Spring Intro 2023

06/03/2023

Hot topics

• Impact of Biosimilars

– Traceability and identification

• Personalised medicine and Biomarkers

• Incorporating increased rigour of Health Technology Assessment and reimbursement – Justification of high drug costs!! • Advanced-therapy medicinal products (ATMPs) and immunotherapies • Impact of new Pharmacovigilance legislation and continuous benefit:risk evaluation • Early Approval and access pathways need careful planning

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Biotechnology - Conclusions

• Know your product and process

• Design non-clinical / clinical programme based on knowledge of pharmacology and intended use

• Follow guidelines but not ‘check-box’ approach

• Biosimilars are changing lifecycle planning

• Joined up HTA and Regulatory strategies required to achieve any premium pricing in right time frame

• ATMPs building the next wave of biotechnology interest

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