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Research and Discovery Process in Drug Development

By Lauren Vagnone / Nov 15, 2016

BioIVT understands the importance of the R&D process, as there are multiple methods that can be leveraged from concept initiation to drug delivery. In an effort to assist in the advancement in personalized medicine we would like to break down the different validation methods that can be leveraged in offering patients faster diagnoses, fewer side effects, and better outcome prior to initiating pre-clinical trials.


Research: Often occurring in academia, a hypothesis is generated via data collection that the inhibition or activation of a protein or pathway will result in a therapeutic effect in a disease state.

Target and Biomarker Validation: Choose a target to interact with a drug and understand its role in a disease.A target is a broad term in which can be applied to a range of biological entities which may include a combination of gene expression or Protein analysis. Hypothesis’ of clinical effect can be evaluated with differing methods such as situ, Quantitative Gene expression, ISH Multiplexing, Gene Expression Profiling (XpresWay), Fluorescent in situ hybridization, Mutation analysis, Laser Capture Microdissection (LCM), Immunohistochemistry (IHC), Tissue Microarrays and XpressArray.

HTS and Lead Identification: In a traditional drug discovery project people often use the method of high-throughput screening (HTS), when libraries of drug like-compounds are screened against a protein target. Such screening may identify one or few compounds with the ability to inhibit the activity of the drug target.

Compound Evaluation and Safety for Lead OptimizationThis can be achieved by analyzing cell-based assays to evaluate the potency, effect, and safety of the compounds identified. All information gathered about the molecule at this stage will allow for preparation of a target candidate profile for preclinical trials.

ADMET: The absorption, distribution, metabolism, elimination, and toxicity predictions of a product. This risk assessment allows researchers to have a clear vision of the new chemical entity in comparison to drugs on the market.

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