Early Evidence Review

Biomarkers

When preparing to go to any regulatory agency in the world, every decision you make is crucial, and every scarce dollar spent on one thing is unavailable for something else. Do you need to review your efficacy, or should you start spending that money on an additional toxicology study? Should you move from injectable to oral administration, before going to market, or go to market first and change the formulation later? 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 subject matter 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. Our team members work closely with our strategic advisory and regulatory groups to help prioritize your drugs for clinical development.

Quantitative clinical pharmacology

Strategic model-based drug development (MBDD) is designed to quickly identify promising new drug candidates that have a high chance of success through late-stage clinical trials. MBDD provides quantitative justification for strategic decisions during trial design and execution.

We can provide an understanding of the relevant biological and chemical mechanisms of action and translate that into a target product profile (TPP) that demonstrates that the asset can generate certain clinical advantages. The target profile will also provide information about the efficacy endpoints as well as the asset’s safety, providing a foundation for more efficient animal and later testing. Our regulatory group examines this data for early evidence review and will advise on which jurisdictions will allow you to proceed and which will require further data, to keep the project running smoothly.

Asset valuation consulting

How effectively will your asset meet patient needs? How will it fit into the market? And which of your assets will have the greatest impact? To answer these questions, you need to understand how markets and patient needs are evolving.

That’s where we come in. We’ll help you understand the possible clinical paths, what regulators will accept, and what commercial stakeholders will pay for. We’ll help you determine the asset’s lifetime potential so you can make those high-stakes, go/no-go decisions.

Market access consulting

You want any patient who can benefit from your drug to have easy and affordable access to it. To ensure this, you need to know why a physician would prescribe your drug, why a payer would cover it, and why a patient would choose it. The needs and responses of these stakeholders are often consulted too late to have the necessary effect on development choices.

We provide you with an early understanding of market access that will inform your TPP, clinical trial design, and label optimization. These insights are based on our deep understanding of prescriber treatment algorithms combined with market knowledge of therapeutic areas and indications.