PDA Pharmaceutical Manufacturing & Quality Conference 2025

SGT Standard Time (UTC +8:00)

• 08:00 – 09:00

  Registration

• 09:00 – 09:10

  Opening Session

  • 09:00 – 09:10

    Opening Remarks by the Committee Chairperson

    • 

      Samuel Tan
      Head of Operations & Strategy, Novartis Singapore Pharmaceutical Mfg Pte Ltd

• 09:10 – 10:40

  Session 1: Regulatory and Industry Session

  • 09:10 – 09:40

    Keynote Speech: Navigating the Pharmaceutical Landscape - Investment Trends and Opportunities in the Region

    Navigating the Pharmaceutical Landscape: Investment Trends and Opportunities in the Region 

    • 

      Pengfei Chen
      Vice President, Healthcare, EDB Singapore

  • 09:40 – 10:10

    New expectations from FDA
  • 10:10 – 10:40

    [Expert Round Table] Evolving Nature of Trade Policies – Their Impact on APAC Pharmaceutical Sector

    • Moderator:

      

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

    • 

      Andy Hopkins
      Senior Director, Lachman Consultants

    • 

      Pengfei Chen
      Vice President, Healthcare, EDB Singapore

    • 

      Wallace Torres
      VP Site Operations, Amgen Singapore Manufacturing

• 10:40 – 11:25

  Coffee Break at the Exhibition Hall

• 11:25 – 12:50

  Session 2: New Modality/Technologies

  • 11:25 – 11:30

    Welcome Remarks by the Moderator

    • 

      Samuel Tan
      Head of Operations & Strategy, Novartis Singapore Pharmaceutical Mfg Pte Ltd

  • 11:30 – 12:00

    Factory of the Future - Autonomous Vaccines Manufacturing
  • 12:00 – 12:30

    Quality Regulatory Considerations for ADCs

    Antibody-drug conjugates (ADCs) are a class of biopharmaceutical drugs designed to specifically target and kill cancer cells. Recent developments in ADC research include next-generation ADCs, bispecific ADCs, and expanding their therapeutic applications beyond oncology.

    
    

    Before a therapeutic product can be marketed, the drug product owner must provide preclinical and clinical data, as well as manufacturing information. Developing ADCs presents several challenges, particularly in meeting the quality requirements set by health authorities.

    
    

    This presentation will discuss the quality regulatory considerations for ADCs, aiming to provide drug product owners with insights into the current quality regulatory landscape for ADCs.

    • 

      Wei Xia ANG
      

  • 12:30 – 12:50

    Panel Discussion and Q&A

    • 

      Wei Xia ANG
      

• 12:50 – 14:20

  Lunch Break

• 14:20 – 16:15

  Session 3: Operational Excellence in Manufacturing

  • 14:20 – 14:25

    Welcome Remarks by the Moderator

    • 

      Vinny Browning, MS
      Executive Director Quality Assurance, Amgen

  • 14:25 – 14:55

    Continuous Improvement Culture
  • 14:55 – 15:25

    Revolutionizing Process Design with GenAI: The Kindeva Approach to Manufacturing Excellence

    This presentation introduces a groundbreaking GenAI-powered approach, as utilized at Kindeva's new Fill-Finish manufacturing facility. By adopting an integrative, end-to-end strategy, Kindeva leverages Generative AI to centralize and automate the design and control of manufacturing processes. A repository of hundreds of micro-process steps enables computer-generated and highly controlled outputs for process design, risk assessment, SOPs, MBRs, monitoring, and training.

    • 

      Sebastian Scheler, MSc
      Managing Director, Innerspace

    • 

      Jeffrey Gensler
      VP Quality, Kindeva Drug Delivery

  • 15:25 – 15:55

    Regulations for AI application: Do we need more?

    This presentation will demonstrate the global regulatory landscape for AI applications used in digitalization supporting development, manufacturing, testing, and Quality Management processes.
    

    It will demonstrate how existing schemes of Quality Risk Management can be used to ensure safe, trustworthy, and ethical implementation of regulatory compliant AI applications where Computerized System Validation play a major role.

    • 

      Sean Tay
      Associate Director Quality Assurance, Amgen Singapore Manufacturing

  • 15:55 – 16:15

    Panel Discussion and Q&A

    • 

      Sebastian Scheler, MSc
      Managing Director, Innerspace

    • 

      Jeffrey Gensler
      VP Quality, Kindeva Drug Delivery

    • 

      Sean Tay
      Associate Director Quality Assurance, Amgen Singapore Manufacturing

• 16:15 – 17:00

  Coffee Break at the Exhibition Hall

• 17:00 – 18:35

  Session 4: Annex 1 implementation and consideration

  • 17:00 – 17:05

    Welcome Remarks by the Moderator

    • 

      Li Wei Chan
      Microbiology Manager, MSD International GmbH (Singapore Branch)

  • 17:05 – 17:35

    CCS From The Perspective of An ex-regulator. 2 Years Post Annex 1 Where and Why Are We Still Struggling On Implementing

    • 

      Andy Hopkins
      Senior Director, Lachman Consultants

  • 17:35 – 18:05

    Sterility Assurance – Meeting an Unmet Industry Technical Need on Design and Operation of RABS Systems

    Related Points to Consider (PtC): Points to Consider for Restricted Access Barrier Systems - Annex 1 Implementation

    • 

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

  • 18:05 – 18:35

    Panel Discussion and Q&A

    • 

      Andy Hopkins
      Senior Director, Lachman Consultants

    • 

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

SGT Standard Time (UTC +8:00)

• 08:00 – 09:00

  Registration

• 09:00 – 09:55

  Session 5: Microbiology Part 1

  • 09:00 – 09:05

    Welcome Remarks by the Moderator

    • 

      Li Wei Chan
      Microbiology Manager, MSD International GmbH (Singapore Branch)

  • 09:05 – 09:35

    Annex 1 White Paper

    • 

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

  • 09:35 – 09:55

    In-Process Controls in Pharmaceutical Production: What to Test and How to Use the Results

    In-process controls form a critical part of the contamination control strategy in pharmaceutical production. Recent regulatory updates will be discussed, how to apply the requirements whilst maximising the value of the data generated. 

    
    

    The talk will discuss some case studies relating to out of trend and out of specification results, how investigative testing and root cause analysis can remediate issues to reduce the likelihood of future failures. The talk will also cover manufacturing hold times and the information needed to support them, and how routine monitoring may support the holistic contamination control strategy. 

    
    Related Technical Reports (TR): Technical Report No.90: Contamination Control Strategy Development

    • 

      Miriam Guest
      Senior Principal Scientific Advisor, Charles River Labs, Microbial Solutions

• 09:55 – 10:40

  Coffee Break at the Exhibition Hall

• 10:40 – 12:10

  Session 6: Microbiology Part 2

  • 10:40 – 11:10

    Disinfectant Field Study

    • 

      David Keen, MRSB CBiol
      Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

  • 11:10 – 11:40

    Enzyme Indicators – The approach to H2O2 Bio-decontamination cycle development, qualification and beyond

    • 

      Kate Marshall
      Technical Director, Protak Scientific

  • 11:40 – 12:10

    Panel Discussion and Q&A

    • 

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

    • 

      Miriam Guest
      Senior Principal Scientific Advisor, Charles River Labs, Microbial Solutions

    • 

      David Keen, MRSB CBiol
      Director Pharmaceutical Microbiology & Consulting, Ecolab Life Sciences

    • 

      Kate Marshall
      Technical Director, Protak Scientific

• 12:10 – 13:40

  Lunch Break

• 13:40 – 14:44

  Session 7: Microbiology Part 3

  • 13:40 – 14:10

    H2O2 As A Decontamination Method

    • 

      Richard Denk
      Senior Consulting Aseptic Processing & Containment, SKAN AG

  • 14:10 – 14:40

    The Dynamics Between Microbial Ingress and Container Closure Integrity
• 14:40 – 15:25

  Coffee Break at the Exhibition Hall

• 15:25 – 16:45

  Session 8: Microbiology Part 4

  • 15:25 – 15:55

    Low Endotoxin Recovery Challenge and QC Case Study

    Related Technical Reports (TR): PDA Technical Report No.82 (TR 82) Low Endotoxin Recovery (Single user digital version)

    • 

      Jennifer Cheung
      VP of Global Quality Assurance Operations, Gilead Sciences

  • 15:55 – 16:25

    Sustainability Topics in Microbiology
  • 16:25 – 16:45

    Panel Discussion and Q&A

    • 

      Jennifer Cheung
      VP of Global Quality Assurance Operations, Gilead Sciences

    • 

      Richard Denk
      Senior Consulting Aseptic Processing & Containment, SKAN AG

    • 

      Edward C. Tidswell, PhD
      Executive Director QA, Merck & Co., Inc.

• 16:45 – 16:55

  Closing Remarks