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REACTA Forum 2024
August 02, 2024 (Friday)
From Ideation to Validation: Clinical Trials in the Digital Era
Welcome and Opening Ceremony
Session 1: Clinical Trials in New Era: Trends and Emerging Technologies
Part I: Streamlined Clinical Trials
Keynote 1: Streamlined Academic Renal Trials: Trends and Key Success
吳麥斯 Mai-Szu Wu
President, Taipei Medical University
Wu, a TMU School of Medicine graduate, has held various leadership roles at TMU and is currently President of the Taiwan Society of Nephrology and Chairman of the Taiwan Kidney Foundation. Trained at INSERM, he established a nephrology lab, led significant clinical trials, and initiated a translational lab at TMUH. Wu aims to elevate TMU to a premier international medical university by focusing on value-based healthcare, digital transformation, and sustainable development.
Lai Seong Hooi
Consultant Nephrologist & Editor, Malaysian Dialysis and Transplant Registry
She was President of the Malaysian Society of Nephrology from 2004 - 2006 and coordinated numerous multinational trials in Malaysia, including SHARP and EMPA-KIDNEY. She participated in several local studies, including three CAPD RCTs and two cost-effectiveness studies on dialysis. With over 70 publications, she has been on the editorial board of Transplantation Proceedings since 2023 and the editor of the Malaysian Dialysis and Transplant Registry since 2022.
Part II: Data Technology and Clinical Validation
Topic 1: The New Era of AI in Clinical Research
Topic 2: Supporting and Validating Clinical Trials through Global RWD/RWE Collaboration with OHDSI
李友專 Yu Chuan Jack Li
Distinguished Professor, Graduate Institute of Medical Informatics, Taipei Medical University
Li, a top AI in medicine and translational biomedical informatics expert, is ranked among the top 2% of scientists globally. He has led numerous national AI projects in disease prevention and patient safety and developed the largest temporal phenomic stochastic model based on medical data. Li's achievements have earned him fellowships in prestigious health informatics colleges and numerous awards.
徐之昇 JasonC. Hsu
Associate Professor, International Ph.D. Program in Biotech and Healthcare Management, Taipei Medical University
Jason C. Hsu, PhD, is an expert in real-world data and evidence in medicine, and an Associate Professor at Taipei Medical University. He holds key leadership positions in data science and clinical research centers and is the Taiwan Chapter Leader of OHDSI. Trained at Harvard Medical School, Dr. Hsu leads large-scale RWD/RWE projects to advance digital and precision medicine globally.
Part III: Trends and New Technology in Cell Therapy
Topic 1: Clinical Trial of Adaptive Cell Therapy
Topic 2: Next-generation Cell-based Immunotherapy via Antibody Cell Conjugation
Sung Yong Oh
Professor, Hematology-Oncology, Department of Internal Medicine, Dong-A University Hospital
Dr. Oh, a distinguished clinician in hematology and oncology, has been a Professor at Dong-A University Medical Center since March 2020. He earned his PhD and Master's degrees from Dong-A University and has been the Director of Dong-A University Hospital Clinical Trial Center since August 2019. Since March 2022, he has also served as Principal of the Busan, Ulsan, and Gyeongnam Regional Society of Medical Oncology, significantly contributing to research and patient care.
蕭世嘉 Sonny Hsiao
CEO/CSO, President and Co-Founder of Acepodia
Dr. Sonny Hsiao, CEO, President, and Co-Founder of Acepodia, was awarded the Dr. Y-T Lee Prize for his achievements in Chemistry. He has extensive experience in immune cell therapy development, leading to the creation of Acepodia’s novel ACC platform, based on Nobel Laureate Professor Carolyn Bertozzi's work in biorthogonal chemistry. Dr. Hsiao worked on this pioneering research while earning his Ph.D. at UC Berkeley. He holds a B.S. in Chemistry from National Taiwan University and a Ph.D. in Chemistry and Molecular Cell Biology from UC Berkeley.
Part IV: Future of Decentralised Clinical Trials
Topic 1: Embracing the Future: Preparing Sites forDecentralized Clinical Trials (DCT) Innovation
Topic 2: Activities to Promote DCTs in Japan
Topic 3: Local Care Model –Patient Centric Approach in Malaysia
Topic 4: Practical Implementation of Decentralized Clinical Trials in Japan and Prospects in Asia
Mandy Yang
Associate Director, Clinical Operations, Clobal Clinical Operations, Syneos Health
Mandy Yang currently serves as Country Head of Clinical Operations at Syneos Health. Leading the Taiwan team in global trials across various therapeutic areas, Mandy's diverse experience stems from collaborations with different sponsors and studies. Her prior experience in hospital settings enriches her understanding of clinical practice and patient care, fueling her commitment to keeping Taiwan at the forefront of clinical trial innovations, including decentralized clinical trials (DCTs).
Mariko Kawakami
Pharmacist, ARO HQ Office, Chiba University Hospital Clinical Research Center
Ms. Mariko Kawakami has graduated from Tokyo University of Pharmacy and Life Sciences. She joined the Chiba University Hospital Clinical Research Center in 2021. She was first in charge of working with the Institutional Review Board and was mainly involved in the review of research involving genome analysis. From 2023, she started her career as a study manager for investigator-initiated registry trial.
Nor Hafiza Johari
Clinical Operations Manager, Clinical Research Malaysia
Nor Hafiza Johari graduated from the Universityof Putra Malaysia with a Bachelor of Science in Biology. Currently, she is the Clinical Operations Manager at Clinical Research Malaysia. For the past 12 years, she has engaged with different sponsors, CROs, investigators, and trial sites to assist in the conduct of trials. She leads her team to ensure smooth operations, compliance with regulations, and achievement of company objectives.
Shinsuke Muto
President, DCT Japan Co. and Tetsuyu Institute Healthcare Corporation Chairman, Integrity Healthcare Co., Ltd.
Dr. Muto, a former cardiologist for the Emperor and Empress of Japan. He became Chairman of Integrity Healthcare in 2016, founded DCT Japan in 2022, and is a clinical professor at Tokyo Medical and Dental University. He also advises the Ministry of Health, Labour and Welfare and is a member of the Regulatory Reform Committee of the Japan Association of Corporate Executives.
Part V: Sharing from Clinical Research Centers in Taiwan
Introduction and Best Practice Sharing from Clinical Trial Centers
劉俊人 Chun-Jen Liu
Director of the Hepatitis Research Center and Clinical Trial Center, National Taiwan University Hospital
黃俊仁 Chun-Jen Huang
Dean, Officeof Human Research, Taipei Medical University
Session 2: International Collaborative Trials: Opportunities and Challenges
Topic 1: A Fork in the Road: Hypothesis Testing with a Clinical Strategy Example.
Topic 2: Enhancing Innovativeand Investigator-Initiated Clinical Trials in Malaysia
Topic 3: Rethinking Clinical Trials: Patient Reported Outcome Measures
Sheamini Sivasampu
Director, Institute for Clinical Research, National Institutes of Health, Ministry of Health Malaysia
Dr. Sheamini Sivasampu is a Public Health Physician and the Director of the Institute for Clinical Research (ICR) at the Ministry of Health (MOH) in Malaysia. She oversees clinical trials, epidemiology, and digital health research across a network of 37 clinical research centres. Additionally, she has extensive experience in evidence-based policymaking and has served as a visiting scientist at Harvard, currently presiding over the Association of Clinical Research Malaysia.
Angela Wang
Clinical Professor, Duke-NUS Medical School
Professor Angela Wang is currently a Clinical Professor at the SingHealth Duke-NUS Academic Medical Centre and Senior Consultant at Singapore General Hospital. She has an international reputation for her research in cardiovascular-kidney-metabolic health, chronic kidney disease, and biomarkers for personalized care. Her latest work focuses on clinical trials and innovations in kidney disease outcomes, including precision and preventive medicine, and she leads several major clinical trials.
Topic 1: Phase 4 Clinical Trial for Cyclosporine A for Kawasaki Disease
Topic 2: Evolving Global Clinical Trials Sites Landscape
Topic 3: Collaborative networks for clinical cardiovascular trials
Hiromichi Hamada
Professor, Department of Pediatrics,
Graduate School of Medicine, Chiba University
Graduating with an MD from Chiba University School of Medicine in 1990, Dr. Hamada Hiromichi completed postgraduate training at Chiba University Hospital by 1997. He earned a PhD from Chiba Graduate School of Medicine in 2000 and held postdoctoral fellowships in cell and vascular biology. He served as a staff physician and faculty member at Tokyo Women’s Medical University from 2007 to 2019. Since 2021, he has been a Professor of Pediatrics at Chiba University's Graduate School of Medicine.
Luis Segovia Sordo
Director, Site Alliances APAC & Hong Kong Office
Luis has over 25 years of experience in clinical trials, having worked in Europe, US, and Asia. He excels in building and managing clinical trial teams, focusing on site relationships and business development. Passionate about fostering growth through site-industry relationships, he has a talent for working across cultures and continents. Recently, he is very excited about the increased use of Real World Data and AI in Health Care and Clinical Research.
Derek John Hausenloy
Director, National Heart Research Institute Singapore (NHRIS)
Derek Hausenloy is a Professor in the Cardiovascular & Metabolic Disorders Signature Program at Duke-NUS Medical School and Director of the National Heart Research Institute Singapore. He conducts research in ischaemic heart disease, heart failure, cardioprotection, and cardiac MRI, focusing on novel therapies to protect the heart against acute ischaemia/reperfusion injury and heart failure. His work spans from cellular and animal models to large clinical trials, and he uses human iPSC-derived cardiomyocytes to study cardiomyopathies and discover new treatment targets.
Session 3: Experience Sharing of Key Clinical Studies in Taiwan
Topic 1: Precision diagnosis, Translational Research, and Multicenter IIT Phase II Trial of Atypical Teratoid Rhabdoid Tumors in Children: Experience in Taiwan
Topic 2: Clinical Trials for Neurological Diseases in Taipei Medical University, Taiwan
Topic 3: Xpert MTB/RIF Assayas the Initial Diagnostic Test for Pulmonary Tuberculosis in Taiwan: a Prospective, Multi-center, Randomized, Pragmatic Trial
Topic 4: Clinical Trials for Cardiovascular Diseases in Taipei Medical University, Taiwan
黃棣棟 Tai-Tong Wong
Professor, Graduate Institute of Clinical Medicine, Taipei Medical University
Dr. Tai-Tong Wong is a renowned specialist in pediatric neurosurgery, focusing on pediatric brain and spinal tumors, epilepsy surgery in children, and hydrocephalus. Currently serving as Chairman of the Division of Pediatric Neurosurgery at TMUH and Director of the Pediatric Brain Tumor Program, Dr. Wong has extensive experience in neurosurgical care. He has held significant leadership positions, including President of the International Society of Pediatric Neurosurgery and the Taiwan Society for Pediatric Neurosurgery.
胡朝榮 Chaur-Jong Hu
Dean, Medical College, Taipei Medical University
Dr. Chaur-Jong Hu, founding director of the Dementia Center at Taipei Medical University-Shuang Ho Hospital, is the Dean of the College of Medicine at Taipei Medical University. With extensive experience in clinical trials for neurological diseases, has published over 250 peer-reviewed papers and serves as Executive Supervisor of the Taiwan Neurological Society and is a Fellow of the American Heart Association.
江振源 Chen-Yuan Chiang
Vice Superintendent, Taipei Municipal Wanfang Hospital
Dr Chiang is a cliniciantrained in Taiwan, specialized in respiratory and critical care medicine, obtained the degree of MPH at UC- Berkeley, US and DrPhilos at University of Bergen, Norway. He joined The International Union Against Tuberculosis and LungDisease (The Union), Paris, France in 2003 and was Director, Department of Lung Health, The Union, between 2007-2015. Currently, he is a Vice Superintendent of WanFang Hospital, and Professor of Medicine atTaipei Medical University.
劉如濟 Ju-Chi Liu
Vice Superintendent, Taipei Medical University Shuang Ho Hospital
Dr. Ju-Chi Liu is a Professor in the Division of Cardiology, Department of Internal Medicine at the School of Medicine. His research interests include atherosclerosis, hypertension, and molecular biology in the cardiovascular system. Dr. Liu currently serves as the Deputy Director of the School of Medicine and Superintendent of Taipei Medical University Shuang Ho Hospital.
Session 4: Industrial Leaders' Panel Discussion
產業代表對談
Carol Chen
Oncology Country Head
Site Management & Monitoring (SMM) Taiwan
AstraZeneca Taiwan LimitedAnchi Huang
Head of Site Management
Medical Department
Bayer Taiwan Co., Ltd.Keris Huang
Executive Director
Global Clinical Trial Operations
MSD TaiwanShuling Cheng
President
Oneness BiotechTien Li Chen
Associate Director
Site and Patient Solution
Syneos HealthClosing Remarks
黃俊仁 人研長 Chun-Jen Huang
Chairperson, REACTA 2024
Dean
Officeof Human ResearchTaipei Medical University
Topic 1: CCRC Activities and Clinical Trial Networks as AROs in Japan
Topic 2: Reflections on Clinical trials in the Era of Evidence-based Medicine
Topic 3: Challenges and Opportunity of Cancer Clinical Trials in Taiwan
Topic 4: Opportunities in Conducting Multi-Regional Clinical Trials in Malaysia
Hideki Hanaoka
Head of Clinical Research Center, Chiba University Hospital, Deputy director of Chiba University Hospital
Dr. Hanaoka graduated from Chiba University Medical School and joined PMDA as a medical reviewer in 2000. He was chief reviewer at NDA 5th review division of PMDIC. In 2003, he moved to Chiba University Hospital Clinical Research Center. He has been director of CCRC since 2008 and professor of the hospital since 2010. In 2023, he became deputy director of Chiba University Hospital. Chiba University Hospital has been one of the core clinical research hospitals since 2012.
Akhmal Yusof
Chief Executive Officer, Clinical Research Malaysia
Dr. Yusof graduated from the Royal College of Surgeons in Ireland in 1992 and practiced medicine for 10 years. He then gained extensive experience in the pharmaceutical industry, leading the Medical Department at AstraZeneca Malaysia, Singapore & Brunei for 13 years. Since 2015, he has been the Chief Executive Officer of Clinical Research Malaysia (CRM) and serves on the National Committee for Clinical Research and the Board of Trustees of the National Institute of Biotechnology Malaysia.
Chao-Hua Chiu
Vice Superintendent, Taipei Cancer Center, Taipei Medical University
Dr. Chao-Hua Chiu is a Professor at the School of Medicine and the Vice Superintendent at Taipei Cancer Center, Taipei Medical University. He specializes in Pulmonology and Medical Oncology, with clinical and research interests in low-dose CT lung cancer screening and the management and new drug development for lung cancer, mesothelioma, and thymic malignancies. Dr. Chiu trained at Taipei Veterans General Hospital and was a visiting scientist at MD Anderson Cancer Center.
Edwin Chan
Chief Scientific Officer, Singapore Clinical Research Institute
Edwin Chan is a clinical epidemiologist with extensive expertise in clinical research and evidence synthesis. He teaches research literature critical appraisal skills to medical students (Duke -NUS Medical School) and mentors students in clinical research (MCI programme, NUS). He has taught many research methodology courses on clinical trials, biostatistics, epidemiology, clinical practice guidelines (CPG) development, meta-analysis & evidence-based medicine (EBM). His interests are in the teaching of critical appraisal skills, epidemiology, health technology assessment and evidence synthesis.
Session 6: Research Innovation and Clinical Validation
Topic 1: Allogeneic platelet lysates for brain administration and treatment of neurological disorders
Topic 2: Translational research experience sharing using TMU biobank
Topic 3: Novel HDAC6 Inhibitor G211: Preclinical Study and Potential in Human Cancer Treatment
Topic 4: Nanofiber artificial bone substitutes development plan
Session 7: Updates on the Latest Regulations and Practices on Clinical Trials
(中文演講)Topic 1: 藥品臨床試驗執行分散式措施指引 (Decentralized Clinical Trial, DCT)
Topic 2: 臺灣再生醫療挑戰與展望
Moderator
汪志雄 Chih-Shung Wong
Director, Anesthesiology Department, Cathay General Hospital
Moderator
林志翰 Chih-Han Lin
Director, JIRB Administration Section, Taipei Medical University
陸怡伶 Yi-Ling Lu
Section Chief, Division of Regulatory Affairs and Compliance
劉越萍 Liu Yueh-ping
Director-General, Department of Medical Affairs, Ministry of Health and Welfare
Session 8: Student Research Awards Oral Presentation
Closing Remarks
黃俊仁 人研長 Chun-Jen Huang
Chairperson, REACTA 2024
Dean
Officeof Human ResearchTaipei Medical University
2024 REACTA TW