Agenda

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OPENING PLENARY SESSIONS


Chair: Geoffrey Brown, QA/QC Manager, Schneider Electric & Conference Chair, ISPE Singapore Affiliate

9:00AM
Chair’s Opening Remarks

9:05AM
KEYNOTE PRESENTATION: Global Regulatory Harmonization

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

9:30AM
GLOBAL REGULATORY HARMONIZATION PANEL

Moderator:
Frances Zipp, President & Chief Executive Officer, Lachman Consultants, United States
Panelists:
Dr. Timothy J.N. Watson, Executive Director & Team Leader, CMC Advisory Office, Pfizer, United States
Dr. Sarah Pope Miksinski, Senior Director, Regulatory CMC, Global Regulatory Excellence, AstraZeneca, United States
Dr. Nitin Bagul, Director – Prescription Medicines Authorisation Branch, Australian Department of Health
Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, OPQ, FDA/CDER/OPQ/OPPQ, United States

10:15AM
GLOBAL COLLABORATION & QUALITY PANEL: Post-COVID-19 Learnings

  • Accelerated approvals and impact on faster transfers, shortening timelines
  • New approaches to working: collaborations and quality agreements
  • Concurrent validations
  • Future pathways / technologies for ATMP approval and adoption

Moderator:
Dr. Georg Singewald, Vice President, Head of Quality Control, Genentech, United States
Panelists:
Ganapathy Mohan, Executive Director, Global Quality Compliance, Merck, United States
Dr. Andrew Chang, Vice President, Quality and Regulatory Compliance, QI&I, Novo Nordisk Quality, Novo Nordisk, United States
Dr. Oliver Schläfli, SVP, Head of Global Quality, Lonza, Switzerland

11:00AM
PHARMA 4.0 & ADVANCED THERAPIES PANEL: Pharma Manufacturing Into the Future

  • Impact of technology and digitalization
  • Advances in continuous, agile manufacturing
  • Requirements of advanced therapies
  • Enabling technologies and applications

Moderator:
Pierre Winnepenninckx, Chief Executive Officer, No deviation Pte Ltd & Marketing Chair, ISPE Singapore Affiliate, Singapore
Panelists:
Dr. Wei-Kuang Chi, Distinguished Consultant, Development Center for Biotechnology, Taiwan
Dr. Niki Wong, Director, Global Technical Operations, CMC, AbbVie, Singapore
Dr. Patrick Gammell, Vice President, Global Manufacturing Sciences, Biogen, United States
Dr. Atul Dubey, Director, Pharmaceutical Continuous Manufacturing, US Pharmacopeia, United States

11:45AM
Stretch Break

REGULATORY & COMPLIANCE TRACK A

Track Sponsor

Chair: Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, Australia

12:15PM
Chair’s Opening Remarks

12:25PM
Overview of EMA’s Pilot OPEN Initiative

Dr. Agnès Saint Raymond, Head of International Affairs, Chair of Portfolio Board, European Medicines Agency, Netherlands

12:45PM
Overview & Updates On ASEAN Joint Assessment Procedure

Rosliza Binti Lajis, Senior Principal Assistant Director, Centre for Product Evaluation & Cosmetics, National Pharmaceutical Regulatory Agency (NPRA), Malaysia

1:10PM
PANEL DISCUSSION: ICH Q12 Implementation in APAC

  • Learnings from implementation of Q12 globally
  • Post-Approval Change Management Protocol (PACMP)
  • Comparability protocols
  • Most important elements to consider in its implementation
  • Biggest challenges in implementing Q12
  • Realistic benefits anticipated for the product life cycle

Moderator:
Alfonsus Karli, APAC GCMC Advisory Office Director, Pfizer Pte Ltd, & Chair, Regulatory Affairs, ISPE Singapore Affiliate
Panelists:
En-Ling Lan, Technical Specialist, Division of Medicinal Products, Food and Drug Administration, Ministry of Health and Welfare, Taiwan
Dr. Subin Sankarankutty, Regulatory Consultant (Lead CMC Assessor), Health Sciences Authority (HSA), Singapore
Dr. Yasuhiro Kishioka, Ph.D., International Liaison Officer, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Jacques Morénas, Technical Advisor, Inspection Division, National Drug and Health Products Safety Agency (ANSM), France

ADVANCED THERAPIES & MANUFACTURING TRACK A

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

1:55PM
Chair’s Opening Remarks

2:00PM
Overview of PIC/S Annex 2A Revision for ATMPs

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

2:25PM
Innovative Process Development and Production Concepts for Cell and Gene Therapy Manufacturing

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

2:50PM
Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0

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

3:15PM
Challenges for GMPs for ATMPs: European Perspective

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

3:40PM
The Roadmap for Operational Readiness/Operational Excellence

Alice Redmond, Chief Strategy Officer, CAI, Ireland

4:05PM
Development and Manufacture of Lentiviral Vectors for Clinical Cell & Gene Therapy

Current challenges in clinical lentiviral vector manufacture
Upstream and downstream process design
Product characterisation
Quality and regulatory expectations

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

4:30PM
Chair’s Remarks and End of Track A

PHARMA 4.0 & DIGITALIZATION TRACK B

Chair: Carissa Choh, Senior Consultant, NNIT & Hon. Treasurer, ISPE Singapore Affiliate

12:15PM
Chair’s Opening Remarks

12:20PM
M4Q & Cloud-Based Reviews

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

12:45PM
The Future of Calibration and Services in Digital World

  • Calibration: The hidden opportunity
  • Leveraging process technologies to take advantage of digital content
  • Using digitalisation as an enabler to optimise processes

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

1:10PM
Pharma 4.0 Challenges In Deployment Within Supply Chain Operations

  • Current state of understanding of how pharma implements digital tools
  • What must be considered in order to make digitization successful
  • Road map for a digitization deployment framework in the pharma supply chain

Ashish Adhikari, Vice President Operations, Gland Pharma, India

1:35PM
“Plug & Produce” in the Pharmaceutical Industry

Josef Trapl, Head of MSci Innovation, Takeda, Switzerland

2:00PM
Process Development And Manufacturing Optimisation For Biopharma Using Predictive Model Driven Monitoring, Control And Maintenance

  • Applying software solution for process development and routine manufacturing
  • Biopharma case studies highlighting benefits of integrating Process Analytical Techniques, Digital Design, Machine Learning and Advanced Process Control (APC) for process development
  • ROIs of incorporating process monitoring and predictive maintenance

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

STERILE & ASEPTIC OPERATIONS TRACK B

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

2:25PM
Chair’s Opening Remarks

2:30PM
Visual Inspection of Sterile Products

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

2:50PM
Aseptic Fill-Finish Operation for Dry Powder and Liquids into Dual Chamber Syringes

  • Innovative new microdosing systems for both liquids and powder
  • Aseptic environment (ISO class 5)
  • High containment isolator technology to enclose the filling, stoppering and capping operations

Frederic Dietrich, Managing Director, Dec Group, Switzerland

3:10PM
Best Practices & Considerations for Design of a Sterile Facility in Pharmaceuticals
Aqeel Ahmed, Senior Manager Production (Sterile), Brookes Pharma Pte Ltd, Pakistan

3:30PM
The Current State of Aseptic Processing & Fill-Finish Manufacturing
MD Atiqur Rahman, Senior Executive Officer, Production (Sterile), Incepta Pharmaceuticals Ltd., Bangladesh

3:50PM
A Project Management Approach to Generating a Contamination Control Strategy

  • How do structure the contamination control strategy
  • How to get the best inputs from the team
  • How to make the document a useful part of your process for assuring product quality
  • Key concerns from international regulators

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

4:10PM
Combined Live Q&A Session

4:30PM
Chair’s Remarks and End of Track B

4.30PM
Women In Pharma Regional Panel Discussion

Discussion and workshop: Charting your Career Goals

  • Career Paths: Personal Examples
  • 8 Things to Consider for an Effective Career Plan
  • 6 Steps to Map your Career Action Plan
  • Non-linear Career Moves: Forward, Sideways, Backwards!
  • Discussion: Career Boosters – Examine the What and How?

Moderator:
Dr. Julia Gandhi, Chair, Women In Pharma , ISPE Singapore
Panellists:
Xiao LIU, Director, Information Systems, Amgen Singapore Manufacturing, Amgen Singapore
Mary Joy Moreno, QA Microbiology and Validation Sr. Supervisor, Baxter Healthcare Philippines, Inc.
Danurus Wattanavekin (Poob), Student and YP Affair Chair, ISPE Thailand

5:30PM
End of Pre-Conference Symposium

9:00AM
Chair’s Opening Remarks

Geoffrey Brown, QA/QC Manager, Schneider Electric & Conference Chair, ISPE Singapore Affiliate


PHARMA MANUFACTURING POST-COVID-19


9:10AM
KEYNOTE ADDRESS: The Big Picture by the International Vaccine Institute (IVI)

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

9:40AM
PHARMA EXPERTS THINK-TANK: Beyond COVID-19: Applying Lessons Learnt Post-Pandemic

  • Coping with remote pharma
  • Communication & collaboration between industry and regulators
  • Diversified supply chains
  • Recovery and the next normal: Implications for the industry

Moderator:
Geoffrey Brown, QA/QC Manager, Schneider Electric & Conference Chair, ISPE Singapore Affiliate
Panelists:
Ee Lynn Kok, Director, Enterprise Regulatory Compliance Independent Audit, Johnson & Johnson, Singapore
Murali Nair, Director of Manufacturing, Cerecin, Singapore
Dr. Dinesh Khokal, Director, External Affairs, Corporate Quality, JAPAC & Intercontinental, Amgen, Singapore
Ellen Sem, Associate Director, Regulatory Policy Lead APAC, Janssen, a division of Johnson & Johnson, Singapore
Dr. Niki Wong, Director, Global Technical Operations, CMC, AbbVie, Singapore

10:25AM
Stretch Break


REGULATORY & COMPLIANCE


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

11:00AM
Chair’s Opening Remarks

11:10AM
Regulatory and GMP/GDP Inspection Trends, Insights and Perspectives

Dr. Dinesh Khokal, Director, External Affairs, Corporate Quality, JAPAC & Intercontinental, Amgen, Singapore

11:35AM
Remote Auditing – A Company’s Perspective

  • Audit Planning and Preparation
  • Conducting a Remote Audit
  • Remote auditing for GMP Compliance during COVID-19
  • Advantages and Limitations of Remote Audits

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

12:00PM
ASEAN REGULATORY ROUNDTABLE: Innovation, Competitiveness & Regional Integration Of ASEAN Pharma Regulations

  • State of regional healthcare-pharma integration
  • ASEAN harmonization efforts: On stability requirements & ASEAN variation guides (applicable to Chem only at this stage) for pharmaceutical products
  • Adopt, adapt or create: Alignment with international standards like WHO and ICH
  • ASEAN Joint Assessment Coordinating Group and incentives for innovation
  • Way forward: New opportunities after COVID-19 & potential areas of collaboration

Moderator:
Dr. Sannie Chong, Asia Pacific Technical Regulatory Policy, Global Regulatory Policy Group, Roche Singapore Technical Operations
Panelists:
Shun Jin, Head, Regulatory Competency Center, Asia Pacific, Middle East and Africa (APMA), Sandoz, Singapore
Kum Cheun (KC) Wong, Head, Asia Pacific Regulatory Policy, Novartis, Singapore
Chong Hock Sia, Director (Quality Assurance) and Senior Consultant (Audit & Licensing), Health Products Regulation Group, Health Sciences Authority, Singapore
Dr. Paul Huleatt, Regional Manager, Indo-Pacific Regulatory Strengthening Program, Australia Therapeutic Goods Administration, Singapore

12:45PM
Stretch Break


‘ASK THE EXPERT’ SESSIONS


1:15PM
CMC Acceleration Through Automation and Digitalization

Kang Zhou, Sr Business Development Manager, Asia & Jaisimha Seshadri, Digital Service Specialist, Asia, Cytiva

1.30PM
Implementing Digitalisation Initiatives – A Step by Step Approach

Amit Samel, Technical Solution Consultant, Honeywell Life Science

1.45PM
Contamination Control Strategy – Annex 1 Draft

Richard Chai, Technical Service Manager & Walid El Azab, Senior Technical Service Manager, STERIS Corporation


ICH Q12 IMPLEMENTATION


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

2:10PM
Chair’s Opening Remarks

2:15PM
Singapore Regulatory Updates On ICH Q12

  • Implementation of Q12 in Singapore
  • Most important elements to consider in its implementation
  • Biggest challenges in implementing Q12
  • Realistic benefits anticipated for the product life cycle

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

2:40PM
ICH Q12 IMPLEMENTATION CASE STUDIES: EC, PLCM & PACMP

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

3:10PM
Stretch Break


CELL & GENE THERAPY MANUFACTURING


Chair: Shan Shan Liu, Senior Manager, No deviation & President, ISPE Singapore Affiliate

3:30PM
Chair’s Opening Remarks

3:40PM
Managing GMP & Manufacturing Challenges for Cell and Gene Therapies

Dr. Gary Khoo, Head of Process Sciences and Technology, Tessa Therapeutics, Singapore

4:05PM
CELL AND GENE THERAPY INDUSTRY PANEL: The Promise, Challenge & Evolution

  • Innovations in new manufacturing technologies
  • How to keep pace with evolving regulatory standards for these therapies
  • Ensuring smooth transition from research use only (RUO) to good manufacturing practice (GMP)
  • Other manufacturing facilities considerations- in clinical trials, quality control and commercial licensing issues

Moderator:
Shan Shan Liu, Senior Manager, No deviation & President, ISPE Singapore Affiliate
Panelists:
Dr. Lucas Chan, Scientific Founder & Chief Scientific Officer, CellVec, Singapore
Dr. Gary Khoo, Head of Process Sciences and Technology, Tessa Therapeutics, Singapore
Dr. Wee Kiat Tan, Chief Operating Officer, CytoMed Therapeutics, Singapore
Dr. David Loong, Senior Consultant, Novel Modalities Asia Pacific, Bioprocessing Strategy, Merck Life Science, Singapore

4:50PM
End of Main Conference Day 1

9:00AM
Opening Remarks


PHARMA FACILITY OF THE FUTURE


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

9:05AM
CASE STUDY KEYNOTE:
Pilot Program On Digitalization For The Local Pharmaceutical Industry

  • Innovative technologies in a sustainable manufacturing hub
  • Used case of Predictive Analytics in Building Infrastructure
  • Application of machine learning to optimize operating cost
  • Pilot program in model development
  • Creating a culture of people growth and development in Industry 4.0

Manuel Ungerer, Head of Site Development APAC, Novartis, Singapore

9:30AM
PHARMA TECHNOLOGY INNOVATION PANEL:
Reimagining Pharma Manufacturing Through Technology Transformation

  • Impact of the pandemic in expediting innovative technology adoption
  • Re-designing infrastructure and processes for flexible, agile manufacturing
  • Optimizing human-automation interface (e.g. high potency environments)
  • Applications to future biologics and small volume manufacturing

Moderator:
Dr. Keith Carpenter, Senior Fellow, A*STAR, Programme Director, Pharma Innovation Programme Singapore (PIPS)
Panelists:
Hock Heng Lim, Vice President & Site Director, GSK, Singapore
Daniel Sanchez, Senior Manager Business Performance, Amgen, Singapore
George Lam, Site Head, Takeda, Singapore

10:15AM
Stretch Break

10:55AM
HUMAN VS. DIGITAL PANEL:
Accelerate Pharmaceutical Agility In The Digital Age

  • Major issues facing digital transformation
  • Quantifying success of digital transformation
  • Pulling levers of cultural change and setting the right structures for digital transformation
  • Beyond “tech talent”: What will pharma’s future digital leaders look like?

Moderator:
Christian Teo, Head of BIOME Digital Innovation Hub, Singapore / Digital Innovation Manager for APAC & MEA, Novartis, Singapore
Panelists:
Mrunalini Jagtap, Data Management Lead, Singapore Institute for Clinical Sciences, A*STAR, Singapore
Chris Willmott, Customer Transformation Leader, Roche, Singapore
Julie Olszewski, Executive Director, Singapore IT Hub CTO Global Change Management Lead, MSD, Singapore
Robin Zhuang, Senior Manager, Asia Business Technology Partner, Allergan Aesthetics, an Abbvie company, Singapore


FROM FACTORY TO FRONTLINE

Track Sponsor


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

11:40AM
PANEL DISCUSSION: Patient-Centricity In The Pharmaceutical Supply Chain

  • Patient-centric industry initiatives in the sphere of pharma manufacturing
  • Supply chain initiatives in development to improve safety and efficiency in delivering medicines to patients
  • Opportunities & challenges in moving to primarily “continuous-processing”-based supply chain
  • Future trends in digitalization and related technologies eg traceability

Moderator:
Thomas Terranova, Managing Director, Terra Asia Consulting, & Vice President, ISPE Singapore Affiliate
Panelists:
Belinda Ang, Head of Supply Chain for APAC, Roche Pharmaceuticals, Singapore
Dermot O’Malley, Director of Technical Operations, MSD, Singapore

12:25PM
Stretch Break


‘ASK THE EXPERT’ SESSIONS


1.00PM
mRNA Vaccines & Therapeutics Manufacturing

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

1.30PM
Master Data Management and Digitalization – why?

Klaus Köhler, Global Industry Manager, Life Science & Adrian Stangl, Business Development Manager, IIOT, Endress+Hauser

1.45PM
Use of Single Use Aseptic Isolator systems

Declan O’Shea, Global Product Manager, Isolation and Containment Systems, ILC Dover


TECHNOLOGY DEVELOPMENTS IN MANUFACTURING


2:15PM
Chair’s Opening Remarks

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

2:20PM
Unlocking The Potential of mRNA Vaccines & Therapeutics: A Manufacturing Perspective

  • The recent success of mRNA vaccines has led to massive interest in mRNA therapeutics
  • Current mRNA lab-scale processes are not suitable for manufacturing due to the use of hazardous solvents
  • Key considerations for mRNA manufacturing and potential solutions

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

2:45PM
Addressing Vaccine Demand with Rapid Capacity Deployment of mRNA Manufacturing

Katarina Stenklo, Enterprise Commercial Activation Leader, Cytiva, Sweden

3:10PM
Stretch Break

3:35PM
Risk Management: From Development to Patient Use

  • Risk Management’s role in the Product Lifecycle
  • Benefits of proper implementation of Risk Management
  • Best Practices of Risk Management throughout the Product Lifecycle

Mark Allan Baldovino, Regional QA Manager, Abbott Manufacturing, Singapore

4:00PM
Cleaning And Disinfection During Cleanroom Startup

  • Overview of the cleaning and disinfection methodology during cleanroom startup
  • Case study on cleaning and disinfection of cleanroom startup

Richard Chai, Technical Service Manager, STERIS Corporation, Singapore

4:25PM
MedTech Regulatory Update & System Overview

  • Global and regional regulatory environment for medical devices
  • How is it related to pharmaceuticals regulation?
  • The Global Medical Device Regulatory framework
  • Tips to accelerate the approval process

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

4:50PM
Chair’s Closing Remarks & End of Conference