PRINCETON, NJ – Mar. 8, 2019 – Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that it will be showcasing its multi-faceted – technology, service and regulatory science – approach to improving new drug safety assessments at the Society of Toxicology (SOT) Annual Meeting and ToxExpo. This conference will be held from March 10-14 at the Baltimore Convention Center in Baltimore, MD.
Non-clinical safety/toxicology is the primary cause of compound attrition during the investigational new drug (IND) selection process, accounting for 60% of compound failures at this advanced pre-clinical stage.1 In addition, more than 40% of compounds fail during Phase I clinical trials due to safety/toxicology issues, with an additional 33% failing in Phase 2. For many on-market drugs, toxicity remains an issue, resulting in adverse drug reactions, leading to black box warnings, restrictions on use, and even product withdrawals. Hence, we need a better approach, which reduces the reliance on animals, reduces failure rates and cost, whilst increasing the speed of delivery of effective medicines to patients.
Medical science is becoming more complex every day as a result of breakthroughs in gene and cell therapy, increased understanding of systems biology and target identification, and the tremendous growth in computing power and data sciences. Advances in modeling and simulation and predictive analytics are occurring in parallel at a similarly rapid rate.
“Certara is rising to meet the challenge, offering a comprehensive lineup of technologies and services designed to identify drug safety issues earlier in the development process,” said Certara’s Simcyp President and Managing Director Steve Toon, PhD.
“Traditional approaches to safety assessment, using in vitro and in vivo assays, rely heavily on animal testing and provide limited mechanistic information. At Certara, we develop and use tools to increase mechanistic knowledge, supporting model-informed drug design and development (MID3). We have established expertise in physiologically-based pharmacokinetic (PBPK) modeling, pharmacokinetic/pharmacodynamic (PKPD) modeling and quantitative systems pharmacology (QSP) and toxicology to take a mechanistic, computational approach to the problem. We integrate large amounts of de novo and legacy data to gain new insights into the relationships between molecular interactions and effects. These computational methods provide targeted, actionable data,” Dr. Toon added.
Transforming toxicology is also a priority for the US Food and Drug Administration (FDA). The Agency’s Predictive Toxicology Roadmap highlights the critical nature of toxicology testing and predictive safety analyses throughout the drug development cycle. The FDA has also taken significant steps towards integrating new predictive technologies into the toxicology programs at its different product centers.
In response, Certara Strategic Consulting (CSC) now provides insight and expertise in understanding and managing off-target interactions, developing mechanism-based chemical safety testing strategies, and modeling and evaluating disease progression and drug-induced toxicity.
CSC also partners with Synchrogenix, Certara’s regulatory science division, which has extensive experience working with global regulators, and in writing and submitting documentation in support of IND, new drug and biologics license applications.
Further highlighting Certara’s technological expertise, the US Centers for Disease Control & Prevention (CDC) just awarded it a contract to strengthen the Agency’s death investigation and surveillance systems. Certara will use its industry-leading OpenPharma™ technologies, and the CDC’s own open functionality in OpenCDC, to create OpenMDI (Open Medicolegal Death Investigation). This new OpenMDI platform will improve the timeliness and quality of drug mortality data collected, and the interoperability of state electronic death registration systems.
Certara toxicology and drug safety experts will be available to answer questions at SOT booth #2409.
Further information about the SOT Annual Meeting is available at https://www.toxicology.org/events/am/AM2019/General-Information.asp.
1. Waring MJ, Arrowsmith J, Leach AR, et al. An analysis of the attrition of drug candidates from four major pharmaceutical companies. Nature Reviews Drug Discovery. 2015;14(7):475-486.
Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
Chief Commercial Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions