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2014 APEC Harmonization Center

Health Sciences Authority Cell- and Tissue-based Therapeutic Products (AHC-HSA CTT) Workshop HSA Auditorium | Singapore | July 1 - 3, 2014 Programme
2014 APEC Harmonization Center : Time, Sessions, Speaker

Time

Sessions

Speaker

Day 1: July 1, 2014 (Tuesday)
08:30 - 09:00 Registration
09:00 - 09:15 Opening and Welcome Address Asst Prof Raymond Chua
(HSA, Singapore)

Mr Jin-Ho Wang (MFDS, Korea)
- Video Presentation
09:15 - 09:35 Introduction and Outline of APEC Life Sciences
Innovation Forum Regulatory Harmonization
Steering Committee (RHSC)
Mr Mike Ward (RHSC)
- Video Presentation
09:35 - 10:15 Plenary Lecture 1:
Five Years Post-Advanced Therapy Medicinal
Products (ATMP) Regulations Implementation

Chair: Asst Prof Raymond Chua (HSA, Singapore)
Dr Paula Salmikangas
(EMA and Fimea, Finland)
10:15 - 10:25 Q & A
10:25 - 11:00 Break
11:00 - 11:15 Overview of Cell- and Tissue-based Therapeutic Product Roadmap Dr Srinivasan N Kellathur (HSA, Singapore)
11:15 - 11:30 Introduction and Outline of International Pharmaceutical Regulators Forum - Cell Therapy Group Ms Judith Arcidiacono (US FDA)
11:30 - 11:35 Q & A
Regulatory Update Session 1
Chair: Dr Paula Salmikangas (EMA and Fimea, Finland)
11:35 - 11:55 Regulatory Framework for Regenerative Medicine in Japan Dr Yoshiaki Maruyama (PMDA, Japan)
11:55 - 12:00 Q & A
12:00 - 13:30 Welcome Lunch
13:30 - 13:50 Recent Developments in Transplant Product Approvals and Clinical Trial Authorization Dr Julia Djonova (SwissMedic)
13:50 - 14:10 Regulation of Cellular Therapies in India Dr Geeta Jotwani (Indian Council of Medical Research)
14:10 - 14:30 U.S. FDA Regulatory Innovation for Cell Therapy Products Ms Judith Arcidiacono (US FDA)
14:30 - 14:40 Q & A
14:40 - 15:00 Break
Regulatory Update Session 2
Chair: Prof Yao-Chang Chen (National Taiwan University)
15:00 - 15:20 Developments and Future Considerations for Regulating Cellular Therapies in Canada Ms Liz Anne Gillham-Eisen (Health Canada)
15:20 - 15:40 Introduction of China’s Provisions and Guidelines on Human Stem Cell-based Medicinal Products Dr Wei Wei (China FDA)
15:40 - 16:00 Regulation of Cell Therapy Products in Taiwan Dr Yi-Chu Lin (Taiwan FDA)
16:00 - 16:10 Q & A
16:10 - 16:50 Plenary Lecture 2:
Cell Therapy: Singapore Style
Chair: Dr Mickey Koh, St George’s Hospital, London, United Kingdom
A/Prof William Hwang
(Singapore General Hospital, Singapore)
16:50 - 17:00 Q & A
Day 2: July 2, 2014 (Wednesday)
08:30 - 09:10 Plenary Lecture 3: Searching for solutions: Cell Therapy Medical Tourism

Chair: Dr Christina Lim (HSA, Singapore)
Dr Mickey Koh (St. George’s Hospital and Medical School, UK)
09:10 - 09:20 Q & A

Special Topic 1:

Special Topic 1 : Time, Sessions, Speaker
Objectives:
    Similarities and/or differences in the manufacturing facility for cell therapy products versus other sterile pharmaceutical product What kind of expenditures and cost are to be expected for building and running a cell therapy manufacturing facility? What are critical stages in construction and commissioning? What are the potential pitfalls to avoid in building, running the manufacturing facility as well as establishing the core management team?

Chair: Ms Liz Anne Gillham-Eisen (Health Canada)

Special Topic 2 : Time, Sessions, Speaker

Time

Sessions

Speaker

09:20 - 09:25 Introduction to Session by Chair
09:25 - 09:45 Challenges During Start-up of GMP Manufacturing - CT Products Mr Ramamoorthy Arivazhagan (Lonza Biosciences, Singapore)
09:45 - 10:05 Industry Perspectives on Manufacturing Facilities for Allogeneic and Autologous Cell Therapy Products Dr Harris Ian (Jansen R&D, USA)
10:05- 10:25 Commercial Manufacturing of Allogeneic Cell Therapy Product with BLA: 2 Years of Market Experience from Korea Dr Antonio S J Lee (MEDIPOST America Inc., Korea)
10:25 - 10:45 Challenges of Japan, Forum for Innovative Regenerative Medicine and J-TEC Mr Yosuke Ozawa (Japan Tissue Engineering Company Ltd, Japan)
10:45 - 10:55 Q & A
10:55 - 11:15 Break

Special Topic 2:

Points to Consider in Product Manufacturing - Cell source, Ancillary materials/reagents quality, Adventitious agents and Aseptic processing
Objectives:
  • Cell sourceDonor screening, testing and traceability
  • Autologous; allogeneic and xenogeneic source
  • Qualification of cell lines
  • Characterization testing of Master Cell Banks and Working Cell Banks
  • Ancillary materials/ reagentsQuality of reagents and availability
  • Qualification programs for reagents
  • Concerns on reagent source; animal derived materials; feeder cells; antibiotics
  • Impact on product quality, safety and efficacy
  • Challenges in removal of ancillary materials in final product and residual testing
  • Risk assessment
  • Reference materials or standards for cell therapy products
  • Aseptic processingPoints to consider in aseptic processing

Chair: Ms Judith Arcidiacono (US FDA)

Special Topic 3 : Time, Sessions, Speaker

Time

Sessions

Speaker

11:15 - 11:20 Introduction to Session by Chair
11:20 - 11:40 Critical attributes of starting and raw materials for the quality of cell-based products Dr Paula Salmikangas
(EMA and Fimea, Finland)
11:40 - 12:00 Manufacturing Cellular Products: US FDA Perspectives Dr Steven S. Oh (US FDA)
12:00 - 12:20 Microbiological Consideration in Manufacturing Cell Therapy Products Dr Won Shin (MFDS, Korea)
12:20 - 12:40 Tissue Procurement for Cell-based Therapies Dr Charlotte Morgan
(Regeneus Pty Ltd, Australia)
12:40 - 12:50 Q & A
12:50 - 14:00 Lunch

Special Topic 3:

Product Characterization - Identity, Purity, Sterility and Potency
Objectives:
  • Challenges in the suitability of methods for product identity
  • Considerations in the design; validation; reference materials; acceptance limits
  • Challenges in maintaining product sterility
  • Challenges in the development of a potency assay

Chair: Dr Marieta Chan (HSA, Singapore)

Special Topic 4 : Time, Sessions, Speaker

Time

Sessions

Speaker

14:00 - 14:05 Introduction to Session by Chair
14:05 - 14:25 Regulatory perspective for ensuring quality and safety of cellular and tissue-based products in Japan Kazuhiro Takekita (PMDA, Japan)
14:25 - 14:45 Introduction to the Product Testing of Bone Marrow Stromal Stem Cell Therapy Product Hearticellgram-AMI Dr Yong Man Kim (Pharmicell Co. Ltd, Korea)
14:45 - 15:05 Tissue engineering Cell-based therapy in corneal reconstruction Adj A/Prof Jod Mehta (Duke-NUS Graduate Medical School and SNEC, Singapore)
15:05 - 15:15 Q & A
15:15 - 15:35 Break

Special Topic 4:

Key Issues/requirements in Production of Cell- and Tissue-based Therapeutic Products: GMP Perspective
Objectives:
  • What are the core principles and requirements in GMP standard common for both cell therapy products and typical medicinal products?
  • What are the unique GMP requirements for CTT products?
  • What is the interpretation of these requirements in the context of CTT products for clinical trials?
  • What are the observations and lessons learnt from GMP inspection?

Chair: Dr Srinivasan N Kellathur (HSA, Singapore)

Day 1 Wednesday, November 20: Time, Sessions, Title, Speaker

Time

Sessions

Speaker

15:35 - 15:40 Introduction to Session by Chair
15:40 - 16:00 GMP Requirements for Cell-Based Medicinal Products: Critical Issues Dr Maria Cristina Galli (Istituto Superiore di Sanita, Italy)
16:00 - 16:20 What is to be Expected in GMP Inspection for Cell- and Tissue-based Therapeutic Products?: From Singapore Perspective Mr Choon Wee Goh (HSA, Singapore)
16:20 - 16:30 Q & A
16:30 - 17:00 Recommendations and Closing Remarks
Day 3: July 3, 2014 (Thursday)
08:30 - 13:00 Regulators-only Session (Closed session)
Venue: HSA Board Room, Level 2
This session is open to regulators ONLY.
Chairs: Ms Judith Arcidiacono (US FDA) and
Ms Liz Anne Gillham-Eisen (Health Canada
13:00 - 14:00 Lunch