Cutting Edge Biosimulation Solutions for Drug Development

Drug development has become more complex and multi-layered.  New combination therapies require more precise and individualized analyses, new approaches such as ‘basket studies’ evaluate potential disease targets through a new lens, safety issues are more challenging, and comparative effectiveness plays an increasingly important role in 'go/no go' decisions.  As the largest and most diverse biosimulation organization, Certara has developed an array of solutions to address these key issues.  

Programmatic consulting delivers unquestionable value to sponsors:

  • Drug program and pharmacometric regulatory strategy
  • What are the regulatory agency expectations?
  • Do we have to run a C-QT study?
  • Have we conducted the right in vitro studies to allow us to reduce or improve clinical studies?

Simcyp physiologically-based pharmacokinetic (PBPK) strategy:

  • Are we best leveraging our in vitro data?
  • What drug-drug interaction (DDI) studies may be required by the regulatory agency and/or can we simulate the result and waive the study?
  • Could we simulate a special population rather than running a study to inform the label?
  • Can we guide formulation decisions by studying absorption and food impact?

Pharmacometrics and pharmacokinetic/pharmacodynamic analysis (PK/PD):

  • Are we collecting the right information in our clinical trials?
  • Do we have the best dosing strategy?  
  • Do we understand the benefit/risk profile?
  • Are our clinical trial aims powered optimally for determining statistical significance, dose/frequency/measurement times and more?

Optimized regulatory agency clinical communication:

  • Use modeling as regulatory currency
  • Articulate the integration of virtual and clinical pharmacology studies

Commercial optimization strategy/Model Based Meta Analysis (MBMA):

  • How will our product stack up against the standard of care?
  • How to best market/position our product?
  • Is our drug commercially and financially viable?

Regulatory writing:

  • What is our filing strategy? Have we briefed the agency and received their buy in?
  • What is the state of our documentation based on our content plan?
  • How do we manage our critical path and our need to file globally and still meet our timeline obligations?