Personalized Medicine was an emerging field of medicine in 2005 when we first held what was to become an annual event, our personalized medicine conference. The importance of personalized medicine was given a boost by the then U.S. Secretary of Health and Human Services, Michael Leavitt, who said in January 2005, “I believe we are moving into a remarkable and powerful new era in medicine and particularly in prescription drugs.
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Less than 15 years ago, submitting an application to the Food and Drug Administration (FDA) for the approval of a new medicine generally involved loading docks, moving trucks, and enough paper to obliterate a small tree farm. Today, those data once supplied on hundreds of thousands of paper pages are now a structured collection of electronic files submitted to the FDA through a secure portal.
Yesterday, the Senate Finance Committee held its first hearing on the Transatlantic Trade and Investment Partnership (TTIP), a comprehensive free trade agreement that the U.S. and European Union have begun negotiating.
Yesterday, I had the opportunity to speak at a conference of regulatory and compliance professionals – those who are dedicated to ensuring that regulation works.
Millions of prescriptions are filled every year in the United States and the patients who depend on these medications must have confidence in their safety and authenticity.
A survey commissioned earlier this year by PhRMA shows 86 percent of Americans believe developing cures for more forms of cancer should be one of the top national health priorities.
Until this morning, on the rare occasions when I thought of Omaha, Nebraska, I would conjure up images of Warren Buffett, thick juicy steaks, a clean quiet Midwestern city and friendly, laid-back folks, not necessarily in that order.
I learned today that I was not inaccurate, all of the above is true, but my picture was far from complete.
Alzheimer’s has proven to be a stubborn, puzzling and perhaps even symbolic disease. In recent years, it has emerged as one of our greatest tests of biopharmaceutical science because of the disease’s vast and growing impact on the health of our aging population and the viability of our health care system.
Today, PhRMA will be hosting a stakeholder action group meeting with the National Council for Prescription Drug Programs (NCPDP) called “Maximizing Prescription Quality Through ePrescribing.” NCPDP is a non-for-profit, American National Standards Institute (ANSI) certified standards development organization.
How can we continue to advance cancer research and improve patient outcomes in an era of cost containment? The issue was recently highlighted in a New York Magazine article that only provided part of the story on cancer progress and cost containment. Last week I had the opportunity to tackle this question as part of a roundtable that convened leaders from across the cancer community.
Today, I’ll be speaking to state-wide leaders in California regarding the state’s fight against obesity.
This year, biopharmaceutical companies committed to transforming how their clinical research can be used to advance innovation for patients through careful sharing of clinical trial data with independent researchers.
More than 30 million Americans suffer from rare diseases – conditions that are classified as such because they affect fewer than 200,000 people in the United States.