Attendees from selected biotechnology companies from across the Nordic region were welcomed by the Simbec-Orion team at our symposium hosted at the British Embassy in Copenhagen on 16 May, supported by the UK’s Department of International Trade (DIT).
The ‘Clinical Development Plans for Rare Disease and Oncology Therapies to Improve your Net Present Value’ symposium included presentations from Dr Simon Hutchings, Dr Fabrice Chartier, Dr Alain Thibault, Sadiq Lutfi, Sivakumar Muthusami and Ronald Openshaw, Q&A sessions, lunch and networking opportunities.
If you would like to request any of the presentations please email information@SimbecOrionCRO.com
The symposium started with an address from Her Majesty´s Ambassador to Denmark, Dominic Schroeder, and then covered the following presentations encompassing areas which can significantly impact an organisations financial value.
- “The Effective implementation of the revised EMA guidelines for First-into-Human studies, including integrated protocol design for rare disease”
- Dr Simon Hutchings, Director of Scientific Affairs
- “Efficient trial design to minimise cash burn in orphan drug devlopment”
- Dr Fabrice Chartier, Group Chief Operating Officer
- “Optimising early phase oncology study design; modular multi-arm approach”
- Dr Alain Thibault MD
- “Practical steps to achieve Orphan Drug Designation status including, eligibility criteria, incentives, marketing approval, market exclusivity, EU & FDA requirements”
- Sadiq Lutfi, Regulatory Affairs Manager
- “Pharmacovigilance, considerations in early phase oncology and rare and orphan studies”
- Sivakumar Muthusami, Director of Pharmacovigilance, QPPV MDS
- “Meeting your commercial, licencing, M&A and financial objectives by collaborating with your CRO as an ally”
- Ronald Openshaw, CEO.