Clinical Trials and Preclinical Infrastructure Asset Map - Genome BC

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APPENDIX 12. PRECLINICAL STUDIES SERVICE ORGANIZATIONS Types of Clients Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing 306 Regulatory Qualifications Animal facility and testing areas compliant with: OECD GLP practices cGMP Clean Room Facility complies with: US FDA 21 CFR Parts 210 and 211 Health Canada HPFBI GMP guidelines. 16 employees based in Vancouver Animal technicians: 5 Study Directors: 2 Tissue Culture Manager: 1 Quality Management/ Documentation: 3 GMP Manufacturing: 2.5 FTE plus 1 FTE co-op student Analytical: 2 Clinical trials support: 2 plus 1 co-op IDP is a business unit within the BCCA, and is part of the Advanced TherapeuticsDepartment. B.C. Cancer Agency Research Centre 675 West 10th Avenue Vancouver, B.C. V5Z 1L3 Tel : 604-675-8000 Head: Marcel Bally Tel :604-675-8020 mbally@bccrc.ca Clinical Trials Support Services Contact: Dawn Waterhouse Tel : 604-675-8022 dwater@bccrc.ca BCCA Investigational Drug Program (IDP) www.bccrc.ca/at/focus_investigationaldrugprogram.html BRITISH COLUMBIA Predominantly services B.C. sciencecommunity;. with some clients in Canada, North America and Europe. Clients include SMEs, Hospitals, Institutions,University Med schools, and small operations requiring CT operations,manufacturing, and services Provides facilities for the pharmaceutical formulation, manufacturing and pre-clinical testing of new parenteral drugs for Phase I and II clinical trials. Complies with Good Manufacturing Practice and Good Laboratory Practice. It has a mandate to develop promising new therapeutic agents for new anticancer agents introduction into clinical trials. IDP operates a pharmaceutical GMP clean room facility for manufacturing and packaging of parenteral drug products for Phase I and Phase II clinical trials, primarily in the cancer sector; and also non-cancer therapeutic applications. Non-Clinical Safety Studies/Toxicology Conducted by IDP through the B.C. Preclinical Research Consortium; compliant with OECD Principles of Good Laboratory Practices GMP Formulation and Manufacturing Services Services range from core batching and filling activities to comprehensive development, validation, production and documentation projects. Core services provided by Investigational Drug Program for all final drug production runs: • Process development and validation • Material control and inventory documentation •Vendor qualification • Master formula/batch record design and implementation •Batch production to 10 litres or 1500 vials/day •Facility cleaning and environmental monitoring •Sterilisation / depyrogenization of equipment and packaging materials •Basic batching processes and formulation •Product sterilization through aseptic filling of final drug product Vial sizes from 1 ml to 50 ml • Comprehensive Quality Management System • Product inspection and labeling
Regulatory Qualifications Types of Clients Company/ URL Contact Information Therapeutic Expertise and Types of Services Structure Number and Type of Staffing CLINICAL TRIALS AND PRECLINICAL INFRASTRUCTURE ASSET MAP Clinical Trials Support Services: • Handling & processing of all bodily fluids • PK sample processing 24 hours/day, 7 days/week • Pharmacodynamic sample processing • Pharmacogenomic and pharmacogenetic sampling • PBMC preparation • Documentation, storage and shipment of samples • Attendance at site initiation visits • Class IIA Biosafety cabinets (certified) • Class IIB Biosafety cabinets (certified) • Restricted access laboratory Regulatory interaction/compliance and facilitation for all levels of studies 307
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1 33 0 34 0 M A G N E T I C V A R 9
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ii BRITISH COLUMBIA
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2 EXECUTIVE SUMMARY BRITISH COLUMBI
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4 INTRODUCTION BRITISH COLUMBIA Wit
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6 Health Authority (URL) Key Facili
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8 FIGURE 2. Clinical Trials Units,
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10 Facility (URL if available) Pedi
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12 Facility (URL if available) Mood
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14 Facility (URL if available) Down
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16 Facility (URL if available) Clin
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18 Facility (URL if available) Gast
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20 TABLE 3. Clinical Trials Support
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22 Much clinical research - particu
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24 FIGURE 3. Source of Funds for Cl
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26 BRITISH COLUMBIA FIGURE 7. Thera
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28 BRITISH COLUMBIA Clinical Invest
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Disease Area Population Information
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32 CV/Cardiology CNS Pulmonary Canc
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34 TABLE 9. Health Economics and He
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36 TABLE 10. Epidemiology and Surve
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38 TABLE 12. Provincial Networks Th
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40 Network B.C. Investigator’s Ro
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42 Network B.C. Investigator’s Ro
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44 TABLE 14. Independent Clinical T
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46 COMPARATIVE POSITIONING OF B.C.
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48 ACKNOWLEDGEMENTS BRITISH COLUMBI
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50 APPENDIX 1-2 TABLE OF CONTENTS B
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52 PROVINCIAL HEALTH SERVICES AUTHO
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54 BRITISH COLUMBIA Edward Miller C
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56 BRITISH COLUMBIA Radiation Thera
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58 The Unit has 15 Principal Invest
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60 BRITISH COLUMBIA Neonatal Resear
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62 The B.C. Children’s Hospital p
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64 BRITISH COLUMBIA The clinical tr
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66 FRASER HEALTH AUTHORITY BRITISH
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68 BRITISH COLUMBIA tional therapis
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70 PROVIDENCE HEALTH CARE SOCIETY 4
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72 BRITISH COLUMBIA Quality control
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74 Clinical trials investigators in
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76 The facility has 13 investigator
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78 Staffing of the Centre is as fol
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80 Investigators: • Ayas, Najib
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82 BRITISH COLUMBIA Quality control
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84 The Research Group consists of t
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86 BRITISH COLUMBIA Multiple Sclero
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88 BRITISH COLUMBIA Gastroenterolog
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Since the Centre is located in St.
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TABLE A1. Providence Health Care So
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94 BRITISH COLUMBIA FIGURE A9. Cent
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96 BRITISH COLUMBIA The Unit suppor
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TABLE A2. CFRI Program-affiliated R
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100 BRITISH COLUMBIA Quality contro
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102 BRITISH COLUMBIA • Knowledge
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104 Its staffing is as follows: Stu
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106 APPENDIX 3. QUALITY CONTROL/ QU
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APPENDIX 5. CLINICAL TRIALS TRAININ
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APPENDIX 5. Clinical Trials Trainin
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112 APPENDIX 6 TABLE OF CONTENTS BR
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6.1 Clinical Trials Researchers Lis
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Pediatrics INSTITUTION EMAIL URL DI
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Pediatrics (cont’d) INSTITUTION E
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248 APPENDICES 7-13 TABLE OF CONTEN
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250 TABLE A3. Patient and Addiction
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252 TABLE A3. Patient and Addiction
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APPENDIX 8. PROVINCIAL AND NATIONAL
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Page 290 and 291: Networks In Which B.C.’s Clinical
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