2021 Speakers


Dr. Timothy J.N. Watson
Executive Director & Team Leader, CMC Advisory Office,
Pfizer, United States


Ashley Boam
Director, Office of Policy for Pharmaceutical Quality, OPQ,
FDA/CDER/OPQ/OPPQ, United States


Nuha Al-Hafez
Head of Connected Health,
Merck Healthcare KGaA, Germany


Dr. Georg Singewald
Vice President, Head of Quality Control,
Genentech, United States


Thomas Terranova
Managing Director, Terra Asia Consulting & Vice President, ISPE Singapore Affiliate


Bob Tribe
Asia Pacific Regulatory Affairs Advisor,
ISPE, Australia


Alfonsus Karli
APAC GCMC Advisory Office Director, Pfizer Pte Ltd, & Chair, Regulatory Affairs, ISPE Singapore Affiliate


Matthew Bugg
Quality Systems Manager (Sterile Manufacturing),
AstraZeneca, Australia


David Lovett
Chief Strategy Officer for Automation Products Group (Process Industries),
Applied Materials, United Kingdom


Dr. Wei-Kuang Chi
Distinguished Consultant,
Development Center for Biotechnology, Taiwan


Frederic Dietrich
Managing Director,
Dec Group, Switzerland


Pierre Winnepenninckx
Chief Executive Officer,
No deviation Pte Ltd, Singapore & Chair, Marketing, ISPE Singapore Affiliate


Dr. Niki Wong
Director, Global Technical Operations, CMC,
AbbVie, Singapore


Ashish Adhikari
Vice President Operations,
Gland Pharma, India


Dr. Sarah Pope Miksinski
Senior Director in Global Medicines Development, Global Regulatory Affairs, Patient Safety, and Quality Assurance,
AstraZeneca, United States


En-Ling Lan, Technical Specialist, Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan


Dr. Nitin Bagul
Director – Prescription Medicines Authorisation Branch,
Australian Department of Health


Ganapathy Mohan
Executive Director, Global Quality Compliance,
Merck, United States


Aqeel Ahmed
Senior Manager Production (Sterile),
Brookes Pharma Pte Ltd, Pakistan


MD Atiqur Rahman
Senior Executive Officer, Production (Sterile),
Incepta Pharmaceuticals Ltd., Bangladesh


John Johnson,
Vice President, Pharmaceutical Services, Pharma and Biotech, Europe,
NSF International, United Kingdom


Lina Ertle,
Head of External Relations EMEA and Japan,
Roche, Switzerland


Dr. Lawrence Yu
Director, Office New Drug Products,
FDA, United States


Dr. Atul Dubey
Director, Pharmaceutical Continuous Manufacturing,
US Pharmacopeia, United States


Dr. Patrick Gammell,
Vice President, Global Manufacturing Sciences,
Biogen, United States


Frances Zipp,
President & Chief Executive Officer,
Lachman Consultants, United States


Dr. Andrew Chang
Quality and Regulatory Compliance, QI&I, Novo Nordisk Quality,
Novo Nordisk, United States


Josef Trapl
Head of MSci Innovation,
Takeda, Switzerland


Serhii Korennov, Ph.D.
Regional Service Director,
Endress+Hauser


Dr. Yasuhiro Kishioka
Ph.D., International Liaison Officer, Office of International Programs,
Pharmaceuticals and Medical Devices Agency (PMDA)


Dr. Oliver Schläfli
Vice President Global Quality,
Lonza, Switzerland


Dr. Subin Sankarankutty
Regulatory Consultant (Lead CMC Assessor), Health Sciences Authority (HSA), Singapore


Jacques Morenas
Technical Advisor, National Drug and Health Products Safety Agency (ANSM), France


Alyce Maksoud
Team Leader Inspection Section, PIC/S Chair, Tissue & Cells, Australian Government Department of Health (TGA)


Carissa Choh
Senior Consultant, NNIT & Honorary Treasurer, ISPE Singapore Affiliate


Dr. Julia Gandhi
Director & Sr Consultant, Geean, Singapore & Chair, Women In Pharma, ISPE Singapore Affiliate


Danurus Wattanavekin (Poob)
Quality Assurance Manager, EEM-APAC, Elanco (Thailand) & Chair, Student and Emerging Leaders, ISPE Thailand


Liu Xiao
Director Information Systems,
Amgen, Singapore


Mary Joy Moreno
QA Microbiology and Validation Senior Supervisor ,
Baxter Healthcare, Philippines


Dr. Jerome Kim
Director General,
International Vaccine Institute (IVI), South Korea


Belinda Ang
Head of Supply Chain for APAC,
Roche Pharmaceuticals, Singapore


Hock Heng Lim
Vice President & Site Director,
GSK, Singapore


Chong Hock Sia
Director (Quality Assurance) and Senior Consultant (Audit & Licensing), Health Products Regulation Group,
Health Sciences Authority, Singapore


Dr. David Loong
Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy, Merck Life Science, Singapore


Dr. Paul Huleatt
Regional Manager, Indo-Pacific Regulatory Strengthening Program,
Australia Therapeutic Goods Administration, Singapore


Kum Cheun (KC) Wong
Head, Asia Pacific Regulatory Policy,
Novartis, Singapore


Dr. Sannie Chong
Asia Pacific Technical Regulatory Policy, Global Regulatory Policy Group,
Roche Singapore Technical Operations


Dr. Subin Sankarankutty
Regulatory Consultant, Therapeutic Products Branch, Medicinal Products Pre-Market Cluster, Health Products Regulation Group,
Health Sciences Authority, Singapore


Dr. Xiaoping Cao
Senior Director, Head of GCMC China,
Pfizer, Singapore


Ee Lynn Kok
Director, Enterprise Regulatory Compliance Independent Audit,
Johnson & Johnson, Singapore


Ellen Sem
Associate Director, Regulatory Policy Lead APAC,
Janssen, a division of Johnson & Johnson Pte. Ltd , Singapore


Manuel Ungerer
Head of Site Development APAC,
Novartis, Singapore


Jack Wong
Founder, Asia Regulatory Professionals Association (ARPA), Singapore


Murali Nair
Director of Manufacturing,
Cerecin, Singapore


Shun Jin
Head, Regulatory Competency Center, Asia Pacific, Middle East and Africa (APMA),
Sandoz, Singapore


Xiangliang Lin
Founder, President & Chief Executive Officer,
Esco Healthcare, Singapore


Christian Teo
Head of BIOME Digital Innovation Hub, Singapore / Digital Innovation Manager for APAC & MEA,
Novartis, Singapore


Mark Allan Baldovino
Regional QA Manager,
Abbott Manufacturing, Singapore


Richard Chai
Technical Service Manager,
STERIS Corporation, Singapore


Mrunalini Jagtap
Data Management Lead, Singapore Institute for Clinical Sciences,
A*STAR, Singapore


Alfonsus Karli
APAC GCMC Advisory Office Director, Pfizer Pte Ltd, & Chair, Regulatory Affairs, ISPE Singapore Affiliate


Dr. Wee Kiat Tan
Chief Operating Officer,
CytoMed Therapeutics, Singapore


Dr. Keith Carpenter
Senior Fellow,
A*STAR, Programme Director, Pharma Innovation Programme Singapore (PIPS)


Julie Olszewski
Executive Director of IT Hub and Global Data Science,
MSD, Singapore


Shanshan Liu
Director, No deviation Pte. Ltd. & President,
ISPE Singapore Affiliate


Dermot O’Malley
Director of Technical Operations,
MSD, Singapore


Dr. Niki Wong
Director, Global Technical Operations, CMC,
AbbVie, Singapore


George Lam
Site Head,
Takeda, Singapore


Robin Zhuang, Senior Manager, Asia Business Technology Partner, Allergan Aesthetics, an Abbvie company, Singapore


Hugh McKee, Senior Process Consultant, PM Group & Chair, Event & Education Committee, ISPE Singapore Affiliate


Dr. Lucas Chan
Scientific Founder & Chief Scientific Officer,
CellVec, Singapore


Chris Willmott
Customer Transformation Leader,
Roche, Singapore


Daniel Sanchez
Business Performance Senior Manager,
Amgen, Singapore


Lee Hong Ping
Director of Sales (ATF), Exyte & Honorary Secretary, ISPE Singapore Affiliate


Gary Khoo
Head of Process Science and Technology,
Tessa Therapeutics, Singapore


Katarina Stenklo
Enterprise Commercial Activation Leader, Cytiva, Sweden


Thomas Terranova
Managing Director, Terra Asia Consulting & Vice President, ISPE Singapore Affiliate


Walid El Azab
Senior Technical Service Manager, STERIS