Research and Markets: Shift Toward 'Personalized Medicine' is Helping the Drug Industry to Achieve the Goal of Cost-Effective and Faster Research
Posted on: Thursday, 23 June 2005, 06:00 CDT
Research and Markets (http://www.researchandmarkets.com/reports/c19689) has announced the addition of Biomarkers in Clinical Development: Implications for Personalized Medicine and Streamlining R&D to their offering.
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/c19689
Source: Business Wire
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