SEA’s Only End-to-End Therapeutic Biologics Platform

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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Dr. Seyed Reza Banihashemi is a Ph.D. in Clinical Immunology from Tarbiatmodares University in Tehran, Iran, and also a Vaccinologist. He is currently the deputy of R&D and Assistant Professor of the Immunology Department at Razi Vaccine and Serum Research Institute. He has extensive experience in vaccine research and development, with a focus on immune responses bacterial and viruses’ vaccines. He is main researcher and developer of the Razi Cov-Pars protein recombinant COVID-19 vaccine (the first intranasal covid-19 vaccine) and he is the manufacturer of the Nano emulsion adjuvant system related to this vaccine. He has published several research papers on topics such as vaccine development, immune response evaluation, and adjuvant and drug delivery system. He is also a reviewer for prestigious scientific journals in the field of microbiology and immunology.

Rakhmat Budi Yuwono is a licensed pharmacist with over 30 years of experience in the pharmaceutical industry. Based in Bogor, Indonesia, he holds a Pharmacy degree and Pharmacist certification from Gadjah Mada University. He actively shares his expertise on pharmaceutical quality with students, industry professionals, and regulatory bodies.

‍Career Highlights​

• PT Etana Biotechnologies Indonesia — Head of Quality & HSE Directs Quality, HSE, and Halal Management operations.​
• Sanofi Indonesia — Country Quality Head & Halal Team Leader - - responsible for country quality activities and directed Halal compliance strategies.​
• PT Ferron Par Pharmaceuticals — Quality Manager Oversee site-wide quality operations, management systems, and regulatory compliance.​
• PT Sandoz Indonesia — Validation & Technology Transfer Manager - responsible for all process validation and technology transfer initiatives.​
• PT Novartis Indonesia — Head of Quality / Quality System Manager - responsible quality management, including QA, QC, product release, validation, GMP compliance, and deviation management.​
• PT Dankos Laboratories — Production Pharmacist = began his career managing sterile and non-sterile drug manufacturing operations.​

Dr. Sandy Qlintang, M.Biomed, is a prominent stem cell researcher and regenerative medicine expert in Indonesia. Since November 2009, he oversees research and development in stem cell and cancer diagnostics at the Stem Cell and Cancer Institute (SCI) under Kalbe Farma. He also leads Cell Therapy Manufacturing - under REGENIC brand, a leading stem cell therapy provider in Indonesia, at PT Bifarma Adiluhung, a subsidiary of Kalbe Farma. Dr. Qlintang has contributed to scientific literature, including research on mesenchymal stem cell secretome for lung fibrosis post-COVID-19 infection. His leadership and expertise have advanced stem cell applications and provided innovative solutions for degenerative diseases in Indonesia.

Mr. Vipul Doshi has been in pharmaceutical Industry from more than four decades with diverse leadership and operational expertise across development, manufacturing, R&D, GXP quality assurance (QA) and manufacturing operations (parenterals, solid dosage forms, biotechnology, transdermal, biologics and vaccines).

He has been leading the Quality and Regulatory affairs function in the Pharmaceutical Companies of high credentials. Throughout his career he has been providing passionate global leadership and pioneered in guiding the companies to meet the Global Regulatory, Quality Standards and Compliance requirements.

He has been a Great Contributor in developing and implementing Quality attributes and Culture of Excellence based upon a set of core values and ethical practices, which integrate and improve business operations and enhance the compliance within the Organization.

An experienced and versatile Ph.D. pharmaceutical R&D/Scientific Affairs professional with about 15 years of experience including 8 years as Founder and CEO of Pinotbio, Inc. Experience in drug discovery programs in the areas of oncology – 2 INDs and many on-going pre-clinical programs. Formerly patent examiner in Korea Intellectual Property Office (KIPO) and possesses extensive knowledge about patents and related matters. Has led many scientific evaluations and due diligence of licensing/partnership opportunities in the academic institute and industry in the field of oncology. Extensive knowledge and understanding of drug discovery and preclinical development, especially related to Antibody-Drug Conjugate (ADC) platforms and ADC candidates. Deep understanding of medicinal and process chemistry, especially related with camptothecin payloads and ADC linkers.

Currently, CEO of Pinotbio, Inc. – a South-Korea based biotech company focusing on the discovery and development of novel ADC platforms.

Shanti Marlina Sibuea is the Acting Director of the Directorate of Production of Drug, Narcotic, Psychotropic and Precursor Control at the Indonesian FDA (Badan POM). With over 15 years of experience as a GMP inspector, she has led and participated in numerous international inspections across China, India, South Korea, Japan, and Puerto Rico. Her expertise spans regulatory systems, quality management, and oversight of biological products and advanced therapies. She serves as a PIC/S assessor and actively contributes to global regulatory convergence, including international regulatory assessments and expert circles on ATMPs. She holds a PhD from Monash University, focusing on stem cell and regenerative medicine, and supports national and regional capacity building in regulatory science.

Butet Manurung is a pharmacist and Master of Public Health. She is as seasoned professional with over 24 years of experience in Quality and Manufacturing within Pharmaceutical, Biopharmaceutical, Cell Therapy, and Cosmetic industries.  Butet has a strong background in regulatory compliance, consulting, and operations, with proven leadership in driving continuous improvement and operational excellence.

Christian Karol Saputra is a seasoned biopharmaceutical professional with over 12 years of experience in advancing drug development and biologics manufacturing. As the Head of Innovation Centre at PT Etana Biotechnologies Indonesia, he plays a pivotal role in overseeing technology transfer and process scale-up for critical biologics, including mRNA vaccines, monoclonal antibodies, erythropoietin, PCV subunit vaccines, and low molecular weight heparin (LMWH). His work also focuses on implementing advanced single-use systems to enhance production efficiency.

At the Etana Innovation Centre, Christian leads cross-functional initiatives that strengthen Indonesia’s biopharmaceutical capabilities. He collaborates closely with academic and funding institutions on strategic R&D programmes, including the development of a novel mRNA vaccine against dengue. Through his leadership, Christian continues to drive innovation and shape the future of biopharmaceutical manufacturing in Indonesia.

Nicolas is the newly appointed Head of Operations at PT. Kalbio Global Medika (KGM), Indonesia’s pioneer integrated biotechnology facility. Managing a complex scope that spans DS Mammalian Cell Culture, DP Aseptic Filling, and Site Engineering, Nicolas is at the forefront of the site’s 2026 transformation. His current mandate focuses on achieving world-class yield optimization and COGS efficiency, while strategically expanding KGM’s portfolio into Monoclonal Antibodies (mAbs) for oncology. He is a key advocate for building a resilient Indonesian biotech ecosystem through local talent development and supply chain sustainability

Dr Abhijit Kayal, working as a Senior Scientist II at Schrödinger. Before joining Schrödinger, I was a part of with several biotech and pharma companies as a scientist. I received my Ph.D. in Computational Chemistry from IIT Kanpur in 2017 in the field of theoretical chemistry. Following this, I pursued a postdoctoral position (2017-2018) at Juelich Research Center in Germany, focusing on QM/MM simulations of ion channels. My areas of expertise are ligand and structural based drug design, molecular dynamics simulations, QM, QM/MM-based simulations, and FEP calculations.

Dr Cheng-Yi Kuo is the Vice General Manager of UWELL Biophama, Taiwan, and is involved with new product development/R&D, clinical development of cell & gene therapy and business development and corporate strategy. Dr Kuo has extensive experience in biological product development, quality requirements and regulatory approval and clinical trial research. Dr Kuo also worked in research and development as a drug and gene delivery scientist and managed a group of scientists in that area. He has 20 years of experience in biologics development, biological product life cycle, quality and regulatory affairs. He is also an assistant professor at National Defense Medical Center and Chung Yuan Christian University. He received his PhD in Pharmaceutical Biology from Monash University.

Dr. Deepak Mukherjee’s career is defined by a 360-degree view of healthcare. While a Medical Doctor by training, his professional journey bridges clinical practice, academia, and leadership within the global pharmaceutical sector. He has spent years analyzing and operating within the distinct healthcare ecosystems of India, Malaysia, Singapore, and Indonesia. Having lent his expertise to industry giants like Boehringer Ingelheim, Novartis, and Novo Nordisk, Dr. Mukherjee now leads as the Country Medical Director for Roche, Indonesia. He is recognized for his versatile leadership, steering high-performing teams not only in Medical Affairs but also in Clinical Trials, Regulatory, and Quality.