From Site to Sample: Considerations for Effective Minimal Risk Diagnostic Research

is being presented by Kathleen Mandziuk & Cathy Michael, Scientific Affairs Director & Senior Director of Comprehensive Solutions, with PRA & BioStorage Technologies and airs on Thursday, May 3rd, 2012. For more details or to register, please visit our site at www.fxconferences.com

*PRA is sponsoring this event, making it complimentary for all registered attendees. Please register for this event, and submit complete attendee information once you've registered, so we can assure you a space in the webinar. Incomplete registrations will not be honored. Please register each line for your group separately.*

Webinar highlights

The exponential increase of discovery, validation and commercialization of diagnostic and companion biomarkers has lead to a greater need for effective, efficient and proven research methods. Many industry experts focus on processing biological samples – however, what happens beforehand to ensure high-quality samples and data is collected?.

This educational webinar will focus on the evolving space of biomarker research and established techniques for cost-effective high-quality execution strategies. The speaker will cover a wide variety of topics from various industry perspectives.

Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting

While considered a relatively novel term in research, biomarkers and diagnostics have been extensively used in the pre-clinical and clinical research and diagnosis arena for many years. Their magnitude in positively influencing the medical community’s ability to accurately diagnose and treat human conditions, although still undefined, seems limitless. Currently, a renewed focus is being placed on healthcare outcomes, and the containment of medical cost, diagnostics, biomarkers and personalized medicine are fostering better outcomes and savings.

In this Webinar, our speakers discuss how the need for more clinical applications for diagnostic biomarker testing is expected to have an explosive growth among several disease categories in the five years. They also explain how the operational execution of biomarker and diagnostic research varies greatly from traditional clinical research, while looking at the unique requirements and challenges.

Establishing Value for Diagnostics & Biomarkers in a Real-Life Setting is being presented by Dr. Jerome Wilson & Kathleen Kushner, Sr. Scientific Affairs Director & Scientific Affairs Director, Late Phase Services, with PRA International and airs on Tuesday, February 23, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development, the question arises as how to interpret the data.
The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range), and from this range, defining the probability of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approach embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation was presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, with Covance Central Laboratory Services and aired on 2009-01-28. For more details or to download this event, please visit our site at www.fxconferences.com

Regulatory Framework to Support Biomarker Development: EU & the USA

The European and US regulatory authorities recognize the potential of biomarkers to support the clinical and nonclinical development of medicinal products. Guidelines to clarify regulatory expectations have been published and both EMEA and FDA have developed procedures for companies to obtain input and advice on biomarker development. Importantly, those same regulatory authorities have both also formalized qualification procedures that result in an opinion on the acceptability/suitability of a biomarker.

This audio conference provides an overview of the EU and US biomarker qualification procedures. The speaker explains the steps involved, the data package required, and provides insight into why going through these procedures can add significant value with regards to investment opportunities, partnering and licensing deals.

Regulatory Framework to Support Biomarker Development: EU & the USA is being presented by Dr. Patricia Hurley, Head of Project Management and Biomarkers Division, with ERA Consulting (UK) Ltd. and airs on Thursday, January 21, 2010. For more details or to register, 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

Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development the question arises as how to interpret the data.

The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range) and from this range defining the probably of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approached based embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation is being presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, Covance Central Laboratory Services and airs Wednesday, January 28th 2009. For more details or to register for this audio conference, please visit our site www.fxconferences.com