Model-Based Drug Development

Biomarkers

When preparing to go to regulatory bodies, every decision you make is crucial, and every scarce dollar spent on one thing is unavailable for something else. You need to understand what the evidence is saying, how to make the best choices based on that understanding, and how to communicate that understanding to your stakeholders. 

Our translational science group will advise you on the best models to run and how to design the studies around those models. We have experts who review data daily across multiple indications and know exactly what to look for if you are developing a monoclonal or need to make a formulation decision. This group works closely with our strategic advisory and regulatory groups to help prioritize your drugs for clinical development.

Bioanalytics

You may need to run multiple models to convincingly demonstrate the efficacy of your drug through quantitative determination of chemical entities and biomarkers. Each model requires a significant amount of experience to do well, and not all laboratories are equipped and experienced on all models. You can’t afford to rely on a subpar bioanalysis.

We have long experience with every provider of clinical and bioanalytical laboratory services. If your asset requires four models, we know which lab is good at the first two, and that another has deep expertise in models three and four. We manage the process of bioanalysis across these different labs, developing a pharmacodynamic model here and performing in vitro translational immunology there. We choose companies for their best-in-class methods and put them together under one umbrella to meet your needs.

Biostatistics

Making optimal choices at every stage of the drug development process requires early involvement from biostatisticians. Trial methodology, modeling in pharmacokinetics, bioequivalence and bioavailability testing, drug safety monitoring, and product quality assessment all support best-practice drug development.

We apply up-to-date statistical methods to a wide range of biological topics, providing high predictive accuracy with minimal unexplained variation, throughout the drug development process. 

PK/PD

We combine clinical pharmacology, modeling, and simulation with clinical pharmacokinetics (PK) and pharmacodynamics (PD) to derive valued data strategically and efficiently throughout development.

Our pharmacological solutions can contribute substantially to the commercial success of your evolving portfolio across therapeutic areas, with modeling and data analytics techniques that help mitigate risk and support decision making every step of the way.

• Phase I: Support go/no-go decisions, safe dose selection, and regimen selection
• Phase II: Determine optimal phase III dose and identify intrinsic/extrinsic factors 
• Phase III: Dial in dose modification for efficacy and safety
• Post-approval: Assess potential for drug interactions and support high quality regulatory packages