The Future of Clinical Development in Pharma and Biotech
Samson Fung, M.D. - Fung Consulting HealthCare and Life Sciences

Despite rising R&D costs the productivity has constantly fallen over the years and attrition rates are still very high. Still, 14 molecular entries are needed to achieve 1 approval although with no guarantee for economic success. Moreover, patent expiry is becoming an increasing threat to “Big Pharma” profit margins.

In recent years, propulsed by advances in molecular and genetic sciences Biotech has become the research and innovation centre for pharma and will remain so in near future via intensified take overs and partnerships.

The increasing innovation pressure on pharma has been triggering a variety of initatives to enhance output amongst which creation of translational science departments and introduction of so called “intelligent trial designs (e.g. adaptive trials designs)” are only a few of many examples.

The forthcoming years will see many changes to the current way of conducting R&D business: a higher degree of specialization driven by regulatory and politicaleconomical requirements will necessitate more focussed and tailored clinical studies, better trained personel…….. and more intelligent drug designs.