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European Pharmaceutical Contractor

Biostatistics: Improving the Chances

With the cost of developing a new drug estimated at about $1 billion, and a continuing decline in new chemical entity approvals worldwide, companies face ongoing pressure to boost the efficiency of their development programmes.

Establishing a sound biostatistical approach at the planning stages of clinical trials can increase the probability of programme success, decrease costs or accelerate timelines. As part of this effort, biostatisticians are increasingly taking an active role throughout all stages of drug development. This activity includes initial strategy; study design and implementation; data analysis; working to engage regulators on key statistical aspects prior to submission; regulatory submissions; and post-submission support.

 


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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.

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Kerry Gordon
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Gary Shorter
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Terry Weber Sosa
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