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

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

2. 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

3. 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.

4. 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!

5. Facilities for Gene Therapy Clinical Trials at the Hammersmith Hospital.

6. 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.

7. 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.

8. 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.

9. Facilities, ground floor

10. Lab

11. Gene Therapy Dosing (1st Floor)

12. Air Handling • Negative Pressure. • Air filtered in • HEPA Filtered air out.

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

14. Transport of GT agents and waste. • No autoclave in centre

15. 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?

16. 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.

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