ABSTRACT
The drug discovery and development process requires the close interaction of a large number of scientific disciplines for as many as 10 to 12 years. Most pharmaceutical and biotechnology firms employ teams to guide the processes involved in taking a discovery lead through the various preclinical/nonclinical (or Safety) and clinical (or Efficacy) drug development stages for making the drug candidate into a therapeutic product. The responsibilities of these project teams include, but are not limited to:
Reviewing research results from experiments conducted by any of the various scientific disciplines.
Integrating new research results with previously generated data.
Planning research studies to further characterize and develop a drug candidate.
Preparing a detailed drug development plan, including designation of key points or development milestones, generating a timeline for completion of key research studies, and defining the critical path.
Monitoring the status of research studies to ensure that they are being conducted according to the timeline and critical path in the development plan and, if appropriate, modifying the plan as new information becomes available.
Comparing research results and development status and timelines with drug candidates under development by competitors.
Conducting appropriate market surveys to ensure that the development of a drug candidate is economically justified and continues to meet a medical need.
Reporting the status of the drug development program to management and making recommendations on the continued development of the drug candidate.
