Once an IND has been filed with the FDA, drug development begins in earnest. The patent has usually been filed years earlier and it is urgent to proceed quickly. At this point, the FDA requires that Phase-2 materials be produced in a GMP facility. This is a major hurdle for any research institution, as this is the first time that an identifiable Quality Assurance (QA) group becomes involved. Although Phase-2 clinical materials can be produced in the lab, the facility controls demanded are beyond the capability of all but a few research institutions and would require extensive (and expensive, time-consuming) retraining of a large, cross-functional group of people. This phase also requires a more extensive network of clinics, which most institutions do not possess or are not equipped to set up. The current trend is to perform clinical trials overseas – particularly in China and India. The challenge is assuring that clinical protocols are followed so that data integrity is not compromised. However, the cost advantages for overseas trials can not be ignored, coupled with the trend toward paperless documentation to save money in the most expensive stage of drug development.
- Qualification of facilities and equipment to FDA standards
- Procurement and installation of equipment for clinical production
- Formulation refinement from Phase I results
- Clinical material production facility assessment
- Clinical material production
- Clinical trial administration