Northern Area Biological Safety Officers Biannual Meeting University of Leeds 15 May 2005

Northern Area Biological Safety Officers 10:00. Paul Murdock, BSO, University of Leeds. Gene Therapy at the Hammersmith Hospital, London. Facilities for containment of Class 2 gene therapy trials. 11:00. Jo Studham, Manager, Sir John McMichael Centre, Hammersmith Hospital. Sharon Wood, Head of Biosafety Group, Universal Safety Consultants. Conducting Gene Therapy Trials at the Hammersmith. 12:00. NBSO business Meeting 12:30. Lunch. 2:00. Sarah Elliot (World Courier account manager for Univ of Leeds), Sue Lee (Packaging and Regulations), BioPharm Division, World Courier. International transportation of Bio hazardous and Pharmaceutical Materials 3:00. Belinda Philipson, Central Science Lab, Defra Plant Pathogen controls: licenses for import & export and usage. 4:00 Coffee, Close

Gene Therapy Clinical Trials  NBSO Edinburgh. A number of participants are getting involved but have concerns.  New regional oncology centre at St James Hospital Leeds. 2 bed gene therapy suite is planned.  Univ of Leeds has lots of lab interest in GT vectors and products …………but trials will be sponsored by pharmaceutical companies under medical supervision. Current lab projects are a long way from clinical trials.  Trust will own the suite, but has limited in-house expertise. Medical School will be involved in trials.

Gene Therapy Clinical Trials  PJM worked on Gene Replacement Therapy for Haemophilia at Royal Free Hospital.  Worked with a medical division with interests in cystic fibrosis therapy at Imperial college.  Worked as consultant to Universal Safety Consultants, Advisor to Hammersmith Hospitals NHS Trust.  Knew who to ask for advice!

Facilities for Gene Therapy Clinical Trials at the Hammersmith Hospital.

Hammersmith Hospitals NHS Trust  Major trust with 4 hospitals in West London, including Charing Cross and the Hammersmith Hospitals.  Close association with Imperial College Medical School.  Universal Safety Consultants are long standing advisors to the trust.

Sir John McMichael Centre  First Established in 2000, as a joint venture between HH NHS trust and Imperial College Medical School.  Primarily, but not exclusively intended for Gene Therapy Clinical Trials  All class 1 and class 2 trials at the Hammersmith have been carried out here.  17 Staff.  Have carried out a number of trials. Centre is increasingly busy.

Planning & Development  Trust Lacked expertise so sought bio-safety advice from USC. USC have been closely involved from earliest days.  Have consulted with HSE and Imperial College Medical School at all stages.  Trust, IC and the safely advisors have developed the physical infrastructure, and establish a GTAC drawing on expertise from a wide area.  Collaborative effort to devise working protocols, all parties are closely involved in running trials.  ‘OTT’ facilities and procedures have proved to be robust and relatively trouble free in practice.

Facilities, ground floor

Lab

Gene Therapy Dosing (1 st Floor)

Air Handling  Negative Pressure.  Air filtered in  HEPA Filtered air out.

Drainage?  Water direct to drain.  Holding tank? How would you validate and disinfection?  Where does vacuum intubation go?

Transport of GT agents and waste.  No autoclave in centre

Summary  ‘Mundane’ i.e. basically a typical wards  Containment Level 2  Important to be Proportionate. CL3 not required!  …but, should we handle CL2 material (adenovirus, genes for bio- active agents) on ordinary wards?

Problems Systems have been robust but:  Improvement notice served in March 03 ‘inadequate storage of GMM’.  Felt to be counterproductive and unjustified, but Trust decided not to appeal.

Guidance and Policy  HSE guidance is long overdue but promised soon!  Early drafts bear striking resemblance to systems and protocols developed at JMC.