Thursday, July 16, 2009
US Senate Committee Approves 12-yr Exclusivity for Biologics
WASHINGTON (AP) — Senators agreed Monday to give high-tech biologic drugs 12 years of market protection before generic versions can compete.
The vote in the Senate Health, Education, Labor and Pensions Committee was a victory for the biotechnology and pharmaceutical industries but a defeat for the Obama administration and AARP.
The Obama administration had pushed for a seven-year exclusivity period so that patients could get quicker access to cheaper versions of costly medicines used to treat ailments including cancer, Parkinson's, diabetes and rheumatoid arthritis.
Proponents of the longer time frame say products like the blockbuster cancer drug Avastin deserve longer market protection because they are more expensive and time-consuming to produce than regular drugs, and the extra time and money is needed to attract investors and promote innovation.
The vote came as the health committee worked to complete a sweeping health overhaul bill it expects to finish Tuesday. The biotech drug portion was a major unresolved issue, but Monday's action doesn't mean it's over. The decision would still need agreement from the full Senate and the House, where Energy and Commerce Committee Chairman Henry Waxman, D-Calif., strongly supporters a shorter exclusivity period.
Biotech drugs currently don't face generic competition because the Food and Drug Administration doesn't have power to approve copies of such medications. Efforts to change that have been held up for nearly a decade by squabbling between the biotech and generic drug industries and their allies on Capitol Hill.
Biotech companies had demanded at least 14 years on the market before their products face generic competition, but the drug industry welcomed Tuesday's vote.
"The overwhelming majority of senators on the committee voted to do what's best in the end for patients and the U.S. economy," said Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. "Our companies in return remain committed to developing the cutting-edge medicines which allow patients everywhere to live longer, healthier and more productive lives."
The powerful senior citizens' lobby AARP expressed disappointment, suggesting it might oppose the underlying bill over the issue.
"While we applaud many of the aspects of the HELP Committee's overall bill, AARP has great difficulty supporting legislation that would delay the availability of safe, affordable generic biologic drugs and impede consumer access to these lifesaving drugs," said Jim Dau, AARP national spokesman.
The health committee voted 16 to 7 in favor of the 12-year measure offered by Sens. Mike Enzi, Orrin Hatch and Kay Hagan. It's the time period previously endorsed by committee Chairman Edward M. Kennedy, whose home state of Massachusetts is a biotech stronghold. Kennedy is away from the Senate while being treated for brain cancer.
By a 5 to 17 vote the committee rejected an alternate measure by Sen. Sherrod Brown, D-Ohio, that would have started with a seven-year exclusivity period, with additional years possible for innovations.
Biotech drugs were not included in the 1984 law that first allowed the FDA to approve copies of traditional, chemical drugs. At the time the biotech industry successfully argued that their drugs, which are made from living cells, were too complex to be duplicated by generic competitors.
By ERICA WERNER
MS in Regulatory Affairs Program
The Johns Hopkins University (JHU) and BD Diagnostics (BD) have partnered to offer a unique master’s fellowship in the field of Bioscience Regulatory Affairs. JHU and BD have a shared interest in cultivating and educating the next generation of workers in the field of regulatory affairs. Students accepted into this fellowship take courses approved by their JHU advisor from the course catalog and offered at existing JHU locations, including online. Selected students will be employed by BD and will, therefore, be required to successfully complete BD's employment process and meet BD's requirements for continued employment. JHU will provide the basic formal educational structure for all students within its program.
BD will provide salary and tuition support for up to five incoming JHU BSRA students each year BD will also provide, through designated members of its staff, mentoring of BSRA fellowship students.
BD Diagnostics, a segment of global medical technology company BD, (http://www.bd.com) is a leading provider of products for the safe collection and transport of diagnostics specimens, as well as instruments and reagent systems to accurately detect a broad range of infectious diseases, healthcare-associated infections (HAIs) and cancers. BD focuses on improving health outcomes for patients and providing laboratories with solutions that improve quality, enhance laboratory system productivity, reduce costs and inform medical decisions.
Students in the MS in Regulatory Affairs Program take six required regulatory courses. With this foundation, students will have the opportunity to specialize in an aspect of regulatory affairs of their choice through three elective courses, including advanced regulatory and science courses. Finally, hands-on, real life experience will be provided to students through a practicum course at the end of the program. The strong science foundation, the opportunity to specialize, and the practicum requirement distinguish this program as a leader in bioscience regulatory affairs education. Students completing the program are expected to be able to lead regulatory affairs initiatives in government and industry.
- Clinical Trial Design
- International Regulatory Affairs
- The Product Development Process: From Intellectual Property to Licensing
- Food and Drug Law
Credentials and Prerequsites
- Undergraduate degree in the life sciences or engineering with at least a 3.0 on a 4.0 scale.
- One semester of Biochemistry and Cell Biology at the undergraduate or graduate level or Bioscience for Regulatory Affairs
Applications deadline for the BD Fellowship has been extended to July 15, 2009 for the Fall 2009 class. Apply now.
Tuesday, July 14, 2009
Schizophrenia and Bipolar Disorder Share Genetic Roots
A trio of genome-wide studies – collectively the largest to date – has pinpointed a vast array of genetic variation that cumulatively may account for at least one third of the genetic risk for schizophrenia. One of the studies traced schizophrenia and bipolar disorder, in part, to the same chromosomal neighborhoods.
"These new results recommend a fresh look at our diagnostic categories," said Thomas R. Insel, M.D., director of the National Institute of Mental Health (NIMH), part of the National Institutes of Health. "If some of the same genetic risks underlie schizophrenia and bipolar disorder, perhaps these disorders originate from some common vulnerability in brain development."
Three schizophrenia genetics research consortia, each funded in part by NIMH, report separately on their genome-wide association studies online July 1, 2009, in the journal Nature. However, the SGENE, International Schizophrenia (ISC) and Molecular Genetics of Schizophrenia (MGS) consortia shared their results - making possible meta-analyses of a combined sample totaling 8,014 cases and 19,090 controls.
All three studies implicate an area of Chromosome 6 (6p22.1), which is known to harbor genes involved in immunity and controlling how and when genes turn on and off. This hotspot of association might help to explain how environmental factors affect risk for schizophrenia. For example, there are hints of autoimmune involvement in schizophrenia, such as evidence that offspring of mothers with influenza while pregnant have a higher risk of developing the illness.
"Our study was unique in employing a new way of detecting the molecular signatures of genetic variations with very small effects on potential schizophrenia risk," explained Pamela Sklar, M.D., Ph.D., of Harvard University and the Stanley Center for Psychiatric Research, who co-led the ISC team with Harvard's Shaun Purcell, Ph.D.
"Individually, these common variants' effects do not all rise to statistical significance, but cumulatively they play a major role, accounting for at least one third – and probably much more – of disease risk," said Purcell.
Among sites showing the strongest associations with schizophrenia was a suspect area on Chromosome 22 and more than 450 variations in the suspect area on Chromosome 6. Statistical simulations confirmed that the findings could not have been accounted for by a handful of common gene variants with large effect or just rare variants. This involvement of many common gene variants suggests that schizophrenia in different people might ultimately be traceable to distinct disease processes, say the researchers.
"There was substantial overlap in the genetic risk for schizophrenia and bipolar disorder that was specific to mental disorders," added Sklar. "We saw no association between the suspect gene variants and half a dozen common non-psychiatric disorders."
Still, most of the genetic contribution to schizophrenia, which is estimated to be at least 70 percent heritable, remains unknown.
"Until this discovery, we could explain just a few percent of this contribution; now we have more than 30 percent accounted for," said Thomas Lehner, Ph.D., MPH, chief of NIMH's Genomics Research Branch. "The new findings tell us that many of these secrets have been hidden in complex neural networks, providing hints about where to look for the still elusive – and substantial – remaining genetic contribution."
The MGS consortium pinpointed an association between schizophrenia and genes in the Chromosome 6 region that code for cellular components that control when genes turn on and off. For example, one of the strongest associations was seen in the vicinity of genes for proteins called histones that slap a molecular clamp on a gene's turning on in response to the environment. Genetically rooted variation in the functioning of such regulatory mechanisms could help to explain the environmental component repeatedly implicated in schizophrenia risk.
The MGS study also found an association between schizophrenia and a genetic variation on Chromosome 1 (1p22.1) which has been implicated in multiple sclerosis, an autoimmune disorder.
"Our study results spotlight the importance not only of genes, but also the little-known DNA sequences between genes that control their expression," said Pablo Gejman, M.D., of the NorthShore University HealthSystem Research Institute, of Evanston, ILL, who led the MGS consortium team. "Advances in biotechnology, statistics, population genetics, and psychiatry, in combination with the ability to recruit large samples, made the new findings possible."
The SGENE consortium study pinpointed a site of variation in the suspect Chromosome 6 region that could implicate processes related to immunity and infection. It also found significant evidence of association with variation on Chromosomes 11 and 18 that could help account for the thinking and memory deficits of schizophrenia.
The new findings could eventually lead to multi-gene signatures or biomarkers for severe mental disorders. As more is learned about the implicated gene pathways, it may be possible to sort out what's shared by, or unique to, schizophrenia and bipolar disorder, the researchers say.
Source: Psychiatric and Neurodevelopmental Genetics Unit, Center for Human Genetic Research, Harvard University.
Jianxin S, et al. Common variants on chromosome 6p22.1 are associated with schizophrenia. July 1, 2009, Nature
Stefansson H, et al. Common variants conferring risk of schizophrenia. July 1, 2009, Nature
Purcell SM, et al. Common polygenic variation contributes to risk of schizophrenia that overlaps with bipolar disorder. July 1, 2009, Nature
Monday, July 13, 2009
HHMI Expands Support of Postdoctoral Scientists
HHMI will now provide each organization with support for eight postdoctoral fellows a year – double the current number – and expand the reach of the program.
Fellows will be selected competitively by each organization. Each fellowship will have a three-year term. When the initiative is at full capacity, HHMI will be supporting 96 postdoctoral fellows at an anticipated annual cost of about $5 million. The program began in 2007 when HHMI announced it would fund up to 16 postdoctoral fellows in HHMI labs each year. There is no requirement that future fellows be appointed in HHMI labs.
“These organizations consistently select outstanding scientists for their prestigious fellowship programs, and this support comes at a critical moment in their careers,” said HHMI President Robert Tjian. “We are pleased to expand our partnership, as well as the funding needed to develop and nurture some of the most talented among a new generation of scientists.”
HHMI's funding will permit each of the four institutions to fund more fellowships than they would otherwise. “By expanding its funding for this program, HHMI anticipates that these organizations will now be able to offer 32 additional fellowships each year,” said Jack E. Dixon, HHMI vice president and chief scientific officer.
More Information about the Organizations HHMI Is Collaborating With:
The Damon Runyon Cancer Research Foundation funds the rising stars of science, recruiting the best new minds into cancer research and seeding their bold ideas. Since its founding in 1946, the Foundation has invested over $220 million and funded more than 3,200 scientists. Eleven scientists supported by the Foundation have received the Nobel Prize, and others are heads of cancer centers and leaders of renowned research programs.
The Helen Hay Whitney Foundation was established and endowed in 1943 by Mrs. Charles S. Payson, the former Joan Whitney, and named in honor of her mother, Helen Hay Whitney. Originally established to stimulate and support research in the area of rheumatic fever and rheumatic heart disease, the foundation later expanded its interests to include diseases of connective tissue and, ultimately, all basic biomedical sciences.
The Jane Coffin Childs Memorial Fund for Medical Research was established in 1937 by the late Alice S. Coffin and Starling W. Childs to create an entity that would honor the memory of Jane Coffin Childs. The purpose of the fund was to support research directed toward understanding and ultimately conquering the disease which caused her death. The fund was created as a gift in trust to Yale University for the furtherance of research into the causes, origin, and treatment of cancer.
Since 1983, the Life Sciences Research Foundation, without benefit of endowment, has administered yearly peer reviews to select the highest quality candidates seeking postdoctoral fellowships in all areas of the life sciences. Sponsors of the fellows are research-oriented companies, foundations, and philanthropists. The foundation is run pro bono by academic scientists.
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