The Clinical Development Plan: Executing the Clinical Strategy

Writing a Clinical Development Plan (CDP) takes time and effort but is ultimately a key part of the navigation system (“the GPS”) to bringing an investigational medicinal product (IMP) to market with a compelling patient and payer value proposition. The CDP is the result of translating the vision into a tactical plan with consideration of the potential risks and opportunities that surround the clinical program.

For an early stage pharma/biotech company, the CDP can be extremely valuable and a key indicator of potential success of a program. The CDP is not merely a bulleted list or project plan on clinical studies with timelines and cost. The CDP is made valuable through the multidisciplinary consideration of all components that enable success of the clinical program, leveraging opportunities and mitigating against anticipated risks. This white paper provides tips and best practices on developing and executing a clinical strategy: Overview of program-level considerations to support the execution of the CDP and, in particular, how recent updates in regulations such as draft ICH E8 (R1) are changing the IMP development process.