CSL Ltd Annual Report 2021

Listening to our patients’ needs We have strong and deep relationships with key stakeholders across the sector, including healthcare professionals, regulators, patients and clinical groups. These ties are an important part of the social capital that adds value to our business. CSL continues to find mutually beneficial ways to partner with patient stakeholders to address community needs and advance collective expertise and thinking across our therapeutic areas. CSL continues to work on developing methods and processes for periodically and consistently engaging with patient stakeholders at key points in the development continuum, thereby ensuring CSL will continue to deliver on its promise to patients. ‘What does Kathrin think?’ The hereditary angioedema (HAE) R&D program is leveraging the power of patients by asking that question and including HAE patient, Kathrin Schön, in clinical trial planning. Ms Schön, a German medical student, was selected to support the HAE operational teamwith the development of two Phase III studies focusing on the rare disease. Her experience as an HAE patient, combined with her medical background, gives her a unique perspective of great value to the CSL Behring team. Ms Schön’s ongoing involvement provided easy access to valuable insights on a continual basis. Clinical trial improvements which will benefit patients In March 2020, following the onset of the COVID-19 pandemic, CSL was forced to make the difficult decision to place all clinical trials on enrolment hold. With patient safety at the forefront of our minds, our clinical teams developed strategies to re-engage clinical investigators before recruitment for clinical trials was recommenced in the second half of 2020. Robust clinical trial and site restart processes were implemented across all studies and included assessment of local conditions and ensuring our clinical sites had taken the necessary safety precautions before allowing patients to return. While enrolment was paused, CSL study teams worked closely with clinical site staff to maintain contact with patients already enrolled in trials to confirm patient safety and conduct study procedures as feasible and appropriate. CSL also established a COVID Management Team (CMT) as the single point of contact to ensure harmonisation across all programs. As COVID-19 vaccines received emergency use authorisation, CSL medical and safety teams played an essential role in the review of available data and the creation of proper guidelines. Through the CMT, vital information was provided to the study teams, ensuring the appropriate and safe use of CSL investigational medicines for clinical trial participants who had received a COVID-19 vaccine. Our teams communicated clear guidelines and recommendations to our investigators on how best to navigate the situation and provided additional flexibility in our protocols, while maintaining patient safety and quality standards as our utmost priority. This flexibility translated into the use of telehealth and/or home visits, where appropriate, to collect study data and provide study medication. Despite the global upheaval brought on by the COVID-19 pandemic, CSL has continued to increase its flexibility and approach to clinical research. This includes enhancing our medicine delivery procedures to include direct shipment of study medication to patients’ homes and continuing to offer telehealth and home visits (where appropriate). During the COVID-19 pandemic, CSL was agile with the start-up and management of COVID-related clinical trials; these learnings will benefit other CSL clinical trials (present and future). CSL’s patient recruitment for outpatient research has also evolved beyond just creating patient outreach programs to using online patient support groups and social media. Clinical trials in progress and new In 2020/21, CSL had 43 clinical trials in operation across all therapeutic areas. Of those, 16 had a first patient enrolled in the trial during the year. CSL conducts ethical clinical trials and adheres to exemplary standards of integrity in the formulation, conduct and reporting of scientific research. This is based upon three primary elements: scientific integrity, patient safety and investigator objectivity. 43 clinical trials in operation across all therapeutic areas 16 regulatory inspections with no impact to clinical licences The CSL Clinical Quality Management System allows us to monitor and effectively oversee the quality of our clinical trials and includes good clinical practice (GCP), pharmacovigilance (PV), good laboratory practice (GLP) and good research laboratory practice (GRLP) audits. Over the reporting period, 12 clinical trial registrations and nine clinical trial results were published and made readily available to stakeholders and the general public. These were all disclosed in a timely manner and in compliance with our transparency policy. Our policy reflects international requirements and standards including requirements from the International Committee of Medical Journal Editors, WHO guidance and legislative requirements. In addition, 16 (seven CSL Behring and nine for Seqirus) inspections were undertaken by regulatory agencies such as the US Food and Drug Administration (FDA), the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, Health Canada, and the Australian Therapeutic Goods Administration (TGA). All inspections confirmed adherence with GCP requirements, validated the data integrity of our clinical trials and had no impact on clinical trial licences or operations. CSL Limited Annual Report 2020/21 30 7 Powered by Innovation