This may be the most important phase in drug development. This is the point at which a new drug is first used on human subjects and evaluated for safety and efficacy. The phase requires kilogram quantities of clinical-quality drugs, produced in facilities that are at least Good Laboratory Practice (GLP) compliant. This is also the point where most research institutions seek help from industry, because drug formulation and production is a skill set that most research institutions do not have. If a research institution manages to get an industrial partner at this stage, the partnership will greatly reduce the potential for a royalty or patent income stream, especially compared to what the institution might realize if it had independent access to the expertise needed to prove efficacy and stability through clinical trials. That is what we will supply via project-specific Tiger Teams. In addition, any drug developer (pharma, academic or other) must be able to truly assess the full market potential for a new drug – this ability is lacking in most research entities, hence limiting solid intelligent business decisions. Again, our Tiger Teams will provide the needed expertise at the right time.
- Qualification of laboratory equipment to GLP status
- Evaluation of clinical facility protocols for GLP/Good Manufacturing Practice (GMP) compliance
- Formulation of compounds into drug delivery presentations
- Production of clinical batches
- Investigational New Drug (IND) writing and filing
- Validation master planning
- Clinical Trial management