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Research & Development

The Drug Discovery and IND Application Process: Navigating the Path to Innovation


The drug discovery process represents the initial and pivotal phase in the development of

pharmaceutical and biologic products. This intricate journey, addressing scientific rigor and

regulatory compliance, paves the way for groundbreaking medications to reach patients in need. From

the moment a potential therapeutic compound is identified to the submission of an Investigational

New Drug (IND) application to regulatory authorities, the drug discovery process unfolds as a

methodically orchestrated sequence of events.


Compound

Collections

Clinical

Candidate

Iterate

DRUG
DISCOVERY
CYCLE

Primary Assays high through-put, in vitro

Secondary Assays counter screen, bioavailability toxicity, metabolism, etc.

Structural Characterization

of Protein-Ligand

complex

Design

Chemical

Synthesis

Lead

compounds

and

SAR

Drug Discovery and Optimization: The Inception of Innovation

Discovery commences with the identification of a promising compound that possesses

therapeutic potential. This phase, often referred to as drug discovery, involves extensive research

and screening, aiming to pinpoint compounds that exhibit the desired pharmacological activity.

Medicinal chemistry and biological screening play crucial roles in fine-tuning these compounds

to optimize their therapeutic properties.


At CureScience, the traditional drug discovery and development process has been refined to
encompass the term translational medicine and to focus more on a personalized approach to drug
discovery. Translational research plays a pivotal role in bridging the gap between fundamental
scientific breakthroughs and their practical application in clinical and community healthcare
settings. This transition from laboratory discoveries to real-world patient care, encompassing the
development of novel drugs, medical devices, and healthcare products, as well as promising
treatment modalities, is commonly referred to as the journey from the "bench-side to bedside".


Successful translational drug discovery necessitates collaboration between clinical and
pharmacological research
, highlighting the critical role that academia plays in identifying potential

drug targets and in the design and development of pharmaceuticals. The translational medicine

process requires recurring interactive feedback between different disciplines for successful new

drug development.

During this stage, a comprehensive understanding of the compound's pharmacological characteristics

is imperative. Scientists assess the compound's efficacy in vitro (in a laboratory setting) and in

vivo (in living organisms). They also delve into the compound's toxicological profile to identify any

potential adverse effects. This early phase is resource-intensive, with substantial investments in

research and development.

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