1. -Challenges for the CSL/Pfizer Animal Ethics Committee John Phelps CSL Biotherapies Meeting Animal Welfare Needs in a Biotherapies Environment

2. Scope of Activities  Human (CSL) & Animal (Pfizer) Biotherapies  Vaccines  Antiserum products  Recombinant Biologicals  40:40 (New: Ext) Applications Year Quality Control Testing of Therapeutic Products Production of Biological materials R&D of New Vaccines & Biotherapies  Animal Facilities Laboratory animals  Mice/Guinea Pigs/Rabbits/Ferrets Housed animals  Dogs/Cats/Poultry/Pigs Livestock  Cattle/Sheep/Horses

3. AEC Membership Serving the AEC needs of 2 institutions confidentiality requirements of internal members differences in lines of company reporting maintaining balanced AEC membership Recruitment availability of C & D Categories identifying potential members selection of the right members Maintenance site inductions and car parking workloads at critical times work hour incompatibility communications & conferencing limited need for conflict resolution Science vs Animal Welfare discussions if the science isn’t right, animals will be wasted scientific vs lay language in applications

4. Meeting all Regulatory Codes Pharmacopeia requirements vs test refinement test procedures must follow compendial methods recognition of invention points is critical test alternatives are being introduced Quarantine restrictions - animal care and fate physical containment vs environmental enrichment approved disposal method vs animal fate Environmental codes vs cage enrichment waste management codes - animal exercise areas effluent codes and cage washing methods air change rates may affect global warming! Interstate projects - regulatory differences differences in site licence conditions Codes are often complementary e.g. requirements for animal welfare reinforced in major biotherapy manufacturing Codes (GMP, GCP)

5. Recognition of Training New research methods/techniques how are the merits of new techniques gauged? who will identify the right system? feedback is critical Proof of expertise – what is acceptable? recognition of trainers does experience necessarily confer expertise? Maintenance of a training database where is the data stored when and how is it updated methods for AEC approval of changes

6. Other Items Ensuring Closure of all AEC Action items methods of monitoring and reporting AEC Communication channels project investigator availability animal facilities/updates/feedback executive management of 2 companies roles of Chairperson and Secretary Training of new investigators using the right (lay) language why and what the AEC needs to know applications in on time !

10. The End