[Source: ScienceDaily] - Despite the well-known dangers of first- and secondhand smoke, an estimated ten percent of pregnant women in the U.S. are smokers. Exposure of a developing baby to harmful cigarette byproducts from mothers who smoke affects an estimated 420,000 newborns each year and poses a significant health care burden.
Now, in the first study of its kind, a team of researchers has completed a global assessment of newborns' umbilical cord blood to better understand the fetal health risks from smoking mothers. The research was led by Johns Hopkins University and included Rolf Halden, a researcher from the Biodesign Institute at Arizona State University.
"Cigarette smoking is a massive onslaught on human physiology," said Halden, who works in the institute's Center for Environmental Biotechnology. Cigarette smoke is known to contain more than 4,000 chemicals, potentially affecting the health of a newborn baby on multiple levels, including low birth weight, premature delivery and small size for gestational age. The exact cause of these health effects continues to be the subject of investigation.
"Unfortunately, maternal cigarette smoking puts babies at risk of adverse birth outcomes and increases susceptibility to other diseases later in life," said Halden.
The research team's goal was to provide the first assessment of proteins detectable in infant blood and to identify possible molecular predictors, or biomarkers, of fetal health risks.
The emergence of improved analytical tools allowed the researchers to address newborn health risks and explore the environmental effects of a well-known toxin in a level of detail not previously available. These tools include high-speed DNA sequencing, a powerful instrumental analysis called proteomic mass spectrometry to enhance the detection of proteins in complex samples, and bioinformatics, or the raw computing power to perform massive data crunching to tease out and identify biomarkers.
In doing so, the team described over 200 serum proteins contained in umbilical cord blood, the vital link between mother and developing baby that shares between the pair both essential nutrients as well as unwanted toxins absorbed by the mother.
"Modern tools in mass spectrometry and bioinformatics have enabled us to obtain a first view of proteins contained in fetal cord blood serum and to single out among these more than a dozen interesting ones whose concentrations change as a function of chemical exposure. These biomarkers of exposure and early effect are the gold of protein mining," said Halden, who is also an associate professor in the Ira A. Fulton School of Engineering.
Halden, who joined ASU's Biodesign Institute in 2008, initiated the study while at Hopkins along with lead author David R. Colquhoun, and colleagues Lynn R. Goldman, Frank R. Witter, Robert N. Cole, Marjan Gucek, Malini Mansharamani, and Benjamin J. Apelberg. The results were published in the early online edition of the journal Environmental Health Perspectives (http://www.ehponline.org).
To best obtain a snapshot of fetal proteins at birth, the study needed to obtain cord blood samples as soon as possible after newborn delivery. This required the coordinated efforts of multiple investigators and the resources of the large teaching hospital at Hopkins to recruit study subjects. Among the participants were many doctors and nurses to help with deliveries and obtain cord blood samples along with graduate students who were on call and had to rush out in the middle of the night to collect samples, transfer and process them, and analyze the data from the study population.
The group started with a large pool of more than 300 cord blood samples, and after adjusting for parameters such as the age of the mothers, narrowed down their focus to a dozen babies, half from non-smoking mothers and the other half from pregnant smokers.
"The study was a little bit challenging in that we went out on a fishing expedition," said Halden. "We wanted to look at everything at the same time, and the ability to tease out from the soup of proteins only those of interest was the chief technical challenge of this project."
The team looked for new proteins or proteins levels that may have changed between the smoking and non-smoking groups. After analyzing more than 200 proteins through mass spectrometry in smoke-exposed and control groups, they found small changes in the levels of some proteins, which represented biomarkers of cigarette smoke exposure.
"Of 17 proteins that were significantly up- or down-regulated in the cord blood of babies born to smoking mothers, 14 have previously been described to be related to smoking in either adults or in the fetus," said Lyne Goldman, a professor in the Department of Environmental Health Sciences at Johns Hopkins' School of Public Health.
The protein biomarkers have been linked to key metabolic pathways involved in regulating nutrients, oxygen and inflammation processes. After their analysis, the team also discovered some surprising results that illustrate the subtlety of using biomarkers as an approach to peer into the molecular makeup of human health. "There was not a single protein unique to either the smoking or non-smoking group," said Halden. "The remarkable finding is that there were no unique biomarkers."
Halden explains that only through the combined use of the new technologies was the research team able to tease out the small differences in the proteins levels between the two study groups.
Asked about the reliability of the biomarkers that the research team identified? Halden said, "The truth is that we don't know yet. We only took a first snapshot of the protein profile in baby blood right after birth. But does it change over time and will the differences we detected persist? We don't know."
The group hopes to use the same techniques to examine a wide range of environmental exposures and their effect on human health. "These findings confirm and underscore the serious metabolic alterations that are occurring in utero to children of smoking mothers, alterations that may increase risk for chronic disease over a lifetime," said Hopkins colleague Frank Witter. "We hope that this method will be sensitive enough to detect proteomic changes associated with environmental exposures as well."
The ultimate hope is that through the use of biomarkers identified by the team, it may become possible to detect effects of toxic exposures early on, before the onset of disease. "This may open opportunities to improve health outcomes by reducing the occurrence and severity of disease from environmental exposures, said Halden."
Showing posts with label Biomarkers. Show all posts
Showing posts with label Biomarkers. Show all posts
Friday, December 5, 2008
Tuesday, August 5, 2008
CLINXUS PARTNERSHIP DEVISES IMPROVED TESTS TO DETECT KIDNEY DAMAGE FOR NEW DRUGS IN DEVELOPMENT
[Source: Joe Gavan, ClinXus] - The Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC), which includes Grand Rapids-based ClinXus, has identified seven new tests to assess the safety of new drugs in development, specifically to monitor the drugs’ effects on the kidneys. The U.S. Food and Drug Administration (FDA) and its equivalent in Europe, the European Medicines Agency (EMEA), recently approved the use of these tests in the pre-clinical phase of drug development, as well as the use of five of the tests in some cases bridging pre-clinical and Phase I clinical studies.
The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Currently, researchers and clinicians typically look for changes in serum creatinine and blood urea nitrogen (BUN), but these may only show up after the onset of kidney injury, which can be permanent.
According to William Mattes, Ph.D., C-Path’s director of the PSTC, “Using current kidney tests that were developed over 100 years ago, 70 percent of kidney function must be lost before damage can be detected. The newly approved biomarkers are far more sensitive and specific for drug-induced kidney damage.”
Many of the newly approved biomarkers are not new to the research and clinical community. But the lack of specific scientific “rules” or standards about their utility has prevented companies from using them for fear that data from the studies could further delay the FDA and EMEA approval process. By quantifying biomarker information and getting approval to use the tests from these regulatory bodies, the PSTC has eliminated a significant barrier to the drug development process.
The next steps are to gather more data to support using these tests more broadly in clinical studies, and eventually to get approval to use some or all of the biomarkers to help guide medical decision-making.
“ClinXus has always been dedicated to introducing molecular biomarkers into the clinical trial process,” said ClinXus Board President Craig P. Webb, Ph.D., Van Andel Institute scientific investigator and director of translational medicine. “Our role in the next phase of the Critical Path’s PSTC effort will be to facilitate the clinical evaluation of these new biomarkers and diagnostic tests.”
This is the most significant accomplishment to-date of the PSTC, which was created in 2006 to identify improved methods to test the safety of new drugs in development and bring life-saving drugs to the FDA more quickly and safely. The collaboration involves over 200 scientists from the sixteen largest pharmaceutical companies, non-profit research organizations, and advisors from the FDA and the EMEA. ClinXus, a community-based clinical research alliance focused on innovative devices/medicines, became the first nonprofit to join the PSTC earlier this year.
The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity. Currently, researchers and clinicians typically look for changes in serum creatinine and blood urea nitrogen (BUN), but these may only show up after the onset of kidney injury, which can be permanent.
According to William Mattes, Ph.D., C-Path’s director of the PSTC, “Using current kidney tests that were developed over 100 years ago, 70 percent of kidney function must be lost before damage can be detected. The newly approved biomarkers are far more sensitive and specific for drug-induced kidney damage.”
Many of the newly approved biomarkers are not new to the research and clinical community. But the lack of specific scientific “rules” or standards about their utility has prevented companies from using them for fear that data from the studies could further delay the FDA and EMEA approval process. By quantifying biomarker information and getting approval to use the tests from these regulatory bodies, the PSTC has eliminated a significant barrier to the drug development process.
The next steps are to gather more data to support using these tests more broadly in clinical studies, and eventually to get approval to use some or all of the biomarkers to help guide medical decision-making.
“ClinXus has always been dedicated to introducing molecular biomarkers into the clinical trial process,” said ClinXus Board President Craig P. Webb, Ph.D., Van Andel Institute scientific investigator and director of translational medicine. “Our role in the next phase of the Critical Path’s PSTC effort will be to facilitate the clinical evaluation of these new biomarkers and diagnostic tests.”
This is the most significant accomplishment to-date of the PSTC, which was created in 2006 to identify improved methods to test the safety of new drugs in development and bring life-saving drugs to the FDA more quickly and safely. The collaboration involves over 200 scientists from the sixteen largest pharmaceutical companies, non-profit research organizations, and advisors from the FDA and the EMEA. ClinXus, a community-based clinical research alliance focused on innovative devices/medicines, became the first nonprofit to join the PSTC earlier this year.
Friday, June 6, 2008
EMEA, FDA jointly qualify renal biomarkers
[Source: EMEA] - The European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have concluded their first joint qualification process for biomarkers.
Based on pooled data submitted by the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC), the two agencies qualified the use of seven biomarkers of drug-induced renal toxicity in the context of non-clinical drug development. The data were filed with both the EMEA and the FDA, which conducted a joint evaluation using state-of-the-art standards, the European agency said.
According to a recent white paper by Thomson Scientific, while biomarkers are set to become “one of the major drivers of pharmaceutical research and development in the 21st Century”, commitment from innovators is patchy and regulatory authorities remain conservative about accepting biomarkers as primary evidence for drug approval. Without more determined efforts at validation, the report warned, there is a danger researchers will lose faith and turn their attention elsewhere.
After assessing the biomarker data filed by the PSTC, the EMEA and the FDA concluded that:
• the renal biomarkers submitted were acceptable in the context of non-clinical drug development for detection of acute drug-induced renal toxicity;
• the biomarkers provided information that was “additional and complementary” to the currently available standards;
• the use of renal biomarkers in clinical trials should be considered on a case-by-case basis, “in order to gather further data to qualify their usefulness in monitoring drug-induced renal toxicity in man”.
As the EMEA pointed out, under the C-Path PSTC programme the pharmaceutical industry “has for the first time pooled together data from different companies in order to achieve the critical mass of scientific information” that enabled the European agency and the FDA to qualify the renal toxicity biomarkers.
The PSTC is a public/private partnership between industry, academia and regulators, intended as a neutral body for co-ordinating activities related to biomarker qualification in drug development. It was set up by the non-profit Critical Path Institute two years ago, with the FDA serving in an advisory capacity.
A consortium of eight leading pharmaceutical companies took the unprecedented step of agreeing to share preclinical laboratory data in order to improve the testing of medicines before they reached human clinical trials. The FDA has made biomarkers central to the Critical Path programme, launched in March 2004 with the aim of modernising and streamlining medical product development.
Recently one of the PSTC partners, Novartis, announced it had completed a two-year co-operative research and development agreement (CRADA) with the FDA, yielding a process for defining and qualifying safety biomarkers as well as real-world data to support regulatory decision-making on renal safety.
The relevant data were shared with the PSTC and, together with data generated by other partners in the Consortium, were filed with the FDA and the EMEA as part of a Voluntary Exploratory Data Submission (VXDS).
Based on the agency’s experience with the first joint qualification process, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) recently published a draft document, Biomarkers Qualification: Guidance to Applicants, which is out for consultation until 30 June 2008.
Based on pooled data submitted by the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC), the two agencies qualified the use of seven biomarkers of drug-induced renal toxicity in the context of non-clinical drug development. The data were filed with both the EMEA and the FDA, which conducted a joint evaluation using state-of-the-art standards, the European agency said.
According to a recent white paper by Thomson Scientific, while biomarkers are set to become “one of the major drivers of pharmaceutical research and development in the 21st Century”, commitment from innovators is patchy and regulatory authorities remain conservative about accepting biomarkers as primary evidence for drug approval. Without more determined efforts at validation, the report warned, there is a danger researchers will lose faith and turn their attention elsewhere.
After assessing the biomarker data filed by the PSTC, the EMEA and the FDA concluded that:
• the renal biomarkers submitted were acceptable in the context of non-clinical drug development for detection of acute drug-induced renal toxicity;
• the biomarkers provided information that was “additional and complementary” to the currently available standards;
• the use of renal biomarkers in clinical trials should be considered on a case-by-case basis, “in order to gather further data to qualify their usefulness in monitoring drug-induced renal toxicity in man”.
As the EMEA pointed out, under the C-Path PSTC programme the pharmaceutical industry “has for the first time pooled together data from different companies in order to achieve the critical mass of scientific information” that enabled the European agency and the FDA to qualify the renal toxicity biomarkers.
The PSTC is a public/private partnership between industry, academia and regulators, intended as a neutral body for co-ordinating activities related to biomarker qualification in drug development. It was set up by the non-profit Critical Path Institute two years ago, with the FDA serving in an advisory capacity.
A consortium of eight leading pharmaceutical companies took the unprecedented step of agreeing to share preclinical laboratory data in order to improve the testing of medicines before they reached human clinical trials. The FDA has made biomarkers central to the Critical Path programme, launched in March 2004 with the aim of modernising and streamlining medical product development.
Recently one of the PSTC partners, Novartis, announced it had completed a two-year co-operative research and development agreement (CRADA) with the FDA, yielding a process for defining and qualifying safety biomarkers as well as real-world data to support regulatory decision-making on renal safety.
The relevant data were shared with the PSTC and, together with data generated by other partners in the Consortium, were filed with the FDA and the EMEA as part of a Voluntary Exploratory Data Submission (VXDS).
Based on the agency’s experience with the first joint qualification process, the EMEA’s Committee for Medicinal Products for Human Use (CHMP) recently published a draft document, Biomarkers Qualification: Guidance to Applicants, which is out for consultation until 30 June 2008.
Thursday, April 17, 2008
FDA soon may support biomarker tests
[Source: Ann Fernholm, Chronicle Staff Writer] - The Food and Drug Administration is poised to throw its support behind a powerful new method of predicting the safety of experimental drugs, a step that could help pharmaceutical companies bring treatments to market more quickly - and reduce patients' risk.
The process being considered uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects.
"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," said Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development.
Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals' reactions aren't always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.
"Using current tests, you have lost about 70 percent of the kidney function before you pick it up," says William Mattes, director of toxicology at the Critical Path Institute in Tucson.
The new biomarker process has the potential to save a patient's kidneys.
The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Co. and Pfizer. The companies contribute their expertise but, according to Woosley, the institute does not accept commercial funding.
Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.
"This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials," said Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology.
Goodsaid is responsible for the development of the FDA's biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.
Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park's SRI International to break a worrying trend within the pharmaceutical industry: In the past decade the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically.
Meanwhile, scares like the one associated with the painkiller Vioxx, which turned out to cause heart attacks and strokes, have further fueled this trend.
Unique for the Critical Path Institute is that FDA is a cofounder. Today, the European Medicines Agency - an agency similar to the FDA - also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA.
"This is the first time they have coordinated their decisions," Mattes said.
Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA's attitude toward present drug safety tests.
"Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said.
He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication.
"Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used," says Wolfe.
The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day.
"It is in a very advanced stage of that process," Goodsaid said. "We should have some news soon."
What are biomarkers?
A biomarker is an indicator that can be used to test a biological function. Some biomarkers turn up when organs are injured and cells within the damaged tissue release substances into the blood, urine or saliva. These substances can then be used to detect dangerous side effects.
E-mail Ann Fernholm at afernholm@sfchronicle.com.
The process being considered uses seven indicators - known as biomarkers - that signal kidney injury when found in the urine of test subjects.
"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," said Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, which is working with the FDA to safely speed drug development.
Currently, experimental drugs are tested in animals before being taken to human clinical trails. But animals' reactions aren't always the best predictor of whether substances will be safe for humans. Drugs harmless to animals can hurt humans, and vice versa. If a drug toxic to the kidneys passes animal tests today, the damage might not show up until it is too late.
"Using current tests, you have lost about 70 percent of the kidney function before you pick it up," says William Mattes, director of toxicology at the Critical Path Institute in Tucson.
The new biomarker process has the potential to save a patient's kidneys.
The ultimate goal of the pharmaceutical industry is to have a range of such marker tests that would signal dangerous side effects like heart failure, liver damage or cancer. Samples of blood, urine or saliva, for example, would be taken from participants in a clinical trial. If certain biomarkers indicated the patient was at risk, the trial could be stopped before any major damage occurs.
Seventeen companies have joined the research into biomarkers at the Critical Path Institute. These include giants like Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck and Co. and Pfizer. The companies contribute their expertise but, according to Woosley, the institute does not accept commercial funding.
Initially, the seven biomarker testing processes will be qualified by the FDA for use in preclinical animal studies, and only as a complement to current tests.
"This qualification process allows the industry to have an accurate view of the application of these biomarkers in drug development. They are not replacing anything that is done today. But the goal, as we gather more and more information, is to eventually be able to include them in clinical trials," said Federico Goodsaid, senior staff scientist at the genomics group at the FDA Office of Clinical Pharmacology.
Goodsaid is responsible for the development of the FDA's biomarker qualification pilot process, which began about a year ago when 23 potential biomarkers for kidney damage were submitted to the federal agency. The evaluation process at the Critical Path Institute has since selected the seven most efficient ones.
Named for the risky period when a drug is taken from the preclinical stage into clinical trials, the Critical Path Institute was founded two years ago by the FDA in collaboration with University of Arizona and Menlo Park's SRI International to break a worrying trend within the pharmaceutical industry: In the past decade the number of innovative therapies submitted for FDA approval dropped by 50 percent, but the cost of drug development increased dramatically.
Meanwhile, scares like the one associated with the painkiller Vioxx, which turned out to cause heart attacks and strokes, have further fueled this trend.
Unique for the Critical Path Institute is that FDA is a cofounder. Today, the European Medicines Agency - an agency similar to the FDA - also participates as an adviser. The agency is expected to qualify the seven biomarker testing method simultaneously with FDA.
"This is the first time they have coordinated their decisions," Mattes said.
Sidney Wolfe, director of the health research group at Public Citizen, a nonprofit public interest organization, supports the use of biomarkers as long as they are properly validated. But he is critical of the FDA's attitude toward present drug safety tests.
"Findings of toxicity in the currently required animal tests are not taken seriously enough by companies or by the FDA," Wolfe said.
He cites two recent examples of drugs in trouble, both of which showed toxicity in laboratory animals: the diabetes drug Avandia from GlaxoSmithKline and Vytorin from Schering-Plough and Merck, a cholesterol-lowering medication.
"Avandia showed evidence of heart damage in animal studies and, for Vytorin, tests showed serious toxicity in laboratory animals, regardless of how low a dose of this combination drug was used," says Wolfe.
The official announcement of the qualification of the seven biomarkers for kidney injury is expected from the FDA any day.
"It is in a very advanced stage of that process," Goodsaid said. "We should have some news soon."
What are biomarkers?
A biomarker is an indicator that can be used to test a biological function. Some biomarkers turn up when organs are injured and cells within the damaged tissue release substances into the blood, urine or saliva. These substances can then be used to detect dangerous side effects.
E-mail Ann Fernholm at afernholm@sfchronicle.com.
Thursday, October 18, 2007
Integrated Biosystems Research 2007 Symposium
"Advances in Proteomics Research," sponsored by the Arizona Proteomics Alliance, will be held Friday, November 16, 2007:
Purpose:
- 8 am ~ Registration (& Coffee), Poster set up
- 8:45 am – 5 pm ~ Lectures, Lunch, Posters Session, Panel Discussion
- 5 – 6 pm ~ Reception
Purpose:
- To foster a collaborative research network in Arizona advancing systems biology and its translation to personalized medicine.
- To advance the proteomics capabilities in the state through improved awareness of the most cutting-edge methodologies and their novel applications.
- Dr. Leland Hartwell, Fred Hutchinson Cancer Research Center
- Dr. Brian Balgley, Calibrant Biosystems, Inc.
- Dr. James Kerwin, House Ear Institute
- Dr. Amanda Paulovich, Fred Hutchison Cancer Research Center
- Dr. Tom Grogan, Ventana Medical Systems
- Dr. Russ Finley, Wayne State University
- Dr. Jeffrey Trent, Translational Genomics Research Institute
- Dr. George Poste, The Biodesign Institute
For more information, visit http://www.integrativeproteomics.org/. To register before the November 9 deadline, contact Pam Young at 480 727-0378 or Pamela.Young@asu.edu
Wednesday, June 27, 2007
Biomarkers consortium launches website to accept proposals, provide funding updates
[Source: GenomeWeb staff reporter] -- The Biomarkers Consortium today said it has launched a website that can be used to submit biomarker project concepts, to obtain funding information, as a contact point, and for updated news about the consortium’s activities. The consortium is a research partnership managed by the National Institutes of Health and funded by contributing members. It comprises 28 public and private partners including companies, patient advocacy organizations, government groups, and non-profit institutions.
The website provides a way for researchers to submit biomarker project concepts to therapeutic area steering committees. The first three steering committees comprise experts in neuroscience, metabolic disorders, and cancer. A fourth steering committee in inflammation and immunity is being assembled. When approved, concepts are developed into formal project proposals and, when approved by the consortium’s executive committee, the Foundation for NIH will seek the funds to implement them, according to the consortium. To date, more than $6 million has been raised to support the consortium’s lung cancer and lymphoma biomarker projects, the consortium said.
Founded in late 2006, the consortium aims to promote groups looking to accelerate delivery of technologies, medicines, and therapies that can help prevent, detect, diagnose, and treat diseases. “In time, we will expand the website’s coverage to include a members-only section, and provide comprehensive information about biomarkers, such as cutting edge research from the scientific and regulatory community,” said Anthony Altar, the consortium’s director.
Link: http://www.biomarkersconsortium.org/
The website provides a way for researchers to submit biomarker project concepts to therapeutic area steering committees. The first three steering committees comprise experts in neuroscience, metabolic disorders, and cancer. A fourth steering committee in inflammation and immunity is being assembled. When approved, concepts are developed into formal project proposals and, when approved by the consortium’s executive committee, the Foundation for NIH will seek the funds to implement them, according to the consortium. To date, more than $6 million has been raised to support the consortium’s lung cancer and lymphoma biomarker projects, the consortium said.
Founded in late 2006, the consortium aims to promote groups looking to accelerate delivery of technologies, medicines, and therapies that can help prevent, detect, diagnose, and treat diseases. “In time, we will expand the website’s coverage to include a members-only section, and provide comprehensive information about biomarkers, such as cutting edge research from the scientific and regulatory community,” said Anthony Altar, the consortium’s director.
Link: http://www.biomarkersconsortium.org/
Friday, June 1, 2007
Alliance Aims to Boost Biomedicine
Arizona’s bioscience efforts continue to grow through an extensive, statewide collaborative network of initiatives. Now, research capabilities are being allied around the state in a new effort to improve medical diagnostics and human health.
The Arizona Proteomics Alliance (AZPA), a statewide consortium, has been formed to advance the emergent science of proteomics, a science whose broad vision is to understand the biological role of the complete set of proteins in the human body, or proteome. The initiative combines the expertise of nine leading Arizona institutions, including ASU, Banner Health, Barrow Neurological Institute, Carl T. Hayden Veterans Affairs Medical Center, Intrinsic Bioprobes Inc., Mayo Clinic, Sun Health Research Institute, Translational Genomics Research Institute (TGen) and the University of Arizona (U of A). “This alliance places Arizona in the forefront of proteomics research capabilities and will no doubt have broad impact on biomedical research and personalized medicine,” said Jeff Trent, president and scientific director of TGen.
AZPA promotes a team approach to solving problems of significant biomedical interest, according to Michael Mobley, administrative director of AZPA and associate director of the Biodesign Institute at ASU. The alliance will advance the role of proteomics research in the understanding of human health and disease by creating a network of scientists who share resources and expertise.
“AZPA facilitates access to technical and intellectual resources that are rarely surpassed within the United States, and provides the state with a distinct competitive advantage in this field,” says Serrine Lau, scientific director of AZPA, director of Southwest Environmental Health Sciences Center at the U of A’s College of Pharmacy, and a member of U of A’s BIO5 Institute. “We are pleased that the resources of the Arizona Proteomics Consortium at U of A will be part of this state-wide alliance,” Lau says.
The Mayo Clinic is also expecting to be able to expand its efforts and bring new diagnostic and treatment options to its patients as part of the proteomics initiative, according to Laurence Miller, director of research and the cancer center at the Arizona Mayo Clinic. “The alliance will put Arizona in a stronger position to compete for federal and private research funding,” Mobley says.
The effort builds on the vast knowledge generated by the Human Genome Project, which has mapped roughly 25,000 genes. Each gene codes for the production of protein, but with all the modifications possible to both the gene transcript and protein, the human body could have well over a million different proteins, according to the Human Proteome Initiative. This entourage of proteins, the proteome, is ultimately responsible for everything, good or bad, related to human health and disease. Developing tests to rapidly obtain protein profiles as a predictive marker for disease or identifying therapeutic targets benefit health care and medicine.
Leslie Tolbert, vice president for research, graduate studies and economic development at U of A, said that the pooling of technologies statewide would allow researchers to maximize capabilities and minimize costs in a field that requires the development of new research methods. For example, this collaborative effort is expected to foster an expansion of the cancer research initiative at Banner Health, the state’s largest hospital system, says Susan Edwards, president of the Arizona region for Banner Health. A unifying research approach within the alliance is “integrative proteomics,” which involves advancing the processes, methods and technologies that elucidate the role of proteins within an integrated understanding of human biology, according to Mark Hayes, director of Arizona Applied NanoSensors in the College of Liberal Arts and Sciences at ASU. “This means developing proteomics research capabilities so that they are complementary to other advancing fields like genomics, bioinformatics and clinical research,” says Hayes, who was an early champion for the expansion of regional proteomics and the formation of this alliance.
The alliance has just launched a Web site (http://www.integrativeproteomics.org/) where researchers can exchange information about resources and the important problems they are working together to solve. “Collaboration is one of the things that sets Arizona science apart from other states, where competition is more often the rule,” says Joseph Rogers, president and senior scientist of the Sun Health Research Institute. The important partnerships formed in proteomics are expected to not only expand research efforts and improve chances for greater funding, but also to promote the future recruitment and training of talented individuals for the field of health care in Arizona.
The Arizona Proteomics Alliance (AZPA), a statewide consortium, has been formed to advance the emergent science of proteomics, a science whose broad vision is to understand the biological role of the complete set of proteins in the human body, or proteome. The initiative combines the expertise of nine leading Arizona institutions, including ASU, Banner Health, Barrow Neurological Institute, Carl T. Hayden Veterans Affairs Medical Center, Intrinsic Bioprobes Inc., Mayo Clinic, Sun Health Research Institute, Translational Genomics Research Institute (TGen) and the University of Arizona (U of A). “This alliance places Arizona in the forefront of proteomics research capabilities and will no doubt have broad impact on biomedical research and personalized medicine,” said Jeff Trent, president and scientific director of TGen.
AZPA promotes a team approach to solving problems of significant biomedical interest, according to Michael Mobley, administrative director of AZPA and associate director of the Biodesign Institute at ASU. The alliance will advance the role of proteomics research in the understanding of human health and disease by creating a network of scientists who share resources and expertise.
“AZPA facilitates access to technical and intellectual resources that are rarely surpassed within the United States, and provides the state with a distinct competitive advantage in this field,” says Serrine Lau, scientific director of AZPA, director of Southwest Environmental Health Sciences Center at the U of A’s College of Pharmacy, and a member of U of A’s BIO5 Institute. “We are pleased that the resources of the Arizona Proteomics Consortium at U of A will be part of this state-wide alliance,” Lau says.
The Mayo Clinic is also expecting to be able to expand its efforts and bring new diagnostic and treatment options to its patients as part of the proteomics initiative, according to Laurence Miller, director of research and the cancer center at the Arizona Mayo Clinic. “The alliance will put Arizona in a stronger position to compete for federal and private research funding,” Mobley says.
The effort builds on the vast knowledge generated by the Human Genome Project, which has mapped roughly 25,000 genes. Each gene codes for the production of protein, but with all the modifications possible to both the gene transcript and protein, the human body could have well over a million different proteins, according to the Human Proteome Initiative. This entourage of proteins, the proteome, is ultimately responsible for everything, good or bad, related to human health and disease. Developing tests to rapidly obtain protein profiles as a predictive marker for disease or identifying therapeutic targets benefit health care and medicine.
Leslie Tolbert, vice president for research, graduate studies and economic development at U of A, said that the pooling of technologies statewide would allow researchers to maximize capabilities and minimize costs in a field that requires the development of new research methods. For example, this collaborative effort is expected to foster an expansion of the cancer research initiative at Banner Health, the state’s largest hospital system, says Susan Edwards, president of the Arizona region for Banner Health. A unifying research approach within the alliance is “integrative proteomics,” which involves advancing the processes, methods and technologies that elucidate the role of proteins within an integrated understanding of human biology, according to Mark Hayes, director of Arizona Applied NanoSensors in the College of Liberal Arts and Sciences at ASU. “This means developing proteomics research capabilities so that they are complementary to other advancing fields like genomics, bioinformatics and clinical research,” says Hayes, who was an early champion for the expansion of regional proteomics and the formation of this alliance.
The alliance has just launched a Web site (http://www.integrativeproteomics.org/) where researchers can exchange information about resources and the important problems they are working together to solve. “Collaboration is one of the things that sets Arizona science apart from other states, where competition is more often the rule,” says Joseph Rogers, president and senior scientist of the Sun Health Research Institute. The important partnerships formed in proteomics are expected to not only expand research efforts and improve chances for greater funding, but also to promote the future recruitment and training of talented individuals for the field of health care in Arizona.
Subscribe to:
Posts (Atom)