Research and initiation of drug and business development
To support you in the planning of a pharmaceutical project, we here describe the different steps in the drug development process.
Transitioning research into the drug discovery and commercialization process
The drug development journey often begins with groundbreaking research in the laboratory. At this stage, it is important to arm yourself with knowledge of the target disease process, understand which molecular target is in focus, and investigate which tools will be necessary to develop a particular substance into the early development phase.
Hypothesis around the treatment
In the next phase, it is important to transition the research finding into the journey towards a commercial product, by formulating a hypothesis around how the treatment will affect its target structure in order to obtain the desired effect by the mode of action.
A business plan should also be developed at this stage, driving research towards the overall end-goal, a commercially viable product with clear patient benefit. This generally requires the help of external expertise in the case of the average small start-up, and should also include projection towards the final goal in terms of patient needs, the state of commercial competition, as well as market share possibilities, with a 5-10 year perspective.
This early phase in the process can vary considerably in length, depending on the approach, the access to disease models, and how successful you are at generating data to support the hypothesis of the involvement of the target in the disease and the mode of action of the treatment being directed against this. This work is generally termed target validation and should include a demonstration that the target is expressed in the diseased tissue, and that engagement of the target results in the desired pharmacological effect, either on the disease itself or on a surrogate pathway central to the disease. At this stage, it is also important to investigate potential safety risks that can arise from engagement of the target, and plan for how these eventual risks can be mitigated during further development.