Today the number of drug candidates passing the drug development process is extremely low. Out of 10000 potential compounds, less than one drug compound reaches the market shelf. Besides, regulatory bodies are raising the bar for drug discovery and development initiatives. Newer drug products must demonstrate significant clinical advantages over existing drug products. Moreover, these drug products must be supported by robust toxicology studies, increased efficiency, and higher potency.
Although a very lucrative endeavor, drug development is challenging and complicated. Hence, sponsors and drug developers continuously focus on identifying opportunities that may accelerate drug development timelines. Here we share seven factors that play a defining role in drug discovery and development.
1. Genomics Approaches
It is well-known that most diseases have genetic or molecular etiologies. Hence, genes can be well grouped into druggable genes, disease-modifying genes, and disease genes. Today sponsors focus on establishing the disease phenotype by identifying and validating the target. This approach prevents downstream attrition, which is the primary reason for poor efficacy in clinical trials. Here, researchers can employ genomics approaches to determine druggable genes and thus expand the targets during drug discovery studies.
2. Repositioning and Repurposing Existing Drugs
Drug products designed for specific therapeutic applications may sometimes have beneficial effects in other areas. They can be easily used in areas outside of their original indications without structural transformations. Thus, drug repurposing can be valuable in new disease domains. Alternatively, some drugs may require modification in the primary structure to elicit a desirable pharmaceutical response. Such repositioning of the primary drug can also assist in targeting other disease areas. The primary benefit of drug repositioning and repurposing is that they don’t require extensive pharmacokinetics and toxicology studies in drug development (tox studies).
3. Collaborative Efforts
Naturally, the pharmaceutical industry is a highly competitive environment. Each company, whether small or big, has unique advantages for launching a new drug into the market. However, considering the astronomical funding of pharma R & D programs, it is apparent that a collective effort will be beneficial to utilize the resources better and fast-track drug development timelines.
4. Exploring Therapeutic Fields
The economic viability of a drug product is crucial for any drug discovery and development initiative. Hence, it is natural that most companies focus on markets with a maximum share of profits. However, exploring under-served therapeutic areas can benefit for a new drug product.
5. Outsourcing
Today several large companies focus on outsourcing specific drug discovery and development activities. These activities include target identification, lead discovery, pre-formulation studies, and many more. Such approaches allow drug developers to focus on more complex internal challenges.
6. Pharmaceutical Modeling
Sponsors employ in silico simulations to predict the pharmacokinetics and pharmacodynamics of a drug product. Sponsors can employ these strategies to predict diverse aspects of the candidate drugs.Such advances in drug assessments have been a boon to the drug discovery process.
7. Adequate use of Target-based and Phenotypic-based Screening Platforms
Sponsors use two screening platforms during efficacy studies; target-based and phenotypic-based screening. Target-based screening platforms are biochemical tools that employ an in vitro approach to test the drug on purified target proteins.
On the other hand, phenotypic platforms are whole-cell screening tools that study the drug effects on cell lines, isolated organs and tissues, and whole animals. Hence, an appropriate combination of target-based and phenotypic-based approaches will increase the efficacy of drug discovery studies.
