Key Speakers • Garry Scrivens, Senior Principal Scientist, Pfizer • David Elder, Externalization Director, GlaxoSmithKline • Ahmed Yasin, BioPharm Analytical & Formulation Research, GlaxoSmithKline • Dagmar Mohr, Group Head Analytical R&D and QC Biotech Products, Roche • Simona Bohanec, Head of Regulatory Analytics, Sandoz • Duu-Gong Wu, Executive Director, PharmaNet • Jan Jiskra, Project leader, Synthon • Jane Robinson, Principal Scientist, Biotherapeutics, National Institute for Biological Standards and ControlFailing to conduct a proper stability testing can be very time consuming and costly for companies, and damaging to their reputation. The cost of taking NCE through the development stages can range anywhere between $800 million to $1.2 billion (source: Springer, 2009). It is therefore, important for companies to understand key factors affecting the stability profile of a potential product, and carry out an effective stability program.