Patient-centred approaches in cell and gene therapy Dr Ewa G Truchanowicz Director [email protected] www.dignio.com 

Progress meets Legacy ❑Recent decades- sea change in patient/provider dynamics ❑Rise of social media and core information accessibility ❑Personalised therapies requiring: ▪ new supply chain structures ▪ novel healthcare pathways ▪ unique economic models for re-imbursement processes ▪ paradigm shift in interaction with the patients, care providers and budget holders 

Current pains in cell and gene therapy (and you may know of many more…) www.dignio.com 3 Post-treatment patient monitoring costs Long-term patient monitoring methods & costs Lack of definitive economic models for reimbursement Multiple unknows in side effects Technological leaps not matched in speed by infrastructure Supply chain traceability Handling of the treatment at the clinic High cost of treatment= pressures on healthcare providers’ budgets 

4 www.dignio.com Dignio Solution 

Patient-centred from the start… ❑A reliable, robust and cost-effective platform for remote patient monitoring; used for 6+ years in Norway for multiple disease groups ❑Adapted for cell and gene therapy context using feedback from subject experts, clinicians, budget holders and most importantly, patients ❑Created in collaboration with University of Birmingham and University Hospitals Birmingham NHS Trust- a Russell Group University and an NHS Digital Exemplar Trust including one of the largest teaching hospitals in Europe ❑Project led by Midland/Wales Advanced Therapy Treatment Centre 

Key features of the current project with ATTC ❑Currently constructed application tailored to capture electronic patient reported outcomes in clinical trials ❑Usability testing in the UK completed and positive feedback obtained ❑Replaces paper-based patient reported outcome systems still prevalent in the UK ❑Streamlines the data pathway from patient to the archiving facility at the end of the trial – ❑ Embeds Real World Data gathering and enables Real World Evidence analysis ❑Allows ‘between clinic appointments’ monitoring and data collection ❑Funded by industrial strategy icsf Innovate UK Grant 

Questions? THANK YOU FOR YOUR ATTENTION [email protected]