飯山達雄, MD
部長(NCGM, 臨床研究センター, インターナショナルトライアル部), Japan

Dr Iiyama is the Director of the Department of International Trials at the Center for Clinical Sciences of the NCGM. He is a Urologist with more than ten years’ experience in managing clinical trial centers in academic institutions.

Currently, his job focuses on:
• Coordinating and managing global stakeholders for the promotion of International clinical research
• Implementing a trial management system that bring together a team of competent international experts.
• Procedure optimization and capacity building for R&D activities and Evidence based Medicine.

佐藤淳子, MD, PhD
国際部長(PMDA), Japan

Dr. Junko Sato is an Office Director, Office of International Program at Pharmaceuticals and Medical Devices Agency (PMDA).
She started to work in regulatory agency in 1998. She spent anti-infectives review area and risk management area before joining international area. During the period, she worked in U.S. FDA as a guest reviewer from 2002 to 2003. From 2012 to 2014, she was dispatched to EMA as the MHLW/PMDA Liaison.
She contributes to some global harmonization activities, for example, ICH, CIOMS etc. Currently she is the chair of IPRP. She is also keen for scientific activities. She works for Japanese Society of Clinical Pharmacology and Therapeutics as a board member, and Japanese Society of Chemotherapy as a member of many committees, and for more than 10 Societies. Her specialty is infection control. She is certified as an infection control doctor by Japanese Association on Infectious Disease.

Adam Hacker, PhD
Head of Global Regulatory Affairs, Coalition for Epidemic Preparedness Innovations (CEPI)

Adam Hacker is the Director and Head of Global Regulatory Affairs, Coalition of Epidemic Preparedness Innovations (CEPI). As part of his role at CEPI, Adam co-chairs the COVAX Regulatory Advisory Group, consisting of thirteen regulatory authorities, where regulatory issues related to COVID-19 vaccine development are discussed. Adam also leads all CEPI’s regulatory activities around the 100-days initiative, collaborating extensively with regulatory authorities worldwide. He has more than 20 years of pharmaceutical industry experience in leadership roles in both vaccine and haematology / oncology development, with expertise extending from Regulatory Affairs to Quality and Medical Affairs, including 10 years at Janssen.

西岡絹恵, BPharm, MSc, PhD
国際部アジア第二課長(PMDA), Japan

Dr. Kinue Nishioka graduated from the University of Tokyo, Faculty of Pharmaceutical Sciences and received her master’s degree from the same university and received her PhD in pharmacology from the Graduate School of the Kyushu University.

She has been working at the Pharmaceuticals and Medical Devices Agency (PMDA) since 2009. She had been reviewing the clinical and non-clinical data of the drugs for metabolic disorders (diabetes mellitus, osteoporosis, inherited metabolic disorders) in Office of New Drug I and for neurological disorders and psychiatric disorders in Office of New Drug III.

She is currently a Division Director of Asia II, which is in charge of ASEAN countries, in the Office of International Programs at PMDA. She had contributed to a global harmonization activity of ICH E14/S7B and ICH E19 from 2013 to 2022.

John Mark S. Velasco, MD, MPH, Msc (Clinical Trials), DTM&H
Research Associate Professor, Institute of Molecular Biology and Biotechnology, National Institute of Health, University of the Philippines, Manila (NIH-UPM), The Philippines

Dr. John Mark Velasco earned his BS in Biology, MPH, and MD from the University of the Philippines, a post-graduate diploma and MSc in clinical trials from LSHTM and a DTM&H from LSTM. Dr. Velasco is a research associate professor of the Philippines National Institutes of Health. His research interests encompass various disciplines, including virology, emerging and re-emerging infections, emerging antibiotic resistance of multidrug-resistant organisms, clinical and molecular epidemiology, electronic disease surveillance/ infectious disease mathematical modelling, clinical trials and vaccinology. He has published more than 30 research articles on infectious diseases clinical/ molecular epidemiology and control, with a focus on respiratory and arboviral infections. He is the chairperson of the Philippines NIH-FDA expert panel on clinical trials which reviews clinical trial protocols for implementation in the Philippines.

Hasniza Zaman Huri, PhD, M. Clin Pharm, B. Pharm
Dean, Faculty of Pharmacy, Professor of Clinical Pharmacy & Pharmacy Practice, Universiti Malaya
Former Director/ Head, Clinical Investigation Centre (CIC), Universiti Malaya Medical Centre (UMMC) Malaysia

Professor Dr Hasniza Zaman Huri is the founder Dean and Professor of Clinical Pharmacy and Precision Medicine in the Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy Universiti Malaya. Her area of expertise is targeted therapy in endocrine diseases, clinical pharmacy, precision medicine and clinical trial industry. She has published nearly 100 papers indexed in Web of Science. She held various administrative posts, including the Manager of Clinical Investigation Centre (CIC) and Director of CIC (2015-2019). CIC, University Malaya Medical Centre is a world-class, reputable and multi-winning clinical trial centre. Under her tenure, CIC is recognised as Malaysia's first Strategic Alliance Site for Parexel Inc, Pfizer’s INSPIRE (Investigator Networks, Site Partnerships and Infrastructure for Research Excellence) Site in Malaysia and the Best Clinical Trial Service Provider in Asia. She is also a member of the Drug Control Authority (DCA) Ministry of Health Malaysia.

Marissa Alejandria, MD, MSc, FPCP, FPSMID
Director, Institute of Clinical Epidemiology, National Institutes of Health University of the Philippines Manila, The Philippines

Dr Alejandria is a Professor of Clinical Epidemiology at the Department of Clinical Epidemiology, University of the Philippines College of Medicine and Clinical Professor at the Division of Infectious Diseases, Department of Medicine, UP – Philippine General Hospital. She currently serves as Director of the Institute of Institute of Clinical Epidemiology, National Institutes of Health, UP Manila and Associate Dean for Research of the UP College of Medicine.

During the COVID-19 pandemic, she served as the National Coordinator of the WHO Solidarity Trial on COVID-19 Therapeutics and Co-Principal Investigator for the WHO Solidarity Trial on Vaccines in the Philippines. She co-leads the development of the Philippine COVID-19 Living Clinical Practice Guidelines and the Philippine Vaccine Effectiveness Project.

Currently, Dr Alejandria heads the Philippine Program for DIAgnostic Biomarkers, Disease Modeling and Nutriceutical Product Development focusing on HIV-related Neurocognitive and Metabolic Complications and the RePORT (Regional Prospective Observational Research for Tuberculosis) Philippines which is part of RePORT International Consortium.

織田奈津子, MSc
部長(塩野義製薬株式会社医薬開発本部臨床開発部), Japan

Ms. Natsuko Oda is the Vice President of the Clinical Research Department, Drug Development and Regulatory Science Division at Shionogi & Co., Ltd.
Graduated from Osaka University, Ms. Oda hold a Master degree of science. She has a long carrier at Shionogi where she has been appointed at different positions from Research associate, medical writer, CRA, Clinical Trial Manager.
During the COVID 19 pandemic, she was appointed as Clinical operation lead of the Covid 19-Vaccine project in the Clinical Research Department.

Tang Sia Chin, BPharm, MRes
Senior Principal Assistant Director, Investigational Product Evaluation and Safety Section, National Pharmaceutical Regulatory Agency (NPRA), Malaysia

Ms. Tang Sia Chin is Senior Principal Assistant Director at the Investigational Product Evaluation and Safety Section of the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia.
She holds Bachelor of Pharmacy and a Master degree in Research for Experimental Cancer Medicine. Ms Tang Sia Chin is an experienced regulatory pharmacist with over 13 years of experience in regulatory review particularly in the field of clinical trials. In the past She had been reviewing applications for Traditional products registration and inspecting bioequivalence centres and ethical committees that comply with Malaysian regulatory requirements and Good Clinical Practice guidelines. Her core job consists of reviewing initial clinical trial applications as well as to evaluate and monitor clinical trial maintenance activities].

Melva Louisa, BPharm, PhD
Research Coordinator, Department of Pharmacology, Faculty of Medicine, Universitas Indonesia, Indonesia

Melva Louisa is currently an Academic staff member in the Department of Pharmacology and Therapeutics, Faculty of Medicine, Universitas Indonesia, where she has taught pharmacology since 2006. Prior to her appointment at the Department of Pharmacology at FMUI, she previously worked at pharmaceutical companies as a medical science trainer for medical representatives. Now, she is the Research Coordinator for her Department. She got her PhD in Biomedical Sciences from the Faculty of Medicine, Universitas Indonesia, in 2012. Her background in clinical research-related activities started in 2006, when she functioned as Clinical Research Monitor at the Clinical Research Supporting Unit at FMUI until 2018. Moreover, she also published many articles in clinical research. Together with her colleagues in the Department, she works with the Indonesian FDA on the new drug evaluation process.

Marlinang D. Siburian, Mbiomed
リージョナルマネージャー(NCGM, 臨床研究センター, インターナショナルトライアル部), Japan

Ms. Marlinang studied Biochemistry and has a master degree in Biomedicine. She is currently doing her Ph.D research on the topic of Clinical Trials conduct in Southeast Asia countries. Ms. Marlinang joined the Department of International Trials at NCGM since 2018 as Regional Manager for Indonesia with main responsibilities to implement international study collaborations. Prior to this she had over 10 years of experience in molecular and epidemiology research on Hepatitis B Virus and liver cancer in Indonesia. She had published in peer-reviewed journals.

兼松美和, MPH
主任専門員(PMDA国際部), Japan

Ms. Miwa Kanematsu is currently a principal coordinator of the Office of International Programs at Pharmaceuticals and Medical Devices Agency (PMDA). She has many experiences working in various office in PMDA, such as post-marketing safety, new drug review, and clinical compliance.

Winai Ratanasuwan, MD, MPH, PhD
Director of Siriraj Institute of Clinical Research, Siriraj Faculty of Medicine, Mahidol University, Thailand

Associate Professor Winai Ratanasuwan, M.D., is a specialist in infectious diseases and immunodeficiency at the Department of Preventive and Social Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University. He also holds the position of Director at the Siriraj Institute of Clinical Research (SICRES). Dr. Winai's research interests revolve around HIV, Adult Immunization, Tuberculosis, Influenza, and Dengue infection.

His remarkable contributions to the field of preventive medicine were recognized when he was honored with the "Outstanding Preventive Medicine Physician in Clinical Preventive Medicine" award for the year 2022. This esteemed accolade was presented to him by The Preventive Medicine Association of Thailand and the Department of Disease Control, showcasing his exceptional skills and dedication to advancing clinical preventive medicine.

Rini Mulia Sari, MD
Vice President of Surveillance and Clinical Research, Bio Farma Company, Indonesia

Rini Mulia Sari is the Vice President of Surveillance and Clinical Research at Bio Farma, the leading life-science products manufacturer in Indonesia. She has dedicated herself to Bio Farma since 2007, specializing in vaccine development & clinical trials. She has been managing important clinical trials for various Bio Farma vaccine products and has published papers on vaccine trials such as influenza vaccine, rotavirus vaccine, typhoid vaccine (in collaboration with IVI), DTP/HB/Hib vaccine, and COVID-19 vaccine.

During the pandemic, her role is notable in the clinical development for COVID-19 vaccine. In the time when only limited information was available regarding the virus, she was willing to learn and persistent in fulfilling her duty. Driven by her strong public health background, years of experience and good collaboration with various stakeholders, she became a key contributor to the successful acceleration of COVID-19 vaccine trials (CoronaVac, in collaboration with Sinovac, and IndoVac, the country’s first domestically produced COVID-19 vaccine).

Akanid Wapeewuttikorn, BPharm, MSc
Pharmacist, Senior Professional Level, Medicines Regulation Division, Food and Drug Administration, Thailand

Ms. Akanid received her Bachelor degree in Pharmaceutical Sciences from Mahidol University, Thailand and Master of Sciences in Public Health in Epidemiology from University of Alabama at Birmingham, USA

Ms. Akanid has joined Food and Drug Administration, Thailand, since 2003. She has been assigned to work at the Drug Control Division, which later becomes Medicines Regulation Division. Recently, just right after reorganization in June 2023, she is working under the New Drug and Clinical Trial Promotion Sub-Division, Medicines Regulation Division, Thai FDA

Her past experience was involving some International Affairs activities, e.g. ASEAN and APEC in the areas relating to Investigational drugs and clinical trial. Also, she has been worked as a clinical trial reviewer and lead inspector for more than 10 years. Currently, she has been actively involved in updating clinical trial authorization and clinical trial oversight functions in Thailand.

Hanis Hafizah Ismail, MBBS, BS
Science Officer, Head of Research Unit, Universiti Malaya Medical Centre (UMMC), Malaysia

Ms Hanis Hafizah Ismail is the Head of Research Unit of the Clinical Investigation Centre (CIC). The unit is in charge with overseeing the clinical trial activities, inclusive of feasibility surveys, medical research ethics committee liaison, application and monitoring of research, research system development, and Good Clinical Practice (GCP) training. Ms Hanis is also one of the key personnels for networking and organisational collaborations.

As a Site Management Organization (SMO) in University Malaya Medical Centre (UMMC), Clinical Investigation Centre is a department dedicated to provide clinical research facilitation services to the pharmaceutical and biomedical industry to conduct quality and safe clinical studies in our hospital. UMMC is proud to be a part of the Malaysia’s premier teaching hospital, with an integrated network of experienced clinical investigators and large pool of potential study subjects including healthy volunteers.

Ahmad Izwan Bin Abdul Rani, BPharm, MSc
Senior Principal Assistant Director, Good Clinical Practice (GCP) & Good Laboratory Practice (GLP) Section, National Pharmaceutical Regulatory Agency (NPRA), Malaysia

Mr. Ahmad Izwan is currently a GCP and Bioequivalence Inspector at the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia.

He is a Regulatory Pharmacist with more than 10 years working experience in reviewing Pharmaceutical Product Registration and conducting GCP and BE Inspection in many countries.
He holds a Master of science in Pharmaceutical Analysis from the Universiti Kebangsaan Malaysia.
He is responsible for coordinating GCP inspection in Malaysia as well as assisting developing policy and guidance documents related to clinical trial.

齋藤浩輝, MD, MPH
講師(聖マリアンナ医科大学医学部医学科救急医学), Japan

Dr. Hiroki Saito is a Japanese physician who is board certified for infectious disease in the U.S. as well as critical care medicine in Japan. He completed the Infectious Disease Emergency Specialist (IDES) training provided by the Ministry of Health, Labour and Welfare of Japanese government, through which he worked on infection prevention and control at the WHO headquarter. He has been in the current position since 2018, and has been working on REMAP-CAP, an international platform trial since the COVID-19 pandemic while working for ICU at a university affiliated hospital in Yokohama.

大亀崇生, MS
(JPMA医薬品評価委員会 臨床評価部会), Japan

Mr. Takao Okame is member of the Decentralized Clinical Trials Task force of the Clinical Evaluation Expert Committee, Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA).
Mr Okame holds a Master of Science in Agricultural sciences and has a long-lasting carrier of more than 15 years at Otsuka Pharmaceutical company where He is currently working at the office of talent development and training in HQ of clinical Development.

杉浦亙, MD, PhD
臨床研究センター長(NCGM), Japan

Dr. Wataru Sugiura is the Director of the Center for Clinical Sciences, National Center for Global Health and Medicine. He is also serving as Guest Lecturer and Researcher at the Joint Research Center for Human Retrovirus Infection, Kumamoto University, at the AIDS Research Center, National Institute of Infectious Diseases and at the Department of Infectious Diseases and Immunology, Nagoya Medical Center. Dr Wataru Sugiura has a wide working experience form Public Universities, at the National Institute of Infectious Diseases (NIID), and private Pharmaceutical companies. His research focus mainly on AIDS and other Human Retrovirus infections. He is serving as Editor of the Journal of AIDS Research (official journal of the Japanese Society for AIDS Research), Acting Chief Director of Japanese Society for AIDS Research, and Editor of AIDS Patients Care and STDs. He holds a PhD from Hamamatsu University, Japan He is well published in peer review journals.