Certara’s customers, who use our software and services, received 90% of US FDA novel new drug approvals for 7th consecutive year
Steady, increasing adoption of modeling and simulation in the drug development process
Regulatory agencies have steadily increased their adoption of modeling and simulation in the drug development process in past two decades, and many global regulatory agencies routinely use Certara’s Simcyp PBPK and Phoenix PK/PD platforms.
The US FDA has encouraged the use of modeling and simulation as an integral part of drug development, as codified in the current PDUFA and GDUFA, as well as the 21st Century Cures Act. During her speech at the Breakthroughs in Medicine conference in 2019, Dr. Janet Woodcock, Director of FDA’s Center for Drug Evaluation and Research (CDER) spoke of the Agency’s commitment to innovation in drug development. “As part of FDA’s broader innovation initiative, we are encouraging the use of state-of-the-art innovations such as adaptive trials, modeling, and simulations to allow an evaluation of a product’s safety and effectiveness…CDER and FDA’s Center for Biologics Evaluation and Research (CBER) are currently deploying these tools to help predict clinical outcomes, inform trial design, support evidence of effectiveness, and evaluate potential adverse event mechanisms.”
Since inception, Certara’s mission has been to advance modeling and simulation and work with regulatory agencies to inform and optimize trial designs, dosing regimens and ultimately the final drug label.
To date, our modeling and simulation software has directly informed more than 250 label claims related to safety and dosing for nearly 90 novel drugs.
Integrate regulatory science with modeling and simulation into the drug development process
Simcyp MechDermA Model achieves regulatory approval, demonstrating virtual bioequivalence
Ten regulatory agencies use Certara's Phoenix PK/PD Platform
The Phoenix PK/PD platform is the most advanced and widely-used validated software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation worldwide. Global regulatory agencies use Phoenix software to evaluate regulatory submissions, including:
- US Food and Drug Administration (FDA)
- China National Medical Products Administration (NMPA)
- UK’s Defence Science and Technology Laboratory (DSTL)
- Japan’s Pharmaceuticals and Medical Device Agency (PMDA)
- Germany’s Federal Institute for Drugs and Medical Devices (BfArM)
- France’s Agency for Food, Environmental & Occupational Health and Safety (ANSES)
- Korea’s National Institute of Food and Drug Safety (NIFDSE)
- Brazil’s National Health Surveillance Agency (ANVISA)
- Serbia’s Medicines and Medical Devices Agency
- Ukraine’s State Expert center Ministry of Health
Simcyp PBPK Platform has been adopted by leading regulatory agencies
Simcyp Consortium members have helped to transform physiologically-based pharmacokinetic (PBPK) modeling and simulation from research into an applied technology that informs all phases of drug selection, development and regulation. PBPK modeling and simulation has been adopted by many global regulatory agencies, including:
- US Food and Drug Administration (FDA)
- US Environmental Protection Agency (EPA)
- UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)
- Germany’s Federal Institute for Risk Assessment (BfArM)
- Health Canada
- Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)
- France’s Agency for Food, Environmental & Occupational Health and Safety (ANSES)
- France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
- Spain’s Agency of Medicines and Medical Devices (AEMPS)
- Croatia’s Agency for Medicinal Products and Medical Devices
- Romania’s National Agency for Medicines and Medical Devices (NAMMD)
Quantitative methods and modeling (QMM) can modernize new and generic drug development
This figure is from an FDA impact story and shows the use of model-integrated drug development for new drugs.*
- The yellow curve represents information and datasets collected through R&D for the active pharmaceutical ingredient (API), formulation, in vitro release, the targeted in vivo release profile, animal and human drug PK, PD response(s), and clinical responses in terms of both efficacy and safety end points
- The green curve represents models describing the relationships between the datasets. Using these models optimize the collection of data and accelerate decisions.
- The dotted curve shows that the combination of models and data results in higher confidence in clinical performance at an earlier time in development
