Oncology
For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
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:
- Getting the most out of early interactions with regulators
- Using clinical pharmacology and modeling and simulation to optimize first-in-human (FIH) trial design
- Multiplying the feedback loops of learning and efficiency with biomarkers
- Planning early for patient diversity in clinical trials