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. Former FDA Commissioner Dr. Scott Gottlieb stated that FDA is using more advanced computing tools and more sophisticated statistical and computational methodologies, as part of the drug development and the drug review process. In his speech to the Regulatory Affairs Professionals Society’s (RAPS) 2017 Regulatory Conference, he reported, “Almost 100 percent of all new drug applications for new molecular entities have components of modeling and simulation.”

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 our inception, Certara’s core mission has been to advance innovation in modeling and simulation and work with regulatory agencies to inform and optimize clinical trial designs, dosing regimens for different populations, and ultimately the final drug label, which is hugely important.

To date, our modeling and simulation software has directly informed over 200 statements on drug labels related to safety and dosing.

Eleven 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. Thirteen global regulatory agencies use Phoenix to evaluate regulatory submissions.

  • US Food and Drug Administration (FDA)
  • China National Products Administration (NMPA)
  • UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Japan’s Pharmaceuticals and Medical Device Agency (PMDA)
  • Germany’s Federal Institute for Drugs and Medical Devices
  • Korea’s Ministry of Food and Drug Safety (MFDS)
  • Australia’s Therapeutic Goods Administration (TGA)
  • Brazil’s National Health Surveillance Agency (ANVISA)
  • Thailand’s Food and Drug Administration
  • Peru’s Directorate General of Drug Supplies and Drugs (DIGEMID)
  • Serbia’s Medicines and Medical Devices Agency
Learn more about Phoenix PK/PD Platform
Simcyp PBPK Platform has been adopted by leading regulatory agencies

Working together, the Certara and Simcyp Consortium members have helped to transformed physiologically-based pharmaockinetic (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 all the leading regulatory agencies, including the:

  • US Food and Drug Administration (FDA)
  • US Environmental Protection Agency (EPA)
  • European Medicines Agency (EMA)
  • UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)
  • China National Products Administration (NMPA)
  • Germany’s Federal Institute for Risk Assessment (BfR)
  • Health Canada
  • France’s Agency for Food, Environmental & Occupational Health and Safety (ANSES)
  • Sweden’s Medical Products Agency (MPA)
  • Brazil’s National Agency of Health Surveillance (ANVISA)
  • Malaysia’s National Pharmaceutical Regulatory Agency (NPRA)
Learn more about Simcyp PBPK Platform
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

*https://www.fda.gov/drugs/regulatory-science-action/impact-story-modeling-tools-could-modernize-generic-drug-development

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