Session Speaker

Challenges in Clinical Drug Development
Julius Anthony Vaz, Binny Krishnankutty
India

Developing new drugs is a tough business. In recent years drugs emerging from pharmaceutical houses have reduced dramatically. Many factors have contributed to this decrease and have been well documented in several publications. Failures in clinical drug development remain an important factor that prevents drugs reaching the market place.
Failures in clinical development can be minimized by having robust clinical trial designs, precise subject selection criteria and appropriate selection of country and sites to name a few. Health authority interactions to discuss the existing data package, clear go/no go decisions at critical stages in drug development and a continuous review of the overall clinical program in contrast to emerging data, emerging competitors and changing standards will go a long way in minimizing the risk in clinical development process.
Risks involved in clinical development are: 1) Negative outcome 2) Cost overruns 3) Timeline delays and 4) Positive outcomes that do not support registration and/or commercialization of a drug. Several real life examples like the development of pulmonary insulin, GLP1 analogues, recombinant factor 7a in intra-cerebral hemorrhage along with several other examples on the challenges in Clinical drug development will be presented.