APAC’s Premier CGT Congress - Uniting Leaders, Innovation, and Quality

Chethan A J is currently working as Assistant Director Quality Assurance and Regulatory Affairs at Center for Ocular Regeneration (CORE), LV Prasad Eye Institute, Hyderabad, India specializing in Quality Management System, Risk Management and Indian Regulatory Affairs. With over 13 years of experience in Cell and Gene therapy field, Chethan has involved and led the team in various aspects of CMC such as manufacturing, Quality Assurance and Regulatory Affairs. Under his leadership the CORE GMP manufacturing facility could achieve to get manufacturing and test license in form CT-11 for 5 unique cell therapy based products and Clinical trial license for Phase I trial for 2 unique cell therapy products in for CT-06 from Indian FDA, CDSCO. He is expert in deriving Quality Management System in Cell therapy products which meets the compliance to the required cGMP standards. He holds a master degree in Medical Biochemistry from Manipal University, MBA in Total Quality Management, Diploma in GMP, Six Sigma Green belt and certified Internal Auditor for ISO 9001:2015 QMS. He is an active member of Society of Quality Assurance (SQA) and Indian Society for Clinical Research (ISCR). Outside of work Chethan enjoys hiking, photography, sports & fitness.

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Ryuichi Morishita, M.D., Ph.D., graduated Osaka University Medical School in 1987, and received Ph. D. from Osaka University in 1991. After following postdoctoral Fellow at Stanford University School of Medicine, he served as an Assistant Professor, Department of Geriatric Medicine, Osaka University Medical School from 1994 to 1998. Then, from 1998 to 2003, he was Associate Professor, Division of Gene Therapy Science, Osaka University Medical School. Then, he became Professor & Chairman of Division of Clinical Gene Therapy, Graduate School of Medicine, Osaka University Medical School from 2003 to present.

Dr. Lin is a biomedical scientist with over 20 years of experience in life science industries, spanning medical devices, pharmaceuticals, biomaterials, and biochips. He previously served as Deputy Project Director at Taiwan’s ITRI, leading global strategic alliances. As Senior VP at Body Organ Biomedical Inc., he expanded operations across Taiwan, China, and the Netherlands, establishing sales networks and securing regulatory approvals.

He led cross-border R&D collaborations, securing a €300,000 SenterNovem grant in 2009, and successfully filed 36 patents through joint research. Earlier, he also completed Taiwan's first bone filler registration. Dr. Lin holds a Ph.D. in Bioengineering from National Taiwan University and an MBA from National Chengchi University.

Dr. Horak brings more than 20 years of experience in the global pharmaceutical industry, predominantly focused on oncology drug development, and is a board-certified medical oncologist. Prior to funding Tikva Allocell, Dr. Horak was Head of Global R&D and Chief Scientific at Tessa Therapeutics, a mid-stage cell therapy company in Singapore. For eight years, he was Chief Medical Officer and Chief Scientific Officer at Symphogen, a clinical-stage antibody company, and President of R&D at Enzon Pharmaceuticals, Inc. Dr. Horak has also held a number of senior research leadership positions in various pharmaceutical companies as well as at the National Cancer Institute (NCI), National Institutes of Health in US. During his career, Dr. Horak has advanced multiple oncology treatments into the clinic, and has successfully led a number of FDA new drug applications.