The Event
In keeping with Oxford Global’s highly successful life sciences series, an expert panel of 20 speakers will present a full conference programme covering the topics outlined below. These topics have been compiled as a result of a comprehensive research process undertaken with advisory board members including VPs, Directors, Senior Research Fellows and Professors from global pharmaceutical organisations and leading research institutions.
Stream Titles
Biosimilars: Market Opportunities, Manufacture & Scale-Up
Developing Biosimilars: Opportunities & Challenges In Clinical Trials
Day 1 – Biosimilars: Market Opportunities, Manufacture & Scale-Up
- Market opportunities & commercial challenges in US, Asia & emerging markets
- Regulatory challenges & developments
- Flexible & cost effective manufacture of high quality biosimilars
- Quality by design
- Early stage selection considerations
- Single use systems
- New production modes & platforms
Day 2 – Developing Biosimilars: Opportunities & Challenges In Clinical Trials
- Complex proteins as biosimilars
- Clinical protocol & patient safety
- Increasing potency
- CMC considerations
- PK/PD testing
- Developing an efficient scale-up process
- Demonstrating biosimilarity & characterisation
- Pharmacovigilence