including the need to innovate new chemicals and products that satisfy ever-changing market demands.
Leadscope has a long-standing relationship with the FDA through their Research Collaboration Agreements to develop in silico solutions to support regulatory needs. Leadscope’s solutions help reduce, refine and ultimately replace animal experiments, while addressing the need to reduce the amount of time spent by scientists in referencing disparate sources of data to aid decision making related to toxicity assessment.
Computational toxicology covers a wide range of endpoints, one of which is now driven by ICH M7, the first international regulatory guideline to include computational toxicology models. The ICH M7 guideline describes a consistent approach, that can be utilized from preclinical through to final submissions, to identify, categorize, and control DNA reactive (mutagenic) impurities in pharmaceutical products to limit potential carcinogenic risk. Leadscope has actively supported the adoptions of ICH M7 and offers a complete solution to support this guideline.
The Leadscope team will be part of Instem’s Scientific division, which currently is providing Target Safety Assessment (TSA) services through its KnowledgeScan™ offering. Through this acquisition, Instem is poised to offer the market better starting points by combining a wider array of key data to help clients gain a clearer picture of candidates from early biology to early chemistry. Going forward, combining Instem and Leadscope’s technologies will provide unique and more seamless solutions for the integration of public data and proprietary information to support the discovery and development of pharmaceuticals and other chemical products.
Teams from both Instem and Leadscope will be exhibiting and presenting at next week’s American College of Toxicology 2019 Annual Meeting in Phoenix, Arizona.
Provided on a subscription or pay-per-use basis, Leadscope’s solutions employ sophisticated artificial intelligence and machine-learning algorithms to help researchers better predict potential safety outcomes. Accessed on-line as a SaaS solution or deployed on-site, Leadscope’s software is used to easily extract knowledge from both public data and proprietary sources enabling scientists to perform expert reviews.
Instem is a global provider of leading software solutions and services that are helping over 500 clients bring their life enhancing products to market faster. We enable clients in the life sciences to more efficiently collect, analyze, report and submit high quality regulatory data, while maintaining compliance for their products around the world.
Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare 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, Japan, China and India.