Dr. Kevin J Carroll offers more than 25 years of drug development experience across all trial phases and multiple therapeutic areas including Oncology, CV, Metabolism, Respiratory, CNS and GI.
This includes extensive experience in the design, conduct, analysis and reporting of clinical trial programmes and in shaping the content and strategy of multiple new drug regulatory submissions both in the US and EU. Uniquely for a statistician in industry, Kevin has contributed directly as primary presenter and Sponsor representative at several critical FDA Advisory Committee meetings and further has valuable experience on ‘the other side’, acting as a mock FDA panellist for Sponsors preparing for their own upcoming Advisory Committee meetings.
Experience with FDA/Advisory Committees and Regulatory Authorities Worldwide
Broad experience with multiple new and supplemental drug applications
Sponsor support, FDA Endocrinologic and Metabolic Drugs Advisory Committee, April 2015
SAG and CHMP Oral Hearing preparation, dapagliflozin, March 2012
Japanese MHLW open public hearing on Iressa, March 2005.
Decades of accumulated experience of face-to-face interactions on critical statistical and drug development issues with health authorities worldwide including the US FDA, Japanese (MHLW), UK (MHRA), Canadian (Health Canada), German (BfArM), Sweden (MPA), Spanish (AEMPS), French (AFSSAPS), Dutch (MEB), Australian (TGA) and Swiss (SwissMedic)