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Targeting Disease through Pharmacogenomics & Personalized Medicine
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Over the last 4-5 years the topics of Pharmacogenomics, the use of genomic or genetic information to predict a drug's efficacy or toxicity and to explain inter-individual differences in response to a drug, and personalized medicine, the tailoring of medical treatment to individuals, have been garnering increasing attention in Washington policy circles. BIO member companies are involved in using innovative pharmacogenomics and personalized medicine approaches across the full spectrum of drug development and commercialization, from target identification to post-market analyses of approved products.
Indeed, changes in the regulatory review process and the healthcare reimbursement system are already underway, and will accelerate in coming months and years. Such changes may either foster or block access to new therapies for patients. Moreover, many related issues pertaining to ethics, privacy, and physician and patient education, will need to be identified and addressed for this emerging arena.
Fact Sheets
BIO’s Principles on Personalized Medicine
Read BIO’s Principles
BIO Comments
HHS Action Plan to Prevent Healthcare-Associated Infections (February 6, 2009)
BIO’s Comments on the HHS action plan
Read the comments
The US System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of HHS. (December 21, 2007)
BIO's comments on the SACGHS draft report
Read the comments
Realizing the Promise of Pharmacogenomics: Opportunities and Challenges (June 1, 2007)
BIO's Comments on the SACGHS draft report.
Read the comments
Response to Stakeholder Questions Regarding Personalized Medicine Posed by the President’s Council of Advisors on Science and Technology (PCAST) (April 4, 2008)
BIO’s Response to PCAST
Read the response
Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays (IVDMIA) (August 7, 2007)
BIO’s Comments on the FDA’s Draft Guidance
Read the comments
Regarding Pharmacogenomic Data Submissions (Feb. 2, 2004)
Read BIO's comments.
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