As debate about the President’s budget for 2012 takes center stage, Michael Milken’s opinion piece in last week’s Wall Street Journal is more timely and apropos than ever. Milken underscores the need to invest in our own health, noting that “improved public health translates directly into greater national productivity, which underpins all economic growth.” But incentives in health care investment are not aligned. The stock market values companies that make cosmetics and beer far above pharmaceutical companies that develop life-saving drugs.
He presents public-policy steps that can remove some barriers to growth in medical research – matching the inducements of other countries, recognizing ROI in federal health research, supporting prevention, and giving the FDA adequate resources. Read the piece in its entirety.
Tuesday, February 15, 2011
Monday, February 14, 2011
FasterCures weighs in on the proposed NIH National Center for Advancing Translational Science (NCATS)
NIH is soliciting feedback on its proposal to create a new NCATS, “to establish a focused, integrated, and systematic approach for building new bridges to link basic discovery research with therapeutics development and clinical care.”
FasterCures considers this a significant development at NIH, a serious effort to centralize and increase the impact of existing translational research programs and activities at NIH and to consider other ways the agency can further the development of promising basic science discoveries. We registered our own approval of this initiative in a letter to NIH.
We encourage others to take a serious look at the proposal, think about how it might impact the work that you do, and offer your comments on the Web site. NIH has engaged in a remarkably transparent process to share it’s thinking and solicit others’, and we know they are taking seriously the commentary they receive.
We hope you will take the time to be part of this important effort. Submit your comments.
FasterCures considers this a significant development at NIH, a serious effort to centralize and increase the impact of existing translational research programs and activities at NIH and to consider other ways the agency can further the development of promising basic science discoveries. We registered our own approval of this initiative in a letter to NIH.
We encourage others to take a serious look at the proposal, think about how it might impact the work that you do, and offer your comments on the Web site. NIH has engaged in a remarkably transparent process to share it’s thinking and solicit others’, and we know they are taking seriously the commentary they receive.
We hope you will take the time to be part of this important effort. Submit your comments.
Monday, February 7, 2011
Crossing Over the Valley of Death
by Angelo Bouselli, Senior Communications Manager
Stem cells. Genes linked to Alzheimer’s, autism, diabetes. Cancer drugs tailored to treat an individual tumor. Every day we see stories in the media about the latest medical “breakthroughs” that could lead to cures for dreaded diseases. And yet, over the years, many breakthroughs like these have yet to bear fruit for patients. Why? FasterCures’ new whitepaper Crossing Over the Valley of Death, examines one significant factor, a gap in funding and support for the critical stage of the research process known as translational research.
Many basic discoveries barely get to start the journey down the therapeutic development pipeline because structural, intellectual, technical, and funding barriers make it difficult to advance any further. They get stuck in an ever-widening gap, known as the "Valley of Death," between a promising scientific discovery and the point at which a company is willing to pick it up and move its development forward.
According to a recent Wall Street Journal article, “the Food and Drug Administration (FDA) approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.” Monthly drug-approval reports on the FDA's website show the number of new drugs approved in 2010 is down from 25 in 2009 and 24 in 2008, but slightly higher from a recent low of 18 in 2007.
The National Institutes of Health (NIH) states that 80 to 90 percent of research projects fail before they ever get tested in humans. By industry’s reckoning the number may be even higher— for every 5,000 compounds tested, only five make it to clinical trials, and only one is ever approved by the FDA. Half of all experimental drugs in Phase III trials never become approved medicines.
In Crossing Over the Valley of Death, FasterCures, in collaboration with the Parkinson’s Action Network, reviews the drug development pipeline from the most basic research conducted at academic research centers and supported by the NIH to the large-scale Phase III clinical trials conducted by pharmaceutical companies. It also features case studies from the sickle cell and neurodegenerative disease communities that illustrate the Valley of Death’s impact on cutting edge therapeutic development.
In the great film “Lawrence of Arabia,” T.E. Lawrence had a gift for making overcoming apparently insurmountable barriers seem merely a matter of taking them on. Confronted by a seemingly impassible desert, Sherif Ali says, “There is the railway. And that is the desert. From here until we reach the other side, no water but what we carry with us. For the camels, no water at all. If the camels die, we die. And in twenty days they will start to die.” Replies Lawrence, “There’s no time to waste then, is there?”
To learn more about the importance of translational research in the therapeutic development process, some promising approaches to trying to bridge the gap, and what more needs to be done, read: Crossing Over the Valley of Death.
Stem cells. Genes linked to Alzheimer’s, autism, diabetes. Cancer drugs tailored to treat an individual tumor. Every day we see stories in the media about the latest medical “breakthroughs” that could lead to cures for dreaded diseases. And yet, over the years, many breakthroughs like these have yet to bear fruit for patients. Why? FasterCures’ new whitepaper Crossing Over the Valley of Death, examines one significant factor, a gap in funding and support for the critical stage of the research process known as translational research.
Many basic discoveries barely get to start the journey down the therapeutic development pipeline because structural, intellectual, technical, and funding barriers make it difficult to advance any further. They get stuck in an ever-widening gap, known as the "Valley of Death," between a promising scientific discovery and the point at which a company is willing to pick it up and move its development forward.
According to a recent Wall Street Journal article, “the Food and Drug Administration (FDA) approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.” Monthly drug-approval reports on the FDA's website show the number of new drugs approved in 2010 is down from 25 in 2009 and 24 in 2008, but slightly higher from a recent low of 18 in 2007.
The National Institutes of Health (NIH) states that 80 to 90 percent of research projects fail before they ever get tested in humans. By industry’s reckoning the number may be even higher— for every 5,000 compounds tested, only five make it to clinical trials, and only one is ever approved by the FDA. Half of all experimental drugs in Phase III trials never become approved medicines.
In Crossing Over the Valley of Death, FasterCures, in collaboration with the Parkinson’s Action Network, reviews the drug development pipeline from the most basic research conducted at academic research centers and supported by the NIH to the large-scale Phase III clinical trials conducted by pharmaceutical companies. It also features case studies from the sickle cell and neurodegenerative disease communities that illustrate the Valley of Death’s impact on cutting edge therapeutic development.
In the great film “Lawrence of Arabia,” T.E. Lawrence had a gift for making overcoming apparently insurmountable barriers seem merely a matter of taking them on. Confronted by a seemingly impassible desert, Sherif Ali says, “There is the railway. And that is the desert. From here until we reach the other side, no water but what we carry with us. For the camels, no water at all. If the camels die, we die. And in twenty days they will start to die.” Replies Lawrence, “There’s no time to waste then, is there?”
To learn more about the importance of translational research in the therapeutic development process, some promising approaches to trying to bridge the gap, and what more needs to be done, read: Crossing Over the Valley of Death.
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