Karthik Mani brings 18 years of progressive experience in the biotechnology experience in a variety of roles across Technical Operations/CMC and Regulatory disciplines. Karthik holds a B.S. Chemical and Biological Engineering degree from University of Wisconsin – Madison. Most recently, Karthik was Head of Global CMC Regulatory and CMC Operations function at ADC Therapeutics and played a critical role in US BLA and EU MA approval and launch activities for Zynlonta®, a CD-19 directed ADC. Prior to ADC Therapeutics, Karthik held CMC Regulatory and Process Development / Technical Operations roles at Stemcentrx (acquired by AbbVie) and Genentech. Karthik’s career has included oversight of various capacities of early stage clinical development through to product launch and commercial production across more than 20 clinical candidates and 4 commercial products. Expertise in CMC and Regulatory functions include:- Application of the Regs and ICH guidance to enable phase appropriate CMC program development and execution. - Lead CMC program development activities from Tox material generation to BLA submission and approval.- Direct and author CMC content in IND/BLA/NDA and IMPD/MAA. - Communicate and liaise with US and EU regulatory health agencies throughout different phases of clinical program development.- Application of process development, analytical development, tech transfer, risk assessments, DOE, process characterization, and process validation principles. Have authored various guidance documents, protocols, reports to this effect.