Insight Brief: Clinical Development of Cell and Gene Therapy Products in Australia (CAGT)

Clinical Development of Celland Gene Therapy (CAGT) Table of contents Why Australia for CAGT trials?Mature R&D ecosystemEstablished and favorable regulatory pathway in Australia Why Australia for CAGT trials? Australia, with its established regulatory framework and expertise, Cost effective Local excellence,global strategy Quality Quality data generated in Australia is acceptable to internationalregulatory agencies to support applications, including U.S. FDA Mature R&D ecosystem CDMO partners Australia is home to several established and capable Contract Development and Manufacturing Organization Established and favorable regulatory pathway in Australia Australia has established regulatory pathwaysfor CAGT clinical trials. Most of these trials •Simple CTN (Clinical Trial Notification)• Investigator’s Brochure (IB) Timeline: ~6 months Timeline: ~7 — 10 days Clinical Trial Approval (CTA) • Involves an evaluation process before aclinical trial begins•Reviews relevant but limited to scientificdata. This may include pre-clinical andearly clinical data • TGA does not evaluate clinical trial data •Instead, the data is reviewed and approved bythe Human Research Ethics Committee (HREC) Any biological or prescription medicineinvolving GMOs may require the reviewof Institutional Biosafety Committee (IBC)and licence from the Office of the Gene Dealings notinvolving KEY INFORMATION TO BE INCLUDED IN APPLICATION *GMO license application can besubmitted to OGTR at the same time assubmission to HREC and if TGA 1. Description of proposed activities involving GMO2.Description of proposed facilities3.Compliance to relevant standards and guidelines4.Endorsement by IBC (Institutional Biosafety Committee) License holder require to be accreditedunder the Gene Technology (GT) act. IQVIA, the leading CRO in Australia Supporting CAGT products from pre-clinical to post marketing CAGT focused team •CAGT Center of Excellence offering medical and scientific expertise to support clinical trials in Australia •CAGT Study Management Team (SMT) specializing in the operationalization of CAGT trialsin Australia •IQVIA AdBoard providing timely feedback on protocols to strengthen trial readiness Site network • Australiansites supporting smarter trial planning •2 prime sitesand14 partner sitesdelivering reliable performance across recruitment, retention,speed, and quality. A dedicated site relationship manager providingclose support to ensure quick •Vendor network accredited for complex logistics including depot and transportation chain for CAR-T Global reach, local impact •IQVIA’s local footprint with global capabilities allow sponsors to seamlessly integrate new countries as Local presence •Largest CRO in Australia and New Zealand with over 1100 employees •Low turnaround of staff bringing stability to your trials Market access and policy shaping •IQVIA’s consulting team to navigate Australia’s complex market access and •End-to-end strategy for CAGT: Commercialization, policy shaping, stakeholder engagement, and IQVIA global footprint Top CAGT therapeutic areas Therapy type KEY MODALITIES: Ready to expand your trial to Australia? Navigating the complexity of clinical trials and market access in Australia demands deep localknowledge and regulatory expertise. IQVIA combines broad CAGT expertise, robust site networks and