- Challenges for the CSL/Pfizer Challenges for the CSL/Pfizer Animal Ethics CommitteeAnimal Ethics Committee

John PhelpsJohn Phelps

CSL BiotherapiesCSL Biotherapies

Meeting Animal Welfare Meeting Animal Welfare Needs in a Biotherapies Needs in a Biotherapies

EnvironmentEnvironment

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

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

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)

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

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!

The End