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AACC Los Angeles, CA
DNA Bridges®, Inc. is presenting the following sessions at the AACC annual meeting in Los Angeles, CA
July 27-28, 2004

http://www.aaccdirect.org/AM/AMProduct.aspx?ID=2861

Chair: Eileen Gorman, Ph.D., CEO, DNA Bridges, Inc.
Leader: Eileen G Gorman, PhD, DNA Bridges, Inc., Wilmington, DE
Barbara Handelin, PhD, Kenna Technologies, West Chester, PA
Steven Peckman, Univ. of California, Los Angeles

Level: Intermediate
CE Credit: 1.5

Intended Audience: This session is intended for laboratory directors, pathologists, clinical chemists, pharmaceutical assay developers, diagnostic industry managers and scientists.

Overview: As new markers are developed, laboratories are called upon to evaluate them and their potential contribution to clinical practice. As a result, knowledge of the Institutional Review Board (IRB) process is key to participating in new marker development and validation. The session focuses on laboratory perspectives of key factors, including which representatives should be involved, the advantages and disadvantages of various study designs, and what studies may be considered exempt by the IRB. A case study will be presented.
Expected Outcomes: After this session, participants will be able to: 1) describe the key representatives required for the institutional review board; 2) identify challenges in study design that can impact the time required to obtain the study data; and 3) explain what types of studies may be exempt from the IRB requirements.

Tuesday, July 27, 2004

http://www.aaccdirect.org/AM/AMProduct.aspx?ID=3013

Tuesday, July 27 7:00 AM - 8:30 AM
4329 Interrelationships Between Drug Discovery, Development and New Clinical Markers

Tuesday, July 27 12:15 PM - 1:45 PM
5329 Interrelationships Between Drug Discovery, Development and New Clinical Markers

Presenter: Eileen G Gorman, PhD, DNA Bridges, Inc., Wilmington, DE

Intended Audience: This session is intended for lab directors, clinical chemists, IVD industrial managers and scientists.

Overview: More and more new clinical markers develop as a result of drug discovery efforts. Relationships between drug development and clinical markers will be explored. Case studies of clinical markers coupled with therapeutics will be explored. Examples at various stages of development and the impact on the laboratory will be discussed.
Expected Outcomes: Describe the critical link between new drug development and new marker development. Participants will also able to evaluate the potential time for commercialization of new markers related to new drugs being developed and summarize the goals for their organization to respond to the new wave of new drug related markers being developed.

2413 Cancer Screening Tests: More Complexity Amid Large Test Volumes
Wednesday, July 28 2:00 PM - 5:45 PM
http://www.aaccdirect.org/AM/AMProduct.aspx?ID=3061

Leader: Barbara Handelin, PhD, Kenna Technologies, West Chester, PA
Tony Shuber, EXACT Sciences Corp., Marlborough, MA
Eileen G Gorman, PhD, DNA Bridges, Inc., Wilmington, DE
Glenn Miller, PhD, Genzyme Genetics, Westborough, MA

Level:Intermediate
CE Credit: 3.5

Intended Audience: This session is intended for laboratory directors, clinical and molecular pathologists, and clinical chemists.
Overview: New cancer screening tests, expected to be performed on millions of samples, will increasingly require the analysis of complex genetic profiles (many mutations or gene expressions). This session will discuss the complexity of the technology combined with its complexity in interpretation, using PreGen Plus, a new colorectal screening test, as an example. Solutions by automation, interpretation software and the opportunity for laboratory clinicians to play an important role in patient management will also be presented.
Expected Outcomes: After this session, participants will be able to: 1) describe why complex genetic profiling is critical in current and future cancer screening tests; 2) identify the specific technical challenges of new cancer tests; 3) identify the specific information and interpretation challenges of new cancer tests; and 4) define appropriate solutions (current and future) for these technical and IT challenges.


 

 

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