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Advanced Therapies (Duke-NUS CoRE)

APEC RHSC Centre of Excellence Pilot Workshop
on Advanced Therapies

July 17-19, 2017 Duke-NUS Medical Shool Singapore
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 1
time Topic Speaker / Facilitator
8:30 - 9:00 Registration and Refreshment
9:00 - 9:10 Welcome Dr Yeowon Sohn (via video recording)
Director, AHC
9:10 - 9:20 Opening remarks A/Prof John Lim
Executive Director,
CoRE
9:20 - 9:30
  • Overview of workshop
      • Introducing APEC RHSC CoE Pilot
      • Progress from 2016
Adj Asst Prof Srinivasan Kellathur
Head,
Advanced Therapy Product Unit
HSA, Singapore
Session 1 - Understanding the Current Landscape
9:30 - 9:50 Pitfalls and upcoming challenges in development and regulation of Advanced Therapies - An Industry perspective Dr Katherine Tsokas
Regulatory Head of Regenerative
Medicine & Advance Therapy
Janssen Research & Development,
LLC
9:50 - 10:00 Q&A
Session 2 - Regulatory frameworks for Advanced Therapies
10:00 - 10:45 Updates on the US FDA and EMA framework Dr Wilson Bryan (via remote presentation)
Director,
Office of Tissues and Advanced
Therapies
US FDA

Dr Ilona Reischl
Vice-Chair,
Committee for Advanced Therapies
EMA
10:45 - 11:30 Understanding the Australia’s TGA framework for regulating advanced therapies Dr Tony Manderson (via remote presentation)
Principal Adviser,
Biological Science,
Scientific Evaluation Branch
TGA, Australia
11:30 - 12:30
  • Understanding the basis of frameworks and processes in Asia for Advanced Therapies
      • Update from Japan PMDA
      • Update from Korea MFDS
Dr Masaki Kasai
Principal Reviewer,
PMDA, Japan


Dr Jeewon Joung
Director,
Cell and Gene Therapy Products
Division
MFDS, Korea
12:30 - 1:30 Lunch and photo session
1:30 - 2:30
  • Understanding the basis of frameworks and processes in Asia for Advanced Therapies (cont’d)
      • Malaysia NPRA
      • Singapore HSA
Dr Azizah Ab Ghani
Senior Principal Assistant Director,
Head of Biologics Section
NPRA, Malaysia


Dr Ong Lee Lee Senior Regulatory Specialist,
Advanced Therapy Product Unit
HSA, Singapore
2:30 - 3:30
  • Case Discussion
      • Grey areas for classifying advanced therapies
3:30 - 3:45 Break
3:45 - 6:00 Site Visit - HSA Cell Therapy Facility
6.00 - 7:00 End
7.00 - Faculty Dinner
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 2
Time Topic Speaker / Facilitator
8:30 - 9:00 Tea reception
Session 2 - Regulatory frameworks for Advanced Therapies (cont’d)
9:00 - 10:00
  • Case Discussion (cont’d)
      • Grey areas for classifying advanced therapies
Dr Lucas Chan Director, GMP Manufacture and Development Stem Med Pte Ltd, Singapore
10:00 - 10:30
  • Overview of the development of advanced therapies
      • Current scope of research
      • Bridging research to market approval and patients
Dr Lucas Chan
Director,
GMP Manufacture and Development
Stem Med Pte Ltd, Singapore
10:30 - 11:00
  • Trials for advanced therapies
      • Typical characteristics of trials
Dr Ilona Reischl
Vice-Chair,
Committee for Advanced Therapies
EMA
11:00 - 11:30 Cell Master File - A novel concept Dr Antonio Lee
CEO & Managing Director,
Medipost America Inc
11:30 - 12:30 Case discussion
12:30 - 1:30 Lunch
Session 4 - Considerations in Manufacturing - GMP and quality control for Advanced Therapies
1:30 - 3:00
  • GMP Requirements For Advanced Therapies
      • Manufacturer’s perspective
      • Regulator’s perspective
Dr Marieta Chan
Laboratory Director,
Blood Services Group
HSA, Singapore


Mr Goh Choon Wee
Regulatory Consultant, Senior GMP
Inspector,
Audit & Licensing Division
HSA, Singapore
3:00 - 3:30 Case discussion Mr Goh Choon Wee
Regulatory Consultant, Senior GMP
Inspector,
Audit & Licensing Division
HSA, Singapore
3:30 - 4:00 Break
4:00 - 4:45
  • USP Standards for Cell and Tissue Therapies
      • Addressing reagents not graded for GMP
      • Validating analytical methods (aiding in review of non-compendial methods)
Dr Fouad Atouf
Vice President,
Global Biologics - Science & Standards
USP
4:45 - 5:00 Q&A
5:00 End
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 3 (AM)
Topic Speaker / Facilitator
8:30 - 9:00 Tea reception
Session 5 - Impacting healthcare through optimal regulation
9:00 - 10:00
  • Group Discussion
      • Potential challenges and opportunities for implementing regulatory processes for advanced therapies
      • Measures and indicators of progress
Asst Prof Tamra Lysaght
Centre for Biomedical Ethics, Yong Loo
Lin School of Medicine,
NUS
10:00 - 10:30 Ethical considerations in advanced therapies Asst Prof Tamra Lysaght
Centre for Biomedical Ethics, Yong Loo
Lin School of Medicine,
NUS
10:30 - 11:00 From research to market - An entrepreneur’s perspective on impacting healthcare Dr Gayatri Sharma
Executive Director,
Yuki Bioscience Pte Ltd
Entrepreneur in Residence,
Duke-NUS
11:00 - 11:30 Stakeholders’ Perspective - Practitioners A/Prof Toh Han Chong
Senior Consultant,
Deputy Director,
National Cancer Centre, Singapore
11:30 - 12:30 Panel Discussion
12.30 Workshop Conclusion and End
2016 APEC Biotherapeutics Centers of Excellence Pilot Training
Day 3 (PM)
Regulators’ Focus Group (by invitation only)
  • Overall objectives of discussion
      • Contribute to enhancing relevance and feasibility of a framework for regulating advanced therapies
      • Provide recommendations for successful implementation of such framework
      • Identify challenges in regulatory oversight of advanced therapies