Commonly Qualifying Tasks:
- Formulation development/improvement & Review
- Laboratory testing
- Pre-Discovery/Drug Discovery
- Pre-clinical development
- Clinical trials
- Manufacturing process development
- Failed product/process development projects
There are many facets of pharmaceutical research that would qualify for the research and development project and qualifying activity can be found throughout the various phases of the process.
During pre-discovery, scientists work to understand the molecular characteristics of specific diseases and conditions. This work informs all of their future decisions which can then take several treatment development paths. In addition, during this phase, a company may begin exploring factors such as how genes are altered, protein interactions, and specific reactions to proposed treatments that have been developed.
Once researchers define a target, whether a single molecule such as a gene or a protein, work begins on determining if the target will be affected and what type of reaction will occur. This is called target identification.
Once a target has been identified, the target validation phase begins in which researchers test the effectiveness of a particular drug they are developing. Target validation is an important part to the process since it allows researchers to explore many development paths without having to invest too much into one particular drug molecule.
During drug discovery, researchers continue their search for a lead compound, or a molecule that they believe will be successful in treating the ailment that is being researched.
This then leads to safety tests and lead optimization in which researchers conduct extensive studies to assess the safety of the lead compound and ultimately, alter its molecular structure to make them more effective and safer. During this optimization process, a company could screen hundreds of different analogues of leads by developing and testing them.
Following these development phases, preclinical testing begins. With the final optimized compounds that they have developed up to this point in the process, scientists conduct extensive experiments to determine if the compounds warrant testing on humans. It is also during this phase the researchers begin evaluating large scale production. After several years of work, scientists will have reduced the initial set of compounds that they evaluated during prediscovery (anywhere between 5,000 to 10,000), the final candidate drugs will be selected for human clinical trials.
Clinical trials are split into three phases. The first phase is human testing in a small group of healthy volunteers to really test safety in the body. Factors like drug absorption, metabolisation, side effects, and efficacy are evaluated. This leads to the second phase which is a test trial in a small group of actual patients. Finally, in Phase 3, a large test group of patients (anywhere between 1,000 – 5,000) are treated with the drug to determine efficacy and safety.
Once a drug has made it through this entire process a New Drug Application is filed and submitted for FDA approval. Though this signals the official close of the drug development process, there is still some R&D that qualifies even after the drug has secured FDA approval.
Specifically, when a drug gets approval and is being manufactured in quantity, a company will have to create a facility or make heavy modifications to an older facility to support the new drug’s production. Time invested in this type of process development/improvement/modification qualifies for the credit.
In addition, after a drug is released to patients by the FDA, companies begin long-term studies on safety by selecting specific subgroups of patients. This will inform them of any long-term side effects which will inform their formulation in a later iteration.