37 leading biopharmaceutical companies now participate in this unique research and development group focused on advancing model-informed drug development
PRINCETON, NJ – Dec. 10, 2019 – Certara®, the global model-informed drug development and decision support leader, today announced that LEO Pharma has licensed its proprietary Simcyp® Population-based Simulator and joined its Consortium. The Simcyp Simulator Consortium, which is the most influential scientific research consortium of its kind, recently celebrated its 20th anniversary. With LEO, there are now 37 biopharmaceutical companies working in a pre-competitive environment to advance physiologically-based pharmacokinetic (PBPK) modeling and simulation, progress new drug and biologics research, create new regulatory frontiers, and foster ongoing modeling and simulation education.
“We are thrilled to have LEO Pharma, a leader in dermatological and rare disease innovation join the Consortium,” said Dr. Steve Toon, Simcyp Managing Director. “We are confident that LEO’s research programs will benefit from using Simcyp PBPK modeling and simulation, which allows difficult or unethical clinical scenarios to be investigated in silico versus in patients. Simcyp Simulator uses include determining the most appropriate drug dose, predicting the potential for drug-drug interactions, understanding drug disposition in vulnerable populations such as pregnant women, pediatric patients and neonates, and patients with complex diseases or co-morbidities that require them to take multiple drugs.”
Pharmaceutical companies and regulatory agencies around the world have embraced PBPK and model-informed drug development. Today, the US Food and Drug Administration (FDA), the European Medicines Agency, Japan’s Pharmaceuticals and Medical Devices Agency, and China’s National Medical Products Administration employ the Simcyp Simulator, as do more than 100 academic research organizations. The Simcyp Simulator has been used to inform more than 200 label claims in lieu of performing clinical studies for FDA novel drug approvals. Additionally, the Simcyp Simulator’s dermal model was used to demonstrate virtual bioequivalence in a topical formulation, thus avoiding the need to perform an in vivo clinical endpoint study. This was the first approval of its kind.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, 90+% of all novel drugs approved by the US FDA in the past four years were supported by Certara software or services. Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.
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