establishment of the hku phase 1 clinical trials centre
TRANSCRIPT
![Page 1: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/1.jpg)
Establishment of
the HKU Phase 1 Clinical Trials Centre
Henry Yau
Managing Director, Clinical Trials Centre, The University of Hong Kong
International Conference on Phase 1
and Early Phase Clinical Trials
April 26, 2013, Hong Kong
![Page 2: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/2.jpg)
The World of Clinical Trials is Flat !
![Page 3: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/3.jpg)
USA European
Union
Japan
International Conference on Harmonization of Technical Requirements
for Registration of Pharmaceuticals for Human Use (ICH)
Year 1996: ICH Good Clinical Practice (ICH GCP)
Globalization of Clinical Trials
![Page 4: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/4.jpg)
East
Europe
Asia South
America
Globalization of Clinical Trials
Hong Kong
![Page 5: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/5.jpg)
HKU Clinical Trials Centre
Founded: Year 1998
Mission: To enhance human healthcare by attracting and facilitating clinical trials and safeguarding the core principles of subject protection, science and data integrity.
![Page 6: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/6.jpg)
Track Records of HKU CTC
By Apr 2013
15 years’ history
148 sponsors worldwide
704 sponsored studies contracted
215 studies ongoing
57 studies under preparation
![Page 7: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/7.jpg)
Clinical & Scientific Expertise of HKU/QMH
HKU Medical Faculty
Queen Mary Hospital
Since 1887
Since 1937
HKU Medical Faculty
• Oldest medical college in Hong Kong
(126 years since 1887)
• Pioneer in medical research and
education
Queen Mary Hospital
• Regional acute care hospital with about
1,700 beds
• Accredited by the Australian Council on
Healthcare Standards (ACHS) since
2010
• Clinical laboratories accredited by the
College of American Pathologists (CAP)
since 2002
• 24 hours emergency / ICU support
![Page 8: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/8.jpg)
Clinical & Scientific Expertise of HKU/QMH
HKU Medical Faculty
Queen Mary Hospital
Since 1887
Since 1937
Clinical Research Expertise
• Over 100 clinical investigators
• 7 clinical specialties accredited by the
China FDA since 2006
• Inspected by regulatory authorities from
Mainland China, Hong Kong, US and
Japan:
Year
US
FDA
Japan
MHLW
HK
DOH
China
FDA
1998
2002
2004
2006
2008
2009
2012
![Page 9: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/9.jpg)
Pre-clinical research
Phase 2-4 trials
The medical research gap
Phase 1 Trials: Bridging the Gap of Medical R&D
Phase 1 trials
![Page 10: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/10.jpg)
The Good News !
106. Hong Kong is well-placed to develop into an international
clinical trial centre and a translational research centre. To
advance the development of the pharmaceutical and
biopharmaceutical industries, the Hospital Authority (HA)
will set up Phase I clinical trial centres in Queen Mary and
Prince of Wales Hospitals to conduct preliminary clinical
trials for new drugs…… We will also map out our way
forward for different phases of clinical trials for drugs, and
strengthen the organisation, management and planning
for clinical trials to promote development in this area.
Budget Speech 2011
![Page 11: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/11.jpg)
Value of Phase 1 Clinical Trials to Hong Kong
Local Healthcare:
- Early access to new medicines
- Safeguarding the quality of generic drugs
Medical Education:
- Supporting education in pharmaceutical medicine
- Training opportunities for medical professionals
Hong Kong Economy:
- Supporting the development of local pharmaceutical /
life sciences industry
Mainland-HK Integration:
- Overseas companies HK Mainland
- Mainland companies HK Overseas
Phase 1 Clinical Trials
![Page 12: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/12.jpg)
Research Focuses
Generic
Drugs
New
Drugs
Healthy
Volunteers Patients
B A
D C
Global shortage of
Phase 1 centres
capable of
conducting phase 1
trials in patients
Local demand for
BA/BE studies for
generic drugs in
healthy volunteers
![Page 13: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/13.jpg)
HKU Phase 1 Facilities
![Page 14: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/14.jpg)
HKU Phase 1 Centre: Clinical Site
2/F Block K
Queen Mary Hospital
Pokfulam, Hong Kong
Location
• 24 beds
• Safety Monitoring System
• Drug Storage & Processing
Facilities
• Specimen Storage &
Processing Facilities
• Resuscitation Facilities
• Dining & Leisure Area
• Access & Security Control
Main Facilities
![Page 15: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/15.jpg)
Nurse Station
![Page 16: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/16.jpg)
Dining & Leisure Area
![Page 17: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/17.jpg)
Beds Area
![Page 18: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/18.jpg)
Physiological Monitors
![Page 19: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/19.jpg)
Resuscitation Room
![Page 20: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/20.jpg)
Drug Processing Room
![Page 21: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/21.jpg)
Drug Storage Room
![Page 22: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/22.jpg)
Specimen Processing Room
![Page 23: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/23.jpg)
Specimen Storage Room
![Page 24: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/24.jpg)
HKU Phase 1 Centre: Pharmacokinetics Lab
6/F Laboratory Block
Li Ka Shing Faculty of Medicine
The University of Hong Kong
Location
• AB SCIEX QTRAP 6500 AMCR
• AB SCIEX TripleTOF 5600
AMCR
• Beckman P/ACE MDQ System
• Waters Acquity UPLC System
• Dionex 2D-NanoLC
Main Equipment
![Page 25: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/25.jpg)
AB SCIEX QTRAP 6500
![Page 26: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/26.jpg)
AB SCIEX TripleTOF 5600
![Page 27: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/27.jpg)
Waters Acquity UPLC System
![Page 28: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/28.jpg)
Beckman P/ACE MDQ CE System
![Page 29: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/29.jpg)
3-tier Governance Structure
Ethics Review & Oversight
Policy & Governance
Operations & Administration
3-tier
Governance
Chairman:
Prof Karen Lam
Chief Director:
Prof YL Lau
![Page 30: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/30.jpg)
Management Structure
![Page 31: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/31.jpg)
Ethics & Scientific Oversight
Joint Scientific Committee
Ethics Committee
Phase 1 Special Panel
Principal
Investigator
A special
panel in the
existing IRB
A panel jointly
operated by
HKU, CUHK
and HA
![Page 32: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/32.jpg)
Ethics & Scientific Oversight
![Page 33: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/33.jpg)
Accreditation by China FDA
Target: Phase 1 Clinical Trials
Anaesthesiology
Cardiology
Endocrinology & Metabolism
Haematology & Bone Marrow Transplantation
Hepatobiliary/Pancreatic Surgery & Liver Transplantation
Obstetrics & Gynaecology
Respiratory Medicine
![Page 34: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/34.jpg)
Acknowledgement
Food and Health Bureau
Department of Health
Hospital Authority
Queen Mary Hospital
![Page 35: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/35.jpg)
Acknowledgement
Peking Union Medical Centre Hospital
Peking University First Hospital
Dong-A University Hospital
Inje University Busan-Paik Hospital
Pfizer Clinical Research Unit
Zenith Technology
![Page 36: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/36.jpg)
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Novartis
PAREXEL
Quintiles
Acknowledgement
![Page 37: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/37.jpg)
Acknowledgement
Hong Kong Association of the Pharmaceutical Industry
Hong Kong Science & Technology Parks
![Page 38: Establishment of the HKU Phase 1 Clinical Trials Centre](https://reader034.vdocument.in/reader034/viewer/2022052106/628730e7c0f7f041891e4891/html5/thumbnails/38.jpg)
Thank You