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Jo-Anne Dillon, Director, Centre for Research in Biopharmaceuticals, University of Ottawa Joe Elliott, President, Lymphosign Inc. John Clement, J.R. Clement & Associates John Goudey, Partner, Ernst & Young Kathleen Brire, Senior IRAP-TPC Project Officer, NRC Kathryn Howard, Director, Life Sciences Branch, Industry Canada Kelly Butler, Public Health Specialist Ken Lawless, Executive Director, Ottawa Life Sciences Council Kevin Fehr, Director, Basic Research and Genetics, Glaxo Smith Kline Krystyna Miedzybrodzka, National Sciences and Engineering Research Council of Canada Lisa Ni, Industry Canada Lorne Meikle, President & CEO, BCY Life Sciences Inc. Luis Barreto, Vice President, Public Policy, Aventis Pasteur Marc Lepage, Genome Canada Mark West, Project Leaser, Medical Imaging TRM, Industry Canada Mario Perek, Industry Canada Mark Gregory, IsaiX Technologies Pharmahorizons Mark Poznansky, Chairman, Viron Therapeutics Inc. Mark Steedman, Director, Business Development, Interface Biologics Martin Barkin, President & CEO, Z-Tech Canada Martin Block, Independent Financial Consultant Martin Sumner Smith, VP Pharmaceutical and Life Science Solutions , Matt Bulst, Manager, City of Toronto Maureen Lofthouse, Director, Technology Partnerships Canada Michael Denny, CFO, Yorkton Securities Michael May, President, Rimon Therapeutics Ltd. Michael Mays, CFO, Cytochroma Inc. Michael Thomas, President & CEO, GYLCODesign Inc. Michelle Peel, Canadian Institutes of Health Research Molly Shoichet, University of Toronto Nancy Kelly, Senior Policy Advisor, Ministry of Enterprise, Opportunity and Innovation ON ; Niclas Stiernholm, CEO, Transplantation Techologies Inc. Nika Ketis, Partner, Heenan Blaikie Owen Powell, Assistant, Industry Canada Paul Arnison, FAAR Biotechnology Group Paul Santerre, President & CSO, Interface Biologics Peter Hadas, Partner, Cap Gemini Ernst & Young Peter Pekos, President, Dalton Chemical Pierre Charest, Director General, Health Canada Robert Dugal, Executive Director, Health Research, Canada's Research-Based Pharmaceutical Companies Robert Foldes, President & CEO, Cytochroma Inc. Ron Layden, CEO, High Tide Ventures Ron Yamada, VP Global Markets, Corporate Affairs, MDS International Rose Papastamos, CFO, Spectral Diagnostics Inc. Sam Ruttonsha, President, Hanbury Management Consulting
Post-treatment in patients with PD versus CB Gee et al. 2004 ; . While increases in EGFR expression could perhaps underlie the absence of pEGFR decline in de novo gefitinib resistance, EGFR phosphorylation mediated in an EGFR kinase-independent manner by other receptors perhaps additional erbB receptors or the insulin-like growth factor receptor IGF-1R may be contributory. Gee et al. 2004, Gutteridge et al. 2004 ; . Interestingly, tumours from PD patients in this study also commonly exhibited increased activity of the signalling molecule AKT, an element that has been linked pre-clinically both to IGF-1R signalling and to gefitinib resistance Jones et al. 2004 ; . inhibitor AI ; or failing first-line treatment with AI. Patients are then equally randomized to two arms: tamoxifen 20 mg day ; plus gefitinib 250 mg day ; or tamoxifen plus placebo. The primary endpoint of the study is comparative time to progression in the two arms and the secondary endpoints are the recurrence rate RR ; and clinical benefit rate. This study should begin to answer the clinically important question of whether gefitinib can delay prevent acquired resistance to tamoxifen. Further immunohistochemical exploration would examine downstream effectors of the erbB family, and also key co-activators such as AIB-1 that may enable interplay between erbB and ER signalling. No results are thus far available for this study. A very similar trial in the United States plans to recruit 174 patients, with the only difference being that it will assess acquired resistance to anastrozole instead of tamoxifen.
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Table 1. Patient characteristics and objective response Characteristics No. of patients Age, years Median range ; Gender Male Female Smoking history Never smoker Former or current smoker Performance status 0 1 2 Histology Adenocarcinoma Squamous cell carcinoma Large cell carcinoma Clinical stage IIIA IIIB IV Previous cancer treatment Chemotherapy One regimen two regimens Thoracic radiotherapy Best response to gefitinib Partial response Stable disease Progressive disease 17 32.7% ; 19 36.5% ; 16 30.8% ; 46 88.5% ; 15 28.8% ; 31 59.6% ; 6 11.5% ; 6 11.5% ; 46 88.5% ; 41 78.8% ; 7 13.5% ; 4 7.7% ; 8 15.4% ; 30 57.7% ; 5 9.6% ; 9 13.5% ; 28 53.9% ; 24 46.1% ; 27 51.9% ; 25 48.1% ; 62 3179 ; All patients 52.
The purpose of these presentations is to help children: o Have a general understanding of Alzheimer's disease. o Be able to describe some symptoms of Alzheimer's disease, and identify ways they can help individuals that are close to them who have Alzheimer's disease. o Create a picture poem or story using both the information from the session and their experience or imagination showing ways they could relate to someone with Alzheimer's disease. Grade three class in Gilbert Plains, MB show what they learned about Alzheimer's disease
From the Institute of Critical Care Medicine, Palm Springs, CA; and the Keck School of Medicine of the University of Southern California, Los Angeles, CA. This work was performed at the Institute of Critical Care Medicine, Palm Springs, CA. This work was supported in part by grant HL54322 from the National Heart, Lung, and Blood Institute, Bethesda, MD; an Established Investigator Research Grant from the Society of Critical Care Medicine, Anaheim, CA; and by a grant-in-aid.
2. Rich JN, Reardon DA, Peery T, et al. Phase II trial of gefitinib in and gemcitabine
1. McMurray J, McDonagh T, Morrison CE, Dargie HJ. Trends in hospitalization for heart failure in Scotland 19801990. Eur Heart J 1993; 14: 115862. Cowie MR, Mosterd A, Wood DA, et al. The epidemiology of heart failure. Eur Heart J 1997; 18: 20825. Waagstein F, Hjalmarson A, Varnauskas E, Wallentin I. Effect of chronic beta-adrenergic receptor blockade in congestive cardiomyopathy. Br Heart J 1975; 37: 102236. Bashir Y, McKenna WJ, Camm AJ. Beta blockers and the failing heart: is it time for a U-turn? Heart J 1993; 70: 812.
To society when consumers do not obtain a product which they value more than the cost of producing it. Guell and Fischbaum 1995 ; , using highly aggregated data, claim that the scale of deadweight loss in the US drug market is on the order of bn- bn annually; in a more detailed paper 1997 ; the same authors estimate deadweight losses of bn on bn of sales, which indicates very large DWL for the market overall.13 Baker and Chatani 2002 ; construct a very rough estimate for DWL of bn - bn annually for the US. Globally, the DWL is certain to be many times this figure, because in many markets, drug insurance is unavailable and so consumers are more price-sensitive. Hollis and Flynn 2003 ; show that the incentives to innovate generated by monopoly pricing in developing countries may be very small in comparison to the deadweight losses created by high prices. The 2003 WTO Doha agreement to allow compulsorily licensed drugs to be supplied to developing countries is testament to the importance of finding a solution to the welfare losses including death and suffering ; caused by high pharmaceutical prices. The problem of "access" to drugs worldwide is also creating a crisis of confidence in the pharmaceutical system worldwide, particularly as so many people in developing countries have been unable to afford drugs for HIV AIDS, aggravating a humanitarian disaster. 2.3 Counterfeit Drugs The high prices of patented drugs compared to production costs, and the difficulty of verifying the legitimacy of products, have led to a flood of counterfeit medicines.14 Counterfeits comprise a substantial share of the global market for pharmaceuticals.15 Many counterfeit products are ineffective, do not contain the claimed amount of the active ingredient if any ; , or are produced under unsanitary conditions, and may therefore have adverse health effects on consumers. Counterfeits also harm the innovating drug company by stealing their sales and, if the counterfeit product is ineffective, damaging their reputation. Counterfeits can thus also reduce the incentives to innovate. 2.4 Price Controls Because of agency problems in drug markets, as well as the substantial deadweight losses caused by high prices discussed above, most developed countries with extensive government health insurance programs have implemented price controls. These price controls require extensive government interference in drug markets and are likely to be cause a variety of market inefficiencies.16 and gemifloxacin.
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Indicators of social sustainability So what facts and figures actually provide concrete information on what we understand by social responsibility worldwide? The sustainability debate has recently devoted much time to discussing such key data or indicators. Non-governmental organizations NGOs ; and research institutes as well as trade associations and investors have prepared extensive lists of indicators. In order to find the most suitable key data for BASF, we focused on the questions that we are repeatedly asked in discussions with various stakeholders. In addition, with support from the Institute of Organizational Communication IFOK ; we identified key areas and checked numerous indicators and lists of key data to see whether they actualEconomy, ecology and society are the three pillars of Sustainable Development. The initial idea for the present publication was to account for the social aspects of our activities in a new report. The question is: How do you measure social sustainability? How can we summarize the social responsibility of the entire BASF Group in 60 pages? Which topics should be included, which not? Can the social effects of our 8, 000 products or our production sites in 39 countries be measured? And if yes, can the results be expressed in numbers that are valid worldwide? These and similar questions were the starting point of our work on the report of BASF's social responsibility that you are now holding in your hands. The principles of the United Nations Global Compact. It was clear from the outset that the report would have to be based on solid data. To collect these, we had to perform a Group-wide survey because the data for BASF's Ludwigshafen headquarters provide only an incomplete picture. Because BASF Group companies operate under different conditions in different countries, central data collection had not seemed to make sense in many cases to date and had to be performed for the first time for this report. We were also aided by the publication The Global Reporters from SustainAbility, London, an institution that also gave us valuable feedback on our reporting to date. Questionnaires from the assessment companies IMUG Research, Eiris and Oekom Research. The conventions of the International Labor Organization, the most important of which are contained in standard SA 8000. The publication Communicating Corporate Social Responsibility from CSR Europe. The Guideline for Sustainability Reports published in June 2000 by the Global Reporting Initiative. The company questionnaire from Bank Sarasin & Cie. The Sustainability Assessment Questionnaire from the Swiss SAM Group on which the Dow Jones Sustainability Group Index is based. ly provide useful information on the BASF Group. We paid particularly close attention to the following.
Increased c-H-ras expression was apparently associated with the presence of a -MHC mutation. Since the sarcomeres containing the mutant -MHC are considered to have impaired contractile function, it is likely that in the defective myocardial fibers, mechanical stress would be increased chronically2 and would directly or indirectly lead to sustained induction and activation of the Ras-dependent signaling pathway.8, 9, 29 The molecular mechanism s ; regulating c-H-ras expression in the HCM patients with a -MHC mutation was not examined in the present study but is worthy of future investigation and gemtuzumab.
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Everyone with Medicare is eligible for this coverage regardless of income level and resources, preexisting conditions or current prescription expenses. Extra help is available for people with limited income. Call 1-800-MEDICARE or go to Medicare's medicare.gov web site for further information. Haroun Habib is a MORE Summer Fellow intern with the Centers for Medicare & Medicaid Services, and presented at the ASP Healthy Choice Healthy Lives forum on Medicare changes, July 19. He can be reached at haroun.habib cms.hhs.gov.
Reescalation was not permitted. Response was evaluated by Response Evaluation Criteria in Solid Tumors RECIST ; criteria 16 ; . Statistical Analysis. Based on the CALGB database from 10 previous prospective studies, the 3-month failure-free survival rate among patients with good performance status Eastern Cooperative Oncology Group PS 0-1 ; is f60%. The primary end point of the study was the percentage of patients who remain alive and progression free 3 months defined ``success'' ; after initial administration of gefitinib. A single-stage study design was used to differentiate between 55% and 75% 3-month failurefree survival rate. If the true percentage of patients who are successfully treated with gefitinib was z75%, it would be considered worthy of further study in malignant mesothelioma. On the other hand, if the true success rate were 55%, this regimen would not be pursued further. Specifically, the hypothesis tested was H0: P 0.55 versus H1: P 0.75, where P is the proportion of patients who remain failure-free 3 months after initial administration. Assuming a type I and II error rate of 10%, the sample size for this study was 40 patients. Based on previous data, we expected that f60% of patients or 24 patients ; enrolled onto this study would have EGFR overexpression. Within this particular patient subgroup, there would be over 90% power to differentiate between a 55% and 80% 3-month failure-free survival rate in the test described above and conducted at the 0.10 level of significance. If 17 or more of the f24 patients with and gemzar.
The discovery that signaling by the epidermal growth factor receptor EGFR ; plays an important role in tumorigenesis prompted efforts to target this receptor in anticancer therapy, leading to the development of inhibitors of its tyrosine kinase activity.1-3 Gefitinib, an orally active inhibitor of the EGFR tyrosine kinase, is a leading agent in the field of EGFR-targeted therapy.4, 5 Two large phase II trials involving previously treated patients with advanced nonsmall-cell lung cancer NSCLC ; revealed that gefitinib monotherapy was well tolerated and manifested clinically meaningful antitumor activity.6, 7 Objective responses that were both rapid and persistent were apparent at a dose of 250.
The FDA issued a caution in December to patients being treated for non-small cell lung cancer with the drug Iressa gefitinib ; following the failure of a clinical trial to show an overall survival advantage for the drug compared to a placebo. Patients currently taking Iressa should consult with their physicians as soon as possible; patients should not change their therapy without first consulting with their physicians. Alternative therapies are available. FDA has approved Taxotere docetaxel ; and Tarceva erlotinib ; , both of which have been shown in studies to improve survival in patients with nonsmall cell lung cancer whose cancer has progressed while on previous therapies. Alimta pemetrexed ; has received an accelerated approval based on the surrogate endpoint for this use but has not yet demonstrated any survival benefit. -- FDA and genotropin.
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Resistance testing if available ; should be used to aid the clinician in selecting an alternative regimen for patients experiencing failure of second or subsequent treatment regimens. The results of resistance testing either genotypic or phenotypic analysis ; should be considered in conjunction with the individual's treatment history. Use of resistance testing has increased over the last two years and is now standard of care in the United States and Europe. 4, 5, 6, ; The presence of drug resistance is determined by either a genotypic or phenotypic resistance assay.
Project, in collaboration with the National Statistics Institute of The Netherlands CBS ; , on the comparison of questionnaires. For this he uses existing techniques and develops new intelligent search techniques and gentamicin.
Propidium iodidestained tumor cells were excited at 488 nm and analyzed using the FL-3 detector 620 nm ; of a Beckman Coulter Epics XL flow cytometer Becton Dickinson ; . Growth inhibition studies. The effect of EGFR inhibitors on the growth of human tumor cell lines was investigated using a colorimetric assay, as described previously 28 ; . Briefly, tumor cells were seeded at a density of 5 103 well in 100 AL of DMEM containing 2% to 10% FCS in a 96-well plate. Following 3-hours of incubation at 37jC, 100 AL aliquots of ICR62 and or gefitinib were added to triplicate wells and the cells were incubated for 6 to 12 days, depending on the cell line, at 37jC until the cells in the wells containing control medium were confluent. Tumor cells were then fixed with glutaraldehyde, washed in distilled water, air-dried, and stained with 0.05% methylene blue. The absorbance of each well was measured at 620 nm using a Labsystems MultiSkan RC plate reader Thermo Electron Corporation, Basingstoke, United Kingdom ; . In order to establish the initial number of cells plated, an extra plate of cells was set up and similarly processed after 3 hours of incubation at 37jC without the inhibitors. Immunofluorescence staining of tumor cells. The location of the EGFR following treatment with the EGFR inhibitors was investigated using immunofluorescence staining. For this purpose, tumor cells in DMEM 10% FCS were grown to near-confluence in 16-well Lab-Tek Chamber Slides Nalge, Hereford, United Kingdom ; coated with fibronectin 1 40 in PBS; Sigma-Aldrich ; . Following washes in DMEM 0.1% FCS, cells were incubated with ICR62 100 nmol L ; , gefitinib 200 nmol L ; , or control medium for 1 or 24 hours at 37jC. Tumor cells were washed thrice in PBS, fixed for 15 minutes at room temperature in 4% paraformaldehyde, washed an additional three times in PBS, and permeabilized for 15 minutes at room temperature in 0.5% Triton X-100 Sigma-Aldrich ; . Following further washes in PBS, tumor cells were incubated in the presence of mAb ICR62 20 Ag mL ; control medium for 1 hour at 4jC. The bound antibody was detected following incubation with rabbit anti-rat FITC-conjugated secondary antibody 1 400; Serotec ; for 30 minutes at 4jC. Following three more washes, cells were incubated with 2 Ag mL Hoechst 33258 nuclear stain Sigma-Aldrich ; for 5 minutes at room temperature, mounted with H-1000 mounting medium Vector Laboratories, Ltd., Peterborough, United Kingdom ; , and examined for fluorescence under a Zeiss Axiovert 100 microscope Carl Zeiss, Ltd., Welwyn Garden City, United Kingdom ; using the Leica Qwin software. Western blot analysis. The effect of anti-EGFR mAb ICR62 and or gefitinib on the downstream signaling of human tumor cells was investigated by Western blotting analysis. Tumor cells were grown to near-confluence in six-well tissue culture plates Greiner Bio-One and gefitinib.
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Statistically significant data from 3 other Phase III trials. Synthetic Blood International Inc. SYBD ; , Costa Mesa, Calif. Product: Oxycyte Business: Hematology Molecular target: Not applicable Description: Perfluorocarbon-based blood substitute and therapeutic oxygen carrier Indication: Blood substitute in patients with traumatic brain injury Endpoint: Increase in brain oxygen tension levels; safety and Glasgow outcomes score at 3 and 6 months Status: Additional Phase IIa data Milestone: NA Additional data from an open-label Phase IIa study in 8 evaluable patients showed that Oxycyte increased glucose metabolism over baseline and significantly increased oxygen levels. Seven patients in the trial survived their brain trauma. There were two mortality cases that the company said were not related to Oxycyte. SYBD said the historical mortality rate for this level of traumatic brain injury is 30%-40%. Last year, SYBD reported that Oxycyte increased brain oxygen tension in all 8 patients see BioCentury, Sept. 4, 2006 ; . Telik Inc. TELK ; , Palo Alto, Calif. Product: Telcyta TLK286 ; Business: Cancer Molecular target: Glutathione S-transferase P1-1 GST P1-1 ; Description: Small molecule glutathione analog prodrug activated by glutathione S-transferase P1-1 GSTP1-1 ; Indication: Treat platinum-resistant ovarian cancer patients Endpoint: Overall tumor response Status: Preliminary Phase III data Milestone: NA TELK said the U.S. Phase III ASSIST-3 trial comparing Telcyta plus carboplatin to Doxil liposomal doxorubicin as second-line treatment for ovarian cancer was compromised and may not be suitable for regulatory submission. Under the trial protocol, patients were to receive treatment until disease progression. However, there was a discordance between the clinical review of the tumor scans and the independent review of the scans. About 25% of the 244 patients were discontinued prematurely, as judged by the independent review of the scans. The compound has Fast Track designation for the indication. Johnson & Johnson JNJ, New Brunswick, N.J. ; markets Doxil. Indication: Treat advanced non-small cell lung cancer NSCLC ; Endpoint: Overall survival Status: Preliminary Phase III data Milestone: NA In the international Phase III ASSIST-2 trial in 520 patients, Telcyta missed the primary endpoint of improved overall survival vs. gefitinib as third-line treatment. Iressa gefitinib is from AstraZeneca plc LSE: AZN; AZN, London, U.K. ; . Indication: Treat platinum-refractory or resistant ovarian cancer Endpoint: Overall survival; time to disease progression and response rate Status: Preliminary Phase III data Milestone: NA In the international Phase III ASSIST-1 trial in 440 patients, Telcyta missed the primary endpoint of improved overall survival vs. Doxil liposomal doxorubicin or Hycamtin topotecan as third-line therapy and gentian.
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