Integrated CMC Strategy for Small Molecules - Early Phase Development

Sponsored by: Syngene International Limited

Focused on:

  • Drug Development

Date: 24 June


Time: 3PM London/10AM New York

Pharmaceutical Development of New Chemical Entities

The objective of early phase drug development is to ensure faster regulatory filing and start of Phase 1 First-in-Human (FIH) study. Rational pharmaceutical development is essential to accomplish this objective and seamless integration of various drug development disciplines is the logical first step. Taking into account the interdependencies and intricacies of each stage such as drug substance, toxicology, drug product, analytical and regulatory considerations is critical for faster initiation of Phase 1 clinical studies.

The CMC activities should be initiated by defining the right strategy at the beginning of development. A thorough assessment of the drug substance quantities and quality attributes and its impact on toxicology and drug product need to be done early on. Similarly, design of pre-formulation studies, analytical methods, dosage form selection and development for toxicology and FIH studies should be considered in parallel to drug substance development. Also understanding the phase appropriate quality and regulatory guidelines by all the CMC functions helps in focusing and achieving IND/IMPD filing faster.

This webinar will focus on how to develop a scientific approach for small molecule pharmaceutical development using success stories as illustrative examples to find out how integration benefits the evaluation of clinical candidate in FIH in a fast and effective manner.

Presented by

Badrinath Doniparthi,

Group Leader – Formulation and CMC, Syngene International Limited

Badrinath has over 16 years of experience in early phase CMC development and successfully delivered Phase 1 clinical supplies for small molecules for several clinical candidates. He has held scientific positions at various organizations including Dr. Reddy’s Discovery Research, Aizant Drug Research Solutions Pvt. Ltd., and Eli Lilly’s joint venture in India, prior to current assignment as Group Leader, Early Phase CMC Development, in Syngene. He has assisted several small biotech and pharma clients across the globe by providing drug development strategies and scientific solutions for successful regulatory filings and FIH studies for small molecules. Badrinath holds a master’s degree in Pharmaceutics from the Rajiv Gandhi University of Health Sciences, Bangalore.

Key Learning Objectives

  • Developing a rational drug development strategy for small molecules for regulatory filing
  • Scientific challenges encountered during execution and ways of addressing the same
  • Implementation of strategies to reduce project timelines


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