spacer
home > epc > spring 2009 > biostatistics: improving the chances
PUBLICATIONS
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.

 


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

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.

spacer
Kerry Gordon
spacer
spacer
spacer
Gary Shorter
spacer
spacer
spacer
Terry Weber Sosa
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Turkish Cargo includes Sheremetyevo Airport near Moscow to its cargo flights network.

As the fastest growing brand among the global air cargo carriers with its extensive flights network, Turkish Cargo included Sheremetyevo Airport (SVO), known as being the most important airport in Russia in terms of cargo activities, to its direct cargo flight destinations network.
More info >>

White Papers

Medpace Reference Laboratories establishes state of the art Flow Cytometry techniques for flexible approaches to clinical trials across multiple therapeutic areas.

Medpace

Cytometry is the process of measuring the properties of individual cells. These properties may include gene or protein expression, chemical properties, deoxyribonucleic acid (DNA) content, and various cellular functions. The earliest methods of cytometry relied upon light microscopy for the classification and observation of cells and cellular components. Microscopy permitted direct visual observation of cells for the first time, leading to the classification of cells by morphology and insight into cellular functions. However, the time required for microscopic analysis constrains the number of samples or number of cells in each sample that can be examined. Therefore, the utility of microscopy for analysis of rare cells or in situations where sample throughput is a priority is limited. Flow cytometry was developed largely to improve upon these limitations.
More info >>

 
Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement