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PGx Tools Will Help Pharmas Mitigate Economic, Regulatory Challenges, Tufts Report Predicts
 
Pharmaceutical companies this year will rely on pharmacogenomic technologies to offset rising drug-development costs, loss of patent exclusivity, and a tight reimbursement environment, according to the Tufts Center for the Study of Drug Development.
 
“Drug developers will work to validate safety and efficacy biomarkers, develop predictive preclinical toxicology screens, utilize micro-dosing studies, and expand
pharmacogenomic programs to improve success rates,” according to an annual outlook report.
 
The report projects that “drug companies will strive to speed development and reduce failure rates” through “greater use of new technologies,” including pharmacogenomic tools.
 
“Despite a growing list of challenges facing drug developers … there is reason for optimism,” according to the report.
 
The report, which can be found here, predicts that drug developers will be compelled “to improve the way they manage risk, especially as they seek to lower late-stage development attrition rates, and to increase their utilization of information technology.”
 
In another nod to pharmacogenomics, the outlook said that these challenges will “encourage sponsors to make greater use of innovative practices, such as clinical trial enhancement, to improve R&D performance and output.”
 
Pharmaceutical companies will also continue to “grapple with the complex economics” of developing drugs for subgroups, “including whether to internalize development of diagnostic markers that can be linked to therapeutics,” the study said.
 
Drug companies “are improving their management of risk, especially by actively lowering late-stage attrition rates through greater use of information technology and other development practices,” Tufts CSDD Director Ken Kaitin said in a statement accompanying the report.
 

 
NCI Announce $4.5M in RFAs for New Cancer Research Technologies, Including Genomic Tools
 
The National Cancer Institute has set aside $4.5 million in fiscal 2008 as part of several new requests for applications for projects that help develop new cancer-research technologies, including tools for molecular analysis and sample preparation.
The NCI said the RFAs are part of the larger NCI-sponsored Innovative Molecular Analysis program.
 
The “Innovative Technologies for Molecular Analysis of Cancer” opportunities seek Small Business Innovation Research applications for “research projects centered on inception and early stage development of new technologies for cancer research.”
 
NCI said it intends to commit $1 million for each of the project RFAs over the course of 2008. These could include Phase I, Phase II, or Fast Track applications.
 
The institute seeks development for technologies that: detect or alter genomic DNA; measure the expression of genes and gene products; analyze and detect gene and/or cellular products; identify and characterize exogenous infectious agents in cancer; assay the function of major signal transduction networks involved in cancer; support molecular analysis in vitro, in situ, or in vivo in discovery, and pre-clinical and clinical trials.
 
Find the full RFAs here and here.
 
The “Application of Emerging Technology for Cancer Research” opportunity seeks to “evaluate the usefulness of emerging molecular technologies that are ready for initial application to clinical or biological questions in cancer research.”
NCI plans to commit $1.25 million in FY ’08 to fund three to five Phase I and/or Phase II grants. Find the full RFA here.
 

 
NCCN Provides Her-2 Testing for Breast Cancer Patients
 
The National Comprehensive Cancer Network and the Research Advocacy Network have created an online report to educate breast cancer patients about the significance and importance of Her-2 testing.
 
A patient’s Her-2 status needs to be established prior to using Genentech’s Herceptin, an oncologic that is indicated for Her-2-positive early stage breast cancer and Her-2-positive metastatic breast cancer.
 
The NCCN Her-2 Testing Report, available here, discusses the different types of tests used to determine Her-2 status, the steps involved in each test, and what the results signify. The report includes a list of frequently asked patient questions about Her-2 testing.
 
The report also includes a set of clinical recommendations, which are based on the findings of an NCCN-convened task force.
 

 
Catalyst Biosciences and Wyeth Sign Two Agreements for Biotherapeutic Platform of Engineered Proteases
 
Catalyst Biosciences has signed two research collaboration and license agreements with Wyeth Pharmaceuticals using Catalyst’s Alterase therapeutics platform (engineered human proteases) in metabolic diseases and oncology.
 
Wyeth will be responsible for the clinical development, manufacturing, and marketing of developed products.
 
Under the agreement Catalyst may potentially see total payments of up to $100 million, exclusive of potential royalty payments, as well as upfront license payments, milestone payments, R&D funding and royalties on product sales, Catalyst said.  
 
Catalyst said it has raised approximately $40 million to date to advance its therapeutic programs.
 

 
Qiagen Partners with Pathway Diagnostics, Sequenom on Dx, Biomarker Discovery
 
Qiagen has agreed to a new marketing partnership with Pathway Diagnostics and has entered into a research agreement with Sequenom, the company said this week.
 
Under the agreement with Malibu, Calif.-based Pathway, Qiagen said the companies will offer customers a bundled solution of Qiagen's assays and Pathway's clinical development and testing services, Qiagen said. The said it will use its sales force to "develop project opportunities" for the companies to address jointly.
 
Qiagen added that it hopes the partnership will enhance the "clinical utility of new biomarkers through comprehensive assay development, sample-to-result qualification and clinical validation of genetic, pharmacogenomic, metabolomic and toxicogenomic biomarkers."
 
Separately, Qiagen said that it has agreed to work with Sequenom to develop a preanalytical solution to enrich nucleic acids for prenatal diagnostics, Qiagen said.
 
Sequenom will retain commercial rights to any tests the companies develop under the partnership.
 
Qiagen said the goal for the Sequenom partnership is to develop reliable reagents for the enrichment of small nucleic acid fragments, such as those found in maternal plasma, for analysis of cancer and other disorders.
 
Financial terms of the agreements were not released.
 

 
Luminex, Thermo Fisher Unit to Use xMAP Tech to Identify Dx Applications
 
Fisher HealthCare, a division of Thermo Fisher Scientific, and Luminex will use Luminex’s xMAP instruments and assays to jointly identify molecular diagnostic applications, Luminex said last week.  
 
Luminex, which develops and manufacture resulting products, said that by granting Fisher the US rights to its xMAP technology it gains a sales avenue through Fisher’s sales teams, its “access to key clinical accounts,” and its “extensive logistics network.”
 
Financial terms of the deal were not released.
 

 
SeqWright to Handle DNA Screening/Genotyping for Third Wave's HPV Trials
 
SeqWright said last week it will perform all of the sequencing and analysis for a set of clinical trials being conducted by Third Wave Technologies.
 
Third Wave is developing two in vitro molecular assays and a genotyping test to screen for human papillomavirus, which has been identified as the cause of approximately 70 percent of cervical cancer cases, SeqWright said.
 
Third Wave’s tests will detect and identify 14 HPV high-risk types and HPV types 16 and 18, the company said.   
 
SeqWright uses gene sequencing and bioinformatics technologies to help companies run clinical trials for FDA submission.
 

 
NIH Awards $1.9M for Genomic, Bioinformatic Projects at Two Colleges
 
The National Institutes of Health said last week it will dish out $1.35 million to the University of Utah and $540,000 to Oklahoma City Community College for genomics and bioinformatics education projects, respectively.
 
The awards are part of the NIH’s National Center for Research Resources, which has awarded $11.5 million for science education programs around the country in a variety of research fields.
 
Under the NCRR program, the University of Utah’s Genetic Science Learning Center has been awarded $1.35 million for phase I and phase II of its education program entitled “Genomic Science for Health: Web-based Curricula for Biology.”
 
The Center, which is part of the school’s Eccles Institute of Human Genetics, will use a blend of education, science and technology to “educate secondary life science students and teachers about the role of NIH-funded research advances and clinical trials in improving health care.”
 
The program will include modules on molecular genetics, cell biology, developmental biology, and clinical trials, and will address regenerative medicine and animal research.
 
The NCRR said it will fund the Oklahoma City Community College $540,000 for the “Biotechnology/Bioinformatics Discovery” program, which focuses on professional development in life sciences informatics teaching techniques, particularly in underserved areas.
 

 
Health Canada Approves Abbott m2000 Molecular Diagnostic Instrument and Viral Load Tests for HIV-1 and HCV
 
Health Canada has approved the Abbott m2000 automated molecular diagnostic instrument and the Abbott RealTime HIV-1 and hepatitis C virus viral load tests, Abbott and Celera announced this week.
 
Abbott’s m2000 system can significantly reduce the time it takes to measure life threatening viruses and bacteria in patient serum or plasma samples over other available tests, the companies said. Celera maintains a strategic alliance with Abbott for the development and commercialization of molecular, or nucleic acid-based, diagnostic products.
 
The Abbott RealTime HIV-1 and HCV assays are used as indicators of disease prognosis and the assays aid in the management of patients undergoing antiviral therapy. Both tests, developed for use on the Abbott m2000 system, are instruments for improving DNA and RNA testing in molecular laboratories. The assays are not screening tests for HIV-1 or HCV, or diagnostic tests to confirm the presence of HIV-1 or HCV infection, the companies said in a statement.
 
The companies touted that the m200 system, a real-time PCR technology platform, can “accurately detect and measure life threatening viruses and bacteria in patient serum or plasma samples in less than five hours.” Other testing methods can take up to two days to yield the results, the firms said.
 
Additional products in development for the Abbott m2000 system include assays for hepatitis B virus (HBV) and HCV genotyping.

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