J. Jack Lee, PhD

Department of Biostatistics, The University of Texas MD Anderson Cancer Center

View abstract in Invited Session 1

Biography

J. Jack Lee, PhD, MS, DDS, is Professor of Biostatistics and the John G. & Marie Stella Kenedy Foundation Chair in Cancer Research at The University of Texas MD Anderson Cancer Center. He also directs MD Anderson's Biostatistics Resource Group. His research focuses on the design and analysis of cancer clinical trials, including Bayesian adaptive designs, statistical methods for precision medicine, drug-combination studies, and biomarker identification and validation. During more than 30 years at MD Anderson, Dr. Lee has collaborated with multidisciplinary teams across clinical, translational, and basic science research. He is a Fellow of the American Statistical Association, the Society for Clinical Trials, and the American Association for the Advancement of Science. He has published extensively in statistical and medical journals and co-authored books on Bayesian adaptive clinical-trial methods and model-assisted Bayesian dose-finding and optimization designs.

Takashi Kohno, PhD

Center for Cancer Genomics and Advanced Therapeutics (C-CAT), National Cancer Center, Japan

View abstract in Invited Session 4

Biography

Dr. Takashi Kohno began his career as a researcher in the Biology Division at the National Cancer Center Research Institute (NCCRI) in 1995. He became Section Head of the Biology Division in 2000 and Chief of the Division of Genome Biology in 2011. From 2018 to 2023, he was Section Head in the Section of Data Science Strategy at the Center for Cancer Genomics and Advanced Therapeutics (C-CAT), National Cancer Center. In 2023, he was appointed Director of C-CAT, where he oversees advanced cancer genomics research and therapy development. His key accomplishments include identifying RET fusion as a novel therapeutic target and implementing NCC Oncopanel, a comprehensive genomic profiling test.

Kouya Shiraishi, PhD

Department of Clinical Genomics, National Cancer Center Research Institute, Japan

View abstract in Invited Session 4

Biography

Since 2008, Dr. Kouya Shiraishi has served as a researcher and laboratory head in the Division of Genome Biology at the National Cancer Center Research Institute, where he has conducted genomic analyses of germline variants in lung cancer. In 2022, he was appointed Chief of the Department of Clinical Genomics. Through genome-wide association studies, he identified several lung adenocarcinoma susceptibility loci and characteristics of EGFR-mutation-positive lung adenocarcinoma in Asian populations. He currently conducts genomic epidemiological research that combines omics data with lifestyle information to identify high-risk groups more accurately. He also serves as a council member and associate editor of the Japanese Cancer Association and Vice Chair of the Biobank Committee at the National Cancer Center.

I-Shou Chang, PhD

National Institute of Cancer Research, National Health Research Institutes, Taiwan

View abstract in Invited Session 4

Biography

I-Shou Chang is an Investigator Emeritus at the National Institute of Cancer Research, National Health Research Institutes (NHRI), Taiwan. He earned his PhD in Mathematics from Columbia University in 1976. He was an associate professor and professor in the Department of Mathematics at National Central University, Taiwan, from 1976 to 2002, and a visiting professor in the Department of Mathematical Statistics at Columbia University from 1989 to 1990. At NHRI, he served as an investigator in the President's Laboratory and the National Institute of Cancer Research, as Director of the Department of Research Resources and Biomedical Research Resources, and as Director of the Department of Academic Planning. His research interests include cancer epidemiology, cancer risk prediction, and multi-omics studies.

Chao-Hua Chiu, MD

Taipei Medical University Hospital, Taiwan

View abstract in Invited Session 4

Biography

Dr. Chao-Hua Chiu is Professor of Medicine, Vice Superintendent at Taipei Cancer Center, and Director of the Clinical Research Center at Taipei Medical University Hospital, Taipei Medical University, Taiwan. He earned his MD from Taipei Medical University and completed dual specialty training in pulmonology and medical oncology at Taipei Veterans General Hospital. From 2006 to 2008, Dr. Chiu served as a visiting scientist in the Department of Molecular and Cellular Oncology at MD Anderson Cancer Center. He later directed the Section of Thoracic Oncology at Taipei Veterans General Hospital from 2016 to 2022 before assuming his current leadership roles at Taipei Medical University. His clinical work and research interests focus on low-dose CT lung cancer screening, targeted therapies, and clinical trials for thoracic malignancies.

Shunsuke Shiota, MMSc

Pharmaceuticals and Medical Devices Agency (PMDA), Japan

View abstract in Invited Session 2

Biography

Shunsuke Shiota, MMSc, is a biostatistics reviewer in the Office of New Drug V at the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He is responsible for the statistical review of anticancer drug applications, with a focus on the design, analysis, and interpretation of confirmatory oncology clinical trials.

Yuki Ando, PhD

Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency, Japan

Biography

Dr. Yuki Ando is a Principal Senior Scientist for Biostatistics at the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She has over 20 years of experience in the biostatistical review of pharmaceutical and medical device products and currently leads biostatistical review and consultation for new drug and medical device applications at PMDA.

In addition to her regulatory review responsibilities, she contributed to several projects across multi-offices in PMDA, including the Real-World Data (RWD) Working Group and the Multi-Regional Clinical Trials (MRCT) Working Group. She also played a leading role in regulatory and standardization efforts related to the submission and utilization of electronic study data in new drug applications.

Dr. Ando previously served as a member of the ICH E9(R1) and E8(R1) Expert Working Groups (EWG) and is currently contributing to the development of ICH E20 as a member of the EWG.

She received a Master's degree in Engineering from Tokyo University of Science and a Ph.D. in Health Sciences from Osaka University.