The drug discovery process can be significantly complex, with expansive time and expenditure associated with developing a new drug from the hypothesis stage to being available on the market. This complex process has led to approaches that can streamline the drug discovery process and lead to higher efficacy in this field.
The Drug Delivery Process
The development of a new drug starts with a novel biological target, such as a receptor, enzyme, or protein, which is involved in a biological process associated with a disorder. Research into new biological targets can aid in designing medicine to treat the effects of disease.
Testing of molecular compounds can be useful to identify the beneficial effects of these potential drug active ingredients against a large number of diseases. The use of new technologies can also provide novel strategies to ensure drugs are targeted toward areas of concern within the body.
The early stage of drug discovery consists of thousands of compounds that start as potential candidates for drug development; however, after further testing, the volume of compounds is reduced to a small promising number.
These drugs are analyzed for their level of absorption, benefits, mechanisms of action, adverse effects, interactions with other drugs, and efficacy compared to other drugs. In vitro and in vivo testing are used in pre-clinical research to find potential toxicities. Clinical trials follow specific study plans by researchers to assess the safety and dosage of drugs within a participant group. These trials follow small-scale phase 1 studies to large-scale phase 3 studies, which can take a large quantity of time. This ensures drugs are ready for review by the FDA (Food and Drug Administration), which is required before drugs are approved. However, post-market monitoring can also be used to provide insight into the drug's safety over months and even years that the drug is available on the market.
Challenges in Drug Discovery
It can take over 12 years for the development of new drugs to reach approval for marketing from the early stage of identifying a biological target. This can be very challenging for drug companies and researchers, as a small number of drugs approved in the end can result in wasted expenditure from researchers.
The estimated cost of developing a small molecular compound or new biological entity is approximately $2.6 billion. This high value demonstrates the significance of streamlining the drug discovery process to ensure an increased approval of valid drugs.
Additionally, target identification can be difficult for researchers as the pathophysiology of many nervous system disorders is not always clear or known. An example of this can include Alzheimer's disease, for which there is no cure, and drug treatments may not always be effective.
Uncertainty in the pathophysiology of a disease can lead to unclear biological targets for drugs, resulting in drugs that go through years of clinical research and trials before being rejected due to their inefficacy. Conversely, clarity in pathophysiology with more disease research can increase the likelihood of targeting the correct mechanism of action more efficiently and successfully.
Streamlining the drug discovery process through various approaches can ensure diseases are being targeted correctly and patient care is being prioritized.
Possible Streamlining Strategies
The complex drug discovery process has enabled companies to use computational strategies to increase the speed of discovery workflows by predicting the probability of the compound failing and ensuring the correct drug candidates are outlined and prioritized for research.
The use of computer-aided drug discovery can be important for streamlining the drug discovery process, as this may provide an algorithm that can outline drug candidates with a higher probability of targeting a disease based on structural molecule design.
Other technologies can consist of a novel 'protein painting' approach, leading previous researchers to discover the exact location of two bind proteins. This is significant as these proteins were ascribed for obscuring cancer cells from the immune system.
This research has led to strides in developing novel cancer immunotherapy drugs and is one approach that demonstrated how novel streamlining strategies could be used to advance medicine. The technology for this research, headed by George Mason University, has enabled rapid performance testing of the drug, which has led to results that have been generated after several days, as opposed to years.
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Streamlining the drug discovery process can revolutionize conventional drug development approaches, which are time-consuming and extremely expensive.
Streamlining this process, which can result in a higher level of comprehension of drug candidates and biological targets for diseases, can lead to faster results and optimization of compounds that are more likely to gain FDA approval. Additionally, this approach consists of having a more effective cost versus benefit calculation, which can further aid research in various disease areas, as it can reduce the high funding associated with supporting drug research.
Subsequently, this can increase research into diseases and drug compounds to ensure patients with diseases without a cure have hope for a potentially better future.
- Amanda Haymond et al., Protein painting, an optimized MS-based technique, reveals functionally relevant interfaces of the PD-1/PD-L1 complex and the YAP2/ZO-1 complex, Journal of Biological Chemistry (2019). DOI: 10.1074/jbc.RA118.007310
- Forum on Neuroscience and Nervous System Disorders; Board on Health Sciences Policy; Institute of Medicine. Improving and Accelerating Therapeutic Development for Nervous System Disorders: Workshop Summary. Washington (DC): National Academies Press (US); 2014 Feb 6. 2, Drug Development Challenges. Available from: https://www.ncbi.nlm.nih.gov/books/NBK195047/
- Mohs R, Greig N. Drug discovery and development: Role of basic biological research. Alzheimer's & Dementia: Translational Research & Clinical Interventions. 2017;3(4):651-657. doi:10.1016/j.trci.2017.10.005
- Review of Scientific Computing World' Streamlining drug discovery' article. Cresset-group.com. https://www.cresset-group.com/about/news/review-scw-streamlining/#:~:text=Drug%20discovery%20is%20an%20increasingly%20complex%20process%20with,enabling%20them%20to%20prioritize%20the%20right%20drug%20candidates. Published 2022. Accessed July 18, 2022.
- The Drug Development Process. U.S. Food and Drug Administration. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process. Published 2022. Accessed July 18, 2022.