Salem Oaks is proud to launch the fourth module in our series on Decision Making in Pharmaceutical Research and Development. The underlying goal of this series is to help equip you to be part of a Research and Development Team.
The first module, Decisions Decisions, gave a high-level overview of the major decisions throughout the process. We then began a three-part series focused on Research called Open Water. This latest module focuses on the decisions required for Phase 1 Clinical Studies.
You will meet several new team members and experience the challenge of bring them up to speed. You will be asked to contribute to the study design, decide on when to consult FDA, and finally make the decision just how high to push the dose. Furthermore, you’ll be there for the first-in-human study.
The Early Clinical Team works differently than the discovery and Pre-Clinical Team. The stakes are higher as people participate in the studies. Because of this, there are many more rules and procedures that must be followed. These first studies establish a beachhead that will allow the team to learn more and more about the compound. It gets pretty exciting!