anna bucsics presentation
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BIOMARKERS DEFINITIONS WORKING GROUP:BIOMARKERS AND SURROGATE ENDPOINTS: PREFERREDDEFINITIONS AND CONCEPTUAL FRAMEWORK.CLIN PHARMACOL THER 2001;69:89 95.
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Maraviroc: Before taking CELSENTRI it has to beconfirmed thatonly CCR5-tropic HIV-1is detectable(i.e. CXCR4 or dual/mixed tropic virus not detected)
using an adequately validated and sensitive detectionmethod on a newly drawn blood sample. The
Monogram Trofile assay was used in the clinicalstudies of CELSENTRI […] Other phenotypic and
genotypic assays are currently being evaluated.
C C:ObjectiveResponse Rate for EGFR-mutation positive patients:71% Objective ResponseRate for EGFR-mutationnegative patients: 1%
A :LA-B*5701BUTIn any patient treatedwith abacavir, theclinical diagnosis ofsuspectedhypersensitivity reactionmust remain the basis ofclinical decision-making
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THE FOURTH HURDLE
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Loss of orphan status – orphan price remains…
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Slide 23
Bi1 Who pays for the test?Helicobacter-Eradicaton & Helicobacter-TestHDL/LDL-Assay and statins
Anna Bucsics, 15/10/2012
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Challenges to Estimating Efficiency of
Personalised Medicines C D :
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Vemurafenib isindicated in mono-therapy for the treat-ment of adult patientswith BRAF V600mutation-positiveunresectable or meta-static melanoma (seesection 5.1).
.
Before taking vemurafenib, patients must haveBRAF V600 mutation-positive tumour statusconfirmed by a validated test. In the phase II andphase III clinical trials, eligible patients wereidentified using a real-time polymerase chainreaction assay (the cobas 4800 BRAF V600Mutation Test). This test has CE marking and isused to assess the BRAF mutation status of DNAisolated from formalin-fixed, paraffin-embedded(FFPE) tumour tissue.
Costs: Ca. €100.000per patientper year*
*S A J 2012S PC
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