Responsibility

Research and Development

Preclinical research

Our policy on the ethical treatment of animals in research ensures that all animal experimentation is performed to the highest standard of ethics, adhering to the three guiding principles of reduction, refinement and replacement. We will only perform studies in territories where animal studies are strictly regulated. Alternatives to animal use will always be assessed and in vitro testing performed as an alternative wherever possible.

Clinical development

We perform our clinical trials in accordance with the listed directives, applicable laws and the global standards of good practice (e.g. Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and the Declaration of Helsinki) and summary information on our studies are made available on www.clinicaltrial.gov. We always obtain written informed consent from trial subjects by providing fair and balanced information to help them understand the potential risks and benefits associated with participation in a given trial. The rights, safety and well-being of trial subjects are paramount and prevail over any commercial or business interests. We always protect the confidentiality of trial subjects and abide by data protection laws. We have set in place procedures to monitor and report any adverse events during trials to the relevant regulatory authorities.

Targets for 2012-13

• Ensure we continue to meet our ethical obligations to clinical trial subjects: Update and relaunch our internal procedures to evaluate and respond to any serious adverse events in our clinical trials.
• Launch and complete mandatory training for all relevant employees on Good Practices (GxP), including Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP).
• Enhance processes for responding to investigator-initiated studies: Finalise new investigator-initiated study policy and standard operating procedure, and provide improved transparency on grant support process.