Dr Srinivasan KELLATHUR is currently the Regulatory Policy Lead for APAC at Hoffmann-La Roche based in Singapore. At Roche he drives regulatory convergence initiatives with a focus on CMC topics and ensures the implementation of reliance pathways across the region.
Prior to joining Roche, Srini was with the Health Sciences Authority (HSA), Singapore where he headed the Advanced Therapy Products Branch, responsible for policy and legislation and implementation of the regulation of cell, tissue, and gene therapy products, the first country in ASEAN to provide a comprehensive regulation. Srini represents the Biotechnology Innovation Organisation as a sub-champion to promote regulatory convergence for advanced therapy products in APEC. He leads the cell and gene therapy workstream at IFPMA in promoting global regulatory convergence. He was also the IFPMA CGT Taskforce Expert, representing the Singapore Association of Pharmaceutical Industries, to support its activities at the ICH CGT Discussion Group. Srini sits on several international groups: APAC Regenerative Medicine Forum, International Society for Cellular Therapy APAC Industry Committee, Asian Cell Therapy Organisation Industry Committee, member of The European Federation of Pharmaceutical Industries and Associations regional networks – ASEAN, Korea-Taiwan and India. Srini has an adjunct faculty appointment at the Centre of Regulatory Excellence, Duke-NUS Medical School.
