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Research and Markets: Shift Toward 'Personalized Medicine' Is Helping the Drug Industry to Achieve the Goal of Cost-Effective and Faster Research


Research and Markets logo. (PRNewsFoto)

LONDON XEN 08/20/2004



DUBLIN, Ireland, June 1 /PRNewswire/ -- Research and Markets
(http://www.researchandmarkets.com/reports/c18540 ) has announced the addition
of Biomarkers in Clinical Development: Implications for Personalized Medicine
and Streamlining R&D to their offering.
(Logo: http://www.newscom.com/cgi-bin/prnh/20040820/RESEARCH )
The cost to discover and develop a drug is increasing dramatically;
however, the number approved new drug products on the decline. Drug
manufacturers, desperate for ways to expedite the drug discovery process while
decreasing the expense, are turning to biomarkers as one possible solution.
Biomarkers in Clinical Development: Implications for Personalized Medicine and
Streamlining R&D examines the current state of biomarker development and
application, with a close look at the technologies and how they are being
deployed from research to the clinic.

Biomarkers can be influential in every phase of drug development, from
drug discovery and preclinical evaluations through each phase of clinical
trials and into post-marketing studies. Biomarkers can predict a patient's
response to a compound, act as a surrogate endpoint, and aid in making
efficacious and cost-saving decisions or terminating drug entities more
quickly during the research process. Patient enrichment strategies are using
biomarkers to identify certain patient populations that are m ore likely to
respond to the drug therapy or to avoid specific adverse events. This shift
toward "personalized medicine," in which the patient receives a treatment
based on their genetic as well as medical profile, is helping the drug
industry to achieve the goal of cost-effective and faster research.

Biomarkers in Clinical Development: Implications for Personalized Medicine
and Streamlining R&D evaluates the following technologies, strategies, and
issues in biomarker research:

* Technologies to discover and screen biomarkers, particularly with
regard to their impact on both biomarker identification and application in
wide-scale clinical use.

* Various approaches to biomarker discovery and development employed by
companies such as Pfizer, Bristol-Myers Squibb, Roche, and Novartis.
Specialist companies, such as SurroMed, are also profiled.

* The FDA's perspective on biomarkers in clinical development, and their
classification of validated and nonvalidated biomarkers.

* The influence of pharmacogenomics on new drug therapies and biomarker
detection devices.

* Biomarker deals among pharmaceutical, biotech, and non-profit
companies.

* Risks associated with biomarker usage.

* The related fields of theranostics, proteomics, pharmacogenomics, and
molecular imaging.

The decision to utilize a biomarker in a drug program needs to be weighed
carefully to ensure that drugs that affect certain biomarkers also affect
clinical outcomes. This report provides the necessary scientific and strategic
insight for all companies wishing to profit from the use of biomarkers in drug
development.

Expert contributors
Felix Frueh, FDA Center for Drug Evaluation and Research; Aaron Kantor,
SurroMed
David Lester, Pfizer; Rick Ludwig, Indiana Center for Applied Protein
Sciences
Robert McBurney, BG Medicine; Rudy Potenzone and Richard Chen, Ingenuity
Systems; Michael T. Stocum, Personalized Medicine Partners

Contents include the following:

Chapter 1. Introduction
Chapter 2. From Discovery to Clinic
Chapter 3. Overall Approach Used by the Pharmaceutical Industry
Chapter 4. Biomarkers: From Clinical Research to Diagnostic Tool
Chapter 5. Business Outlook and Conclusion

Company Profiles
Affymetrix
Beckman Coulter
BG Medicine
BioMarker Pharmaceuticals
Ciphergen Biosystems
Clinical MicroArrays
Gene Logic
High Throughput Genomics
MDS Pharma Services
ParAllele BioScience
SurroMed
Xenogen

List of Figures
List of Tables

For more information visit
http://www.researchandmarkets.com/reports/c18540

Laura Wood
Senior Manager
Research and Markets
[e-mail]
Fax: [phone]


SOURCE Research and Markets
Web Site: http://www.researchandmarkets.com/reports/c18540
Photo Notes: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20040820/RESEARCH AP Archive:
http://photoarchive.ap.org PRN Photo Desk,
[e-mail]


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