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GPhA, NHGRI, X Prize Foundation, GeneGo, Sorenson Genomics, US Department of Justice

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New US Legislation Could Open Door to Generic Biologics
 
Two US legislators last week introduced a bill that would allow generic drug makers to develop and market generic biologics.
 
This is noteworthy because if generic biotech companies materialize they could represent a new revenue stream for pharmacogenomic tool vendors and create new R&D options for theranostic development. This is so because biologic drugs, unlike traditional chemical generics, require different kinds of technologies to ensure that they are as safe and efficiacious as their brand-name predecessors.
 
Representative Henry Waxman and Senator Charles Schumer introduced the bill, called the "Access to Life-Saving Medicine Act," last week. The legislation would establish “the necessary clear, efficient abbreviated pathway for approval of generic biopharmaceuticals,” according to the Generic Pharmaceutical Association, which supports the bill.
 
As Pharmacogenomics Reporter reported in 2002 [see 09/18/2002 PGx Reporter, GPhA said it hoped to take advantage of consumer complaints over soaring drug costs to lobby Congress to instruct the Food and Drug Administration to let generic biologics on the market.
 
If it succeeds, GPhA will likely open the door for generic drugmakers to tuck in to the tens of millions of dollars in sales that will be up for grabs over the coming years as a cascade of biotech drugs loses patent exclusivity.
Biopharmaceuticals sales are currently growing almost twice as fast as traditional drugs, according to GPhA, and represent around $30 billion in US sales and 12 percent of total pharmaceutical products.
 
GPhA said sales of biologics are growing by around 20 percent a year and by 2010 will double.
 

 
NHGRI Gives Genetics Center $2M to Gauge Americans' Opinion on Large Population Studies
 
The National Human Genome Research Institute last week said it has given the Genetics and Public Policy Center $2 million to conduct a pilot “public discussion” about how the government can structure future studies looking at how genes and the environment affect human health.
 
NHGRI director Francis Collins said that “before we even think of moving forward” with the idea of launching large, population-based genetic studies “it is imperative that we begin a dialogue with the American public. This grant opens the door to that discussion.”
 
As part of the two-year project, the GPPC, which is part of the Berman Bioethics Institute at Johns Hopkins University, will hold a “series of focus groups” in six US cities to gauge how the public perceives this kinds of research.
 
The cities include: Jackson, Miss.; Kansas City, Mo.; Middletown and Philadelphia, Pa; Phoenix, Ariz.; and Portland, Ore.
 
The GPPC also plans to survey 4,000 individuals over the Internet and to conduct “town hall” meetings in these locations that it said will be attended by 1,000 people. The center said it will interview “community leaders” as well.
 
The initiative comes one year after the NHGRI and other NIH institutes brought together specialists from the fields of genetics, epidemiology, biostatistics, ethics, law, and social issues to “examine the scientific rationale and the logistical and technical challenges of a large, population-based study of genes, environment and health in the United States.”
 
Today, the NHGRI said that even though the project hasn’t identified where it can raise the cash it needs — it also hasn’t disclosed how much it believes such a project would cost — it said that “carefully outlining and considering the goals and key design aspects” of these kinds of studies “was deemed of high scientific importance.”
 
The NHGRI said such a study would include “hundreds of thousands” of volunteers who would be followed for “many years” to “ascertain and quantify the major environmental and genetic contributors to common illnesses.”
 
It would also try to explain why “health disparities” exist for certain “groups,” which the NHGRI said is “a topic of much concern.”
 
The NHGRI decided to ask the “American public” about its views for such a study after a Department of Health and Human Services genetics committee “concluded that broad-based public engagement will be essential in designing and implementing such studies” and recommended that “efforts begin to assess public attitudes toward this area of research.”
 
See PGx Reporter’s interview with GPPC director Joan Scott for more information on the project.
 

 
$10M Genome X Prize Will Go to First Team to Map 100 Human Genomes in 10 Days
 
The X Prize Foundation this week announced its $10 million Archon X Prize for Genomics, which will go to the first team to create a technology that can map 100 human genomes in 10 days.

According to the Foundation, the prize “is designed to usher in a new era of personalized preventative medicine.”

 
Three teams are currently enrolled in the competition: VisiGen Biotechnologies, led by Susan Hardin; 454 Life Sciences, led by CEO Christopher McLeod; and a group comprising the Westheimer Institute for Science and Technology, the Foundation for Applied Molecular Evolution, and Firebird Biomolecular Sciences. This group will be led by Steve Benner.
 
“Many other companies have inquired and more teams are expected to register soon,” the X Prize Foundation said.
 
The prize was announced at a press conference Wednesday at the National Press Club in Washington, DC. On hand were Craig Venter; Francis Collins; Anousheh Ansari, the first female private space explorer and co-founder and chairman of Prodea Systems; Sharon Terry, president and CEO of the Genetic Alliance; Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturing Association; and Stewart Blusson, president of Archon Minerals, which became the title sponsor of the prize after a “generous multi-million dollar” donation by Blusson.
 

 
NHGRI Awards $13M for Next-Gen Sequencing Technologies
 
The National Human Genome Research Institute this week said it has awarded 11 grants worth a total of more than $13 million to develop technologies that will lower the cost of DNA sequencing.
 
The agency has a near-term goal of lowering the costs of sequencing a mammalian-sized genome to $100,000, and to eventually cut the cost of whole-genome sequencing to $1,000 or less. Lowering the cost will make genome sequencing possible as part of routine medical care, NHGRI said.
 
Nine grants fund researchers developing technologies that will make the $1,000 genome possible and two grants for researchers working on the $100,000 mammalian genome: 
  • General Electric Global Research received $900,000 over two years to use existing enzyme and dye-tagged nucleotide resources. NHGRI will increase the phased award if specific milestones are met.
  • University of North Carolina, Chapel Hill, received $3.8 million over four years to use nanoscale fluidic technologies to rapidly sequence single DNA molecules.
  • University of California, San Diego, received $275,000 for genome sequencing using nanoarrays of single DNA molecules. The process involves cyclic sequencing by ligation. NHGRI will increase the award if specific milestones are met.
  • Boston University received $2.2 million over three years to use design polymers and nanpore arrays to develop high-throughput DNA sequencing.
  • Helicos Biosciences received $2 million over three years to develop a strategy of obtaining short reads from DNA strands immobilized on a surface inside a reagent flow cell.  
  • Lehigh University received $905,000 over three years to apply force spectroscopy to DNA. 
  • Arizona State University received $895,000 over three years to fabricate universal DNA nanoarrays using nano-contact printing.
  • Case Western Reserve University received $815,000 over three years to develop large-scale nanpore arrays.
  • University of Washington, Seattle, received $605,000 over two years to also use nanopore sequencing, but will tailor an alternative protein pore, Mycobacterium smegmatis porin A.
  • The Human Genome Sequencing Center at Houston’s Baylor College of Medicine received $500,00 to improve its fluorescent nucleotides to sequence large-scale genomes.
  • Intelligent Bio-Systems received $425,000 to develop a high-speed, massively parallel DNA sequencing system using unique base analogues and the sequencing by synthesis approach.
 
Since 2004, NHGRI has awarded $83 million to investigators to develop both near-term and next-generation sequencing technologies.
 

 
Genomic Tools to Play Role in New NIH Consortium to Improve Clinical Research
 
The National Institutes of Health this week said it will reallocate at least $100 million from the Roadmap Initiative to help pay for a new consortium that will bring together 60 institutions that will use genomic and other technologies to improve clinical research.
 
According to the NIH, the institutions plan to “assemble interdisciplinary teams that cover the complete spectrum of research, [including] biology, clinical medicine, dentistry, nursing, biomedical engineering, genomics, and population sciences; develop better designs for clinical trials to ensure that patients with rare as well as common diseases benefit from new medical therapies; produce enriched environments to educate and develop the next generation of researchers trained in the complexities of translating research discoveries into clinical trials and ultimately into practice; design new and improved clinical research informatics tools; expand outreach efforts to minority and medically underserved communities; [and] forge new partnerships with private and public health care organizations.”
 
The CTSA will pay for this by redirecting existing clinical and translational programs, including Roadmap funds. Total first-year funding will be around $100 million; when fully implemented in 2012 the initiative is expected to dole out around $500 million a year to 60 academic health centers.
 
More information can be found here.
 
The consortium “represents the first systematic change in our approach to clinical research in 50 years," NIH Director Elias Zerhouni said in a statement. "Working together, these sites will serve as discovery engines that will improve medical care by applying new scientific advances to real world practice.
 
“We expect to see new approaches reach underserved populations, local community organizations, and health care providers to ensure that medical advances are reaching the people who need them,” he added. 
 
There are currently 12 academic health centers and 52 additional centers receiving planning grants to join the consortium, according to the NIH.
 
The first set of 5-year awards will go to: Columbia University Health Sciences in New York; Duke University in North Carolina; the Mayo Clinic College of Medicine in Rochester, Minn.; Oregon Health & Science University in Portland; Rockefeller University in New York; the University of California, Davis; the University of California, San Francisco; the University of Pennsylvania; the University of Pittsburgh; the University of Rochester in New York; the University of Texas Health Science Center at Houston; and Yale University.
 

 
NCI Awards GeneGo $1M Phase II SBIR Grant to Discover Breast Cancer Biomarkers
 
The National Cancer Institute has awarded GeneGo a phase II SBIR grant worth $1 million over two years related to help it discover breast cancer biomarkers, GeneGo said this week.
 
The research program includes a large-scale gene-expression and genotyping study to be conducted at the Mayo Clinic. GeneGo will use its MetaCore data-mining program for data analysis.
 
GeneGo said that in phase I of the grant it performed a network analysis of previously published microarray expression data.
 

 
Sorenson Genomics Forms Forensics Division
 
Sorenson Genomics said this week that it has created an advanced forensics division.
 
The new division, called Sorenson Forensics, will provide casework services for federal, state, and local crime laboratories. It will also help court officers in individual criminal cases and offer genetic forensic services for private industry clients, Sorenson said.
 
The new division will be based in Sorenson’s existing Salt Lake City headquarters
 
Other details were not disclosed.
 

 
NHGRI Issues 10 RFAs to Fund Genome Sequencing Technology Development
 
The National Human Genome Research Institute this week said it may fund approximately $24 million in fiscal year 2007 under requests for applications for 10 new and/or competing continuation grants for genome sequencing technologies.
 
There are five RFAs for near-term development of genome sequencing technologies, each with a different award mechanism, and five for genome sequencing technologies aimed at the $1,000 genome, also with several award mechanisms.
 
Both RFAs are modifications of RFAs announced in December 2005. The application deadlines are in late November 2007.
 
Near-Term Technology Development for Genome Sequencing
 
For the “Near-Term Technology Development for Genome Sequencing” RFAs, NHGRI expects to fund $12 million in awards, to be allocated as follows:
 
Under the R01 mechanism, NHGRI plans to make two to seven awards for a total of $4 million, subject to funding approval. Each project can apply for up to $1.5 million in direct costs per year. More information is available here.
 
Under the R21 mechanism, NHGRI may make five to nine awards for a total of $2 million. The direct costs are limited to $200,000 each year. More information is available here.
 
Under the R21/R33 mechanism, NHGRI will try to fund two to six awards for a total of $2 million. Direct costs are limited to no more than $200,000 per year for the R21 phase and no more than $1.5 million per year for the R33 phase. More information is available here.
 
Under the SBIR R43/R44 mechanism, NHGRI expects two to six awards for a total of $2 million. Each project will be restricted to $250,000 total costs per year and time periods up to 2 years may be requested for Phase I grants. For Phase II grants, the budgets are increased to $1.5 million total costs per year and time periods up to 3 years. More information is available here.
 
Under the STTR R41/R42 mechanism, NHGRI expects two to six awards for a total of $2 million. Each project will be restricted to $250,000 total costs per year and time periods up to 2 years may be requested for Phase I grants. For Phase II grants, the budgets are increased to $1.5 million total costs per year and time periods up to 3 years. More information is available here.
 
Revolutionary Genome Sequencing Technologies
 
For the “Revolutionary Genome Sequencing Technologies – The $1000 Genome” RFAs, NHGRI expects to fund $12 million in awards, subject to funding approvals, to be allocated as follows:
 
Under the R01 mechanism, NHGRI plans to make two to seven awards for a total of $4 million, subject to funding approval. Each project can apply for up to $1.5 million in direct costs per year. More information is available here.
 
Under the R21 mechanism, NHGRI may make five to nine awards for a total of $2 million. The direct costs are limited to $200,000 each year. More information is available here.
 
Under the R21/R33 mechanism, NHGRI will try to fund two to six awards for a total of $2 million. Direct costs are limited to no more than $200,000 per year for the R21 phase and no more than $1.5 million per year for the R33 phase. More information is available here.
 
Under the SBIR R43/R44 mechanism, NHGRI expects two to six awards for a total of $2 million. Each project will be restricted to $250,000 total costs per year and time periods up to 2 years may be requested for Phase I grants. For Phase II grants, the budgets are increased to $1.5 million total costs per year and time periods up to 3 years. More information is available here.
 
Under the STTR R41/R42 mechanism, NHGRI expects two to six awards for a total of $2 million. Each project will be restricted to $250,000 total costs per year and time periods up to 2 years may be requested for Phase I grants. For Phase II grants, the budgets are increased to $1.5 million total costs per year and time periods up to 3 years. More information is available here.
 

 
US Justice Department Earmarks $125M for President's DNA Initiative
 
The US Department of Justice has earmarked $125 million for funding opportunities available through President George Bush’s 3-year-old DNA Initiative, the DOJ said this week.
 
The DNA Initiative is a 5-year, $1 billion commitment from the government to improve the nation’s capacity to use DNA evidence by improving crime lab capacity, funding R&D, eliminating backlogs of criminal genetic evidence, and other projects.
 
In addition to the funding provided through the DNA Initiative, $18.5 million has been awarded to improve criminal justice forensic services.
 
All of the grants will be administered by the National Institute of Justice, the R&D and evaluation arm of the Dept of Justice, the DOJ said.

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