Since the 1980s, the number of new drug products coming through the drug discovery and development pipeline has started decreasing. Data suggest that out of 10000 drug compounds entering the initial drug discovery phase, less than one drug finds its way to the patient population. Experts hypothesize that all easily developed drugs are now exhausted, and hence increased efforts will be required to develop and bring novel drug products to the clinic. Besides, regulatory agencies require the demonstration of significant advantages of a novel drug product over its existing counterparts to be considered for marketing authorization. These features include higher potential, ease of administration, increased efficacy, affordability, and reduced toxicity. 

With an ever-increasing cost and resources for developing drug molecules, companies are now focusing on mergers and acquisitions to reduce the finances associated with drug discovery and development. A promising alternative to generate new drug products is exploring the potential of advanced bioanalytical services that can accelerate the drug discovery and development process. Bioanalytical labs such as NorthEast analytical laboratories employ high-technology platforms to streamline the drug development process. Therefore the current article highlights different advanced bioanalytical services employed by bioanalytical CROs. 

Genomics and proteomics approaches

Most diseases and medical conditions have a genetic or molecular etiology. Some diseases, such as cystic fibrosis, are caused by a mutation in a single gene, while other syndromic conditions, such as cardiovascular diseases, include mutations in multiple genes. Hence, in the era of precision medicine, a target must be identified and validated against a disease phenotype. Such an approach helps decrease the downstream attrition of a drug in subsequent clinical trials. 

Combining target-based and phenotypic screening platforms

Target-based approaches are biochemical screening methods, while phenotypic approaches are whole-cell screening methods. Phenotypic screening methods identify molecules that can elicit pharmacological effects, and hence they are empirically driven. Besides, phenotypic approaches are more relevant as they provide information in biological systems. Combining phenotypic and target-based screening methods is a rational, systematic, and holistic technique. Labs employ advanced methods and molecular techniques to identify and isolate the target. Both these approaches have unique advantages. And therefore combining both target-based and phenotypic-based screening approaches can accelerate the drug discovery and development process. 

Repositioning and repurposing existing drugs

Drugs developed for a specific condition may, in time, reveal potential benefits in areas outside their original indications. Hence researchers and clinicians may use these molecules in new therapeutic areas without structurally modifying the primary drug. On the other hand, a specific drug product may require modifications in its molecular structure to deliver a desirable effect while reducing the primary activity of the drug. This approach can repurpose and reposition a drug for newer therapeutic applications. 

Outsourcing strategies

Today developers are heavily relying on CRO and contract bioanalytical laboratories for outsourcing specific processes in drug development. Outsourcing studies can enhance the efficiency and throughput of the entire drug development project. Some studies outsourced to contract laboratories include the development of disease models, pre-formulation studies, target identification and validation, and lead discovery and optimization. 

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