Patient experience Relationships with key stakeholders, including healthcare professionals, regulators, clinical groups, patients, and their communities deepen over time, adding significant value to the business and securing CSL’s license to operate. By working closely with patients, CSL can identify and pursue innovations that address unmet medical needs. In recent years, the biopharmaceutical industry has acknowledged the central role of the patient, acknowledging that patients are the experts on the reality of living with their condition. CSL, which develops and manufactures medicines and vaccines, lists patient focus as its foremost value and, for several years, has actively supported outreach programs. One such initiative is the Center for Information and Study on Clinical Research Participation (CISCRP) which is focused on clinical trials and improving the patient experience. Additionally, CSL is a founding member of PALADIN (Patient Advocacy Leaders and Drug Development Industry Network), a new organisation dedicated to optimising collaboration between the industry and patient advocacy groups in researching new treatments, as well as engaging in the EUPATI (European Patient Academy on Therapeutic Innovation). Clinical trials in progress and new In 2023/24, CSL had 60 clinical trials in operation across all therapeutic areas. Of those, seven trials had a first patient enrolled in the trial during the year. CSL conducts clinical trials ethically and adheres to the highest 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. The CSL Clinical Quality Management System allows CSL to monitor and effectively oversee the quality of clinical trials and includes both regulatory authority inspections and internal audits for good clinical practice (GCP), good pharmacovigilance practice (GVP), good manufacturing practice (GMP), good laboratory practice (GLP), good clinical laboratory practice (GCLP) and good research laboratory practice (GRLP). Over the reporting period, eight clinical trials were added, and 13 clinical trial results were posted, on an International Committee of Medical Journal Editors (ICMJE)-recognised public clinical trial registry. These were all disclosed in a timely manner and in compliance with CSL’s transparency policy. This policy reflects international requirements and standards including requirements from ICMJE, WHO guidance and legislative requirements. In addition, 13 inspections were undertaken by regulatory agencies including the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The inspections included nine GCP Inspections (two Sponsor and seven Investigator Sites), two GCLP inspections, one GVP inspection and one GMP inspection. All inspections confirmed adherence with GCP requirements, validated the data integrity of CSL clinical trials and had no impact on clinical trial operations. One of CSL’s most significant achievements for this fiscal year is the development of a Patient Focus Playbook. The Playbook was created as a guide to help R&D stakeholders navigate any uncertainties, and provide some standards, regarding how patient engagement should be included across the product development lifecycle. The Playbook was developed utilising a network of peer stakeholders from across the organisation and external best practices. These are only a few examples that exemplify CSL’s dedication to embedding patients’ insights and fostering a culture of patient focus into the daily work ethic of employees to maintain a strong patient-focused infrastructure. CSL understands the importance of diverse participation in clinical trials. Ideally, the mix of clinical trial participants would mirror the demographics of the population affected by the studied indication, yet minorities often remain underrepresented in clinical trials. Participants in clinical trials help answer important questions about potential new treatments, paving the way for innovation that will benefit future patients. Participation may also offer patients the opportunity to be among the first to receive innovative treatments. Therefore, it is crucial that the composition of clinical trials reflects that of the general population. Patient experience commitment CSL’s ambition is to elevate the Patient Experience in drug development by embedding patient insights and lived experience through patient-informed clinical development programs and formalising diversity plans to include representative populations. CSL’s Goals for 2030: • Informed Product Development: ensure all of CSL’s therapeutic product development programs are informed by patient insights. • Diverse Clinical Trials: ensure Phase III clinical trials incorporate diversity that is representative of the target indicated population. 60 clinical trials in operation across all therapeutic areas 13 regulatory authority inspections with no impact to clinical trial conduct 47
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