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,

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