DIA-CoRE Singapore Annual Meeting 2020
Audrey Ooi, MSc
- Head- Business Development
- Clinical Research Malaysia, Malaysia
Audrey Ooi is Head of Business Development at Clinical Research Malaysia (CRM). In this role, Audrey grows new business opportunities and collaborations with local and global clinical research industry players to attract international clinical trials into the country, besides networking with local regulators, agencies and ministries to advocate for a robust clinical research ecosystem in Malaysia.
Dorothee Grimald, PharmD
- Director, Global Regulatory Policy
- MSD, Germany
Dorothee Grimald leads the Regulatory Policy activities for Asia Pacific at MSD (Merck Sharp & Dohme). She holds this position for over 6 years and has now relocated to Europe (Germany).Mrs Grimald has over 20 years of experience in the Life Science Industry, mainly in the Regulatory Affairs field. She is an active representative in several regional and international industry collaboration platforms. Before moving back to Europe, she worked in Singapore, China, France and the UK. Dorothee Grimald is French and Pharmacist by training with a degree in Management.
John CW Lim, MD, MSc
- Professor Duke-NUS CoRE, Consortium for Clinical Research & Innovation Singapore
- Duke-NUS CoRE, Singapore
Professor John CW Lim is founding Executive Director of the Centre of Regulatory Excellence (CoRE) at the Duke-National University of Singapore (Duke-NUS) Medical School and inaugural Chairman of the Consortium for Clinical Research & Innovation Singapore. He is a medical doctor with graduate degrees in Public Health from NUS and Health Policy & Management from Harvard University, Professor of Practice at Duke-NUS and the NUS Saw Swee Hock School of Public Health, Senior Advisor at Singapore's Ministry of Health, and Policy Lead at the SingHealth Duke-NUS Global Health Institute. He was formerly CEO of Singapore's Health Sciences Authority. In 2018, Professor Lim received the Drug Information Associations Global Connector Inspire Award.
Finny Liu, MSc, RPh
- APAC Regional Regulatory Policy Lead
- Roche Singapore Pte Ltd, Singapore
Finny Liu is the APAC Regional Regulatory Policy Lead, Product Development Regulatory, at Roche based in Singapore, responsible for leading regional Regulatory Policy activities, developing and executing a regional policy roadmap and associated Roche positions to drive global regulatory convergence in APAC. Previously, she was the Head of APAC International Operations at Roche located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for Roche products to ensure right first-time submissions to Health Authorities during Aug. 2013 to Jun. 2016. She holds a Master Degree in Pharmaceutical Technology and a Bachelor Degree in Pharmacy, both from the National Taiwan University, Medical College.
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.
- Vice President, Technology
- Medidata, a Dassault Systèmes company, United States
Ross Rothmeier, VP Technology, Medidata Since 2013, Ross’ role at Medidata has specialized in thought leadership and trends in the world of clinical trials. He brings both technical and business perspectives to the solutions and processes needed to conduct clinical trials and works with clients to develop roadmaps that maximize the value of their investments and build for the future. With experience in the pharmaceutical industry since 1993 and a software developer since 1972, he has been responsible for strategy, implementation and the operation of EDC, EHR, and e-clinical systems at large and medium pharmaceutical companies and CROs.
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.
- Director, Clinical Clinical Engagement
- TriNetX, United Kingdom
- Regulatory Consultant with the Pharmaceuticals & Biologics Branch
- Health Sciences Authority Singapore, Singapore
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.
- CEO and Co-founder
- MyDoc , Singapore
- Regional Business Leader
- Microsoft Asia, Singapore
As Regional Business Lead of Worldwide Health for Microsoft Asia, Dr. Keren Priyadarshini leads the company’s healthcare business segment across 17 markets in Asia Pacific. Dr. Priyadarshini is responsible for driving and implementing Microsoft’s healthcare initiatives across the region as well as developing solution offerings and strategies that meet the needs of healthcare and life science customers. She also plays a leading role in establishing thought leadership by defining and articulating the company’s vision for the future of healthcare and sharing how Microsoft technologies and partner solutions are making it a reality.
- Principal Consultant
- Manifeste LLP, Singapore
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.
- Senior Vice-President Diagnostic Imaging Asia-Pacific
- Siemens Healthineers, Singapore
Marc Engelhardt, DrMed
- Manager Regulatory/Clinical Affairs
- Stryker Leibinger GmbH & Co. KG , Germany
- Deputy Director
- SGINNOVATE, Singapore
Lisa Palladino Kim, MS
- Director of Capstone / Lecturer
- Rutgers School of Health Professions, United States
Lisa Palladino Kim, is the Director of Capstone (Field Mentorship) and a Lecturer at Rutgers School of Health Professions MS in Clinical Research Management Program. Lisa has 15 yrs of Pharmaceutical expertise, concentrated in Clinical Ops (Pt Recruitment, Data Mgt, and Project Mgt), which allowed her to gain experience leading career, policy, and process development initiatives. She received several Awards of Excellence, a Special Achievement Award, and was nominated for 2 Excellence in Teaching awards. She is currently pursuing her doctorate degree and resides in South Korea.
- 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.
Sethuraman Rama, PhD, RAC
- Director, Medical Devices Branch
- Health Sciences Authority, Singapore
Dr Rama is the Director, Medical Devices Branch, Health Sciences Authority (HSA). She oversees the pre-market registration and the post-market controls for medical devices in Singapore. She also oversees the device development consultation that aims to support safe innovation in medical technologies locally. She has been working in the area of Medical Device Regulations for over 11 years now. Prior to joining the HSA, she was involved in Research on chronic pain and neuropathic pain at the National University of Singapore, identifying novel biomarkers and developing novel diagnostic methods. Dr Rama currently represents Singapore as a member of the Management Committee of the International Medical Device Regulators Forum (IMDRF).
- Transformation Lead, Foundation Medicine Pharma International,
- Roche Singapore Pte Ltd, Singapore
- Regulatory Affairs - Med Devices
- Alcon , Singapore
- Assistant Professor- Ophthalmology
- SingHealth, Singapore
Po-Wen Yang, MPharm
- TFDA, Taiwan
Samvel Azatyan, MD, PhD
- Team Lead, Regulatory Convergence and Networks (RCN/REG)
- World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 20 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration, convergence and harmonization, as well as regulatory capacity building and facilitation of products introduction in the countries. Dr Azatyan has also led various projects aiming at development of national regulatory systems, as well as the development and implementation of the concept of reliance in regulation of medical products. Dr Azatyan is currently leading the Regulatory Convergence and Networks Team at the WHO's Headquarters in Geneva, Switzerland.
- Regulatory Affairs Director
- Allergan Singapore Pte. Ltd., Singapore
Tan Wee Kiat
- Chief Operating Officer
- Cytomed, Singapore
- Japan Program Head, Development Division
- Novartis Pharma K.K., Japan
- Morgan, Lewis & Bockius LLP, Singapore
- Executive Director Global Regulatory Policy
- MSD`, Netherlands
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.
- Nanyang Technological University Senior Lecturer
- Singapore Biodesign - Curriculum Co-head , Singapore
Siti Hidayah binti Kasbon
- Senior Principal Assistant Director
- The National Pharmaceutical Regulatory Agency (NPRA), Malaysia
- Managing Director, Asia Pacific
- MedTech Innovator, Singapore
Dr. Fredrik Nyberg is the Managing Director Asia Pacific at MedTech Innovator, based in Singapore. He was most recently the Founding CEO of Asia Pacific Medical Technology Association (APACMed). Fredrik brings over 30 years of healthcare industry experience, 25 of which were spent in Asia-Pacific. He has held senior sales/ marketing, general management and strategic consulting positions. Fredrik serves as Board Member and advisor to several healthcare startup ventures and is a frequent speaker on the healthcare industry in Asia-Pacific. He holds a BSc from Gothenburg University, Sweden, and an MBA from Henley Management College, UK.”
Chris Leo Pashos, PhD
- Independent Consultant , United States
Dr. Pashos oversees AbbVie’s Real-World Evidence Generation and Patient Centric Research Center of Excellence, demonstrating the value of medicines in addressing needs perceived by regulators, health technology assessment agencies & payers, the medical community and patients. He began his RWE & HEOR career at Harvard Medical School, where he managed the AMI Patient Outcomes Research Team. Subsequently, he founded and led a consultancy that served most of the world’s leading pharmaceutical companies, and then led Takeda’s Global Outcomes & Epidemiology Research team. His work has appeared in >100 journal articles and >250 presentations. He served as President of the International Society for Pharmacoeconomics and Outcomes Research.
Yee Liang Thian
- Senior Consultant, Department of Diagnostic Imaging
- National University Hospital , Singapore
Wai Ming Yap
- Morgan Lewis Stamford LLC, Singapore
Jesusa Joyce N CIRUNAY
- Director IV - Center for Drug Regulation and Research
- Food and Drug Administration Philippines, Philippines
JESUSA JOYCE N. CIRUNAY is a Registered Pharmacist (cum laude). She is currently the Director IV of the Center for Drug Regulation and Research at the Food and Drug Administration Philippines. Her government service began at the Product Services Division (PSD) covering Marketing Authorizations as Pharmaceutical Researcher then as Senior Drug Evaluator including New Drug Applications and Vaccines. Before her current post, she was assigned to head several key offices of the Agency at various timelines, i.e., Field Cluster Director in various parts of the Philippines, as Head of the GMP Inspectorate; as Head of the Distribution Inspectorate and as Head of the Marketing Authorization.
Jean-Christophe Delumeau, MD, PhD
- Head of pharmacovigilance Policy Strategy
- Bayer Pharma, Singapore
Jean-Christophe Delumeau graduated in medicine (MD), molecular pharmacology (PhD), toxicology and psychiatry in France. Then he joined a research program on intracellular signaling at Inserm. In 1991, he re-oriented to clinical research in neurology in France, Switzerland and Japan. In 2002 he was appointed by Bayer to lead pharmacovigilance organisations in Japan (until 2009) then in Asia-Pacific. He is a founding member and coordinator of ISoP’s Special Interest Group on Risk Minimisation Methods for Asian Countries. His focus is to create and facilitate the deployment of novel risk minimization methods applicable to a wide array of countries and health care systems, especially in developing countries.
- Roche Diagnostics APAC
- Regulatory Affairs & Policy , Singapore
Yasha Huang is currently the Regional Regulatory Affairs and Policy Lead at Roche Diagnostics. She was most recently the Regulatory Affairs Director at APACMed, the region’s first and only MedTech industry association. Yasha also worked as a regulator for 7+ years with the China FDA, where she was actively involved in global governance and stakeholder engagement, with international organizations, government agencies, NGOs, etc. She authored papers on regulatory competency framework, acceptance of overseas clinical performance evaluation, regulatory agility during pandemic, IVDR impact on Asia Pacific markets, etc. She is currently Vice Chair of IVD Working Group within APACMed RA Committee.
- Senior Regulatory Policy Advisor
- Roche Diagnostics, United States
- Head of Quality and Regulatory Asia Pacific
- Roche Diagnostics Asia Pacific Pte Ltd., Singapore
Thean Soo Lo
- Regulatory Affairs Management Consultant, Singapore
Thean Soo Lo is a Regulatory Affairs Management Consultant specializing in the design and development of a robust, efficient, forward looking regulatory department within the organization to provide optimal support to the business, through optimal and expeditious product registration and product license maintenance within the organization. Thean Soo Lo is a pharmacist by training, with a B. Pharmacy (Hons) degree, and a MSc degree on comparative analytical methodology and pharmacokinetics of drugs in biological fluids. Prior to his current role, Thean Soo Lo had prior experience as the AP Lead for regulatory policy & intelligence, and AP Regulatory Affairs Head in Janssen Pharmaceuticals, J&J.