DIA Asia 2021- The evolution of clinical trials and regulatory science in a post-pandemic digital world in Asia
Shun Jin, MBA
- Head, Regulatory Affairs, APMA
- Sandoz Asia Pacific Pharmaceutical Pte., Ltd., Singapore
Mr. Jin is currently Head, Regulatory Competency Center Asia Pacific, Middle East and Africa (APMA) at Sandoz Asia Pacific Pharmaceutical Pte. Ltd. He is responsible for all regulatory related activities in Asia Pacific, Middle East and Africa (APMA). Mr. Jin has been working in regulatory affairs field in pharmaceutical industry for more than 20 years. He has extensive expertise in regulatory affairs and in the drug development in the region. Prior to joining Sandoz, he worked in Abbott, AbbVie, Takeda, Parexel and GE Healthcare. Mr. Jin is trained as a pharmacist with business degree.
Jing Ping Yeo, PhD
- Director, Research Integrity, Compliance and Ethics
- Singhealth, Singapore
Dr Yeo Jing Ping is the Director for Research Integrity, Compliance and Ethics in Singapore Health Services Pte Ltd. She ensures that research involving human participants are conducted according to legislative requirements, ethical principles and standards. She is also responsible for research Integrity matters in SingHealth. She has more than 20 years of experience in Clinical Research in the Pharmaceutical and CRO industries. Prior to joining SingHealth, she was the Corporate Vice President for PAREXEL International CRO, responsible for leading the global biopharmaceutical unit in project delivery and for providing the strategic consultancy. Dr Yeo is currently the Steering Committee Member for the Singapore Chapter of DIA.
Kum Cheun Wong, PharmD
- Head Asia Pacific Regulatory & Development Policy
- Novartis Asia Pacific Pharmaceuticals Pte. Ltd., Singapore
Kum Cheun (KC) is Head of Asia Pacific Regulatory & Development Policy for Novartis, leads in the development of regulatory and development policy, and regulatory intelligence for Asia Pacific. He is Co-Chair of Singapore Association of Pharmaceutical Industries (SAPI) Regulatory Affairs Committee, Chair of EFPIA ASEAN Regulatory Network, ASEAN Pharmaceutical Research Industry Association (APRIA) and active member of EFPIA International Regulatory Expert Group (IREG), EFPIA regional regulatory networks (India, Korea-Taiwan), DIA Steering Committee of Singapore, DIA Asia Labelling Community member, ISPE Asia Pacific Focus Group, Steering Committee of APAC, member of APAC RA-EWG, member of APACRM and CoRE Duke-NUS Visiting Expert.
Vicky (Fengyun) Han
- Senior Director, Asia Pacific Regulatory Policy Group Lead, Asia Pacific
- Johnson & Johnson Pte. Ltd., Singapore
Vicky Han is Senior Director at Janssen Pharmaceuticals and head up the Asia Pacific Regulatory Policy since 2016. Her experiences spans in Asia & Europe and cross pharmaceutical, biological, vaccines and generics. She dedicated more than 10 years in regulatory affairs in China in GSK and Novartis, she led GSK vaccine RA team before relocated to Belgium in 2008 for dealing with cross-product vaccines' EMA registration & worldwide strategy; in 2011, she transferred to GSK Pharmaceuticals in London for oversight of regulatory strategies for China and relevant Asia markets. She returned to Asia in 2014 as the Head of Asian Regulatory Affairs in Hospira(a Pfizer company now) before joining Janssen pharmaceutical.
Jessica Liu, MD
- Vice President, Head of International Business
- Tigermed Consulting Co., Ltd, China
Dr. Liu is currently the VP and Head of International Business of Tigermed Co. Ltd, the leading CRO in China, as well the acting CEO of DreamCIS, a Tigermed Company as one of biggest domestic CROs in Korea. She is focusing on business expansion to the oversea market and integration of clinical operations across the different countries, including but only limited to US, Korea, Japan, Taiwan, Hong Kong, and Southeast Asia.
Ling Su, PhD
- Shenyang Pharmaceutical University, China
Ling Su, PhD, is Professor in Shenyang Pharmaceutical University, and a Venture Partner with Lilly Asia Ventures. Dr. Su has over 25 years of experience in drug regulatory and development. He had worked in the Chinese regulatory agency and US FDA, as well as in various R&D management positions in the pharma industry, including VP for Clinical Research Asia Pacific at Wyeth, and SVP and Head of Pharma Development China at Novartis. In addition, he is a Research Fellow at the Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University and an inaugural member of the Biotech Expert Advisory Panel of Hong Kong Stock Exchange. He is the past president and a Fellow of DIA.
Rie Matsui, RPh
- Senior Director, Regional Labeling Head for APAC
- Pfizer, Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group(ILG), Global Regulatory Affairs, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and won the DIA Japan regional award in 2015. She has been actively involved in a number of conferences in Japan, China, Singapore, and the U.S., both as a session chair and speaker. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee.
Junko Sato, PhD
- Director, Office of International Programs
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Office Director for the Office of International Programs. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 6 yrs. She also worked in U.S. FDA as a guest reviewer from 2002-2003, and in EMA as the Japan Liaison Officer from 2012-2014. She is actively involved in many academic societies, and contribute them as counselor, committee member, and a board member.
Hideki Maeda, PhD
- Professor, Department of Regulatory Science
- Meiji Pharmaceutical University, Japan
Dr. Hideki Maeda, PhD is Professor of Regulatory Science, Meiji Pharmaceutical University. He has about 30 years of pharmaceutical industry experience. He had engaged in clinical development for 25 years. He managed the clinical development of oncology, bone, and urology drugs and he had been leading for successful launches of many products. He was also Vice President of Medical Affairs, Astellas Pharm. In 2019, he moved to the field of academia and became his current position. He currently teaches drug development to the students, and also actively engaged in research on regulatory science. He received a PhD of pharmaceutical sciences from Keio University and he is a Registered Pharmacist. He has authored many peer-reviewed journals.
Shinichi Nishiuma, MD
- Head of Oncology Medical Science, Japan medical
- Bristol-Myers Squibb K.K., Japan
Dr. Shinichi Nishiuma is Head of Oncology Medical Science, Japan medical at Bristol Myers Squibb In this position, Dr. Nishiuma is responsible for leading and overseeing all medical activities across Celgene Japan. Dr. Nishiuma has over 15 years' experience in pharmaceutical industries, including clinical development, drug safety, RWE/epidemiology and medical affairs. Dr. Nishiuma holds M.D. from Kobe University and worked at Kobe city general hospital as a gastroenterologist prior to joining the industry. Dr. Nishiuma also serves as a board member and vice-president at Japanese association of pharmaceutical medicine.
Tomoko Ohsawa, PhD
- Director of Office of Informatics and Management for Safety
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
<Current job> Director of Office of Informatics and Management for Safety Pharmaceuticals and Medical Devices Agency (PMDA) <Background> ·Joined PMDA in 2005 2005.4 -2010.9 Office of New Drugs 2010.10-2014.3 Office of Non-clinical and Clinical Compliance 2011.4- Director for GCP inspection 2014.4-2017 3 Office of General Affairs, Director for personnel coordination 2017.4-2018.3 Director for Personnel Affairs and Human Resources Development 2018.4-2018.12 Director of Office of Standards and Guidelines Development 2019.1-2020.12 Director of Office of Non-clinical and Clinical Compliance 2021.1- Director of Office of Informatics and Management for Safety
- Executive Vice President
- LinkDoc Technology (Beijing) Co. Ltd, China
Dr. Tong Guo is in charge of the to-B business of LinkDoc. He was the CEO and Board Member of Gem Flower Pharma Tech., an ARO based in Beijing. He was VP and Head of BD at IQVIA China.He was the Head of Biostatistics Africa & Asia and managed the off-shore Biostatistics functions at legacy Quintiles. He used to work as the Head of Global Data Sciences & Analytics Beijing R& D Center at Bayer HealthCare;VP & Head of Clinical Informatics & FSP at WuXiPRA. He began his clinical research career in 1998 as a Biostatistician at McMaster University in Ontario, Canada. He was a Biostatistician in the USA in both CRO (MDS Pharma Services) and pharmaceutical companies (BMS and J&J) with increasing responsibilities.
- Senior Director, Strategy and Innovation, Global Regulatory Policy
- Janssen, Spain
Since 2000, Kai has been a pioneer in patient-facing solutions for clinical trials working with young innovative technology companies. In 2012, Kai co-founded eClinicalHealth, the developers of the Clinpal remote clinical trial platform. Through his involvement in technical, operational & scientific roles he has gained deep understanding of broad aspects of the patient journey in clinical trials from recruitment & engagement through data capture. Director in the Janssen Clinical Innovation group, within the digital health focus area delivering scalable solutions for digital transformation of clinical trials. He leads digital health innovation projects, focusing on direct-to-patient / decentralized trial methods & novel digital endpoints.
Takahiro Nonaka, PhD
- Head of Epidemiology, Medical information Division
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Takahiro Nonaka is currently a Epidemiology Director of Office of Medical Informatics and Epidemiology at Pharmaceuticals and Medical Devices Agency (PMDA). Since he joined PMDA in 2008, he has been engaged in the review of oncology drugs until March 2020. He is also a leader of the working group of RWD working group in PMDA. Prior to joining PMDA, Dr. Nonaka worked at the Ontario Cancer Institute / the University of Toronto as a postdoctoral fellow, after having received his PhD degree in Medical Science from the University of Tokyo. He has also received his PhD degree in Statistical Science from the Graduate University for Advanced Studies (the Institute of Statistical Mathematics).
- Chief Executive Officer Consortium for Clinical Research & Innovation Singapore
- Executive Director Singapore Clinical Research Institute, Singapore
Dr. Danny Soon is Chief Executive Officer at the Consortium for Clinical Research and Innovation, Singapore (CRIS) and concurrent Executive Director at the Singapore Clinical Research Institute (SCRI). As the inaugural CEO, Danny has the responsibility of bringing together five research programmes and platforms under the auspices of CRIS, promulgating synergies and strategies, building corporate functions to service the entire entity. Danny was previously Executive Director, Biomedical Research Council (BMRC) in A*STAR. His team in BMRC was responsible for incepting and coordinating efforts and programmes in drug development, precision medicine, medical technology and biomanufacturing.
Kinwei Chan, DrSc, MD, FISPE
- Director, Clinical Trial Center
- National Taiwan University Hospital, Taiwan
Dr. Chan is a physician epidemiologist with more than 30 years of global research experience in academia and private sector. He received medical training at NTU (MD-equivalent, 1987) and advanced training in epidemiology at Harvard School of Public Health (Doctor of Science, 1992). He is currently a professor at NTU College of Medicine, Director of the NTU Health Data Research Center and Director of the Clinical Trial Center at NTU Hospital. In addition to scientific research, he has provided consultation for Taiwan FDA and related health authority for more than 20 years. He has authored or co-authored more than 140 peer-reviewed articles and co-edited a textbook on pharmacoepidemiology.
- Head of Healthcare Investment
- Pavilion Capital International Pte Ltd, Singapore
Dr. Timothy Low is a member of the Board of Directors at Farrer Park Hospital in Singapore and also the Head of HealthCare Investment at one of Singapore’s leading investment firm.With over 30 years of tenure in both public and private sectors, Dr. Low is widely recognized as an outstanding medical expert who contributes strategically, with deep technical know-how and intuitive financial acumen. He is a passionate transformational leader, maximizing human assets to deliver exceptional experiences for customers. Dr Low is a proven leader with a track-record of success with start-up ventures and operational turnarounds.
Guohua (James) Pan, PhD
- China Head of Statistics and Decision Sciences
- Janssen China R&D Center, China
Dr. Guohua Pan is currently the China Head of Statistics and Decision Sciences, Janssen Research & Development, Johnson & Johnson (J&J).He has been working at J&J since 2003. Prior to J&J, his work experience includes: Associate Professor of Statistics with Tenure at Oakland University, USA; University Visiting Scholar at University of California at Berkeley, USA; Principal Statistician at Novartis Pharmaceuticals Corporation. At J&J, Dr. Pan’s group leads or supports statistical strategies for pharmaceutical research and development, design and implementation of clinical trials, analysis and interpretation of trial data, and collaboration with regulatory authorities and reviewers around the world.
Shimon Yoshida, PhD
- Executive Director, International Labeling Group, Global Regulatory Affairs
- Pfizer Inc, United Kingdom
Dr Shimon Yoshida is Executive Director at Pfizer, and heads the International Labeling Group in Global Regulatory Affairs. Dr Yoshida obtained a PhD in Chemistry from Reading University, UK, and held postdoctoral positions at Durham University before joining the Royal Society of Chemistry in Cambridge. After joining Pfizer in 1999 he worked in a variety of roles across pharmacovigilance, medical writing, safety, and labeling, and is currently leading Pfizer’s global digital innovation project to transform Regulatory Operations processes.
- Global Head RWE
- Novartis Oncology, Switzerland
Jing Liu, MD
- Vice President and Head of Medical Services APAC
- PAREXEL International, Japan
Dr. Jing Liu is a nephrologist with 14 years of experience in clinical drug development for nephrology, immunology, dermatology, and over 10 years of leadership and management of associate medical directors, medical directors, and senior medical directors across therapeutic areas. Dr. Jing Liu is a China registered physician who received her education and training from Xi’an Jiaotong University medical school in China, got her Ph.D. degree from the University of Tokyo in Japan, and did postdoctoral research work in the US. She can speak fluent Chinese, Japanese and English.