[Source: SFAz] - Science Foundation Arizona (SFAz), an Arizona nonprofit, private/public partnership helping strengthen the state's research infrastructure to spur new technology sector growth, awarded a $9 million investment grant to the Critical Path Institute (C-Path), a Tucson-based nonprofit coalition that works to streamline and accelerate the development of crucial drug therapies for major diseases including Alzheimer's and Parkinson's.
C-Path was formed as part of the FDA's Critical Path Initiative of 2004 calling for safer and more rapid U.S. drug development. The organization is seeking to reduce the high failure rate of bringing lifesaving new drugs to market along with the billions in excess dollars spent each year in the current bottleneck process. Today, only 5 percent of new medicines entering clinical testing ever succeed; C-Path plans to lift that success rate to 95 percent saving significant dollars and lives.
Globally, the need for efficiently introducing new pharmaceuticals is urgent. "Without breakthroughs, we face a medical tsunami of healthcare costs posing immense economic and social threats," stated Dr. Raymond L. Woosley, C-Path's president and CEO. "In the United States alone, the cost of coping with one debilitating disease, Alzheimer's, is $170 billion and is projected in the near future to reach $1 trillion or 8 percent of today's total U.S. economy. C-Path acts as the neutral third party between the FDA, private industry and the public resulting in decreased time, costs, and failure rates in pharmaceutical product development."
In southern Arizona, the SFAz grant is expected to have a continued impact on the state's rise as a center for medical and pharmaceutical sector growth as industry collaborators are slated to match an additional $18 million over four years. Three of the fifteen companies that C-Path has partnered in this consortium including Roche Ventana, Sanofi-aventis and Merck - through its affiliate High Throughput Genomics - now have major research facilities in southern Arizona. In addition, C-Path has formed alliances that include nearly all the major drug corporations in the United States and Europe.
"This initiative is the first of its kind in the U.S. and represents a major strategic move in positioning Arizona to be highly competitive and of interest to the pharmaceutical community. With C-Path's success, the Tucson area, in particular, has potential to increase substantially its biomedical capacity with innovation, spin-off companies and a growing base of knowledge workers," added Dr. William C. Harris, president and CEO of SFAz."
(SFAz), established in 2006, supports communications technology, sustainable systems including renewable energies, and biomedical infrastructure development to capitalize on the state's growing research base by spurring business opportunities, attracting investment, and creating new technology sector growth.
Tim Bee, Arizona State Senate President summarized the impact of the grant, "C-Path is providing the infrastructure and scientific expertise to provide a faster and less expensive pathway to market for crucially important drugs. And, this benefits not only Arizonans and the state's economic diversity, but helps a lot of people in combating diseases around the world."
Showing posts with label C-Path. Show all posts
Showing posts with label C-Path. Show all posts
Wednesday, November 19, 2008
Wednesday, November 12, 2008
Science Foundation Arizona Invests to Increase Arizona Biomedical Capacity
[Source: BUSINESS WIRE] - The Critical Path Institute (C-Path), a Tucson-based nonprofit that works with the FDA and the biomedical industry to streamline the development of crucial new medicines, has been awarded a $9 million investment grant from Science Foundation Arizona (SFAz). These funds will result in better testing methods that accelerate the development of therapies for major diseases, including lung cancer, stroke, Alzheimer's and Parkinson's.
C-Path was formed as part of the FDA's 2004 Critical Path Initiative that called for safer and more rapid U.S. medical product development. The organization is seeking to reduce the high failure rate in bringing lifesaving new drugs to market by improving the current slow and often unreliable process, thereby saving lives and billions of dollars each year. Today, even after extensive laboratory research, only 5 percent of new medicines that enter human testing ever reach the market. C-Path plans to lift that success rate to 95 percent and shorten the process to less than three years.
Globally, the need for efficiently introducing new pharmaceuticals is urgent. "Without breakthroughs, we face a medical tsunami of healthcare costs posing immense economic and social threats," stated Dr. Raymond L. Woosley, C-Path's president and CEO. "In the United States alone, the annual cost of caring for patients with just one disease, Alzheimer's, is $150 billion, a staggering figure that is projected to reach $1 trillion, or 8 percent of today's total U.S. economy. C-Path, acting as a neutral third party between the FDA and private industry, enables the sharing of knowledge that can decrease time, costs, and failure rates in pharmaceutical product development."
The SFAz grant is expected to have a continued impact on the state's rise as a center for biomedical and pharmaceutical sector growth. C-Path has formed partnerships that include nearly all the major drug corporations in the United States and Europe. Three of the 18 companies that C-Path is working with -- Roche's Ventana Medical Systems, sanofi-aventis and Merck (through its affiliate High Throughput Genomics) -- now have major research facilities in southern Arizona.
"C-Path is the first initiative of its kind, and represents a major strategic move in positioning Arizona to be highly competitive and of interest to the global pharmaceutical community. With C-Path's success, the Tucson area has the potential to increase substantially its biomedical capacity with innovation, spin-off companies and a growing base of knowledge workers," added Dr. William C. Harris,president and CEO of SFAz.
Science Foundation Arizona (SFAz) is a public/private partnership established in 2006 that supports communications technology, sustainable systems including renewable energies, and biomedical infrastructure development to capitalize on the state's growing research base by spurring business opportunities, attracting investment and creating new technology sector growth.
Critical Path Institute (C-Path), headquartered in Tucson, Arizona, was established in 2005 as a publicly funded, nonprofit research and education institute to enable and lead collaborations among scientists from the FDA, industry and academia. C-Path's mission is to help implement the FDA's Critical Path Initiative by developing faster, safer and smarter pathways to new medical products.
C-Path was formed as part of the FDA's 2004 Critical Path Initiative that called for safer and more rapid U.S. medical product development. The organization is seeking to reduce the high failure rate in bringing lifesaving new drugs to market by improving the current slow and often unreliable process, thereby saving lives and billions of dollars each year. Today, even after extensive laboratory research, only 5 percent of new medicines that enter human testing ever reach the market. C-Path plans to lift that success rate to 95 percent and shorten the process to less than three years.
Globally, the need for efficiently introducing new pharmaceuticals is urgent. "Without breakthroughs, we face a medical tsunami of healthcare costs posing immense economic and social threats," stated Dr. Raymond L. Woosley, C-Path's president and CEO. "In the United States alone, the annual cost of caring for patients with just one disease, Alzheimer's, is $150 billion, a staggering figure that is projected to reach $1 trillion, or 8 percent of today's total U.S. economy. C-Path, acting as a neutral third party between the FDA and private industry, enables the sharing of knowledge that can decrease time, costs, and failure rates in pharmaceutical product development."
The SFAz grant is expected to have a continued impact on the state's rise as a center for biomedical and pharmaceutical sector growth. C-Path has formed partnerships that include nearly all the major drug corporations in the United States and Europe. Three of the 18 companies that C-Path is working with -- Roche's Ventana Medical Systems, sanofi-aventis and Merck (through its affiliate High Throughput Genomics) -- now have major research facilities in southern Arizona.
"C-Path is the first initiative of its kind, and represents a major strategic move in positioning Arizona to be highly competitive and of interest to the global pharmaceutical community. With C-Path's success, the Tucson area has the potential to increase substantially its biomedical capacity with innovation, spin-off companies and a growing base of knowledge workers," added Dr. William C. Harris,president and CEO of SFAz.
Science Foundation Arizona (SFAz) is a public/private partnership established in 2006 that supports communications technology, sustainable systems including renewable energies, and biomedical infrastructure development to capitalize on the state's growing research base by spurring business opportunities, attracting investment and creating new technology sector growth.
Critical Path Institute (C-Path), headquartered in Tucson, Arizona, was established in 2005 as a publicly funded, nonprofit research and education institute to enable and lead collaborations among scientists from the FDA, industry and academia. C-Path's mission is to help implement the FDA's Critical Path Initiative by developing faster, safer and smarter pathways to new medical products.
Thursday, November 6, 2008
ABI, Asuragen to Collaborate with Critical Path Institute on Drug Toxicity Biomarkers
[November 6, 2008]
[Source: a GenomeWeb staff reporter, GenomeWeb News] – Applied Biosystems and Asuragen are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium to develop a predictive gene signature panel that pharmaceutical companies can use to screen pre-clinical therapeutics for toxicity, ABI announced today.
The Critical Path Institute, or C-Path, is a publicly funded non-profit research and education institute established in 2005 to help create and nurture industry, academic, and government collaborations that support the FDA’s 2004 Critical Path Initiative. Under the new collaboration, the institute plans to work with ABI and Asuragen to develop a panel of assays with gene targets associated with carcinogenicity in laboratory rats.
Researchers intend to develop a new biomarker panel based on ABI’s TaqMan Gene Signature Array and real-time PCR technology using ABI assays for risk assessment and determining and differentiating genotoxic and non-genotoxic modes of action for candidate drugs.
ABI will provide PSTC scientists with RNA expression assays, which the researchers plan to use to develop a biomarker panel that allows them to screen pre-clinical samples for carcinogenicity. Asuragen will contribute laboratory services, pharmacogenomic expertise, and bioinformatics capabilities to the PSTC project.
Drug toxicity is the leading cause of pre-clinical drug failures and costs the pharmaceutical industry billions of dollars each year. That, combined with calls from the US Food and Drug Administration and other regulatory bodies to bring better drugs to the market more quickly, has spurred efforts to come up with tools for avoiding drug toxicity.
C-Path established its PSTC as a means for bringing together pharmaceutical companies to improve drug safety and speed up their development. The PSTC currently has 16 members as well as scientists from the US Food and Drug Administration, the European Medicines Agency, and academic experts.
[Source: a GenomeWeb staff reporter, GenomeWeb News] – Applied Biosystems and Asuragen are collaborating with the Critical Path Institute’s Predictive Safety Testing Consortium to develop a predictive gene signature panel that pharmaceutical companies can use to screen pre-clinical therapeutics for toxicity, ABI announced today.
The Critical Path Institute, or C-Path, is a publicly funded non-profit research and education institute established in 2005 to help create and nurture industry, academic, and government collaborations that support the FDA’s 2004 Critical Path Initiative. Under the new collaboration, the institute plans to work with ABI and Asuragen to develop a panel of assays with gene targets associated with carcinogenicity in laboratory rats.
Researchers intend to develop a new biomarker panel based on ABI’s TaqMan Gene Signature Array and real-time PCR technology using ABI assays for risk assessment and determining and differentiating genotoxic and non-genotoxic modes of action for candidate drugs.
ABI will provide PSTC scientists with RNA expression assays, which the researchers plan to use to develop a biomarker panel that allows them to screen pre-clinical samples for carcinogenicity. Asuragen will contribute laboratory services, pharmacogenomic expertise, and bioinformatics capabilities to the PSTC project.
Drug toxicity is the leading cause of pre-clinical drug failures and costs the pharmaceutical industry billions of dollars each year. That, combined with calls from the US Food and Drug Administration and other regulatory bodies to bring better drugs to the market more quickly, has spurred efforts to come up with tools for avoiding drug toxicity.
C-Path established its PSTC as a means for bringing together pharmaceutical companies to improve drug safety and speed up their development. The PSTC currently has 16 members as well as scientists from the US Food and Drug Administration, the European Medicines Agency, and academic experts.
Monday, November 3, 2008
C-Path to ease process for diagnostic-test OK
[Source: Dan Sullivan, ARIZONA DAILY STAR] - The Tucson-based Critical Path Institute is working to create a standard-setting body to evaluate the performance of diagnostic medical tests before their submission to the U.S. Food and Drug Administration.
This project has been approved by the C-Path board of directors, and initial funding for the project has come from a $2.16 million grant from Science Foundation Arizona. U.S. Rep. Gabrielle Giffords, D-Ariz., has also backed appropriation of another $2 million in the 2009 fiscal year budget to supplement the grant from SFAz.
C-Path has hired PricewaterhouseCoopers to create a business plan for the new non-profit agency, and has received a federal trademark for its name, United States Diagnostic Standards.
This week, C-Path started approaching diagnostic companies to get commitments. The drug institute also is planning a new facility for the project and hiring employees.
To get a drug approved by the Food and Drug Administration, it may take 15 years and $1 billion, but the process is well-defined, according to Dr. Raymond Woosley, the president and CEO of C-Path. However, there is no such pathway for diagnostic tests, he said.
Companies like Ventana Medical Systems, which markets tests for cancer, have had difficulties getting these tests through the FDA system, Woosley said.
United States Diagnostic Standards, or USDS, will help streamline the process, filling a national need to advance the field of personalized medicine — the evolving process of matching patients to specific treatments based on genetic data.
"We think this is a huge unmet need, and, by filling it, will create jobs in Arizona, but more importantly it will really break the logjam so that we can get personalized medicine available to people in a more reliable fashion," Woosley said.
Woosley pointed to institutions like United States Pharmacopeia (USP) and Underwriter Laboratories that have set standards in their industries and have seals of approval.
"We don't have an Underwriter Laboratories or USP for diagnostic tests," Woosley said. "So that's why we got a grant from SFAz to see if such an entity would be viable, and then start it in Arizona."
The new standards agency would take a product closer to final FDA approval by establishing performance standards for each test.
Initially, USDS is working closely with Ventana Medical Systems to establish standards for a diagnostic test the company has developed for lung cancer.
The business plan for United States Diagnostic Standards calls for a further $24 million in investment over the next five years for USDS to break even, Woosley said. He estimates it will be six to nine months before the facility is operating.
"It's not a business because if it started making a profit, people wouldn't value our seal of approval," he said.
The non-profit status of USDS and its neutrality are essential for companies and the FDA to trust the results it produces, according to Dr. Gary Greenburg, a program officer at SFAz.
Greenburg sees this new national lab as very important to Arizona because it will raise the profile of Arizona and Southern Arizona in the diagnostic and bioindustry community and hopefully spin off new technology as a result.
"SFAz believes that the USDS will also help attract high-wage professionals to Southern Arizona, as well as acting as a magnet to attract and foster diagnostic and biotechnology companies," Greenburg said in an e-mail.
This project has been approved by the C-Path board of directors, and initial funding for the project has come from a $2.16 million grant from Science Foundation Arizona. U.S. Rep. Gabrielle Giffords, D-Ariz., has also backed appropriation of another $2 million in the 2009 fiscal year budget to supplement the grant from SFAz.
C-Path has hired PricewaterhouseCoopers to create a business plan for the new non-profit agency, and has received a federal trademark for its name, United States Diagnostic Standards.
This week, C-Path started approaching diagnostic companies to get commitments. The drug institute also is planning a new facility for the project and hiring employees.
To get a drug approved by the Food and Drug Administration, it may take 15 years and $1 billion, but the process is well-defined, according to Dr. Raymond Woosley, the president and CEO of C-Path. However, there is no such pathway for diagnostic tests, he said.
Companies like Ventana Medical Systems, which markets tests for cancer, have had difficulties getting these tests through the FDA system, Woosley said.
United States Diagnostic Standards, or USDS, will help streamline the process, filling a national need to advance the field of personalized medicine — the evolving process of matching patients to specific treatments based on genetic data.
"We think this is a huge unmet need, and, by filling it, will create jobs in Arizona, but more importantly it will really break the logjam so that we can get personalized medicine available to people in a more reliable fashion," Woosley said.
Woosley pointed to institutions like United States Pharmacopeia (USP) and Underwriter Laboratories that have set standards in their industries and have seals of approval.
"We don't have an Underwriter Laboratories or USP for diagnostic tests," Woosley said. "So that's why we got a grant from SFAz to see if such an entity would be viable, and then start it in Arizona."
The new standards agency would take a product closer to final FDA approval by establishing performance standards for each test.
Initially, USDS is working closely with Ventana Medical Systems to establish standards for a diagnostic test the company has developed for lung cancer.
The business plan for United States Diagnostic Standards calls for a further $24 million in investment over the next five years for USDS to break even, Woosley said. He estimates it will be six to nine months before the facility is operating.
"It's not a business because if it started making a profit, people wouldn't value our seal of approval," he said.
The non-profit status of USDS and its neutrality are essential for companies and the FDA to trust the results it produces, according to Dr. Gary Greenburg, a program officer at SFAz.
Greenburg sees this new national lab as very important to Arizona because it will raise the profile of Arizona and Southern Arizona in the diagnostic and bioindustry community and hopefully spin off new technology as a result.
"SFAz believes that the USDS will also help attract high-wage professionals to Southern Arizona, as well as acting as a magnet to attract and foster diagnostic and biotechnology companies," Greenburg said in an e-mail.
C-Path is No. 7 way to fix health care
[Source: Inside Tucson Business staff ] - The editors of Reader’s Digest started a countdown of the "18 big ideas to fix health care now (This won’t hurt a bit)" and when they got to No. 7 they stopped at Tucson C-Path.
In the November issue, the magazine’s editors wrote "Could it really be this simple? Get the (U.S. Food and Drug Administration) and the pharmaceutical industry to talk more openly so patients can get safer drugs more quickly and inexpensively."
Formally known as the Critical Path Institute, C-Path was lauded for getting 18 competing drug, biotech and diagnostic companies together to collaborate on a major lung cancer trial which could allow the FDA to get results in as little as a week rather than years.
Founded in 2005 to support the FDA and the Critical Path Initiative, C-Path’s goal is to get the government, academia and the medical industry to work together to advance new medical products.
C-Path is now also working with the University of Arizona to develop a drug development curriculum and with the University of Utah on genetic testing for a new cardiovascular drug.
C-Path fits well into the Tucson region’s emphasis on developing a biotech industry. Others include Roche Holding’s Ventana Medical Systems, Sanofi-aventis and the University of Arizona’s BIO5 institute.
What were some other "big ideas to fix health care"?
1. A Kaiser Foundation Health Plan that focuses on fighting the five common chronic conditions (coronary atery disease, diabetes, congestive heart failure, asthma and depression), which are responsible for 75 percent of health care spending.
2. A Mayo Clinic system that investigates hospital mistakes that works much like aviation investigations following a crash.
3. Best Doctors, a Boston-based health benefit that offers member-customized second opinions from a network of specialists around the world to reduce the number of misdiagnoses and wrong treatments.
In the November issue, the magazine’s editors wrote "Could it really be this simple? Get the (U.S. Food and Drug Administration) and the pharmaceutical industry to talk more openly so patients can get safer drugs more quickly and inexpensively."
Formally known as the Critical Path Institute, C-Path was lauded for getting 18 competing drug, biotech and diagnostic companies together to collaborate on a major lung cancer trial which could allow the FDA to get results in as little as a week rather than years.
Founded in 2005 to support the FDA and the Critical Path Initiative, C-Path’s goal is to get the government, academia and the medical industry to work together to advance new medical products.
C-Path is now also working with the University of Arizona to develop a drug development curriculum and with the University of Utah on genetic testing for a new cardiovascular drug.
C-Path fits well into the Tucson region’s emphasis on developing a biotech industry. Others include Roche Holding’s Ventana Medical Systems, Sanofi-aventis and the University of Arizona’s BIO5 institute.
What were some other "big ideas to fix health care"?
1. A Kaiser Foundation Health Plan that focuses on fighting the five common chronic conditions (coronary atery disease, diabetes, congestive heart failure, asthma and depression), which are responsible for 75 percent of health care spending.
2. A Mayo Clinic system that investigates hospital mistakes that works much like aviation investigations following a crash.
3. Best Doctors, a Boston-based health benefit that offers member-customized second opinions from a network of specialists around the world to reduce the number of misdiagnoses and wrong treatments.
Sunday, August 31, 2008
Biotech firms plant roots in Tucson area to lure top talent
[Source: Ken Alltucker, The Arizona Republic] - A key goal among Phoenix bioscience interests is to create a cluster of research companies that offer high-wage jobs and discover important breakthroughs.
That idea is that a critical mass of companies located near one another would draw batches of smart, talented workers who seek out those employers for challenging and lucrative careers. Such an achievement would spur the type of wealth and innovation that could drive the region's economy.
But some biotech observers believe such a cluster may be emerging in Arizona, just 90 miles south of the Valley in the growing southern Arizona bedroom community of Oro Valley.
The freshest evidence of that is Ventana Medical Systems' recent purchase of a 17-acre site next to its existing campus. About six months after Swiss drug giant Roche plunked down $3.4 billion to purchase Ventana, the company acquired a large chunk with an eye toward a major expansion of its tissue-diagnostics business.
Ventana isn't the only company that has planted its biotech roots in the Tucson suburb. French drugmaker sanofi-aventis is building a new research lab in the same technology park where Ventana is headquartered, and the small-but-growing tech firm Integrated Biomolecule Corp. also is expanding its workforce.
All companies have ties to the University of Arizona, and all the companies have big growth plans.
"This is a good model of what you want to happen in Phoenix and Flagstaff," Walt Plosila, a senior adviser to Ohio-based Battelle Technology Partnership Practice, said of the emerging Oro Valley cluster.
Science Foundation Arizona President and Chief Executive Officer William Harris also has taken note. The foundation's charge is to improve the state's science and technology initiatives through strategic investments in companies and education.
"It shows how you can diversify the economy," Harris said.
Similar efforts are under way to foster such bioscience growth in the Phoenix area.
The state of Arizona and city of Phoenix has invested tens of millions on a downtown biomedical hub anchored by the Translational Genomics Research Institute and a new medical school. And Arizona State University's five-year-old Biodesign Institute is beginning to churn out companies in research areas as alternative energy.
But Plosila and others believe that the Phoenix-area's growing biotech scene has not reached a critical mass of private bioscience companies yet that rivals such clusters as San Diego, San Francisco or Boston.
Phoenix and Flagstaff have made some biotech niches, particularly in medical-device manufacturing. The keys to attracting more research jobs and company clusters are sustained, targeted investment to nurture good ideas and attract private capital.
"It is sort of the entrepreneurial hotbed of Arizona in terms of research and development," Plosila said of Oro Valley.
University of Arizona roots
Ventana, in particular, shows the potential for one idea to have a major impact on the community, Harris said.
Dr. Thomas Grogan, a UA pathology professor, started the company in the mid-1980s over his frustration with the accuracy of cancer tests. He developed his own testing methods, arranged findings and built a company that went public in 1996 until its purchase by Roche this year.
"It's the genius of one person who created an idea that has been purchased by Roche and has created a lot of wealth," Harris said.
Today, Ventana employs about 900. About 600 research and development, executive, administrative and manufacturing positions are at the company's headquarters, and the company has 165 positions it plans to fill, spokeswoman Alana Bolton said.
The company has not laid out detailed plans for its expansion other than to say Roche's global business and international ties are expected to generate more jobs in Oro Valley.
"We will be the hub and center for tissue-based diagnostics for cancer," Bolton said. "We will grow and get bigger."
Among the major pharmaceutical companies, Roche has been the most aggressive in pursuing the personalized drugs based on a person's genetic makeup.
"The reason why Roche bought Ventana is because they recognize personalized medicine will only come from having the expertise that Ventana has," said Ray Woosley, president and chief executive officer of the Tucson-based Critical Path Institute, a non-profit group that works with federal regulators and biotech companies to speed the approval process for pharmaceuticals and medical devices.
On the heels of its Ventana acquisition, Roche is seeking to further bolster its biotech business with an attempt to purchase South San Francisco-based Genentech. Genentech has rebuffed Roche's initial offer of $89 per share but has appointed a special committee that will consider subsequent offers.
Roche largely plans to keep Ventana's operations and culture in tact. One sign of that is that Ventana CEO Christopher Gleeson has retained his position. Bolton declined to say how many people left the company after the merger.
More expansion
Sanofi-aventis is another pharmaceutical company that is investing millions in Oro Valley. The drugmaker is building a $60 million research lab slated to open in June. The company now employs 60 chemists, biologists and other staff. The new facility has the capacity for 108 workers, but the company has no firm timeline on when those positions will be filled, spokeswoman Janet Metz said.
Sanofi-aventis has recruited scientists from UA as well as attracted talent from out of state. "They (Oro Valley) seem to be building the new biotech hub, and that's where we wanted to be," Metz said.
Robert Green has seen the growth of Oro Valley's biotech sector since relocating his company to the town in 2004. His company, Integrated Biomolecule Corp., provides services such as analytical testing and product development for pharmaceutical companies.
"It was a town that clearly said they would like us to be here and like us to help build a biotech cluster," said Green, who founded the company in his garage and later worked from UA's science and technology park before locating to Oro Valley.
He said Oro Valley has a wide range of housing prices and quality schools, two factors that help draw employees.
"For years, we were an outpost in Oro Valley with clients out of state," Green said. "Now that is switching. We have a lot of support with companies in the state. All of this clustering activity contributes to that."
Representatives of the region's main economic development group, Tucson Regional Economic Opportunities, said years of investment in UA is beginning to pay off for Southern Arizona.
TREO counts more 100 biotech companies employing more than 2,000 non-hospital workers in the Tucson-Oro valley region.
"The investment in the university system is paying huge economic dividends for us now," said David Welsh, TREO's senior vice president for strategic partnerships.
Oro Valley Mayor Paul Loomis said large employers such as Ventana benefit the town more than just economically. The company supports a half marathon and cultural groups such as the Greater Oro Valley Arts Council.
"They are the flagship of our biotech community," Loomis said.
That idea is that a critical mass of companies located near one another would draw batches of smart, talented workers who seek out those employers for challenging and lucrative careers. Such an achievement would spur the type of wealth and innovation that could drive the region's economy.
But some biotech observers believe such a cluster may be emerging in Arizona, just 90 miles south of the Valley in the growing southern Arizona bedroom community of Oro Valley.
The freshest evidence of that is Ventana Medical Systems' recent purchase of a 17-acre site next to its existing campus. About six months after Swiss drug giant Roche plunked down $3.4 billion to purchase Ventana, the company acquired a large chunk with an eye toward a major expansion of its tissue-diagnostics business.
Ventana isn't the only company that has planted its biotech roots in the Tucson suburb. French drugmaker sanofi-aventis is building a new research lab in the same technology park where Ventana is headquartered, and the small-but-growing tech firm Integrated Biomolecule Corp. also is expanding its workforce.
All companies have ties to the University of Arizona, and all the companies have big growth plans.
"This is a good model of what you want to happen in Phoenix and Flagstaff," Walt Plosila, a senior adviser to Ohio-based Battelle Technology Partnership Practice, said of the emerging Oro Valley cluster.
Science Foundation Arizona President and Chief Executive Officer William Harris also has taken note. The foundation's charge is to improve the state's science and technology initiatives through strategic investments in companies and education.
"It shows how you can diversify the economy," Harris said.
Similar efforts are under way to foster such bioscience growth in the Phoenix area.
The state of Arizona and city of Phoenix has invested tens of millions on a downtown biomedical hub anchored by the Translational Genomics Research Institute and a new medical school. And Arizona State University's five-year-old Biodesign Institute is beginning to churn out companies in research areas as alternative energy.
But Plosila and others believe that the Phoenix-area's growing biotech scene has not reached a critical mass of private bioscience companies yet that rivals such clusters as San Diego, San Francisco or Boston.
Phoenix and Flagstaff have made some biotech niches, particularly in medical-device manufacturing. The keys to attracting more research jobs and company clusters are sustained, targeted investment to nurture good ideas and attract private capital.
"It is sort of the entrepreneurial hotbed of Arizona in terms of research and development," Plosila said of Oro Valley.
University of Arizona roots
Ventana, in particular, shows the potential for one idea to have a major impact on the community, Harris said.
Dr. Thomas Grogan, a UA pathology professor, started the company in the mid-1980s over his frustration with the accuracy of cancer tests. He developed his own testing methods, arranged findings and built a company that went public in 1996 until its purchase by Roche this year.
"It's the genius of one person who created an idea that has been purchased by Roche and has created a lot of wealth," Harris said.
Today, Ventana employs about 900. About 600 research and development, executive, administrative and manufacturing positions are at the company's headquarters, and the company has 165 positions it plans to fill, spokeswoman Alana Bolton said.
The company has not laid out detailed plans for its expansion other than to say Roche's global business and international ties are expected to generate more jobs in Oro Valley.
"We will be the hub and center for tissue-based diagnostics for cancer," Bolton said. "We will grow and get bigger."
Among the major pharmaceutical companies, Roche has been the most aggressive in pursuing the personalized drugs based on a person's genetic makeup.
"The reason why Roche bought Ventana is because they recognize personalized medicine will only come from having the expertise that Ventana has," said Ray Woosley, president and chief executive officer of the Tucson-based Critical Path Institute, a non-profit group that works with federal regulators and biotech companies to speed the approval process for pharmaceuticals and medical devices.
On the heels of its Ventana acquisition, Roche is seeking to further bolster its biotech business with an attempt to purchase South San Francisco-based Genentech. Genentech has rebuffed Roche's initial offer of $89 per share but has appointed a special committee that will consider subsequent offers.
Roche largely plans to keep Ventana's operations and culture in tact. One sign of that is that Ventana CEO Christopher Gleeson has retained his position. Bolton declined to say how many people left the company after the merger.
More expansion
Sanofi-aventis is another pharmaceutical company that is investing millions in Oro Valley. The drugmaker is building a $60 million research lab slated to open in June. The company now employs 60 chemists, biologists and other staff. The new facility has the capacity for 108 workers, but the company has no firm timeline on when those positions will be filled, spokeswoman Janet Metz said.
Sanofi-aventis has recruited scientists from UA as well as attracted talent from out of state. "They (Oro Valley) seem to be building the new biotech hub, and that's where we wanted to be," Metz said.
Robert Green has seen the growth of Oro Valley's biotech sector since relocating his company to the town in 2004. His company, Integrated Biomolecule Corp., provides services such as analytical testing and product development for pharmaceutical companies.
"It was a town that clearly said they would like us to be here and like us to help build a biotech cluster," said Green, who founded the company in his garage and later worked from UA's science and technology park before locating to Oro Valley.
He said Oro Valley has a wide range of housing prices and quality schools, two factors that help draw employees.
"For years, we were an outpost in Oro Valley with clients out of state," Green said. "Now that is switching. We have a lot of support with companies in the state. All of this clustering activity contributes to that."
Representatives of the region's main economic development group, Tucson Regional Economic Opportunities, said years of investment in UA is beginning to pay off for Southern Arizona.
TREO counts more 100 biotech companies employing more than 2,000 non-hospital workers in the Tucson-Oro valley region.
"The investment in the university system is paying huge economic dividends for us now," said David Welsh, TREO's senior vice president for strategic partnerships.
Oro Valley Mayor Paul Loomis said large employers such as Ventana benefit the town more than just economically. The company supports a half marathon and cultural groups such as the Greater Oro Valley Arts Council.
"They are the flagship of our biotech community," Loomis said.
Tuesday, August 26, 2008
Southern Arizona bioscience industry is doing amazing things
[Source: Joe Pangburn, Inside Tucson Business] - Southern Arizona is quickly becoming one of the nation’s more recognized bioscience centers and a global leader in innovation.
This is thanks to the more than 100 companies in Southern Arizona’s bioscience industry that are doing some amazing things.
"We are the world leaders in providing systems to detect cancer in tissue," said Chris Gleeson, chief executive officer of Ventana Medical Systems, 1910 E. Innovation Park Drive, which last year was acquired by Swiss-based Roche Group. "[Roche] has effectively doubled our R & D spending. We are probably going to spend more than all of our competitors combined in the next year on tissue diagnostic research and it is all being done here in Tucson and Oro Valley."
Ventana Medical develops and manufactures diagnostic instruments and reagent systems that provide leading-edge automation technology. In addition, the company has premier workflow solutions designed to improve laboratory workflow efficiency.
Across the street, Integrated Biomolecule Corporation, 2005 E. Innovation Park Drive, contracts with smaller pharmaceutical companies testing raw material and finished product.
"We have the technical ability to take a pill and spilt it apart into its different parts and then measure each to tell you exactly whether or not you have 20 mg of copper or if you have 18 or zero," said Robert Green, president of Integrated Biomolecule. "We can also tell you how much lead, if any, is present in a substance. Which is especially important with raw materials that are coming from China and the recent lead scares."
Moving in as a new neighbor on Innovation Park Drive will be Sanofi-Aventis, currently at 1580 E. Hanley Blvd. along Oracle Road.
The Paris-based, global pharmaceutical company has more than 100,000 employees in more than 100 countries. The research arm in Oro Valley houses 57 scientists who are testing incalculable drug molecule combinations to see what may go together and has potential to require further testing.
"There are 10 to the 40th possible drug-like molecules and we would want to test them all to be comprehensive," said Ken Wertman, scientific director of the Oro Valley research site. "But if you wanted to make a milligram of each of those molecules, there is enough matter in the universe to do so."
Wertman said it takes around $1.2 billion and around 12 to 15 years to bring a drug to the market.
"That is the most challenging thing emotionally about this business; you plug away year after year working on a compound and find out after years of work, it isn’t viable and you have to go back to the drawing board," he said.
Years ago it would take a scientist a year to get through and research 1,000 to 2,000 molecules; today’s technology allows two scientists to look at 5,000 in two weeks.
We’re not just looking for a needle in a haystack," he said. "but we’re looking for a particular piece of hay in an entire field of hay."
Sanofi-Aventis made the move into Oro Valley because of the work of a few University of Arizona professors who began work in that field and were eventually bought out.
The university is a huge player in the bioscience industry in Southern Arizona.
The UA has become one of the nation’s top 20 public research institutions featuring a world-class faculty. The National Science Foundation ranks the UA No. 13 among public research institutions.
"Biotech companies have the most difficult path to emerging success than any new startup company," said Bruce Wright, the associate vice president for economic development at the University of Arizona. "That’s why having an incubator in place to nurture and support them through that stage is really critical."
The business incubator at the Science and Technology Park on the southeast side allows companies to come in and begin working on their business, products and devices and have access to laboratories for far less than it would cost in a stand-alone building.
"That is often the most expensive part of getting started for these companies and by letting them come in and grow, we increase their success rate," Wright said.
Wright said there is still a long way to go in the biotech commercialization infrastructure to make sure Southern Arizona plays a big role in the field. But he is pleased with the direction it is heading.
"With the kind of development happening out there, I think we are beginning to put the pieces in place that will allow us to compete for the attraction of bioscience companies and to grow and retain the homegrown companies," he said. "We’ve got a ways to go but I am encouraged that all of the major players in the bioscience field are now working together through the Southern Arizona Bioscience Steering Committee."
The Committee is made up of members from area governments, TREO, the university and members of the industry. They are working to advance bioscience in the area by bringing to light need and issues companies are facing and working to address them.
The university’s Office of Economic Development has mapped out as many companies in the area involved in the bioscience industry and is about to begin contacting them and finding out what issues they are facing in Southern Arizona. The map is available at http://econdev.web.arizona.edu/Biomap.html.
"We can’t be competitors in this," Wright said. "We all need to be working in a complementary fashion to advance bioscience in this area. I think if we can demonstrate that this is a community with an aptitude and an interest in growing biotechnology that will be helpful in attracting other companies into the region from around the world."
Also located at the UA is the BIO5 Institute. BIO5 works on bringing together faculty and other researchers from five disciplines to tackle complex biology-base problems affecting humans today, such as trying to address world hunger while preserving the environment, and diagnose, treat and prevent disease.
Another asset the industry has in Southern Arizona is the C-Path Institute.
C-Path works as a neutral third party with scientists from government, industry and academia to create and foster transparent efficient partnerships that support the U.S. Food and Drug Administration’s efforts to identify methods that will better serve the industry in the rapid development of safe medical products.
The need for this was outlined in 2004 by the FDA itself. It is referred to as the Critical Path Initiative. The FDA called attention to the alarming decline in the number of new medical products submitted to them for approval, and cited the need for new methods in drug development. Only 16 new medicines were approved in 2007, one of the lowest numbers in more than two decades.
"We’ve identified seven new tests to replace two tests for the FDA that were 100 years old," said Ray Woosley, president of the C-Path Institute. "We want to serve as a trusted third party to enable innovative collaborations between government, academia and business. Companies like Ventana will tell us their secrets and we don’t tell it to anyone else. But when they are preparing to bring something to the FDA we can go first and say, we have not taken any money from this company, but we want to tell about this product and let you know the science is good on it."
With that kind of advocation and support, and the world-class companies located here, Tucson could become the Silicon Valley of the biotech world, at least developer Roger Ford thinks so.
"Silicon Valley was born out of two companies locating there," Ford said. "But the lure of being around like-minded people attracted all kinds of companies. That is what is going to happen here."
In preparation, Ford is developing Innovation Campus, just north of Innovation Park.
"Companies want to be able to move to a space that already exists, not one they have to build before they can move here," he said. "If you build it they will come."
There is certainly enough support for biotech, and Southern Arizona is well poised to become a leader.
Contact reporter Joe Pangburn at jpangburn@azbiz.com or (520) 295-4259.
This is thanks to the more than 100 companies in Southern Arizona’s bioscience industry that are doing some amazing things.
"We are the world leaders in providing systems to detect cancer in tissue," said Chris Gleeson, chief executive officer of Ventana Medical Systems, 1910 E. Innovation Park Drive, which last year was acquired by Swiss-based Roche Group. "[Roche] has effectively doubled our R & D spending. We are probably going to spend more than all of our competitors combined in the next year on tissue diagnostic research and it is all being done here in Tucson and Oro Valley."
Ventana Medical develops and manufactures diagnostic instruments and reagent systems that provide leading-edge automation technology. In addition, the company has premier workflow solutions designed to improve laboratory workflow efficiency.
Across the street, Integrated Biomolecule Corporation, 2005 E. Innovation Park Drive, contracts with smaller pharmaceutical companies testing raw material and finished product.
"We have the technical ability to take a pill and spilt it apart into its different parts and then measure each to tell you exactly whether or not you have 20 mg of copper or if you have 18 or zero," said Robert Green, president of Integrated Biomolecule. "We can also tell you how much lead, if any, is present in a substance. Which is especially important with raw materials that are coming from China and the recent lead scares."
Moving in as a new neighbor on Innovation Park Drive will be Sanofi-Aventis, currently at 1580 E. Hanley Blvd. along Oracle Road.
The Paris-based, global pharmaceutical company has more than 100,000 employees in more than 100 countries. The research arm in Oro Valley houses 57 scientists who are testing incalculable drug molecule combinations to see what may go together and has potential to require further testing.
"There are 10 to the 40th possible drug-like molecules and we would want to test them all to be comprehensive," said Ken Wertman, scientific director of the Oro Valley research site. "But if you wanted to make a milligram of each of those molecules, there is enough matter in the universe to do so."
Wertman said it takes around $1.2 billion and around 12 to 15 years to bring a drug to the market.
"That is the most challenging thing emotionally about this business; you plug away year after year working on a compound and find out after years of work, it isn’t viable and you have to go back to the drawing board," he said.
Years ago it would take a scientist a year to get through and research 1,000 to 2,000 molecules; today’s technology allows two scientists to look at 5,000 in two weeks.
We’re not just looking for a needle in a haystack," he said. "but we’re looking for a particular piece of hay in an entire field of hay."
Sanofi-Aventis made the move into Oro Valley because of the work of a few University of Arizona professors who began work in that field and were eventually bought out.
The university is a huge player in the bioscience industry in Southern Arizona.
The UA has become one of the nation’s top 20 public research institutions featuring a world-class faculty. The National Science Foundation ranks the UA No. 13 among public research institutions.
"Biotech companies have the most difficult path to emerging success than any new startup company," said Bruce Wright, the associate vice president for economic development at the University of Arizona. "That’s why having an incubator in place to nurture and support them through that stage is really critical."
The business incubator at the Science and Technology Park on the southeast side allows companies to come in and begin working on their business, products and devices and have access to laboratories for far less than it would cost in a stand-alone building.
"That is often the most expensive part of getting started for these companies and by letting them come in and grow, we increase their success rate," Wright said.
Wright said there is still a long way to go in the biotech commercialization infrastructure to make sure Southern Arizona plays a big role in the field. But he is pleased with the direction it is heading.
"With the kind of development happening out there, I think we are beginning to put the pieces in place that will allow us to compete for the attraction of bioscience companies and to grow and retain the homegrown companies," he said. "We’ve got a ways to go but I am encouraged that all of the major players in the bioscience field are now working together through the Southern Arizona Bioscience Steering Committee."
The Committee is made up of members from area governments, TREO, the university and members of the industry. They are working to advance bioscience in the area by bringing to light need and issues companies are facing and working to address them.
The university’s Office of Economic Development has mapped out as many companies in the area involved in the bioscience industry and is about to begin contacting them and finding out what issues they are facing in Southern Arizona. The map is available at http://econdev.web.arizona.edu/Biomap.html.
"We can’t be competitors in this," Wright said. "We all need to be working in a complementary fashion to advance bioscience in this area. I think if we can demonstrate that this is a community with an aptitude and an interest in growing biotechnology that will be helpful in attracting other companies into the region from around the world."
Also located at the UA is the BIO5 Institute. BIO5 works on bringing together faculty and other researchers from five disciplines to tackle complex biology-base problems affecting humans today, such as trying to address world hunger while preserving the environment, and diagnose, treat and prevent disease.
Another asset the industry has in Southern Arizona is the C-Path Institute.
C-Path works as a neutral third party with scientists from government, industry and academia to create and foster transparent efficient partnerships that support the U.S. Food and Drug Administration’s efforts to identify methods that will better serve the industry in the rapid development of safe medical products.
The need for this was outlined in 2004 by the FDA itself. It is referred to as the Critical Path Initiative. The FDA called attention to the alarming decline in the number of new medical products submitted to them for approval, and cited the need for new methods in drug development. Only 16 new medicines were approved in 2007, one of the lowest numbers in more than two decades.
"We’ve identified seven new tests to replace two tests for the FDA that were 100 years old," said Ray Woosley, president of the C-Path Institute. "We want to serve as a trusted third party to enable innovative collaborations between government, academia and business. Companies like Ventana will tell us their secrets and we don’t tell it to anyone else. But when they are preparing to bring something to the FDA we can go first and say, we have not taken any money from this company, but we want to tell about this product and let you know the science is good on it."
With that kind of advocation and support, and the world-class companies located here, Tucson could become the Silicon Valley of the biotech world, at least developer Roger Ford thinks so.
"Silicon Valley was born out of two companies locating there," Ford said. "But the lure of being around like-minded people attracted all kinds of companies. That is what is going to happen here."
In preparation, Ford is developing Innovation Campus, just north of Innovation Park.
"Companies want to be able to move to a space that already exists, not one they have to build before they can move here," he said. "If you build it they will come."
There is certainly enough support for biotech, and Southern Arizona is well poised to become a leader.
Contact reporter Joe Pangburn at jpangburn@azbiz.com or (520) 295-4259.
Friday, August 22, 2008
A new weapon to fight cancer - tobacco plants
[Source: Ken Alltucker, The Arizona Republic] - Tobacco is better known as a cause of cancer rather than a potential cure.
But scientists in Arizona and elsewhere believe tobacco plants may hold the key to developing a personalized cancer vaccine as well as treatments for other diseases.
The experiments are part of a growing field of plant-based biotechnology, and the cancer treatment has gained enough traction to interest the likes of German drug giant Bayer.
"Most important is that the vaccine has been successfully used in human clinical trials," said Charles Arntzen, director of the ASU Biodesign Institute's Center for Infectious Diseases and Vaccinology.
The made-to-order vaccine has been tested in an early-stage clinical trial, and it showed an immune response in 70 percent of non-Hodgkin's lymphoma patients without harmful side effects.
Even though it is called a vaccine, it will not prevent a person from getting non-Hodgkin's lymphoma, which is the seventh-leading cause of cancer-related deaths in the United States. Rather, the vaccine is made from a person's diseased cells and programmed to attack that individual's cancer.
Bayer has spent nearly $15 million on a facility in Germany that initially will grow the tobacco plants to make personalized vaccines for lymphoma patients. The German drug manufacturer plans to explore treatments for other diseases, too.
"It is a huge investment by a company to gamble that they will make it through clinical trials," said Arntzen, who wrote about the personalized plant-based vaccines in an article published Thursday in the journal Science.
Arntzen said he has collaborated with scientists at Stanford University who are developing plant-based vaccines. Earlier this year, the Biodesign Institute secured a $1.5 million grant from the federal government to study whether tobacco plants can yield a vaccine that blocks the West Nile virus from attacking a person's central nervous system. It is a similar technology that is being studied and used by Bayer and Stanford researchers, Arntzen said.
Although scientists are excited about the prospect of using plants to develop individual cancer treatments, no one has yet estimated how much such personalized treatments would cost to make.
Plant-based biotechnology already has been used to produce drugs for diseases such as cystic fibrosis and Gaucher's disease, but some of these personalized drugs can be pricey for consumers.
Avastin, a cancer drug made by South San Francisco-based Genentech, can cost up to $8,800 per month, and Genzyme's Cerezyme, which is used for Gaucher disease, costs about $200,000 a year.
Experts say drug development increasingly is shifting from a one-size-fits-all approach. Drug manufacturers realize that personalized drugs hold great promise as being more effective with fewer side effects. Yet producing such individualized drugs can be expensive and fraught with regulatory challenges.
It would be tough to replicate such a personalized drug in a manner consistent enough to pass muster with the Food and Drug Administration.
"It is going to take some innovative methods to generate that kind of product," said Ray Woosley, president and chief executive officer of the Tucson-based Critical Path Institute, which works to make the drug-development process quicker, safer and more effective.
"It is going to be a challenge to have that kind of individuality and to make sure you produce it the same way (to pass the FDA's review)," Woosley said.
How it works
Bayer envisions a personalized vaccine that is made based on a patient's unique genetic makeup. The vaccine is produced by taking DNA from a person's cancer cells, genetically modifying the DNA strands and transferring the virus to a tobacco plant. The plant responds by producing a protein that can help a cancer patient battle the disease.
The plant-based vaccine works by prodding a person's immune system to attack cancer tumors.
Other scientists have explored the possibility of using animals to make the vaccine, but the tobacco-plant vaccine can be produced much more quickly.
Indeed, speed is a key to growing these personalized treatments.
Scientists estimate that such vaccines can take just six to 10 weeks to produce from the time of a patient's biopsy. That would give doctors a quick time frame to administer the vaccine rather than revert to traditional cancer treatment such as chemotherapy, which has harmful side effects.
Arntzen said that non-Hodgkin's lymphoma is a relatively low-moving cancer, so it gives researchers time to grow, cultivate and give the vaccine to patients.
But scientists in Arizona and elsewhere believe tobacco plants may hold the key to developing a personalized cancer vaccine as well as treatments for other diseases.
The experiments are part of a growing field of plant-based biotechnology, and the cancer treatment has gained enough traction to interest the likes of German drug giant Bayer.
"Most important is that the vaccine has been successfully used in human clinical trials," said Charles Arntzen, director of the ASU Biodesign Institute's Center for Infectious Diseases and Vaccinology.
The made-to-order vaccine has been tested in an early-stage clinical trial, and it showed an immune response in 70 percent of non-Hodgkin's lymphoma patients without harmful side effects.
Even though it is called a vaccine, it will not prevent a person from getting non-Hodgkin's lymphoma, which is the seventh-leading cause of cancer-related deaths in the United States. Rather, the vaccine is made from a person's diseased cells and programmed to attack that individual's cancer.
Bayer has spent nearly $15 million on a facility in Germany that initially will grow the tobacco plants to make personalized vaccines for lymphoma patients. The German drug manufacturer plans to explore treatments for other diseases, too.
"It is a huge investment by a company to gamble that they will make it through clinical trials," said Arntzen, who wrote about the personalized plant-based vaccines in an article published Thursday in the journal Science.
Arntzen said he has collaborated with scientists at Stanford University who are developing plant-based vaccines. Earlier this year, the Biodesign Institute secured a $1.5 million grant from the federal government to study whether tobacco plants can yield a vaccine that blocks the West Nile virus from attacking a person's central nervous system. It is a similar technology that is being studied and used by Bayer and Stanford researchers, Arntzen said.
Although scientists are excited about the prospect of using plants to develop individual cancer treatments, no one has yet estimated how much such personalized treatments would cost to make.
Plant-based biotechnology already has been used to produce drugs for diseases such as cystic fibrosis and Gaucher's disease, but some of these personalized drugs can be pricey for consumers.
Avastin, a cancer drug made by South San Francisco-based Genentech, can cost up to $8,800 per month, and Genzyme's Cerezyme, which is used for Gaucher disease, costs about $200,000 a year.
Experts say drug development increasingly is shifting from a one-size-fits-all approach. Drug manufacturers realize that personalized drugs hold great promise as being more effective with fewer side effects. Yet producing such individualized drugs can be expensive and fraught with regulatory challenges.
It would be tough to replicate such a personalized drug in a manner consistent enough to pass muster with the Food and Drug Administration.
"It is going to take some innovative methods to generate that kind of product," said Ray Woosley, president and chief executive officer of the Tucson-based Critical Path Institute, which works to make the drug-development process quicker, safer and more effective.
"It is going to be a challenge to have that kind of individuality and to make sure you produce it the same way (to pass the FDA's review)," Woosley said.
How it works
Bayer envisions a personalized vaccine that is made based on a patient's unique genetic makeup. The vaccine is produced by taking DNA from a person's cancer cells, genetically modifying the DNA strands and transferring the virus to a tobacco plant. The plant responds by producing a protein that can help a cancer patient battle the disease.
The plant-based vaccine works by prodding a person's immune system to attack cancer tumors.
Other scientists have explored the possibility of using animals to make the vaccine, but the tobacco-plant vaccine can be produced much more quickly.
Indeed, speed is a key to growing these personalized treatments.
Scientists estimate that such vaccines can take just six to 10 weeks to produce from the time of a patient's biopsy. That would give doctors a quick time frame to administer the vaccine rather than revert to traditional cancer treatment such as chemotherapy, which has harmful side effects.
Arntzen said that non-Hodgkin's lymphoma is a relatively low-moving cancer, so it gives researchers time to grow, cultivate and give the vaccine to patients.
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.
Monday, June 30, 2008
Local C-Path leads project for drug-firm info sharing
[Source: Dale Quinn, arizona daily star] - For the first time, 17 major pharmaceutical companies have agreed to share information to fight major diseases such as Parkinson's and Alzheimer's, said the president of the Tucson-based non-profit institute that's leading a drug-safety consortium.
The companies still need to hammer out the legal details of such an agreement, and that could take until the fall, said Dr. Raymond Woosley, the president and CEO of the Critical Path Institute, known as C-Path.
"One of the reasons drugs have been failing, even though they've had millions of dollars of lab work … (is that) most of the time we don't understand the diseases well enough," Woosley said.
It's just one project C-Path is looking into with several pharmaceutical companies. Together they're exploring how genetic indicators can lead to more effective disease treatment and reduce risks patients face when taking new drugs.
The Predictive Safety Testing Consortium, which is the cooperative effort of the 17 pharmaceutical companies led by C-Path, recently yielded its first major results by producing data that could help detect kidney damage from new drugs faster.
The Food and Drug Administration and its European equivalent, the European Medicines Agency, have announced that they would accept data from animal tests identifying new renal "biomarkers," or proteins secreted by injured kidneys.
The current indicator of kidney damage is creatinine, which doesn't show up in tests until the kidneys have suffered significant damage, said Federico Goodsaid, an associate director in the FDA's Office of Clinical Pharmacology.
The seven new protein signals, or biomarkers, were confirmed in data from rat studies, and they show kidney damage much sooner than the current method does, Goodsaid said.
It's the first time a new method for detecting kidney damage has been developed in more than 100 years, Woosley said.
The drug companies can now move toward using the biomarkers for detecting kidney damage in humans, Woosley said.
The FDA is more likely to trust research when it comes from several drug companies, said J. Lyle Bootman, dean of the University of Arizona's College of Pharmacy.
"In the past, companies just did the tests individually, so the FDA was much more hesitant about approving them," Bootman said.
Goodsaid said one drug company would not likely have the resources or the necessary perspective to develop a new process for detecting kidney damage.
"What we're asking them to do is pool together knowledge," he said. "And above all, this is a step forward, because we're asking companies to look into what they already know and what they've already done, and then share that."
Some treatments, while beneficial to some people, can be ineffective, or even dangerous, to others. When the pharmaceutical companies share information through C-Path, Goodsaid and Woosley said, they can more quickly identify how effective treatments will be for certain people.
C-Path is working with the drug companies to find out who will respond to drugs that treat lung cancer, Woosley said. The research centers on the epidermal growth factor receptor — EGFR — and finding out how drug companies get information about the presence of that protein.
"If your lung cancer has EGFR, you've got a much better chance to respond to certain drugs," Woosley said.
Another C-Path project involves warfarin, a blood-thinning drug that if administered in the wrong dose can cause excessive bleeding or stroke.
Determining the proper dose of warfarin can be challenging for doctors, Woosley said. Giving a patient too much can cause him to bleed to death, but too little can lead to a stroke, he said.
C-Path is working with the University of Utah and the drug companies to develop a genetic test that will predict the proper dose of warfarin for a person, which Woosley estimated could prevent as many as 17,000 strokes every year, based on a study by the Brookings Institute.
The process doesn't end when the products hit the market, because people can have an adverse reaction to drugs that already have been approved, said Don Featherstone, the pharmacy division supervisor for Bashas' in Southern Arizona.
C-Path conducted a pilot program with Bashas' pharmacies and the FDA called Community Pharmacy Safety Network, allowing people to report potential side effects of drugs to the UA's poison control center.
Featherstone said Vioxx — a painkiller developed by Merck & Co. that was removed from the market because of its potential to increase risk of heart attack — is an example of such a drug.
C-Path wants to take the program to all pharmacies nationwide, but it currently lacks the funding, Woosley said.
Historically, treatments have been developed that battle the symptoms of disease, Woosley said. But it's an understanding of the underlying causes of disease that leads to the most effective treatments, he said.
When it comes to sharing information about Parkinson's and Alzheimer's, the drug companies won't discuss drug development, Woosley said.
But they have made a verbal agreement to pull together everything they know about the diseases, including drugs that have failed, he added.
● Contact reporter Dale Quinn at 573-4197 or dquinn@azstarnet.com.
The companies still need to hammer out the legal details of such an agreement, and that could take until the fall, said Dr. Raymond Woosley, the president and CEO of the Critical Path Institute, known as C-Path.
"One of the reasons drugs have been failing, even though they've had millions of dollars of lab work … (is that) most of the time we don't understand the diseases well enough," Woosley said.
It's just one project C-Path is looking into with several pharmaceutical companies. Together they're exploring how genetic indicators can lead to more effective disease treatment and reduce risks patients face when taking new drugs.
The Predictive Safety Testing Consortium, which is the cooperative effort of the 17 pharmaceutical companies led by C-Path, recently yielded its first major results by producing data that could help detect kidney damage from new drugs faster.
The Food and Drug Administration and its European equivalent, the European Medicines Agency, have announced that they would accept data from animal tests identifying new renal "biomarkers," or proteins secreted by injured kidneys.
The current indicator of kidney damage is creatinine, which doesn't show up in tests until the kidneys have suffered significant damage, said Federico Goodsaid, an associate director in the FDA's Office of Clinical Pharmacology.
The seven new protein signals, or biomarkers, were confirmed in data from rat studies, and they show kidney damage much sooner than the current method does, Goodsaid said.
It's the first time a new method for detecting kidney damage has been developed in more than 100 years, Woosley said.
The drug companies can now move toward using the biomarkers for detecting kidney damage in humans, Woosley said.
The FDA is more likely to trust research when it comes from several drug companies, said J. Lyle Bootman, dean of the University of Arizona's College of Pharmacy.
"In the past, companies just did the tests individually, so the FDA was much more hesitant about approving them," Bootman said.
Goodsaid said one drug company would not likely have the resources or the necessary perspective to develop a new process for detecting kidney damage.
"What we're asking them to do is pool together knowledge," he said. "And above all, this is a step forward, because we're asking companies to look into what they already know and what they've already done, and then share that."
Some treatments, while beneficial to some people, can be ineffective, or even dangerous, to others. When the pharmaceutical companies share information through C-Path, Goodsaid and Woosley said, they can more quickly identify how effective treatments will be for certain people.
C-Path is working with the drug companies to find out who will respond to drugs that treat lung cancer, Woosley said. The research centers on the epidermal growth factor receptor — EGFR — and finding out how drug companies get information about the presence of that protein.
"If your lung cancer has EGFR, you've got a much better chance to respond to certain drugs," Woosley said.
Another C-Path project involves warfarin, a blood-thinning drug that if administered in the wrong dose can cause excessive bleeding or stroke.
Determining the proper dose of warfarin can be challenging for doctors, Woosley said. Giving a patient too much can cause him to bleed to death, but too little can lead to a stroke, he said.
C-Path is working with the University of Utah and the drug companies to develop a genetic test that will predict the proper dose of warfarin for a person, which Woosley estimated could prevent as many as 17,000 strokes every year, based on a study by the Brookings Institute.
The process doesn't end when the products hit the market, because people can have an adverse reaction to drugs that already have been approved, said Don Featherstone, the pharmacy division supervisor for Bashas' in Southern Arizona.
C-Path conducted a pilot program with Bashas' pharmacies and the FDA called Community Pharmacy Safety Network, allowing people to report potential side effects of drugs to the UA's poison control center.
Featherstone said Vioxx — a painkiller developed by Merck & Co. that was removed from the market because of its potential to increase risk of heart attack — is an example of such a drug.
C-Path wants to take the program to all pharmacies nationwide, but it currently lacks the funding, Woosley said.
Historically, treatments have been developed that battle the symptoms of disease, Woosley said. But it's an understanding of the underlying causes of disease that leads to the most effective treatments, he said.
When it comes to sharing information about Parkinson's and Alzheimer's, the drug companies won't discuss drug development, Woosley said.
But they have made a verbal agreement to pull together everything they know about the diseases, including drugs that have failed, he added.
● Contact reporter Dale Quinn at 573-4197 or dquinn@azstarnet.com.
Monday, June 16, 2008
C-Path Announces New Scientific Appointments
[Source: InsideArizonaBusiness.com Report] - The Critical Path Institute (C-Path) is pleased to announce the appointments of Klaus Romero, M.S., M.D. to the position of Clinical Pharmacologist, and Elizabeth Gribble Walker, Ph.D. to the position of Assistant Director, Predictive Safety Testing Consortium (PSTC). In these new positions, Doctors Romero and Walker will advance C-Path’s collaborative programs to accelerate the development of faster, safer medical products.
“It is an honor to welcome next-generation scientific talent to Tucson – Drs. Walker and Romero have precisely the type of scientific thinking we envisioned recruiting to Tucson when we started C-Path,” said Raymond L. Woosley, C-Path President and CEO.
As Clinical Pharmacologist at C-Path, Klaus Romero, M.S., M.D. will primarily serve as co-investigator in the C-Path housed Arizona Center for Education and Research on Therapeutics (AzCERT), a program focused on prevention of adverse reactions caused by drug-drug interactions. He will initially focus on the web-based educational program www.QTdrugs.org and the registry for cases of the drug-induced arrhythmia, torsades de pointes (www.torsades.org). In addition to this work, Dr. Romero will collaborate with C-Path, industry and FDA scientists and others to help design quantitative disease progression models to improve the design of drug development programs.
A native of Colombia, Dr. Romero earned his medical degree from the School of Medicine at Javeriana University in Bogota and completed his residency in medical epidemiology at the Colombian School of Medicine at El Bosque University in Bogota. He also holds a Master of Science degree in Pharmacology from Colombian National University in Bogota. (Check with Klaus on my revisions.
Dr. Romero is married to Olga-Lucía Parga, also a native of Colombia. Olga-Lucía, an accomplished accessory designer and TV producer, holds dual Bachelor of Arts degrees in Social Communications and Fashion Design. She is currently perfecting her English at the U of A, where she started a successful dance club. Olga-Lucía plans to get into graduate school at the U of A, to get an MA degree in media studies.
Elizabeth Gribble Walker, Ph.D. Assistant Director, PSTC, will support what has become a global endeavor to identify and qualify laboratory safety testing methods used to test new drugs. Over 190 scientists from 17 Member companies, along with scientists from the U.S. Food and Drug Administration (FDA) and its European equivalent, the European Medicines Evaluation Agency (EMEA) are collaborating in this consortium.
Dr. Walker most recently served as a Scientist in Preclinical Drug Development at ZymoGenetics. She earned her Ph.D. in Toxicology in 2005 from the University of Washington where she was an NIH/NIEHS Environmental Pathology and Toxicology Training Grant recipient for four years.
Dr. Walker is married to Matt Walker, M.A., ABS. Matt is a Primary Therapist and Wilderness Director at In Balance Ranch Academy and in private practice through Inner Passage where he offers coaching and counseling for individuals, families, and organizations.
“It is an honor to welcome next-generation scientific talent to Tucson – Drs. Walker and Romero have precisely the type of scientific thinking we envisioned recruiting to Tucson when we started C-Path,” said Raymond L. Woosley, C-Path President and CEO.
As Clinical Pharmacologist at C-Path, Klaus Romero, M.S., M.D. will primarily serve as co-investigator in the C-Path housed Arizona Center for Education and Research on Therapeutics (AzCERT), a program focused on prevention of adverse reactions caused by drug-drug interactions. He will initially focus on the web-based educational program www.QTdrugs.org and the registry for cases of the drug-induced arrhythmia, torsades de pointes (www.torsades.org). In addition to this work, Dr. Romero will collaborate with C-Path, industry and FDA scientists and others to help design quantitative disease progression models to improve the design of drug development programs.
A native of Colombia, Dr. Romero earned his medical degree from the School of Medicine at Javeriana University in Bogota and completed his residency in medical epidemiology at the Colombian School of Medicine at El Bosque University in Bogota. He also holds a Master of Science degree in Pharmacology from Colombian National University in Bogota. (Check with Klaus on my revisions.
Dr. Romero is married to Olga-Lucía Parga, also a native of Colombia. Olga-Lucía, an accomplished accessory designer and TV producer, holds dual Bachelor of Arts degrees in Social Communications and Fashion Design. She is currently perfecting her English at the U of A, where she started a successful dance club. Olga-Lucía plans to get into graduate school at the U of A, to get an MA degree in media studies.
Elizabeth Gribble Walker, Ph.D. Assistant Director, PSTC, will support what has become a global endeavor to identify and qualify laboratory safety testing methods used to test new drugs. Over 190 scientists from 17 Member companies, along with scientists from the U.S. Food and Drug Administration (FDA) and its European equivalent, the European Medicines Evaluation Agency (EMEA) are collaborating in this consortium.
Dr. Walker most recently served as a Scientist in Preclinical Drug Development at ZymoGenetics. She earned her Ph.D. in Toxicology in 2005 from the University of Washington where she was an NIH/NIEHS Environmental Pathology and Toxicology Training Grant recipient for four years.
Dr. Walker is married to Matt Walker, M.A., ABS. Matt is a Primary Therapist and Wilderness Director at In Balance Ranch Academy and in private practice through Inner Passage where he offers coaching and counseling for individuals, families, and organizations.
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, June 5, 2008
Start-up to link doctors, cancer patients online
[Source: Ken Alltucker, The Arizona Republic] - A Scottsdale start-up company wants to create a social-networking site that could link doctors and pharmaceutical companies to help get cutting-edge cancer treatments to patients.
The vision of MedTrust Online will develop a customized Web site and database that compiles medical literature, clinical trial information, treatment options and other data tailored to physicians who treat cancer patients.
MedTrust, a spinoff of Arizona-based TGen, believes the site will give doctors access to the best and most timely information that they do not always have access to now.
"We are trying to solve a problem that has been thrust upon the (medical) industry as a whole," said Chris Yoo, the company's president and chief executive officer. "Patients may not be getting the best options because there is a problem with communication."
MedTrust formed last year and hired its first batch of workers early this year. The company now has eight employees and has raised nearly $3 million in venture financing from local investors. The company expects to gradually hire staff as it adds more customers.
So far, MedTrust has signed up one Texas cancer group, South Texas Oncology and Hematology, and is nearing agreement with three other groups, including one in Arizona, Yoo said.
MedTrust expects to launch a test site for South Texas Oncology and Hematology later this year. The company did not say how much it will charge doctors or pharmaceutical companies for the service.
Dr. Daniel Von Hoff, physician in chief of TGen (Translational Genomics Research Institute), will lead a panel of six oncologists who will look to identify and share information about new drug treatments. TGen has had more than a half dozen spinoff companies since in formed in 2002.
Backers say MedTrust aims to eliminate the "silo" mentality that exists in medicine with some top doctors not willing or able to share information on promising treatments. The Web site will draw from a wide variety of sources, including peer-reviewed medical journals and pharmaceutical databases.
The Food and Drug Administration restricts pharmaceutical companies from marketing drugs "off-label," or for uses not approved by the FDA. Such restrictions are meant as safeguards so patients are not harmed by drugs that have not met the FDA's safety and effectiveness measures. But some pharmaceutical interests believe these restrictions make it difficult to share information about potentially effective treatments.
Yoo said the company's strategy is to create a link of sorts between willing doctors and pharmaceutical companies.
Now, doctors receive limited information from pharmaceutical sales representatives who give brief pitches for FDA-approved drugs. The database could give doctors a much wider range of information.
Ray Woosley, president and CEO of the Critical Path Institute in Tucson, agrees that sharing good, quality information about potential drug therapies can be challenging.
"Doctors are just overwhelmed with information and it is not packaged very well," said Woosley.
"The challenge has always been getting the information to doctors at the time they are making decisions."
The vision of MedTrust Online will develop a customized Web site and database that compiles medical literature, clinical trial information, treatment options and other data tailored to physicians who treat cancer patients.
MedTrust, a spinoff of Arizona-based TGen, believes the site will give doctors access to the best and most timely information that they do not always have access to now.
"We are trying to solve a problem that has been thrust upon the (medical) industry as a whole," said Chris Yoo, the company's president and chief executive officer. "Patients may not be getting the best options because there is a problem with communication."
MedTrust formed last year and hired its first batch of workers early this year. The company now has eight employees and has raised nearly $3 million in venture financing from local investors. The company expects to gradually hire staff as it adds more customers.
So far, MedTrust has signed up one Texas cancer group, South Texas Oncology and Hematology, and is nearing agreement with three other groups, including one in Arizona, Yoo said.
MedTrust expects to launch a test site for South Texas Oncology and Hematology later this year. The company did not say how much it will charge doctors or pharmaceutical companies for the service.
Dr. Daniel Von Hoff, physician in chief of TGen (Translational Genomics Research Institute), will lead a panel of six oncologists who will look to identify and share information about new drug treatments. TGen has had more than a half dozen spinoff companies since in formed in 2002.
Backers say MedTrust aims to eliminate the "silo" mentality that exists in medicine with some top doctors not willing or able to share information on promising treatments. The Web site will draw from a wide variety of sources, including peer-reviewed medical journals and pharmaceutical databases.
The Food and Drug Administration restricts pharmaceutical companies from marketing drugs "off-label," or for uses not approved by the FDA. Such restrictions are meant as safeguards so patients are not harmed by drugs that have not met the FDA's safety and effectiveness measures. But some pharmaceutical interests believe these restrictions make it difficult to share information about potentially effective treatments.
Yoo said the company's strategy is to create a link of sorts between willing doctors and pharmaceutical companies.
Now, doctors receive limited information from pharmaceutical sales representatives who give brief pitches for FDA-approved drugs. The database could give doctors a much wider range of information.
Ray Woosley, president and CEO of the Critical Path Institute in Tucson, agrees that sharing good, quality information about potential drug therapies can be challenging.
"Doctors are just overwhelmed with information and it is not packaged very well," said Woosley.
"The challenge has always been getting the information to doctors at the time they are making decisions."
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.
Wednesday, January 9, 2008
ClinXus joins international Critical Path Institute Consortium
[Source: Sarah Lamb, Van Andel Institute] - ClinXus, a Grand Rapids-based, life-sciences alliance, recently became the first non-profit organization to join the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC). Critical Path Institute supports the U.S. Food and Drug Administration (FDA) with collaborative research and education programs that enable the safe acceleration of medical product development. The PSTC brings pharmaceutical companies together to share and validate each other’s safety testing methods under advisement of the FDA and its equivalent in Europe, the European Medicines Agency (EMEA). “The PSTC has been described as a model for modernizing the development of medicinal products,” said ClinXus Board President Craig P. Webb, Ph.D., Van Andel Institute scientific investigator and director of translational medicine. “It allows pharmaceutical companies and partners to share knowledge and resources to bring life-saving drugs to the FDA more quickly and safely.”
The FDA launched the Critical Path Initiative in March 2004, to identify medical product development problems and opportunities for improvement. The study identified the process for preclinical and clinical testing of drugs as a major contributor to delays in drug development. Critical Path Institute was established in 2005 as an independent nonprofit research and education institute to facilitate collaboration between scientists in government, industry and academia. In March 2006, Department of Health and Human Services Secretary Mike Leavitt, announced the formation of the PSTC involving scientists from the FDA, Critical Path Institute and several of the United States’ largest pharmaceutical companies to share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans.
The initial PSTC members include Bristol-Myers Squibb Company, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, LLC, Merck and Co., Inc., Novartis Pharmaceutical Corporation, Pfizer, Inc., Roche Palo Alto, LLC, and Schering Plough Research Institute. Since that time, the PSTC has added seven additional pharmaceutical industry members and invited EMEA to serve in an advisory role similar to that of the FDA.
William Mattes, Ph. D., director of the PSTC noted, “The PSTC has made rapid progress since its inception last year and this is a testimony to the commitment and willingness of the member companies to share their testing methods and data. We have already found a number of improved tests for drug safety that can be used in the early stages of drug development. ClinXus will greatly facilitate the next phase that includes clinical evaluation of these new tests.”
ClinXus, a life-sciences alliance dedicated to introducing molecular biomarkers into the clinical trial process, a fundamental component of personalized medicine, becomes the first non-profit organization to join the consortium. ClinXus was formed in July 2006, with the assistance of a $1.5 million grant from the Michigan 21st Century Jobs Fund in addition to funding and in-kind donations from each of the six member institutions. The alliance uses the expertise and services of each member institution to provide a single point of contact for clinical research clients, as well as patients and physicians that participate in clinical studies. Its focus is to develop innovative clinical trials that are primarily biomarker driven, involving new medicines, devices and diagnostics in all stages of testing. ClinXus’ members include Van Andel Institute (VAI), Spectrum Health, Saint Mary’s Health Care, Jasper Clinical Research & Development, Grand Valley State University (GVSU) and Grand Valley Medical Specialists. For more information, contact Joe Gavan, (616) 234-5390.
The FDA launched the Critical Path Initiative in March 2004, to identify medical product development problems and opportunities for improvement. The study identified the process for preclinical and clinical testing of drugs as a major contributor to delays in drug development. Critical Path Institute was established in 2005 as an independent nonprofit research and education institute to facilitate collaboration between scientists in government, industry and academia. In March 2006, Department of Health and Human Services Secretary Mike Leavitt, announced the formation of the PSTC involving scientists from the FDA, Critical Path Institute and several of the United States’ largest pharmaceutical companies to share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans.
The initial PSTC members include Bristol-Myers Squibb Company, GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development, LLC, Merck and Co., Inc., Novartis Pharmaceutical Corporation, Pfizer, Inc., Roche Palo Alto, LLC, and Schering Plough Research Institute. Since that time, the PSTC has added seven additional pharmaceutical industry members and invited EMEA to serve in an advisory role similar to that of the FDA.
William Mattes, Ph. D., director of the PSTC noted, “The PSTC has made rapid progress since its inception last year and this is a testimony to the commitment and willingness of the member companies to share their testing methods and data. We have already found a number of improved tests for drug safety that can be used in the early stages of drug development. ClinXus will greatly facilitate the next phase that includes clinical evaluation of these new tests.”
ClinXus, a life-sciences alliance dedicated to introducing molecular biomarkers into the clinical trial process, a fundamental component of personalized medicine, becomes the first non-profit organization to join the consortium. ClinXus was formed in July 2006, with the assistance of a $1.5 million grant from the Michigan 21st Century Jobs Fund in addition to funding and in-kind donations from each of the six member institutions. The alliance uses the expertise and services of each member institution to provide a single point of contact for clinical research clients, as well as patients and physicians that participate in clinical studies. Its focus is to develop innovative clinical trials that are primarily biomarker driven, involving new medicines, devices and diagnostics in all stages of testing. ClinXus’ members include Van Andel Institute (VAI), Spectrum Health, Saint Mary’s Health Care, Jasper Clinical Research & Development, Grand Valley State University (GVSU) and Grand Valley Medical Specialists. For more information, contact Joe Gavan, (616) 234-5390.
Wednesday, October 3, 2007
New federal law paves way for CPath, others in drug development field
[Source: Phoenix Business Journal] -- Legislation aimed at promoting drug safety and economic development is paving the way for The Critical Path Institute in Tucson. U.S. Rep. Gabrielle Giffords, D-Ariz., said her bill was signed into law today by President George W. Bush as part of the Food and Drug Administration Amendments Act of 2007.
Dr. Raymond Woosley, president and chief executive of The Critical Path Institute, known as CPath, said the bill authorizes creation of a public/private partnership to work on accelerating drugs to market, which is what CPath does. "It puts $5 million out there for us to request," Woosley said. One of the big problems in drug development is that testing methods need to be updated, he said. "We test drugs today the same way we did 50 years ago," he said. CPath is helping to change that, he said. "We've got 16 companies working with the FDA," Woosley said. "We developed an agreement between those 16 companies to come together and share with each other how they test drugs."
He said the goal is not for these pharmaceutical companies to make more money, but to develop safer drugs by accelerating testing and focusing on safety. The FDA and its European and Japanese counterparts are part of the consortium. "We've got 190 scientists working together, and it all started because Arizona gave us the funding," Woosley said. "We had to have a legal agreement that said we've got a model that doesn't break antitrust rules." [Note: For more information, visit www.c-path.org.]
Dr. Raymond Woosley, president and chief executive of The Critical Path Institute, known as CPath, said the bill authorizes creation of a public/private partnership to work on accelerating drugs to market, which is what CPath does. "It puts $5 million out there for us to request," Woosley said. One of the big problems in drug development is that testing methods need to be updated, he said. "We test drugs today the same way we did 50 years ago," he said. CPath is helping to change that, he said. "We've got 16 companies working with the FDA," Woosley said. "We developed an agreement between those 16 companies to come together and share with each other how they test drugs."
He said the goal is not for these pharmaceutical companies to make more money, but to develop safer drugs by accelerating testing and focusing on safety. The FDA and its European and Japanese counterparts are part of the consortium. "We've got 190 scientists working together, and it all started because Arizona gave us the funding," Woosley said. "We had to have a legal agreement that said we've got a model that doesn't break antitrust rules." [Note: For more information, visit www.c-path.org.]
Monday, March 19, 2007
C-Path using Rosetta's Resolver in predictive safety testing consortium
NEW YORK (GenomeWeb News) -- The Critical Path Institute will use Rosetta Biosoftware’s Resolver system, Rosetta said today. C-Path will use the software for data management and analysis in its Predictive Safety Testing Consortium, which is a collection of pharmaceutical companies that work with C-Path to share information that may help improve drug safety.
C-Path is a publicly funded research and education institute in Tuscon, Ariz., and is a research arm of the US Food and Drug Administration’s Critical Path Initiative. Financial terms of the deal were not released.
C-Path is a publicly funded research and education institute in Tuscon, Ariz., and is a research arm of the US Food and Drug Administration’s Critical Path Initiative. Financial terms of the deal were not released.
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