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

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