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
- Key Presenter for Sponsor, Brilinta (ticagrelor) for acute coronary syndrome (Cardiovascular and Renal Drugs AC), July 28, 2010
- Key presenter for Sponsor, Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Committee, March 10-11 2010
- Key presenter for Sponsor, Joint Meeting of the Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Committee, December 10-11 2008
- Key Presenter for sponsor, Iressa for advanced non-small cell lung cancer, 3-4 March 2005 (Division of Oncologic Drug Products AC)
- Presenter FDA Public Workshop on Clinical Trial Endpoints in Prostate Cancer, June 21-22, 2004
- Public Presenter, Oncologic Drugs AC, Colorectal Cancer Endpoints. May 3-4, 2004
- CHMP Oral Hearing, Iressa, June 2004
- 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)