Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines

One of the greatest risks to successful drug development today is delayed clinical development timelines. Detailed planning and appropriate site and country selection is the most critical factor in meeting target patient accrual goals within the planned timeline. Historically, site and country selections have been made primarily utilizing survey-based prospective feasibility. Unfortunately, survey-based feasibility alone is no longer sufficient to provide the detail necessary to select countries and sites to maximize patient accrual and minimize development timelines. An evidence-based methodology approach coupled with survey-based feasibility provides the most accurate forecast for patient accrual and the selection of sites and countries with the highest likelihood of being productive.

In this audio conference we will discuss the key items of an evidence-based approach to feasibility and ultimately, site and country selection.

Beyond Global Feasibility: An Evidence-Based Approach to Creating Realistic Development Timelines is being presented by Kent Thoelke, Sr. Vice President of Therapeutic Expertise, Scientific & Medical Affairs, with PRA International and airs on Wednesday, March 25, 2009. For more details or to register, please visit our site www.fxconferences.com

Proteomics Role in Biomarker Discovery and Validation

Regulatory agencies continue to support the use of biomarkers and encourage biotech and pharmaceutical companies to have a biomarker strategy for all compounds. Biomarkers can play a significant role in identifying signal in early compound candidates as well as clinical targeting and stratification of efficacious populations.

We’ll examine proteomics role in the identification of novel protein biomarkers and subsequent high-throughput assay development and validation that can significantly reduce risk and enhance clinical development productivity and decision making in Pharmaceutical research.

Proteomics Role in Biomarker Discovery and Validation is being presented by Dr. Daniel Chelsky, Chief Scientific Officer with Caprion Proteomics and airs on Wednesday, February 11th, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Improving Clinical Development with Six Sigma

The current industry model for drug development is premised on failure by the investigative sites, and most funds are spent finding and repairing mistakes. In comparison to most other industrial systems in the last 30 years, this reactive and repair-focused approach is an anachronism, which causes delays and cost overruns. In contrast, Six Sigma facilitates a systematic attack against site and project management performance variance by shifting the focus from error remediation to error prevention.

This presentation provides a high-level introduction to Six Sigma, practical examples of how has Six Sigma has been deployed, and its impact on drug development. The speaker explores how Six Sigma process improvements can be applied to clinical program execution and provide several real life examples. Other topics of discussion include hurdles to success, necessary organizational commitments to support transformative measures such as Six Sigma, and what types of results can be expected.

Six Sigma is NOT a quick fix for all development woes, and this presentation will provide examples not only of the good, but also the bad and the ugly, where Six Sigma projects were inappropriately selected or scoped, or not well operationalized.

Improving Clinical Development with Six Sigma was presented by Tim Strauss, Executive Director Business Process Improvement of Covance on 2007-07-12. This audio conference is available for download at www.fxconferences.com

Asian Clinical Trials: What to Know Before You Go

Thinking of conducting clinical trials in Asia?

Certainly more and more pharmaceutical companies are, and with good reason. The predominantly secondary healthcare environment, treatment-naïve patients and large population can mean less time to recruit and faster clinical development. Data quality is high, there are fewer competing studies, and the presence of large hospitals means more patients per site and dramatically reduced trial costs. But jumping on the Asian bandwagon without the proper forethought and knowledge could turn your trial into a tribulation

This audio conference is presented by Anthony Bishop, Quintiles East Asia. For more details, please visit our site www.fxconferences.com