14 Years of Excellence: South Korea’s Biggest Biologics Manufacturing Conference

He has extensive experience for over 18+ years in the biopharmaceutical industry as he previously worked at Global and Korea biopharma companies such as Green Cross, Samsung Biologics, GSK and Sanofi as a key Quality member, and profound knowledge in building and management of Quality Systems including Deviation investigations and CAPA programs.

Woo Chi is Director of Cell Line Development group at Samsung Biologics, managing multiple client and internal development projects while representing the CLD team in various settings. During his first 6 months at SBL, his CLD team had projects with a record breaking pool and clone productivity, adapted process simplification to lower the development cost. His team also embarked on ambitious internal project to develop a license free cell line development platform to reach 6g/L titer, a transient expression system  with competitive productivity and scalability as well as in-house-MCB facility inititives.  Woo has more than 20 years of experience in pharmaceutical industry and academic research and has held roles across CHO cell line development, platform improvement, and assay development. Prior to joining Samsung Biologics, Woo served as a principal scientist at Evotec Biologics where he led cell line development projects and established a new CDO lab with automation capability. Woo holds a doctor’s degree in Genetics from Yale school of Medicine.

Dr. Ryu received his Ph. D in Department of Chemical Engineering, Hanyang University, Korea at August 2002 After Ph.D course, he had experience for 4 years in US as Post Doc and researcher.

In 2006, he returned into Korea and worked as research professor at the Catholic University, medical center in GangNam General Hospital. And then he worked in company, JW Creagen and CKD (ChongKunDang) Pharm. as principal researcher and Investigator.

In CKD Pharm., he performed 1) R&D Department construction planning & management for construction planning of Bio-Engineering Department and Project planning and management for 2nd generation long acting therapeutic protein and management for pre-clinical stage

After, he was worked as CTO in Hyundai Bioscience. In this time, He have performed Management of R&D and Manufacturing Facility and 1) developed IMD(Incrementally Modified Drugs) and 2) Development of siRNA delivery system using specific targeting nano particle carriers for anticancer gene carriers (breast cancer, prostate cancer, uterine cancer).

2023 to 2024, He worked as director of JBRC (Jeonnam Biopharmaceutical Research Center). At that time, He attracted the WHO Global Bio Campus in 2023 and the National Advanced Strategic Industry Bio-Specialized Complex of the Ministry of Commerce, Industry and Energy of the Republic of Korea in 2024. The bio-specialized complex is specialized in commercializing cutting-edge pharmaceuticals such as vaccines, immunotherapy, and especially cell gene therapy.

Since 2025, he has been serving as the CSO of the strategic division of Vaxcell-Bio and is leading the development of global cutting-edge pharmaceuticals.

Dae-Won Kim is dedicated to the discovery and validation of novel therapeutic genes for the treatment of degenerative diseases through AAV–based gene therapy. By integrating advanced molecular and genetic technologies with rigorous preclinical validation platforms, his work aims to establish transformative and durable gene therapies that deliver meaningful and sustained clinical benefits. The primary areas of focus include 1) joint degeneration (OA), 2) degenerative retinal diseases (AMD, IRDs), and 3) congenital hearing loss. The overarching objective of this research is to develop first-in-class, disease-modifying AAV gene therapies capable of treating these chronic and debilitating conditions.

Paul Y. Song, MD is currently Chairman and CEO of NKGen Biotech.

Dr. Song’s last clinical role was Asst. Professor at the Samuel Oschin Cancer Center at Cedars Sinai Medical Center. Dr. Song also served as the very first visiting fellow on healthcare policy in the California Department of Insurance in 2013.

He is the Co-Founder/former CEO of Fuse Biotherapeutics which was sold in May. He is also on the board of PeproMene Bio, Hawkeye Bio, the Pritzker School of Molecular Engineering at the University of Chicago, Mercy Corps, and Gideon’s Promise.

Dr. Song graduated with honors from the University of Chicago and received his M.D. degree from George Washington University. He completed his residency in radiation oncology at the University of Chicago where he served as Chief Resident and did a brachytherapy fellowship at the Institute Gustave Roussy in Villejuif, France. He was also awarded an ASTRO research fellowship in 1995 for his research in radiation inducible gene therapy.

His late maternal grandfather, Sang Don Kim, was the first democratically elected mayor of Seoul, South Korea.

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.

Dr. Changshou Gao is currently CTO and Head of Biologics Research at Shanghai Allist Pharmaceuticals. From 2020–2024, he served as CTO, SVP, and US Site Head at Innovent Biologics, advancing five ADCs and multiple projects into early clinical development. Prior to that, he spent over 18 years at MedImmune/AstraZeneca, leading biologics discovery, bispecific antibodies, ADCs, nnAA platforms, targeted nanoparticles, and AAV gene therapy. His teams advanced more than 20 therapeutic antibodies into clinical trials across oncology, immunology, infectious disease, and metabolic disorders. Dr. Gao earned his Ph.D. in Chemistry and Molecular Biology from The Scripps Research Institute.

Yosup Rew, Ph.D., earned his B.Sc. and M.Sc. in Chemistry from Seoul National University and began his career as a research scientist at LG Chem. He later moved to the University of California, San Diego, where he received his Ph.D. in Organic Chemistry, followed by postdoctoral research at The Scripps Research Institute focused on the total synthesis of ramoplanin.

In 2004, Dr. Rew joined Amgen, where he spent more than a decade contributing to metabolic disease and oncology drug discovery and played a key role in advancing four compounds into clinical development. He later joined ORIC Pharmaceuticals, where he led oncology drug discovery programs and contributed to the discovery of ORIC-101 and ORIC-533.

Since 2020, Dr. Rew has served as Head of R&D at IntoCell, leading the company’s research and development efforts in next-generation ADCs. He has authored more than 30 publications and holds over 60 patents and patent applications.

A highly experienced pharmaceutical professional with a proven track record in site-specific conjugation technology and CMC process development. For the past 8 years, I has been instrumental in advancing clinical ADC projects, from early development to IND submissions, by leading robust CMC process development efforts. Excels at managing complex CMC changes, including site transfers, process scale-up, and formulation development, ensuring seamless and compliant transitions.

Hyemi Kim is a seasoned expert in IT and process innovation, currently leading the Digital Innovation Office’s DX Team at SK Bioscience. She holds a degree in Atmospheric Sciences from Yonsei University and completed the CAIO program at KAIST, integrating AI technologies into her work. At Samsung Group, she spearheaded projects enhancing operational efficiency across various sectors using Six Sigma, TRIZ, and SAP. Her tenure at Samsung Biologics focused on IT strategy, ERP enhancement, data integrity, GxP processes, and digital governance. As a consultant, she collaborated with private and public entities on digital platform models. At SK Bioscience, Hyemi drives digital innovation strategies, applying AI and digital technologies in R&D, manufacturing, and business development. The next-generation ERP system is set to launch in the first half of 2025. In this conference, she will share experiences on 'Automation and Bioprocessing 4.0' in bio/pharmaceutical companies.

Sammi Hsu is the Senior Manager and Spokesperson of Ever Supreme BioTechnology (TWSE:6712), with over 17 years of experience in cell & gene therapy, exosome platforms, and clinical development. She has led multiple FDA and TFDA IND submissions, Phase I–III trials, and successful GCP inspections, and contributed to Ever Supreme’s 2021 IPO.

Sammi oversees regulatory strategy, clinical operations and scientific communication for programmes including CAR001, the company’s mRNA-engineered allogeneic γδ T-cell CAR-T therapy for solid tumours.

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.