Kerry Gordon is Executive Director of Biostatistics at Quintiles Europe. He completed his PhD in Medical Statistics part-time, whilst working as a statistician in the National Health Service in the UK. Following spells with Ciba-Geigy AG and the University of Kent, Kerry joined Quintiles in Bracknell, UK in 1993. Kerry has established and developed SOPs, developed and delivered training courses and participated on a number of data safety monitoring boards. He is a Chartered Statistician and is ex-chairman of PSI (Statisticians in the Pharmaceutical Industry Limited).
Gary Shorter is Director for Global Biometrics Business Planning at Quintiles head office in Durham, NC. He has over 15 years’ experience in the industry, previously working at Pfizer and the University of Kent before joining Quintiles in 2003. He has supported many Phase I-IV studies, along with four submissions to the FDA (concentrating on the CV, GUGI and CNS therapeutic divisions) that have included the latest regulatory requirements on ICH, CDISC and eCTDs.
Terry Weber Sosa has over 20 years’ experience in clinical trials in both the CRO and pharmaceutical setting, including 15 years of management experience, with over six years of direct oversight of large biostatistics and statistical programming groups. She has served as biostatistical lead and consultant on many large, multi-study programmes and submission programmes and has broad experience covering all phases of clinical trials, particularly Phase III studies, regulatory submissions, interaction with the FDA and participation in FDA meetings.