Neglected Diseases
Incentives to Develop Medicines for Neglected Diseases Highlighted at 2008 BIO International Convention (June 16, 2008)
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Read the white paper (2.31 MB PDF)
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Pharmacogenomics & Personalized Medicine
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
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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
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Realizing the Promise of Pharmacogenomics: Opportunities and Challenges (June 1, 2007)
BIO's Comments on the SACGHS draft report.
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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
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Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays (IVDMIA) (August 7, 2007)
BIO’s Comments on the FDA’s Draft Guidance
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Regarding Pharmacogenomic Data Submissions (Feb. 2, 2004)
Read BIO's comments.
The Value of Biotech Medicines
Recently, the rising prescription drug cost and access issues have dominated the U.S. domestic agenda, sparking debates on issues such as "drug importation" and increased access to generic drugs. But even though some important issues were resolved in 2003, the debate over the value of medicines is unlikely to subside with overall U.S. health-care spending climbing at near double-digit annual rates.
Although prescription drugs account for only 10.5 percent of health-care spending, they are a lightning rod because the sector is growing - thanks primarily to biotech and greater use of pharmaceuticals.
Biotechnology products are only a small part of the overall market for pharmaceuticals, but they are attracting increasing scrutiny from the media and legislators. In response, BIO is supporting a series of independent studies on the value of biotechnology drugs. Those studies will document the impact of biotech medicines on the health-care system and quality of life.
Realizing the Value of FDA-Approved Therapies (March 31, 2007)
by Bruce Pyenson, FSA, MAAA, Principal and Catherine Murphy-Barron, FSA, MAAA
The study, prepared by the international actuarial firm Milliman, Inc. found new innovative therapies, including both new drugs and biologics, will add 1 percent to the healthcare costs covered by private commercial payers, such as insurance companies and employer-sponsored health plans.
Read the study
Read the press release
Vaccines: We Must Prepare Now
The medical and public health communities long have recognized the tremendous value of vaccines and immunization, which in some instances have eradicated devastating diseases from affected populations and made enormous inroads in infectious disease prevention. Vaccines harness the power of the immune system to prevent disease before it occurs and some therapeutic vaccines target life-threatening diseases, such as cancer and HIV, after they have progressed.
Existing vaccines and novel, new vaccines in development promise enormous benefit in the fight against disease. However, the complexity of processes to develop and produce vaccines, consequent regulatory hurdles, and the high-risk nature of the vaccine market all raise barriers to vigorous vaccine production.
BIO's Principles on Vaccine Financing Policy (April 30, 2008)
Read the letter (99 KB PDF)
The Promise and Challenge of Adolescent Immunization (May 7, 2007)
Comments to the National Vaccine Advisory Committee.
Read the comments (147 KB PDF)
Pandemic Flu: We Must Prepare Now (January 12, 2006)
Read Jim Greenwood's statement
Greenwood Praises Passage of Pandemic Influenza Plan (December 22, 2005)
Read Jim Greenwood's statement
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