Global Regulatory Landscape and Indian Regulatory Framework of Car-T Therapies

The workshop aims to share and discuss the regulatory experience gained during the development of CAR-T cells, the approval of clinical trials and marketing authorization applications, and the prevailing regulatory framework of cell therapy products in Europe, the US, and emerging markets like India.  

Presented by Yogananth Rajendran, M. Pharm. RAC. Head – Regulatory Affairs and Quality Assurance (Cell and Gene therapy) at Immuneel Therapeutics Private Limited

Yogananth Rajendran is the Head of regulatory affairs and Quality Assurance-cell and gene therapy at Immuneel Therapeutics Private Limited, a clinical-stage Indian cell, and gene therapy company. Yogananth is an experienced biologics regulatory professional with expertise in driving early, and late-stage development and marketing authorization of biologics, biosimilars, and advanced therapy medicinal products. He has over 19 years of experience in global regulatory strategies for commercializing biologics, biosimilars, orphan drugs, and cell and gene therapy products. He has contributed to multiple biosimilar approvals in the EU, US, and other global markets.