How To Accelerate Your Molecule's Pathway To IND And Beyond

The drug development process is a distinctively lengthy process and often has a low success rate. Consequently, there is a great deal of interest in finding ways to accelerate the process and bring new therapies to patients faster. As the ongoing trend of highly potent and complex small-molecule drug candidates continues to rise, there is high demand for contract drug development and manufacturing organizations (CDMOs) to meet ever-shorter timelines and reduce costs while avoiding common pitfalls on the development pathway.

During the first step — choosing the optimum molecule to move forward into clinical development — it is crucial to accurately rank molecules based on their early biopharmaceutical ‘developability,’ in-vitro activity, and ability to demonstrate acceptable specificity and selectivity for the biological target of the desired therapeutic area. After completing CMC development and safety studies to support regulatory approval for Phase I clinical trials, developing an optimized synthetic manufacturing process that is robust and commercially scalable helps to avoid common issues.

Typically, processes related to the drug substance, drug product, and clinical trials are carried out by separate organizations, which can be inefficient and costly. Employing an integrated approach means that process development, analytical, and formulation development chemists can interact regularly with each other from the outset of the project. The overall benefit is a significant reduction of drug development timelines, enhancing the likelihood of clinical and commercial success and reducing the overall program risk. Learn more as Eleanor Row, Executive Director of Commercial at Quotient Sciences, discusses the challenges facing drug developers today and how collaborative, integrated approaches can help advance their molecule to IND.