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
Related Insights
Article
Key strategies to mitigate the risks of asthma drug development
Jan 24, 2025
Video
Part 1: Risk-based Quality Management (RBQM) Video Series
Nov 11, 2021
Playbook
The upward trend of FSP outsourcing
Sep 29, 2022
Blog
Including patients in DCT design
Sep 13, 2022
Podcast
Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment
May 9, 2022
Blog
End-to-end risk management: Getting the most from your program
Apr 4, 2022
Video
Part 2: Practically Speaking: Driving Clinical Transformation
Feb 9, 2022
Video
Part 1: Practically Speaking: Driving Clinical Transformation
Feb 9, 2022
Blog
Master Protocol Trials: What Are the Elements of Success?
Dec 1, 2021
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Video
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Whitepaper
Master Protocols from Design to Delivery
Sep 30, 2021
Related Insights
Article
Key strategies to mitigate the risks of asthma drug development
Jan 24, 2025
Video
Part 1: Risk-based Quality Management (RBQM) Video Series
Nov 11, 2021
Playbook
The upward trend of FSP outsourcing
Sep 29, 2022
Blog
Including patients in DCT design
Sep 13, 2022
Podcast
Decentrally Speaking | Episode 2: The Shifting Roles of Pharmaceutical Depots within a Decentralized Trial Environment
May 9, 2022
Blog
End-to-end risk management: Getting the most from your program
Apr 4, 2022
Video
Part 2: Practically Speaking: Driving Clinical Transformation
Feb 9, 2022
Video
Part 1: Practically Speaking: Driving Clinical Transformation
Feb 9, 2022
Blog
Master Protocol Trials: What Are the Elements of Success?
Dec 1, 2021
Video
Part 3: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Video
Part 2: Risk-based Quality Management Video (RBQM) Series
Nov 11, 2021
Whitepaper
Master Protocols from Design to Delivery
Sep 30, 2021