Preparing the Clinical and Regulatory Master Plan

Developing an accurate clinical and regulatory master plan is the key to getting any new drug or device product to the global marketplace quickly and in a cost-efficient manner. The master plan provides an invaluable roadmap of what needs to be done, and will also be used as a business plan in dealings with your notified body and potential investors. In this audio conference, our speakers discuss not just planning for CE marking, but incorporating the overall global market access into one plan. Attendees learn how key parameters and claims are defined, which is an important starting point.

The presentation also covers how to ensure compliance throughout the regulatory pathway to the global market, and how to ensure there is sufficient data available for immediate success of your products in global markets.

Preparing the Clinical and Regulatory Master Plan is being presented by Efraim Roe Kozorovitsky & Dr. Sunita Ahir, Executive Director, Medical Devices & Manager, Regulatory Affairs, with Premier Research and airs on Thursday, September 24, 2009. For more details or to register, please visit our site at www.fxconferences.com

Oncology Trials in 2009: Challenges & Innovative Approaches

One of the greatest risks for oncology trials today is the delay in clinical development timelines. The main reason for the timeline delay is patient recruitment. Due to the increase in the number of ongoing clinical trials in recent years, and subsequently decreased enrollment in the developed countries, innovative approaches are necessary to mitigate the risk of delay.

To meet clinical development timelines, proactive planning and comprehensive data analysis are necessary to mitigate the risk. Detailed planning and appropriate site and country selection are the most critical factors in meeting target patient accrual goals. This audio conference provides practical guidelines and innovative ideas which are useful when conducting oncology trials in the current environment.

Oncology Trials in 2009: Challenges & Innovative Approaches is being presented by Dr. Ute Berger, Vice President & Head of Medical Affairs - Europe, Africa & Asia-Pacific, with PRA International and airs on Tuesday, July 28, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Optimizing Your Chemistry, Manufacturing & Control Program

Chemistry, Manufacturing, and Controls (CMC) programs are an integral part of the development process which brings a drug from the preclinical phase to the market. Without a CMC program that is properly integrated with the clinical, non-clinical, and marketing programs, the entire development cycle can be delayed, resulting in lost time, revenues and market life cycle. However, the extent of necessary activities in CMC programs can vary depending on the development phase of the drug.

In this audio conference we explore how the skillful combination of drug characterization, manufacturing and packaging processes, analytical test methodology, compliance with applicable regulations and adequate documentation all help to ensure that the CMC portions of an application meet the necessary requirements, as well as supporting the clinical and nonclinical studies being performed to establish the safety and efficacy of the drug.

Optimizing Your Chemistry, Manufacturing & Control Program is being presented by Dr. Miguel de Soto-Perera, Vice President of Pharmaceutical Sciences, with Beckloff Associates, Inc. and airs on Wednesday, June 10, 2009. For more details or to register for this event, please visit our site at 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