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?
- 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?