 Spectrum --
August 2006
 Introduction:
Pharmacogenomics will
revolutionize the drug industry by linking the right drug to the right patient.
Several companies and regulatory agencies are leading the charge to implement
this approach of developing targeted medicines. PGx’s integration is
inevitable; pharma companies must get on board now or risk being left behind.
Get the Answers You Need to Shape Your Strategy:
 Big pharma companies have become increasingly interested in
PGx. These companies realize that PGx offers a way to develop better and safer
drugs. Which companies are leading the charge to integrate PGx into drug
discovery and development?
Appropriate genetic markers and well-documented patient
samples are critical to determining disease correlations. How are companies
obtaining this information, and how are they using it to create personalized
medicines?
Although PGx is being integrated into many aspects of drug
discovery and development, many regulatory and ethical challenges persist. What
are the major issues remaining, and what are companies and regulatory agencies
doing to overcome these challenges?
Scope:
PGx leaders: review of companies that are leading the
implementation of PGx.
Patient populations: examples of well-documented
patient samples used to determine disease correlations.
PGx in practice: ways companies are currently using PGx
in drug development, patient segmentation, drug dosing, and postmarketing.
Remaining challenges: review of regulatory, ethical,
reimbursement, and legal hurdles that companies must overcome.
Spectrum Expert Commentaries: an official with
the FDA and Decision Resources’ principal director for epidemiology share their
insights.
Related Spectrum Reports:
The Role of Pharmacogenomics in Personalized Medicine
Has Genomics Failed to Deliver?
The Trend Toward Personalized Medicine
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