Case Study

How Integrated CMC Can Help Expedite Early Phase Development Of Small Molecules — A CRO Perspective


Transformative innovation in the pharmaceutical industry has resulted in an explosion in the types of novel modalities and therapies. The world of drug discovery and development is rife with new approaches within immunotherapy, personalized vaccines, microbiome therapies, and CRISPR-based therapies to provide novel treatments and cures for a wide range of diseases. Even though progress is being made in these areas, more than 90% of the drugs currently available on the worldwide therapeutics market are small molecules based.

As recently as in 2017, 9 of the top 10 selling-medicines in the US were small molecules, demonstrating why they are so important, even in our current-day personalized approaches to medicine.

The challenges involved in small molecule drug development are highlighted by the fact that only 1 out of every 10,000 compounds synthesized will eventually obtain FDA approval. The right strategy for early phase development can go a long way towards maximizing the chances of success for small molecule new chemical entities (NCEs).

An important lever in early phase drug development is Chemistry, Manufacturing and Controls (CMC) — all the activities that go into ensuring that a drug product is safe, effective and consistent. Designing and implementing a scientifically-sound, phase-appropriate CMC development strategy can reduce costs while building asset value. What we at Syngene propose is an integrated CMC strategy that will help achieve faster regulatory filing and Phase 1 First-in-Human (FIH) studies while helping maintain tight control over quality and spends.


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