Where better medicines begin

Scientific, regulatory, and societal upheavals in the last three years are making early-stage product development more complex. In our recent work with clients, we’ve found that a multidisciplinary approach to early-stage development is the most cost-effective way to mitigate risks while navigating this complexity. Integrating regulatory, clinical pharmacology, modeling and simulation, and biomarker strategies enables more informed advancement decisions. Companies can learn fast and lay a solid early foundation for future success with every asset in their portfolio.

In this playbook, we share our best thinking on where better medicines begin, focusing on four early-stage imperatives:

  1. Getting the most out of early interactions with regulators
  2. Using clinical pharmacology and modeling and simulation to optimize first-in-human (FIH) trial design
  3. Multiplying the feedback loops of learning and efficiency with biomarkers
  4. Planning early for patient diversity in clinical trials

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