Speakers

Shanthi is the Associate Director, CMC (Chemistry Manufacturing Controls) within Apotex Global R&D, responsible for providing scientific expertise on the CMC aspects of existing commercial and future biosimilars and complex generics.

For Apotex’s biosimilar products, Shanthi has strategized and lead various CMC aspects including, product development, characterization, analytical similarity assessment, technology transfer etc., directly contributing to successful regulatory filing, defense, approval, commercial launch as well as their continued life cycle management.

Shanthi has an overall in-depth and extensive industry experience of about 25 years in both pharma and biopharma areas. Starting at Apotex in the year 2001as an Analytical Development Chemist, with progressive leadership roles within the organization, she has evolved into a CMC Subject Matter Expert for biosimilars and complex generics.
Shanthi has a Bachelor’s degree in Chemistry; Master’s and PhD degrees in Biochemistry – all from the University of Madras, Chennai, India.