The Pharmaceutical Research and Manufacturers of America (PhRMA) reports that America's pharmaceutical research and biotechnology companies are the primary source of R&D funding for new medicines, both for projects in their own laboratories and for research licensed from other sectors. Industry-wide spending on research reached a record $58.8 billion in 2007 - nearly double the National Institutes of Health's entire budget - and is a major reason why America leads the world in developing cures for such diseases as cancer and AIDS.
There must be assurance that "the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm are established and documented." (CFR Title 21-Part 211).
A record 750 new medicines to treat cancer are in research pipelines at America's pharmaceutical research companies. These therapies are being tested in human clinical trials now or await approval by the FDA.
The medicines represent many cutting-edge approaches, including one medicine that targets and kills specific cancer cells and then activates the patient's immune system to destroy any remaining cancer. An experimental kidney cancer drug boosts life expectancy by about one-third in this difficult-to-treat disease.
In commenting on a recent study that found women who survive five years after breast cancer diagnosis have a good chance of remaining cancer-free, the American Cancer Society's Len Lichtenfield said "[t]hanks to new drugs, women today may fare better" than women in the study, who were treated between 1985 and 2001, USA Today reported on Aug. 13.
Advances in cancer treatments have improved survival rates across the disease spectrum; patients diagnosed with breast cancer, prostate cancer, colorectal cancer and lung cancer all have improved survival rates since 1975. According to a Columbia University study, up to 60 percent of the survival gain is attributable to advances in cancer treatments.
The nation's arsenal of cancer medicines has tripled since 1971. On average, a cancer patient now lives one year longer than in the 1970s. Today, there are 3 million more cancer survivors than just one year ago.
A new generation of cancer therapies target specific molecules in cancer, such as remedies for chronic myelogenous leukemia. Not only are the remedies more powerful but sparing normal cells results in less severe side effects.
"These newest cancer medicines add to substantial progress made in the last five years by pharmaceutical research and biotechnology companies in developing new and more effective cancer treatments, said PhRMA President and CEO Billy Tauzin.
PhRMA also reported that "America's pharmaceutical and biotechnology companies...are testing a record 633 new biotech medicines."
"The 633 biotechnology medicines being developed nationwide include 254 medicines for cancer; 162 for infectious diseases; 59 for autoimmune diseases; 34 for HIV/AIDS and related conditions; 25 for cardiovascular disease; and 19 for diabetes and related conditions," it states.
The Association's recently issued "Profile 2008: Pharmaceutical Industry"1 details the research and development conducted by American biopharmaceutical companies. The report states that in 2007, the entire industry invested $58.5 billion in research and development. That's about $2 billion more than the figure the association recorded in 2006.
1 Pharmaceutical Research and Manufacturers of America, Pharmaceutical Industry Profile 2008 Washington, DC: PhRMA, March 2008
Robyn Barnes is a marketing communication specialist at MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies (www.mastercontrol.com).
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