Nursing Diagnosis and cooperation between the pharmaceutical industry
diagnostic industry and pharmaceutical industry has not yet become a reality
2008 Joint Declaration of the seven pharmaceutical and diagnostic companies partnerships for the development of nursing diagnosis. This cooperation in 2007 compared to 14, is a significant decline, but 2004-2008 was not a clear downward trend, or the average number of transactions, changes in the 6-14. and pharmaceutical co-care diagnostics industry has yet to be achieved practice.
2008 for all transactions focused in the tumor area
2008 partnership announced in response to the three themes:
tumor development options as a nursing diagnosis has attracted strong interest in .2008, all transactions are concentrated in tumor diagnosis.
large pharmaceutical company as the pharmaceutical and diagnostics industry cooperation side, with a dominant .2008, seven pharmaceutical partners in the six are the top 20 selling prescription drugs ( IMS2008 ranking). OSI is the only exception, but Roche is in this transaction the joint partners, to develop cancer drugs to determine whether the patient responded to Tarceva genetic pharmacology testing. In this study, we believe that contains all of Genetech transactions are transactions for large pharmaceutical companies, because there Roche Holding of Genetech, and in 2009 will become a wholly-owned;
have a competitive advantage in vitro diagnostic reagents and pharmaceutical manufacturers in the industry side of the cooperation in the initiative. In 2008, Abbott is a pharmaceutical company with third-party co-operation nursing diagnosis the only major manufacturers in vitro diagnostic reagents other diagnostic .2008 trading partners announced mmAureon, Celera, Dako and DxS are the top ten in vitro diagnostic reagents. < br> 2008 年 Nursing Diagnosis cooperation
similar theme appears also found in the 2004-2008 nursing diagnosis of pharmaceuticals and diagnostics industry, licensed trade cooperation.
Roche, Pfizer and Merck in 2004-2008 is the most active partners
Roche pharmaceutical pharmaceutical sector, including Genetech, is the field of diagnosis 2004-2008, the most active third-party pharmaceutical licensing partners, announced the 10 transactions, while the annual average 2. Pfizer, Merck and AstraZeneca followed by Roche, were co-diagnosis of 6,5 and 3.
2004-2008, if we consider the other in vitro diagnostic reagents with a large pharmaceutical company subsidiaries mmAbbott , Bayer and Johnson & Johnson mm have announced more than one diagnostic companies and third-party collaboration, Roche Diagnostics as the pharmaceutical industry with the party leadership in companies is significant. However, these diagnostic or panoramic field of view is not known because their cooperative projects pharmaceutical companies, diagnostic internal transparency is very low.
pharmaceutical company announced two years in the 2004-2008 nursing diagnosis of cooperation, including:
large pharmaceutical companies: Amgen, Bristol-Myers Squibb, Eli Lilly and Schering-Plough;
small and medium sized pharmaceutical companies: Biogen Idec and Ipsen.
other nine laboratories for the nursing diagnosis, only a licensing deal announced:
the first time in the company: Aphton, ARCA, Isis and Keryx.OSI Pharmaceuticals and Abbott in 2008 is not taken into account and the transaction.
Biogen Idec and medium-sized pharmaceutical company Ipsen in Chinese
the most active partners completed a series of partners from the pharmaceutical diagnostic industry transactions are concentrated in large pharmaceutical companies .2004-2008, only two top 20 after the company announced at least two transactions.
Biogen Idec United States and France, Ipsen, respectively, ranked by sales of prescription drugs 44 and 69, announced their diagnostic reagents have two licensing deals.
in Ipsen's trading, the company CEO, Jean-Luc Belingard, has important diagnostic industry experience, he was a senior executive Roche Diagnostics Division staff, Later, the company has done some diagnostic board. compared to other medium-sized pharmaceutical companies, Ipsen may therefore be more understanding when and how to best develop the potential value of nursing diagnosis. In the case of Biogen Idec, the company's antibody technology used and in vitro diagnostic reagents can enhance the potential application of synergistic effect.
Ipsen announced it in 2007 and bioMerieux, Celera Diagnostics cooperation of the two:
bioMerieux agreed to use its NucliSENS EasyQ molecular diagnostic testing platform for R & D to help doctors determine patients the effect of BN83495 Ipsen drug candidates. BN83495 breast cancer I was being experimental.
Celera agreed to help develop technology replacement therapy Ipsen drug testing. Celera first determine the classification of genetic markers and development diagnostic prediction. The purpose is to develop nursing diagnosis Ipsen.
Biogen Idec2004 announced Dyax and Epigenomics of two diagnostic cooperation:
Dyax agreed to provide the human antibody library and Biogen Idec to identify therapeutic and diagnostic classification antibody;
? Epigenomics announced that it will use the DNA methylation technology to help Biogen Idec classification potential cancer biomarkers, and to detect patients with drug reactions that can be used as biomarkers for predicted objects. Its purpose is to provide information to help provide basic medical treatment guidance.
deal with the pharmaceutical industry, the most active partners are diagnostic manufacturers a competitive advantage for the nursing diagnosis
a series of transactions are limited to diagnostic companies. only 4 a diagnostic company announced in 2004-2008 that at least two years and the cooperation of pharmaceutical companies, and they are all advantages of companies: Celera, Dako, Epigenomics and Perlegen.Dako is one of the largest companies, net sales in 2008 reached 322 million dollars.
this, there are 3 comments:
1. For the diagnosis of companies, the pharmaceutical industry is not a priority market. R & D risk and time to market pharmaceutical-related industries make the diagnosis of a large manufacturer of nursing diagnosis lost interest, and concentrated in a relatively traditional clinical laboratory market.
2. Company Limited deal flow that the company even if the diagnosis of strengths, R & D as expected economic effects of nursing diagnosis is not always attractive. Nursing Diagnosis project is expected to net present value of the key factors include the strength of intellectual property rights, pricing and compensation, scope, and extent of testing required by regulators.
3. against those targeting the pharmaceutical industry, diagnostic companies, some are independent of the cooperation of pharmaceutical companies, nursing diagnosis research. When diagnostics company has received funding and adequate, high-quality biological samples, this method can guarantee to keep profits within the company.
2004-2008 attracted a half years of cancer care Diagnosis of deal flow
2004-2008, about half of the nursing diagnosis cooperation (45 in 21) is for tumor diagnosis, which consists of three key factors driving:
1. pathology of the disease , the importance of genetic causes;
2. The extent of research in the field;
3. high-priced cancer treatment.
2004-2008 years of nursing diagnosis of different disease areas of cooperation
2004-2008 half of the tumor to attract deal flow
2004-2008 nursing diagnosis, about half of the nursing diagnosis cooperation (45 of 21) was diagnosed for cancer, and this driven by three key factors:
1. pathology of the disease, the importance of genetic causes;
2. The extent of research in the field;
3. high-priced cancer treatment.
2004-2008 in the field of nursing diagnosis of different diseases co < br> Looking
Dako announced in 2009 and the first nursing diagnosis pharmaceutical co. In this transaction, Dako will use it pharmDx line of kits with OSI to develop new cancer drugs test.
We expect the next five years, more and more every year pharmaceutical and diagnostic companies on the diagnosis of co-operation. regulators and consumers need to help the diagnosis of drug use, which will increase the urgency of pharmaceutical companies .
personalized medicine
ten major R & D more personalized medicine, ideas, although not new, but it has not transformed from concept to reality, except a few public examples, such as Herceptin. the completion of the Human Genome Project and advanced tools for molecular medicine advances give us hope. but in a clinical innovation is often required on longer than expected to achieve. In addition to time, the opportunities large events is also critical. do not have such big events and scientific or technology related. recombinant DNA may be today on the progress of the bio-pharmaceutical giant Amgen and Genetech preconditions appear, but some people would say is a key implementer of the Orphan Drug Act of 1983, it is also a small market size indicator When given a valuable indicator of market protection. Many biomarkers market looks relatively small, which may make the diagnosis of the largest companies do not conduct basic research in this area.
overview of personalized medicine that may be important for the big event, we announced early last year a major event from the selected 10:
? EU level the Netherlands, Luxembourg, and the U.S. government fund;
? U.S. and European regulatory proposals;
? consumption testing and clinical testing technology;
? new molecular diagnostics in clinical practice recommendations.
2008 年 1 months of personalized medicine practice
ten major events would tell us, what events in individual the development of medicine is the most important. We offer these ten major events further background.
1. the Dutch government allocated 150 million euros to finance industry and academia in personalized medicine project (April 7, 2008)
Dutch PSV The Centre for Translational Molecular Medicine (CTMM) announced that for cardiovascular disease, cancer, genetic diseases, mental illness and infection field of personalized medicine research project on the 300 million euros fund. the public - individual cooperation projects by the Government of the Netherlands (50%), academic (25%) and industry (25%) funded, are working to improve the clinical treatment of specific diseases and to reduce future government spending in the health sector. All funded projects For the diagnosis must be accelerated to reduce the excessive intervention, fewer side effects and more effective drug use. To achieve these, many CTMM project will focus on the early development of the disease associated with biological markers. All CTMM projects will The Advisory Committee is an independent assessment.
2. Luxembourg government allocated 140 million euros to develop bio-banks, testing and systems biology of lung cancer (June 5, 2008)
Grand Duchy of Luxembourg government announced five years, investments 140 000 000 euros in three personalized medicine projects. a project beyond its original motivation of the health and research to promote Luxembourg's life sciences cluster, to help national economic classification. The program design 3 with a personalized medicine knowledge of American Studies sector participation: Phoenix of the Translational Genomics Research Institute (TGen), Partnership for Personalized Medicine (PPM) and the Seattle Institute for Systems Biology (ISB). three additional projects:
? Luxembourg integrated biological Bank (IBBL) of the establishment;
? Luxembourg Systems Biology Centre (CSBL) establishment;
? to more effective diagnosis and control of diseases, lung cancer biomarkers in the selection and confirmation.
3. EU-funded SMART-BIOMEMS DNA diagnosis equipment development project (December 10, 2008)
Desktop DNA of a new medical diagnostic equipment commercially in 2012. The project is called SMART-BIOMEMS development of equipment, funded by the European Union, concerned about personalized medicine on direct clinical significance. SMART-BIOMEMS diagnosis includes a mobile micro-system to connect personal computers, used in the diagnosis of early disease spectrum. prototype shape in March 2009, was specifically designed to detect and diagnose cancer .
4. the U.S. government for specific diseases, funding medical treatment comparison (February 16, 2009)
7870 billion economic stimulus includes $ 110 in funding for the disease, the effects of different treatment comparison. of action by a committee of 15 federal employees coordinate regulation, they also President of the United States the distribution of the Fund to make recommendations on the issue. scientific literature review and clinical trials may provide a lot of evidence of treatment effectiveness and value. congressman Peter Stack said the United States to spend 2 trillion dollars per year (GDP of 16%) on health care, but Congress did not specify the use of funds, critics fear it would interfere with doctor-patient relationship. Although details of the project has not yet defined, but the diagnosis plays an important role in the treatment have been instructions. provide a more comprehensive diagnosis of the molecular differences in depth, so that researchers can more accurately assess which therapy on which patients effectively, why it works.
5. the United States of genetic information non-discrimination Act (GINA) signed (May 21, 2008); the European Parliament signed a similar agreement (2008 May 7)
GINA protect individuals, protect them from the health insurance and work, to bring the genetic information may experience discrimination. Similar laws have been effective in 34 states, but the federal level, GINA the first law. GINA through before Congress for 13 years it's discussion to identify personalized medicine to help individuals in the benefit of new technology, without fear of being discriminated against. diagnostic industry in the hope of encouraging the use of clinical trials in the GINA benefit and other research activities. to increase patient education and understanding of the genetic characteristics of the disease is expected to increase patient demand for diagnostic tests. Although a relatively new technology based on genetic and chromosome testing is limited in the United States, but the potential increase in patient requests change. Diagnostic molecular diagnostic company wants Congress to give a favorable position to support the effective personalized medicine. This in turn encourages more research and development. In the May 7, 2008, similar programs in Europe have been used: the European Parliament Committee of Ministers adopted the Convention on Human Rights and the purpose of genetic testing on health care biomedical new additional protocol.
6.Genetech citizens submitted a petition requesting FDA in vitro diagnostic reagents for all treatment decisions to use the same standard test
Genetech Research launched a series of targeted therapies, including Herceptin, Avastin and Tarceva, which requires a number of diagnostic tests to support prescribing decisions. some tests based on different clinical testing and regulatory process. petition submitted at the December 5, FDA requires testing of all in vitro diagnostic reagents test is not FDA regulated. Deadline June 1, 2009, was FDA petition registration Ten Genetech opinion:
? Johns Hopkins University Genetics and Public Policy Center, Fujirebio Diagnostics, and Agendia support;
? Coalition for 21st Century Medicine in two instalments, the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology of the opposition;
? Roche's support;
? The Advanced Medical Technology Association (AdvaMed) for the the risk of regulatory 7.FDA consider Centers for Medicare and Medicaid Services in the diagnosis of co-operation (December 25, 2008)
from FDA regulation in vitro diagnostic reagents, said the representative of the test suite, FDA will look and Centers for Medicare and Medicaid Services (CMS) cooperative approach, CMS through CLIA Laboratory United States regulatory body tests to identify their products in the regulatory role of gene diagnosis. The comments, in September 2008 by the President's Council of Advisors on Science and Technology (PCAST ) published on the new diagnostic tools for major obstacle. We look forward to the discussion of Genetech citizen petition.
8.deCode issue assess the risk of prostate cancer DNA testing method deCode PrCa (2008 年 2 月 20 日)
deCODE announced the release of deCODE PrCa , an increased risk of prostate cancer to determine the genetic changes related to testing methods. The test method standard in the process of CLIA laboratory markers, is designed to detect single nucleotide polymorphisms (SNPs). deCode believe that this test for the improvement and personalized diagnosis and treatment of prostate cancer has important clinical relevance agreement. deCODE also effective tests include type II diabetes, atrial fibrillation, stroke and heart attack.
9. large sample test of the gene guiding warfarin dose test (February 20, 2009)
the optimal dose of medication to prevent blood clots warfarin differ significantly between different patients. one from seven hospitals in Europe included 2700 patients in clinical trials and research groups will be used to detect a genetic profile to determine the patient developed based on the ideal dose method. The international research team has developed a mathematical formula based on genetic information, it seems than the traditional method gives more accurate prediction correct dosage.
10. Netherlands Cancer Institute breast cancer test MammaPrint Agedia health standards (February 4, 2009)
molecular diagnostics company, Agendia, announced that its method of breast cancer tumor recurrence test, MammaPrint, has been The Dutch Institute for Healthcare Improvement (CBO) in 2008 included the updated guidelines. In February 2007, MammaPrint been reported is the FDA in vitro diagnostic reagents in the new multiple index detection (in vitro diagnostic reagents MIA) guidelines for the first cleared in vitro diagnostic test kit . CBO now provided from the Netherlands MammaPrint predictive value of clinical recognition, and its purpose is to determine each patient's risk profile and guide subsequent treatment. MammaPrint is a DNA microarray test, measurement, surgical removal of breast cancer in women of 70 genes expression. The test results in combination with other clinical information and laboratory tests to help doctors plan treatment and follow.
personalized medicine
Case Study Case Study 1 - Translational Genomics Research Institute Translational Genomics
Institute (TGen) is a nonprofit organization dedicated to the development of predictive diagnostics and treatment with precisely. TGen by the Dr. Jeffrey Trent established in 2002.
TGen researchers on the validity of the translation process has contributed to , by studying common and complex genetic component of diseases, including oncology, neurology and metabolic diseases, the progress of the process into a clinical study. eventually, TGen's goal is to increase the medical knowledge of individual genetic variation, and rapid development of diagnosis and treatment for the disease.
this concern started in 2008 with the diagnosis, gene technology, biomarkers identification and commercial activities related to:
? in January 2008, TGen, and a International Working Group announced a blood test indicates the risk of men suffering from prostate cancer study results;
? 2008 年 9 月, TGen investors announced that they have developed a rapid detection method for human genome, the cost for other methods of 1 / 10. This technology can quickly find the genes that may affect changes in human health;
? or in September 2008, a TGen-led international team identified a specific brain protein KIBRA and late onset Alzheimer's disease relationship. The discovery of the translation phase of protein as biological markers to determine disease risk;
? in October 2008, TGen spin-off third company MedTrust Online, to help doctors access patient information, providing them the best treatment.
Case Study 2-Genomic Health Company
Genomic Health to find gene-based molecular diagnostic development and commercialization of improved cancer treatment. Founded in 2000, from the current Executive Chairman Randy Scott in California RedWood City established. the company is committed to development based on genetic characteristics of patients with a more personalized cancer treatment tools.
research and development company focused on identifying those unique identifying specific genes and gene expression of tumor types. These features can help doctors understand tumor-specific treatment is effective, and whether the tumor will recur. Genomic Health clinical cooperative network.
in the first round 4 times before the public offering to raise 0.51 billion dollars, and in 2005 listed Also raised 060 million U.S. dollars.
in January 2004, Genomic Health's CLIA certified clinical laboratory has been to complete the company's first test, Oncotype DX. the same month, the first commercial Oncotype DX-tumor samples test was also analyzed. Oncotype DX in January 2006 by the Medicare company, in November 2006 by the United States largest personal insurance company Aetna, one of the certification on compensation. Now Oncotype DX through contracts, policies and agreements have been covered 90% of the U.S. insurance population. Oncotype DX is recommended in clinical guidance, and included into the standard of care of patients with early breast cancer.
now Oncotype DX has been to help doctors choose the right, there are cost-effective drugs for treatment.
the company is also developing other tumors. In June 2006, the Company and National Surgical Adjuvant Breast and Bowel Project (NSABP) released the results of colon cancer; January 2009, the company announced the Oncotype DX clinically effective in colon cancer.
in co-operation, in January 2008, the company announced that Pfizer R & D cooperation and assess the recurrence of non-metastatic renal cell carcinoma risk of the diagnosis of disease.
Case Study 3-DxS
DxS is a personalized medicine company providing molecular diagnostics to help physicians and pharmaceutical companies based on the patient the drug of choice, especially for lung and colon cancer. company uses its unique real-time polymerase chain reaction (PCR) technology, Scorpions, as the technology base of products and services.
company is headquartered in Manchester, has 60 employees. the company was founded in 2001 by CEO Dr. Stephen Little and CSO Dr. David Whitcombe established. They are all former employees AstraZeneca Diagnostics Division.
DxS product detection and drug reactions associated with cancer gene mutation, and includes nursing diagnosis of a CE mark program, used in:
? CE mark, including cancer mutation diagnostic products, TheraScreen range of lung and colon cancer to help doctors make more effective prescription treatment. DxS plan released in the next 2 years more in the diagnosis of cancer sets;
? diagnostic reagents, including EGFR, RAS, RAF, BCF-ABL cancer gene mutation and other products.
the cooperation of a large industrial companies DxS help develop its business. Dr Stephen Little said: including:
? pharmaceutical industry: In December 2008, DxS and Amgen signed an agreement to provide the K-Ras Vectibix nursing diagnosis;
? diagnostic industry: In February 2009, DxS authorized DuPont Qualicon a license to use it to develop diagnostic platform Scorpion food industry to use the test.
company also provides genetic analysis services to support drug discovery, tumor variation analysis and DNA extraction services. This business is pharmaceutical and diagnostic industry more and more support.
DxS has chosen a business model for diagnosis, including product development activities from the services business generated cash flow support, and now the product started to have their own profit.
DxS plans to hire more than 20 people, scheduled June 30, 2008 generated £ 3,000,000 before income generated 10 million pounds this time next year.
Case Study 4 - dose of warfarin genetic testing of health economics, science
warfarin
Lin, commonly used anticoagulant for the prevention and control of blood clots, it is difficult to use because a reasonable doses vary greatly between patients. If the dose is too strong, increasing the risk of serious bleeding; if the dose is too small, increased risk of stroke .
The Critical Path Institute organized a major pharmaceutical manufacturers in the body, as an independent third party to manage their private data. The findings, presented to the FDA, FDA in September 2007 changed the warfarin label. Now doctors are required to use genetic testing before treatment. This is achieved in the clinical progress of personalized medicine.
Economics
2006 年 11 月, the influential Brookings Institute issued its decision on genetic testing for reasonable warfarin dose, medical savings report. Their conclusion is: ;
However, in April 2008, the largest U.S. insurance company BlueCross-BlueShield announced their conclusion: genetic test can not serve as standards of care.
further study confirmed that the dose of warfarin genetic testing will improve the patient's clinical outcome, but the high cost of the improved method. In January 2009, published in international medical research annual, researchers based data model, that access to each of the cost of more than 170,000 U.S. dollars. They further calculated only when the high-risk bleeding patients only on the selective use of economic force and therefore can prevent at least 1 / 3 of major bleeding events.
2009 年 5 months, the U.S. Federal Government Medicare health insurance over 65 issued a decision not to pay millions each year patients dose of warfarin genetic test.
but recommended for participation in clinical trials, Medicare patients pay for genetic tests to help doctors continue to study. NIH COAG in 2009 began a period of 3 years of large-scale research will continue to choose warfarin further clinical and economic evidence.
Case Study 5 - today the development of bio-banks
this case based Dr. Robert Hewitt's report, He was designated as a Comprehensive Biological Luxembourg bank executives.
from the early history of medical research since the beginning of the collection and analysis of biological samples has been a demand. These samples should be stored appropriately, is conducive to clinical studies and patient privacy protection. particularly in the demand for diagnostic tests developed, so that high-quality standardized research as possible.
banking sector in a growing number of biological research collaboration, sharing, and the same sample under the standard, becoming more organized In 1987 in the US Cooperative Human Tissue Network (CHTN) the establishment of an important milestone in the network of biological banks, as well as 1999, the International Society for Biological and Environmental Repositories (ISBER) establishment. ISBER provide clinical and bio-banks from the full name bio-environment and biodiversity banks to capture the full spectrum of services. Its members include the US National Cancer Institute (NCI), Centers for Disease Control (CDC. ..
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