APEC RHSC Centre of Excellence Pilot Workshop
on Advanced Therapies
July 17-19, 2017
Duke-NUS Medical Shool
Singapore
| 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 |
|
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 |
|
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 |
|
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 |
|
|
| 3:30 - 3:45 | Break | |
| 3:45 - 6:00 | Site Visit - HSA Cell Therapy Facility | |
| 6.00 - 7:00 | End | |
| 7.00 - | Faculty Dinner | |
| 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 |
|
|
| Dr Lucas Chan Director, GMP Manufacture and Development Stem Med Pte Ltd, Singapore | ||
| 10:00 - 10:30 |
|
Dr Lucas Chan Director, GMP Manufacture and Development Stem Med Pte Ltd, Singapore |
| 10:30 - 11:00 |
|
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 |
|
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 |
|
Dr Fouad Atouf Vice President, Global Biologics - Science & Standards USP |
| 4:45 - 5:00 | Q&A | |
| 5:00 | End | |
| Day 3 (AM) | ||
|---|---|---|
| Topic | Speaker / Facilitator | |
| 8:30 - 9:00 | Tea reception | |
| Session 5 - Impacting healthcare through optimal regulation | ||
| 9:00 - 10:00 |
|
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 | |
| Day 3 (PM) |
|---|
| Regulators’ Focus Group (by invitation only) |
|
