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
Head - Transformation, George Clinical, Singapore
Dr Yeo Jing Ping has more than 25 years of experience in Clinical Research in the Pharmaceutical and CRO industries. She was previously the Vice President and Head of Asia Pacific in Cytel, responsible for leading the growth of Cytel. Prior to Cytel, she was the Research Director, leading the compliance and IRB matters, ensuring all research at the institutions/hospitals were conducted according to legislative requirements, ethical principles and standards. She was previously the Corporate Vice President for PAREXEL International CRO, leading the global biopharmaceutical unit in project delivery and for providing strategic consultancy to the biopharma companies.
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.
Senior Director, Head of Regulatory Policy for 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 span Asia & Europe and cross pharmaceutical, biological, vaccines, and generics. She dedicated 18 years of her career to GSK where she held several positions in various countries. She led the RA team in pharmaceuticals and vaccines in GSK China before moving to GSK vaccines headquarters in Belgium in 2008. In GSK Vaccine, she led the cross-product regulatory affairs team to deal directly with the European Medicines Agency (EMA) regarding vaccine registration. In 2011, she relocated to GSK Pharmaceuticals headquarters in London as the Senior Director to oversee the regulatory strategies in China/Asia.
Jessica Liu, MD
VP, Head of Merges and Acquisition Management Department, Tigermed Consulting Co., Ltd, China
Dr. Liu is VP and Head of M&A Management at Tigermed Co. Ltd, a global CRO focused on clinical development. Her recent 1.5-year role involves finding and acquiring well-matching partners for Tigermed's global service platform. With 29 years of experience in clinical research and development for global pharmaceutical companies and CROs, she has managed Phase I-IV studies across multiple therapeutic areas. Jessica is trained in Clinical Medicine and has a post-graduate diploma in Pharmaceutical Medicine from the University of Basel. She has also dedicated much of her personal time to DIA China development.
Ling Su, PhD
Research Fellow, Shenyang Pharmaceutical University, Yeehong Business School, China
Dr. Ling Su is a Research Fellow in Shengyang Pharmaceutical University Yeehong Business School and a Venture Partner in Lilly Asia Ventures (LAV). He has 30 years of experience in drug regulatory and development. He had worked in various R&D management positions in the pharma industry, including Medical Director at MSD, Pharma Development Director at Roche, VP for Clinical Research Asia Pacific at Wyeth, and SVP and Head of Pharma Development China at Novartis. Prior to that, he worked in the Chinese regulatory agency and CDER, US FDA. He is a Fellow of DIA and was the President of DIA (2012-2013). Ling holds BS in pharmacology from Shanghai Medical University and PhD in Epidemiology from University of North Carolina at Chapel Hill, USA.
Rie Matsui, RPh
Senior Director, International Labeling APAC, Pfizer R&D Japan G.K., Japan
Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, 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 received the DIA Japan regional award in 2015. 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. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.
Junko Sato, PhD
Associate Executive Director, 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
Executive officer, Chief Medical Officer , Aculys Pharma Inc,, Japan
Dr. Shinichi Nishiuma is Executive Officer, Chief Medical Officer at Aculys Pharma Inc. After graduating from Kobe University School of Medicine in 1997, he began his medical career as an internist and a gastroenterologist at Kobe City General Hospital. Recognizing issues with the drug lag for hepatitis C treatment, he took on the role of a physician in clinical development at Schering-Plough (now merged into MSD). Following that, he was responsible for clinical development and safety management at Eli Lilly Japan. From 2018, he served as the Head of Medical Division at Celgene Japan (now merged into BMS). In 2022, he became the Chief Medical Officer at Aculys Pharma Inc., where he remains to this day.
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.
Tomoko Ohsawa, PhD
Director of Office of Informatics and Management for Safety, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Tomoko Osawa is Director of Office of Informatics and Management of Safety at Pharmaceuticals and Medical Devices Agency (PMDA). Dr. Osawa majored in Biochemistry and got a PhD in Pharmacy from the University of Tokyo. Dr. Osawa joined PMDA in 2005 and engaged in business related to review for new drug approvals, GCP and GLP inspections, personnel affairs and human resources development, and standards and guidelines development. Dr. Osawa has been in the current position since 2021.
Partner, Global Healthcare Co-Head, L.E.K Consulting , Singapore
Fabio has over 20 years of experience working with clients to diagnose, design and implement strategies and organizations in Life Sciences in Asia Pacific, Europe and the Americas.He co-leads the Healthcare practice globally for L.E.K., and serves as Executive Director of the L.E.K. APAC Life Sciences Centre of Excellence.In addition, Fabio serves as expert advisor Central Gap Fund for Biotech for the National Research Foundation, Singapore office of the Prime Minister, and as Member of the SME Innovation Committee for the Singapore Business Federation.He earned his MBA at Kellogg School of Management, Northwestern University, and Business Administration Degree from Bocconi University in Milan.
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, CRIS, Executive Director, SCRI, Interim Executive , Director, ACTRIS, Singapore
A/Prof Danny Soon is CEO at the Consortium for Clinical Research and Innovation, Singapore (CRIS) and concurrent Executive Director at the Singapore Clinical Research Institute (SCRI). Danny is also the Interim Executive Director for Advanced Cell Therapy and Research Institute, Singapore (ACTRIS). Danny has had a long experience in drug development, having worked at Eli Lilly and Company for 15 years, where he headed up the Lilly-NUS Centre for Clinical Pharmacology (LNUS). As the inaugural CEO of CRIS, 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.
Kinwei Arnold Chan, DrSc, MD, FISPE
Senior Vice President, Insight and Evidence Generation, TriNetX, LLC, United States
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 has served on the faculty at Harvard School of Public Health and National Taiwan University, and as Chief Scientist of the Epidemiology Unit at Optum. 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 150 peer-reviewed articles and co-edited a textbook on pharmacoepidemiology. He joined TriNetX LLC recently.
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.
Daniel Millar, MBA
Senior Director, Strategic Business Transformation, Johnson & Johnson, United States
Daniel Millar leads Strategic Business Transformation in Quantitative Sciences at Janssen R&D. He is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Daniel is a founding leader and champion for multi-stakeholder engagement in the recently launched Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms. Daniel obtained a MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling. His current “country number” is 115.
Global Head RWE, Novartis Oncology, Switzerland
Gorana Capkun is heading Enablement of Real World Evidence at Novartis Oncology. She is a published leader within the healthcare industry, with a particular interest in identifying novel ways of creating evidence, defining value, developing and bringing healthcare solutions to improve the lives of patients. She is a strong believer in the power of dialogue between all partners in finding sustainable solutions to healthcare challenges.She successfully combines her knowledge in statistics, health economics, real world evidence and market access with her experience from all phases of drug development across multiple disease areas to estimate product value and optimize access for patients.
Jing Liu, MD
Corporate VP, Regional Head, Medical Sciences, APAC, Parexel International Inc., Japan
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.
Managing Director, Eisai (Singapore) Pte Ltd, Singapore
Ms Celine Ting graduated from the Faculty of Pharmacy, Curtin University of Technology in Australia in 1994. After graduation, she worked as a retail pharmacist in Australia and obtained a Master of Business Administration degree from the Curtin University of Technology, Australia in 1998.She has over 25 years of experience working in various healthcare sectors; in retail pharmacy Australia, Singapore General Hospital, Novartis (Singapore) Pte. Ltd., Diethelm Healthcare (DKSH) and she is currently the MD of Eisai (Singapore) Pte. Ltd since 2004.With special interest in Regulatory, Ms Ting assumed the role as the first Chairman for the ASEAN Pharmaceutical Research Industry Association (APRIA) from August 2006 till March 2009.
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