Dr. Kyung Won Seo is the Director General of the National Institute of Food and Drug Safety Evaluation at the Ministiry of Food and Drug Safety Korea since February 2021. Dr. Seo has involved in many toxicological research and studies and reviewed non-clinical data for 15 years. Dr. Seo was in charge of several divisions as Director including metabolic, reproductive and respiratory product; antibiotics and oncology product; and bioequivalence evaluation. Prior to her current position, Dr. Seo served as Director General of Pharmaceutical and Medical Device Research Department from 2015 to 2019.

Dr. Younjoo Park serves as Director General of the Drug Evaluation Department at the Ministry of Food and Drug Safety, Republic of Korea since March 2021. Dr. Park is responsible for overall drug review and approval, pharmaceutical standardization, and generic drug review. For 20 years after joining MFDS, Dr. Park took charge of several divisions as Director including oncology and antimicrobial products, recombinant protein products, and cell and gene therapy products etc. Before the current position, Dr. Park served as Director General of Pharmaceutical and Medical Device Research Department in 2019-2021. Dr. Park obtained her Ph.D. in pharmcology from Seoul National University in 2001.

Yil-Seob Lee, MD, PhD, is a professor, Dept of Clinical Pharmacology and serves as a director of Global Clinical Trials Center, CHA Bundang Medical Center in Korea. Dr. Lee has previously been President of the Korean Society of Pharmaceutical Medicine; President of the Korean Society of Clinical Pharmacology & Therapeutics; and President of the International Federation of Association of Pharmaceutical Physician & Pharmaceutical Medicine. He had industry experience in GlaxoSmithKline Korea and in Aventis Pharma Korea. Dr. Lee earned his MD from Yonsei University, and PhD in Pharmacology from Korea University and MBA from Yonsei University Business School.

Mijeong has over 30 years of experience in regulatory review, research & development, regulatory policy and regulatory compliance in the field of pharmaceuticals and medical devices, where she is currently a Director of the Pharmaceutical Standardization Division in the Drug Evaluation Department. In her role as a director, she is responsible for CMC assessment of drug products and is an active participant in global harmonization as a member of ICH Quality Discussion Group and IPRP Quality Working Group. She has a PhD in medicinal chemistry (Chung-buk Uni., Korea) and post-doctoral research experience in pharmaceutics (Trinity College Dublin, Ireland).

Dr. Kim is Director of Bioequivalence Evaluation Division in MFDS. Dr. Kim was in charge of fast review of COVID-19 treatments under ‘COVID-19 Emergency Response Support HQ’. In her 24 year career, Dr. Kim has dedicated in scientific review and regulatory work for innovative medicines. In Pre-submission Consultation Division, Dr. Kim provided consultation for orphan drugs and innovative medicines. In Oncology Products Division, Dr. Kim played a key role in development of guidelines of clinical and non-clinical evaluation for anticancer drugs and expedited review to introduce innovative medicines. Dr. Kim studied overseas pharmacometrics through Korean Government Fellowship program. Dr. Kim participated ICH E18 EWG.

Hyun Ok, SEO is a senior scientific officer in Bioequivalnece Evaluation Division at Drug Evaluation Department, NIFDS. She has received a BS in Pharmacy and MA in Pharmaceutical Science from Duksung Women’s University. Since joining MFDS in 2006, she has been working as a reviewer for safety and efficacy of generic drug and new drug applications.

Performed R&D and quality control for 7 years at a pharmaceutical company, and performed quality and bioequivalence reviews at drug evaluation department of NIFDS for 11 years.

Jee Eun Lee, PhD is currently working at LG Chem, Life Sciences as a Senior Research Fellow (VP). After joining LG Chem, she has built the Clinical Pharmacology Team where pharmacometrics is essentially centralized. The team is in charge of clinical PKPD data analysis and modeling & simulation for better clinical study design and outcomes. Translational research tools are also being developed for early stage Go/No-Go decisions. Moreover, the team creates innovative systems for data analysis and reporting which enhance not only R&D efficiency but also data integrity.

Sora Lee is currently heading up Syneos Health Korea as a General Manager to drive operational excellence and business growth of the organization. A seasoned business executive with more than 25 years in the pharmaceutical industry, heading Clinical Operations for Country Clinical Operations (CCO) in North Asia, providing operational and strategic leadership as well as ensuring that clinical trials were conducted with exceptional efficiency. Deep experience in managing client models and maintaining partnerships with contract research organizations (CRO). Master of Business Administration, Yonsei University; Master’s in Pharmacology, Seoul National University; Bachelor’s in Pharmacy, Duk-Sung Women’s University.

Dr. Choongyul Ahn currently works as Senior Reviewer for Bioequivalece Evaluation Division, MFDS. He majored in Clinical Pharmacy and has many years of review experience in bioequivalence test and safety/efficacy data in regulatory agencies. He also participated in the development of various guidelines related to drug product evaluation.

Tae Hyun (Ryan) Jung, Ph.D., is a Senior Statistical Reviewer in the Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. He specializes in regulatory reviews of NDA/BLA/PMR submissions, with particular focus on RWE in rare diseases, pediatrics, pregnancy, urology, and reproductive medicine. At FDA, Dr. Jung leads critical regulatory research initiatives in RWE designs/methods, digital twin/synthetic patient data, and digital health technology applications in drug development. Dr. Jung earned his Ph.D. in Biostatistics from Yale University.

Steven E. Kern, PhD is the Interim CEO of Global Health Labs, an innovation laboratory based in Bellevue, Washington working in partnership with the Bill and Melinda Gates Foundation. He was previously Deputy Director of Quantitative Sciences at the Gates Foundation. Prior to joining the Gates Foundation, he was Global Head of Pharmacology Modeling at Novartis Pharma AG based in Basel Switzerland where he led a team focused on providing model based drug development support to therapeutics in many disease conditions across all stages of drug development.

Geoffrey Kim, MD joined BeiGene as the VP, Applied Innovation. In this role, Geoff and his team innovates and incubates technological solutions to ultimately increase patient access to clinical trials and novel therapeutics. The team also creates novel methodologies to capture, house, integrate, and analyze data from disparate sources to drive strategies to advance pipeline development and streamline the advancement of effective therapies and combinations. Prior to joining AstraZeneca, Geoff was director of the Division of Oncology Products 1 in the Office of Hematology Oncology Products at the U.S. Food and Drug Administration.

Barbara Lopez Kunz served as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s largest, most respected R&D organizations. She has also served as Senior Vice President/General Manager for Thermo Fisher Scientific’s Biosciences Division, as SVP for DuPont, and head of R&D for ICI. A dedicated volunteer for children's health, Barbara chairs the board of Children's National Research Institute, serves as advisor to the UC I4H Fellowship, and as Director for Aptevo Therapeutics.

Markham C. Luke, MD, PhD is the Director of the Division of Therapeutic Performance (DTP) in the Office of Research and Standards, Office of Generic Drugs. DTP is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has research interests in dermatopharmacology, clinical pharmacology, clinical study design and endpoints assessment (including patient-reported outcomes) for medical, surgical, and aesthetic products and serves as consultant dermatologist to various parts of FDA.

Dr. Matsuda is a pharmacist and a senior scientist for Quality, Pharmaceuticals and Medical Devices Agency (PMDA). He received Ph.D. degree in Medicine from Tokyo Medical and Dental University in 2003. He joined the Pharmaceuticals and Medical devices Evaluation Center, the predecessor of PMDA, in 2003 and he is currently responsible for quality assessment of medicines. He was a member of ICH Q9 Expert Working Group, ICH Quality Implementation Working Group (Q-IWG) and ICH Informal Quality Discussion Group (IQDG). He leads Innovative Manufacturing Technology Working Group (IMT-WG) at PMDA and he is a regulatory chair of ICH Q13.

Shun Tezuka is now a reviewer in the New Drug Office I, IV, and V at PMDA. He is also a medical doctor and PhD in gastroenterology, and his specialty as a doctor is hepatobiliary pancreatic cancer.

Wonim Do is a Senior Reviewer in Cardiovascular & Neurology Products Division/MFDS. In 2022, she has reviewed & published pharmaceutical guideline about Neurology products. In 2021-22, she was responsible for revision of Pharmaceutical regulation on drug approval, electronic system management for data quality control related to approval dossier Including CTD. In 2018-21, Drug approval(product manager of anticancer drug, orphan drug, herbal medicine), review and publication of pharmaceutical rule, guideline(including product quality and pharmacopoeia).

Jessica possesses over twenty years of extensive experience in blood product evaluation from CBER, as well as safety, bioequivalence, and biosimilar evaluation from CDER. Presently, she serves as a supervisory mathematical statistician at the Division of Biometrics VIII, CDER/FDA, where her primary focus lies in assessing generic and biosimilar drug products. Her research interests span various areas, including the detection of influential observations, non-inferiority design, adaptive design, and meta-analytic methods in clinical trials. Jessica has been actively involved in organizing clinical trial training courses and workshops for the FDA community, demonstrating her commitment to advancing knowledge and expertise within the field.

Kevin is Market Compliance Manager at the Health Products Regulatory Authority (HPRA) in Dublin, Ireland. He has been with the HPRA since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. Kevin obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM and is also Rapporteur for the ongoing revision of ICH Q9.

Mr. Younghwan Park majored in pharmacy and pharmaceutical analysis at college of pharmacy, Gangwon National University located in South Korea. He has worked in the pharmaceutical industry over than 25 years and have various experience in drug delivery, in vitro – vivo simulation, pharmacokinetics. He is also founder and CEO of SN BioScience Inc, a bio-venture company focusing nanomedicine research such as nanoparticle, nanoliposome, and micelle.

Responsible for a scientific memory database called EPITT (European Pharmacovigilance Issues Tracking Tool), used by the EU Regulatory Network; Active work in the implementation of the new legislative requirements, in particular regarding PSUR, additional monitoring; Scientific administrator for Signal Management.

Prof. Bae graduated from Seoul National University. He conducted more than 100 phase 1 trial as principal investigator since 2002. His major research area is new drug development science such as pharmacometrics, clinical trial, strategic decision, and software development for clinical pharmacology.

Bruce is responsible for the Real-World Evidence team in Japan and APAC and is based in Tokyo, Japan. With ~30 years consulting experience focused on Real World Evidence & Insights, Bruce has considerable expertise in health economic and outcomes evaluations, and helps clients link clinical and market data to further the successful development and marketing of their products. Bruce focuses on methodologies and execution of non-interventional studies, patient-reported outcomes, pharmacoeconomics, and epidemiologic studies.

Jaeyeon Kim is a Senior Director of Pharmacometrics at Novartis supporting early oncology programs. He received his Ph.D. in Biomedical Engineering at Case Western Reserve University. He is interested in informing drug development decisions by utilizing various modeling and simulation methodologies.

Jeff is an epidemiologist within Amgen’s Center for Observational Research, based in Hong Kong. During his ten years at Amgen, he has been enhancing the use of pharmacoepidemiology to inform drug development and to support regulatory decision-making. He received his PhD from the University of Iowa.

Hyang Won (Harriet) MIN is currently Vice President, Head of Regulatory Affairs Asia Pacific, Janssen, a Pharmaceutical Company of Johnson & Johnson, based in Singapore. Harriet has diverse and extensive industry experiences over 20 years, covering various related area in pharmaceutical and medical device industry: Regulatory Affairs, Medical Affairs, Pharmacovigilance, Quality Assurance, Market Access, and New Product Introduction. She is a seasoned and respected industry thought leader, while actively serving on multiple industry task forces to champion changes of regulatory policy in AP countries to harmonize with global regulations.

Xun Liu, the Head of Medical & Regulatory Affairs, Sandoz China. Xun started her career in pharmaceutical industry since 2001. Continuously worked at Novartis and Sandoz for 10 and 5 years, Xun gained experience across different lifecycle of medicines. With the agility and strategic analysis of new regulatory policy, Xun led team extended mature brand indication in 2019.

JaeHyun has over 25 years of experience in regulatory review, research & development, regulatory policy and regulatory compliance in the field of pharmaceuticals. In her role as a senior reviewer, she supervises CMC evaluation of drug, which includes control of nitrosamine impurities in drug products.