Understand The R&D Process
The development of new therapies for any disease can be loosely categorized into different stages, with the final goal of a therapy being approved by the U.S. Food and Drug Administration (FDA) for marketing. Because the stages—and the components within each stage—are not necessarily linear, you may find that your patient group already has completed some of the important pieces in the process or that some of the pieces may not be necessary for your disease. Understanding the whole process can help you develop an overall plan of the best approach for your group to engage in the therapy development process.
From a patient group perspective, the stages to develop new therapies may be organized into:
- Discovery or developing a therapeutic approach.
- Preparing for clinical trials, including preclinical studies.
- Clinical trials.
- FDA review and marketing approval.
- Postmarket approval.