Crossing the chasm with pharmacometrics

Successful drug development and commercialization requires getting critical development and regulatory decisions right.

  • What is the exposure-response relationship for the drug?
  • What is the optimal dosing strategy?
  • Which patients would derive greatest benefit from this drug?

Pharmacometrics uses mathematical and statistical models to quantify drug, disease, and trial information to help address these decisions. The data used to build pharmacometric models comes from both internal preclinical and clinical data as well as external data on competitor drugs in the same class.

Pharmacometrics increases our understanding of factors that drive pharmacokinetic (PK) and pharmacodynamic (PD) variability. A well-designed pharmacometric strategy can also integrate knowledge across a drug’s preclinical and clinical development to support a “learn and confirm” paradigm.

We partner closely with clients, forming one cohesive and integrated team.  What our clients say:

“What I like most about Certara is not only their expertise, but also their commitment to their client.” – Clinical PK Manager at pharmaceutical company based in Switzerland

“What stands out about Certara is their timely responses and open dialogue.” – Translational Scientific Manager at mRNA therapeutics biotech

Optimize go/no-go decisions

Certara provides high-quality, regulatory-compliant pharmacokinetic and pharmacodynamic (PK/PD) analyses and modeling for regulatory submission packages. Our pharmacometricians support pre-clinical and clinical study analysis for new drug approvals, line extensions, in-licensing options, and product portfolio decisions for global biopharm companies.

With the largest global team of PhD, PharmD and MD consultants, we leverage quantitative methods to build a comprehensive knowledge-base of drug discovery, pre-clinical, early-phase clinical, literature, and competitor data, which can be used to optimize decisions, including the “go/no go” that will lead to commercial activities.

These analyses can also inform post-approval study decisions.

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Benefits of quantitative approaches

90%+ of all novel drugs approved by the US FDA over the past few years have used pharmacometrics in their development program, with most leveraging Certara’s services or technology.

  • Make data-driven decisions at all stages of drug development through a quantitative framework
  • Design safer, targeted, and more efficient trials
  • Select the right dose for the right patients, the first time
  • Maximize the probability of commercial success
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Modeling is only as good as your data

Want to ensure the highest quality dataset for your analysis?  Certara’s data programmers are experts in using SAS to code pharmacokinetic and pharmacodynamic (PK/PD) datasets.

  • Our data programmers create datasets for our projects
  • We create higher quality datasets that require fewer quality control cycles.
  • We can decrease the time between database lock and performing noncompartmental analysis (NCA), exploratory analysis, or PK/PD modeling
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Michael Dodds, PhD Executive Director, Integrated Drug Development

Specializing in pharmacometrics application to complex biotechnology products since 2005, Mike’s research focuses on the application of mathematical models of biology, (patho)-physiology, pharmacology and disease that quantify beneficial and undesirable interactions between drugs and patients to predict outcomes. He has held roles at ZymoGenetics and Amgen.

Rik de Greef, MSc Senior Vice President, Integrated Drug Development

Rik’s key interests are in the integration of model-based components with overall clinical pharmacology and clinical development deliverables throughout the development trajectory. He enjoys combining his analytical skills and creativity in designing efficient drug development strategies that address the right questions at the right time.

JF Marier, PhD Senior Vice President, Integrated Drug Development

JF has 25 years of experience performing PK, PK/PD and exposure-response analyses to support dosing rationale in various therapeutic areas.  Specialties include oncology, rare diseases and pediatric populations.  Over the last decade, he has provided pharmacometric analyses and strategic decisions that supported the regulatory approval of more than 25 small and large molecules.