gene therapy at hammersmith hospitals nhs trust northern biological safety officers meeting, leeds...
TRANSCRIPT
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Gene Therapy at Hammersmith Hospitals NHS
Trust
Northern Biological Safety Officers Meeting, Leeds
15 May 2006
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Once upon a time……Jo’s Story
Sir John McMichael Centre Gestation 5+ years DOB - 9/10/00 Height - two floors Weight - equivalent of an inpatient ward
and outpatient area combined
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Jo’s Story part 2…..
New addition to the family announced Spring 2000
Gene Therapy Suite required Due date early 2001 Plans adapted - from rooms originally
intended as a one-bedded patient room with en-suite facility…….
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Office
Patient
Monitoring
L
a
b
Clinical
Pharmacology
Dr’sOfficeSingle
room
Interview room
Quiet Room
Office
Emergency Exit
StaffRoom
Clinical Store
Consulting2
Consulting1
DirtyUtility
Shower
Toilet
Domestic
Clean Utility Kitchen
Head Nurse
Ground Floor - C2
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Female Bay
Male Bay
Nurses Station
Femaleside room
Male side
room
Gene Therapy Suite
Dayroom
Store
Office
Kitchen
Clean Utility
First Floor - C4
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Sharon’s Story
Heard ‘by chance’ from two sources (Imperial College and Trust)
Registered premises / set up GMSC Consider Trustwide approach Assess 1st activity Design training Produce forms / procedures / guidance One system for Class 1 and 2
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Areas involved
Pharmacy Primary ward Diagnostic labs Research labs
(HHT/ IC / MRC) Labs off site - inc
overseas
‘Secondary ward’ e.g. ITU / CCU
Theatres A/E Mortuary / PM room
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The GMSC Hammersmith Hospitals NHS Trust Gene Therapy
and Genetic Modification Safety Committee (HHT GT/GMSC)
Sub committee of the Trust’s Health, Safety, Fire and Security Committee (HSFSC)
Set up to consider gene therapy and GM proposals Chaired by Consultant in Infectious Diseases Terms of Reference – reviewed annually Risk register (one high risk – ‘adverse publicity’)
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HHT GT/GMSC
Safety Office R&D Office Partner Organisations Unions (JUP) Partner Organisations
Safety Office (GM Officer)
Dept of Infectious Diseases
Facilities Environmental
Manager Research Heads SJMMC Pharmacy Infection Control Occupational Health Ethics Committee
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Biological Safety Officer
One for each project Not in the traditional role – support via
Safety Office (USC) First volunteer…? Support from Senior Management (via
Clinical and Non-clinical routes)
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Communication issues
Academic and clinical staff Defined roles / responsibilities Defined reporting routes PI must talk to all involved Contingency plans / emergency contacts Cross representation on committees Accident reporting
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Projects
11 approved so far 4 active (three now ‘closed’) – Schering,
Trovax, Oncovex and MetXia 2 about to start - approved in March 1 not directly Trust (drug administered
elsewhere - scans carried out on HHT premises) – need to be aware in event of emergency admissions
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GT/GM Risk Register
Adverse publicity Exposure to GMOs Unforeseen clinical
outcomes Release of GMOs
Waste management Unrecognised risks
of the biological agent used
Unauthorised work Malicious acts
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Standards
1. Board level commitment to gene therapy development in the Trust
2. GMSC to endorse all GM activities, guidance, policy, monitoring etc
3. Properly constituted investigative team
4. Written policies, procedures, guidance
5. Regular report to HSFSC, Risk Management Committee and Trust Board
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Standards continued…
6. GMSC and BSO have access to relevant, up to date legislation and guidance
7. Staff trained to an appropriate level
8. Monitoring and review by management
9. Audit – internal and external
10. Use of GMMs should comply with good research governance within the Trust and Partner Organisations
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Contacts / Further Info
Josephine Studham
Sharon Wood
K.B. Bamford, S. Wood, R.J. Shaw ‘Standards for gene therapy clinical trials based on pro-active risk assessment in a London NHS Teaching Hospital Trust’ Q J Med 2005; 98 75-86
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First floor – C4
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Gene therapy Suite
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Suction containment
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Waste
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Labelling
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Procedures