Have you ever wondered how the drugs our doctors prescribe are developed and get to market? Do you know how long it takes or what must happen for prescription medications to be deemed safe for us to take? The drug development process is quite complex and takes time, the skills and knowledge of a broad range of medical experts and money…a lot of money. In fact, it takes an average of 12 to 15 years for a drug to go from the lab to your local pharmacy.
Drug development stages
Before a prescription drug makes it to market, it must go through an extensive multi-stage process that includes discovery, pre-clinical development, clinical development and, if the drug makes it this far, review and approval from the Federal Drug Administration (FDA). What do each of these stages include? Here is a brief overview:
The discovery stage includes:
- Target Identification. This is a biological target that the drug manufacturers want to modulate or change in some way to lead to a desired therapeutic effect. Targets are typically identified through genomics (genetic targets), bioinformatics or targets that are expected to impact the symptoms or outcome of a disease without having a direct connection to the underlying pathology.
- Compounds library design. Compound sets can be designed to focus on a specific protein target or family, a desired therapeutic area, a method of administration or a combination of these. This can be achieved using industry and proprietary software, including structure- and ligand-based virtual design and screening, statistical model, physicochemical property distribution and similarity/substructure searching throughput screening. Similar strategies can be used for antibodies or larger biological therapies.
- Medicinal chemistry for small molecules. This process includes chemical synthesis and studies to identify the structures that are relevant to the activity.
- In-vitro preclinical studies. These studies are used mainly to refine lead drug candidate selection through testing in cellular disease models, drug selectivity, specificity, efficacy and optimized drug properties.
Preclinical drug development
This stage includes:
- In vivo animal models (disease models)
- Investigational New Drug (IND) enabling studies focused on drug safety and drug manufacturing
The three phases of clinical trials (Phase I, II and III) are designed to establish safety and efficacy of the therapeutic agent in humans. Phase IV trials are typically required by the FDA after the drug receives FDA approval.
My thoughts on the drug creation pipeline
This outline makes it look simple, but it is important to appreciate that a lot of experimentation and hundreds of studies are generally needed to get a new medication through the pipeline and approved by the FDA, and available to patients. This is a multidisciplinary and multistage process that requires several groups at various stages to work together to advance new treatments efficiently and effectively.
My strategy is to always ask this question: how will the work or studies I am proposing support the next phase of the drug creation process? We also need to keep the patient population in mind by asking questions like: What is the greatest need? What is the best route of administration? Is the proposed frequency of dosing convenient for patients and/or clinical staff? Is the drug stable when stored at pharmacies or in patients’ homes? These are just a few of the issues that can impact treatment access and adoption.
Keeping in mind whether the work you’re doing supports the next phase of the project should be an integral part of each stage of drug development. Being in a field where we still have a lot to learn, it is very easy to get distracted, trying to understand a science that is interesting but not critical to the drug’s development. While innovation is the engine behind our industry, a level of extreme focus is required to achieve optimized timelines and cost for drug development.