The market for biologics is growing at nearly twice the rate of Pharma as a whole. Given their often high costs compared to chemical-based traditional pharmaceuticals, this trend is placing increasing financial pressure on healthcare budgets. Against this context, biosimilar medicines offer a major opportunity to provide greater access to affordable health care. In order to be cost-effective, a biosimilar product needs access to global markets based on a single development programme that meets the requirements of regulators internationally.
Despite the challenges associated with the development of biosimilar drugs, many drug manufacturers are entering the race to develop biosimilars especially for blockbuster mAbs creating acute demand for investigators and patients. With increased clinical trial activity through Phase III, the ability to recruit patients into these important studies becomes a key stepping stone to Biosimilar commercial success.
PRA International, sponsors of the 2nd Global Clinical Trials Summit are leading a Half-Day Workshop: A Step by Step Approach to Globalize your Biosimilars Product. The Workshop Leader is Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA International. The Workshop addresses:
- Regulatory landscape – Global view
- Regulatory Scientific Advise- how to get the best result?
- Phase I Bioequivalence studies
- Bioanalytical and Immunogenecity
- Phase III Design considerations
- Reference product
- Operational Challenges
- What are the key study design considerations that drive recruitment?
- Does investigator/ patient education make a difference?
- Country selection: East vs. West?
- What are the key operational considerations for optimum cost and time to deliver?
- Safety data
The 2nd Global Clinical Trials Summit takes place in Seoul, South Korea on 20th & 21st May 2013 and is also supported by KHIDI – the Korean Health Industry Development. It offers an unique opportunity to network with an international Pan-Asia, European & American platform of speakers, sponsors and delegates to debate developments in Clinical Outsourcing, Regulation, Data Management and Operations.
Source: Global Clinical Trials Summit