'Although lack of efficacy is an important cause of late stage attrition in drug development the shortcomings in the translation of toxicities observed during the preclinical development to observations in clinical trials or post-approval is an ongoing topic of research.'
‘A key aspect of realizing the full potential of database interoperability is to promote the use of consistent terminology and “cross-walk” approaches for addressing the different terminologies already in use.’
‘I believe that we are now in toxicology at the point where clinical medicine was 30 years ago. Evidence-based methods hold promise to not only provide a way to objectively assess the evidence underlying regulatory decisions, but, given time, to improve the quality of individual studies and methodologies.’
'As scientists, we need to get together in small groups, to find a more open, more blunt, more cohesive way to move science and regulation forward in the same direction. There is a Valley of Death between scientific discovery and the time it takes to get regulatory acceptance.'