Developing a new medicine is a long and complicated process. According to the Europeans Patients’ Academy, on average it takes over 12 years and $1 billion dollars to develop medication that is ready for use by patients.
Due to advancements in science and technology, research and development is now more intricate than ever. While there are many steps involved in developing a new medicine, pre-discovery has become the starting point for biopharmaceutical research. According to Modeling the Effects of Promotional Efforts on Aggregate Pharmaceutical Demand: What We Know and Challenges for the Future, the pre-discovery stage begins with “basic research, fundamental knowledge, and understanding of the mechanisms of pathology.”
Determining if There is an “Unmet Need”
An important part of early pharmaceutical research is determining if there is an unmet need in the industry. This refers to diseases where there is currently no appropriate medicine; or there is medicine available but the side effects are too severe.
If the researcher finds that there is an unmet need, they will continue with their research and development to develop a new medicine for their targeted disease.
Target Identification
Target identification is the ultimate goal of the pre-discovery phase of pharmaceutical research. The pre-discovery stage allows researchers the time to understand the disease and choose a valid target molecule. This understanding allows for the potential of discovering and developing more advanced medicines.
Once the researcher has identified the unmet need, they must understand the disease at a molecular level. They will study “how genes have changed, how these changes affect the proteins encoded by the genes, how those proteins interact with each other in living cells, how the affected cells change the specific tissue they are in, and how all these processes combine to affect the patient.”
Once this is completed, they will choose the biological target for a prospective medicine. The biological target is a “biomolecule, which is involved in that particular disease and can be modulated by a drug.”
Researchers will then validate their biological target by performing studies in cells, tissues and animals to verify that their target can be influenced by medicine. This validation is important to help scientists identify the most promising approaches before further developing a potential medicine; increasing the effectiveness of their research. This research is also cost-effective, helping to save large amounts of money having conducted the requisite research prior to target identification.
While there are many steps involved in developing a new medicine, pre-discovery has become the new starting point for biopharmaceutical research.
While there are many steps involved in developing a new medicine, pre-discovery has become the new starting point for biopharmaceutical research.
Utilizing “Literature-Based Discovery”
The pre-discovery phase of pharmaceutical research is not possible without in-depth literature to assist in formulating a new hypothesis. Researchers must be able to identify connections to their work from various pieces of literature. However, due to the sheer volume of literature available, this can be a difficult task.
To address this issue, Literature-Based Discovery (LBD) systems have been created to aid in identifying connections between disjointed pieces of data. LBD works in the following way:
- A starting term (such as “cancer”) is identified by the researcher.
- The LBD system uses a “correlation-mining approach” to identify terms associated with the starting term, known as “linking terms.”
- For each “linking term,” the LBD uses the same “correlation-mining” method to recognize additional terms that correspond with each linking term.
- The LBD system then orders these terms with a “ranking approach.”
Literature-based discovery works best when there is a large amount of full-text literature that can be mined, creating a greater possibility to uncover the connections between literature that could lead to a scientific breakthrough.
There are many tools available that make literature-based discovery possible for the researcher. EBSCO offers databases that facilitate this type of research by providing thousands of full-text journals available from a single search platform. To learn more about EBSCO’s full suite of research and development products, visit our website.