Managing Challenges in Early Drug Development: Biologicals and Small Molecules

April 28 & 29, 2009, Lyon (Hotel Espace Tete d’or), France

Biologics and small molecules are a challenging experience and expectations as to their potential are high. However, the first administration of a new compound to man is a particularly critical moment in drug development, pre-clinical information is limited and not necessarily transferable to humans. New molecules with not yet fully understood pharmacological action can yield unpredictable outcomes of otherwise well designed trials.

This meeting addressed how sponsors, investigators, regulatory authorities and ethics committees might adapt to these new challenges. It was also the third Joint Meeting of AGAH and Club Phase 1 and we were delighted to welcome also many of our colleagues from Belgium and the UK.