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DIA Asia 2021-The Evolution Of Clinical Trials And Regulatory Science In A Post-Pandemic Digital World In Asia

The timing is as per Singapore Time Zone


Speakers

  • Shun  Jin, MBA

    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

    Jing Ping Yeo, PhD

    • Vice President- Asia Pacific head
    • Cytel International , Singapore

    Dr Yeo Jing Ping has more than 20 years of experience in Clinical Research in the Pharmaceutical and CRO industries. Dr Yeo has recently joined Cytel International as the Vice President - head for Asia Pacific. Prior to this, she was the Director for Research Integrity, Compliance and Ethics in Singapore Health Services Pte Ltd, responsible for all research integrity matters, and ensure all research activities conducted at the institutions/hospitals were according to legislative requirements, ethical principles and standards. She was previously the Corporate Vice President for PAREXEL International CRO, responsible for leading the global biopharmaceutical unit in project delivery and for providing the strategic consultancy.

  • Kum Cheun  Wong, PharmD

    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

    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

    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

    Ling Su, PhD

    • Professor
    • Shenyang Pharmaceutical University, 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

    Rie Matsui, RPh

    • Senior Director, Regional Labeling Head for APAC
    • Pfizer R&D Japan G.K., 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

    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

    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

    Shinichi Nishiuma, MD

    • Head of Oncology Medical Science, Japan medical
    • BMS, 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.

  • Shimon  Yoshida, PhD

    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

    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.

  • Fabio  LaMola

    Fabio LaMola

    • 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.

  • Kai  Langel

    Kai Langel

    • 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

    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).

  • Danny  Soon

    Danny Soon

    • 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

    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.

  • Tong  Guo

    Tong Guo

    • 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

    Daniel Millar, MBA

    • Senior Director, Strategic Business Transformation Quantitative Sciences
    • Janssen Research & Development, 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.

  • Gorana  Capkun-Niggli

    Gorana Capkun-Niggli

    • 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

    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.

  • Timothy  Low

    Timothy Low

    • 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.

  • Celine   Ting

    Celine Ting

    • 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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