Talk title: Have We Lost the Plot in Phase III Development?
Abstract: In 2010 twenty one NDA/NBAs were approved. The ratio of NME:NBE was 15:6. A decade earlier 29 entities were approved; NME:NBE ratio was 27:2. The rapid evolution of the science base has enabled access to new targets, but the failure rate has grown dramatically too. This can be traced back to poor decision making. The main reason is that candidates were inappropriately nominated at the end of Phase II or did not have the appropriate characterization during Phase II.
Dr. Doogan has been part of pharmaceutical R&D for most of his professional life, starting first in the Netherlands as a project physician. He joined Pfizer in 1982, where he was in charge of the sertraline (Zoloft) clinical development program. He has held a number of senior positions in R&D in the US, UK, China and Japan. He retired from Pfizer in April 2007 where he was Senior Vice President World Development. Subsequently, Declan joined Irish pharmaceutical outfit, Amarin, to help re-calibrate its R&D focus from CNS to its current cardiovascular program.
Dr. Doogan holds a number of executive board appointments principally in the fields of pharmaceutical R&D and life science investments. He is also a Visiting Professor at Harvard School of Public Health, Glasgow University Medical School and Kitasato University (Tokyo). He is interested not only in the scientific aspects of drug development but also in defining new strategies to improve yield and effectiveness in human drug development. He is also involved in charities such as the Haitian Health Foundation, the Pulmonary Vascular Research Institute and Odessey, a cancer charity. Doogan is also president and co-founder of health focused social network, WeAre.Us.
Dr. Doogan received his medical degree from Glasgow University in 1975. He is a Fellow of the Royal College of Physicians and the Faculty of Pharmaceutical Medicine in the UK.
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