Upendra Marathi, Co-founder, President & CEO, 7 Hills Pharma LLC,Houston, TX
I am pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared 7 Hills Pharma’s investigational new drug (IND) application for 7HP349, a first-in-class, oral integrin activator for solid tumors. A large part of the preclinical development work comprising CMC, ADME/DMPK and toxicology/safety assessment was outsourced to Eurofins Advinus Limited, Bangalore, India. We are pleased with the experience, professionalism, capability and enthusiasm of the Advinus team in completing this work. Their professionalism, understanding of regulatory requirements, and drive to resolve complexities faced during the 7HP349 preclinical development program in ADME, formulation development, toxicology and process development contributed significantly to the timely preparation of a comprehensive and compelling IND application to the FDA. It is my pleasure to recommend Advinus for preclinical drug development and IND-enabling studies.