Thought Leaders
Opportunity Next.
Gear up to interact with the game changers. Hear, observe, learn and connect with the best of Industry Leaders and policy Influencers. BioAsia 2013 brings you the best of best under one roof on the 28th, 29th and 30th of January, 2013.
Be There.
Dr.Charu Manaktala is Medical Director at Quintiles Research India Private Limited, where she is responsible for providing strategic advice on the clinical development of biosimilars.
Prior to joining Quintiles, she held various positions of responsibility at Ranbaxy Laboratories Limited in India, where she headed the clinical teams responsible for medical writing and aggregate reporting for global regulatory authorities, clinical development of biosimilars and products in various therapeutic areas, primarily in diabetes, metabolism and infectious diseases, including pediatric program for an anti-malarial NCE.
She has comprehensive hands-on experience in clinical development of biosimilars. Overall, she has expertise spanning complete clinical product development and post authorization lifecycle management. She has worked in all stages of clinical drug development from Phase 1 through to commercialization in many therapeutic areas, primarily infectious diseases, diabetes and metabolism, and spanning a variety of disciplines including medical writing and pharmacovigilance.
Dr.Manaktala led a cross functional team for global development of a biosimilar product. Additionally, she led evaluation/clinical development activities for different biosimilars and vaccines. She has provided inputs for clinical development of biosimilars for filgrastim, erythropoietin, rituximab, etanercept, trastuzumab, bevacizumab. She successfully co-ordinated and led discussions for scientific advise meetings with the EMEA for a biosimilar product. She has faced regulatory inspections and partner audits for pharmacovigilance functions, and successfully communicated and negotiated with EU competent authorities and Australian TGA for marketing authorization of many generic products.
Prior to joining the pharmaceutical industry, DrManaktala worked for two years in high end pediatric cardiac intensive care.
Dr.Manaktala holds an MBBS degree from the University of Delhi and a Post Graduate (MD) in Clinical Pediatrics from the University of Delhi, India with a research thesis on the effect of maternal iron status on the fetal iron status and outcomes.
To Connect and Network with Freda C. Lewis-Hall Click Here
