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Presentation on theme: "Graphics & Diagrams presmedic.com (917) 856-0582."— Presentation transcript:

1 Graphics & Diagrams presmedic.com (917)

2 Aim To study gene expression in KRAS or BRAF mut tumours To compare KRAS and BRAF mut gene expression To identify additional subgroups within KRAS and BRAF mut – Microsatellite instability (MSI) Adapted from Tejpar S, et al. J Clin Oncol 28:7s, 2010 (suppl; abstr 3505) Normanno N et al. Nature Rev Clin Oncol, 2009.Before presmedic.com (917)

3 Aim To study gene expression in KRAS or BRAF mut tumours To compare KRAS and BRAF mut gene expression To identify additional subgroups within KRAS and BRAF mut – Microsatellite instability (MSI) Adapted from Tejpar S, et al. J Clin Oncol 28:7s, 2010 (suppl; abstr 3505) Normanno N et al. Nature Rev Clin Oncol, P13K RGL2RGL Ral GDS RAFPLC E RacPDK1RALMEKPKC AktPLDERK ELKJUN Cytoskeletal organization Apoptosis cell survival Cell adhesion Cell trans- formation Cell proliferation Calcium signaling RAS TP RAS GDP GAPs GNEFs SOS GRB2 SHC P P P P P PAfter presmedic.com (917)

4 Another example of pre-medication Prednisone 50 mg PO q 6 h·3 doses beginning the day (10 a.m.; 4 p.m.; 10 p.m.) prior to chemotherapy Prednisone 50 mg PO q 6 h·3 doses beginning the day (10 a.m.; 4 p.m.; 10 p.m.) prior to chemotherapy Famotidine (Pepcid) 20 mg IV 30 minutes prior to treatment Famotidine (Pepcid) 20 mg IV 30 minutes prior to treatment Dexamethasone 20 mg IV 30 minutes prior to treatment Dexamethasone 20 mg IV 30 minutes prior to treatment Diphenhydramine 50 mg IV 30 minutes prior to chemotherapy Diphenhydramine 50 mg IV 30 minutes prior to chemotherapy Zileuton (Zyflo) 600 mg PO QID For 5 days prior to chemotherapy Zileuton (Zyflo) 600 mg PO QID For 5 days prior to chemotherapy Montelukast sodium (Singulair) 10 mg PO QD HS For 5 days prior to chemotherapy Montelukast sodium (Singulair) 10 mg PO QD HS For 5 days prior to chemotherapy Indomethacin 50 mg PO TID For 1 day (10 a.m.; 4 p.m.; 10 p.m.) prior to chemotherapy Indomethacin 50 mg PO TID For 1 day (10 a.m.; 4 p.m.; 10 p.m.) prior to chemotherapy Albuterol sulfate (Volmax) 8 mg PO BID For 1 day (10 a.m.; 10 p.m.) prior to chemotherapy Albuterol sulfate (Volmax) 8 mg PO BID For 1 day (10 a.m.; 10 p.m.) prior to chemotherapy Markman M. J Cancer Res Clin Oncol (2004) 130: 25–28 Markman M. J Cancer Res Clin Oncol (2004) 130: 25–28Before presmedic.com (917)

5 Another example of pre-medication Markman M. J Cancer Res Clin Oncol. (2004) 130: 25–28. Prednisone50 mg PO q 6 h-3 doses beginning the day prior to chemotherapy Famotidine20 mg IV 30 minutes prior to treatment Dexamethasone20 mg IV 30 minutes prior to treatment Diphenhydramine50 mg IV 30 minutes prior to chemotherapy Zileuton600 mg PO QID For 5 days prior to chemotherapy Montelukast sodium10 mg PO QD HS For 5 days prior to chemotherapy Indomethacin50 mg PO TID For 1 day prior to chemotherapy Albuterol sulfate8 mg PO BID For 1 day prior to chemotherapyAfter presmedic.com (917)

6 Before

7 R GLM 100 mg + MTX Same GLM 100 mg + MTX (n=87) GLM 100 mg + MTX Same GLM 100 mg + MTX Same GLM 50 mg + MTX Same GLM 50 mg + MTX Same PBO + MTXGLM 50 mg + MTXSame GLM 50 mg + MTX (n=86) PBO + MTX (n=88) Week 16 EE Week 24Week 52 R: Randomization; EE: Early EscapeAfter presmedic.com (917)

8 8 A Little About maxIT Our Passion IT Driven Performance Improvement Our Passion IT Driven Performance Improvement Our Focus Healthcare IT Solutions Our Focus Healthcare IT Solutions Outcome Meaningful AssistanceOutcome Meaningful Use Requires Meaningful Assistance Engage Seasoned Professionals + Clear Roadmap + Ability to Scale as Necessary + Value Based Pricing = maxIT Meaningful AssistanceBefore presmedic.com (917)

9 9 A Little About maxIT Meaningful Assistance Outcome IT Driven performance improvement Our Passion Healthcare IT Solutions Our Focus Meaningful Use Requires Meaningful Assistance maxIT Meaningful Assistance Engage Seasoned Professionals Clear Roadmap Ability to Scale as Necessary Value Based PricingAfter presmedic.com (917)

10 10 Key CPOE Deliverables Initiate Project: Readiness Assessment, Project Charter and Scope, Project Workplan, Team Charter, Acquired Hardware, Acquired Software System/Workflow Design: Reporting Needs Analysis, Current State Workflow Assessment, Interface Analysis, Outcomes Baseline Measurement, Future State Workflow Design, Order Set and Rules/Alert Development System Build: Data Configuration, Design Validation, Coded Interfaces, Computing Environment, Content Build (e.g. outlines, iforms, etc) Training: Policy and Procedures, Project Team Training, Train-the-Trainer Training, End User Training Change Management: Adoption Assessment, Adoption Strategy, Connector Strategy Program/Project Management: Communication Plan, Session Reports, Project Status, Risk Assessments, Workplan Updates Project/Program Close: Outcomes Measurement (ongoing), Turnover to Support Go-Live: Activation Strategy/Plan, Activation Readiness Assessment, Activation Support Testing: Test Plans, Unit Testing, Functional Testing, Integrated Testing, Volume/Stress Testing, Tested SoftwareBefore presmedic.com (917)

11 11 Key CPOE Deliverables Readiness Assessment, Project Charter and Scope, Project Workplan, Team Charter, Acquired Hardware, Acquired Software Reporting Needs Analysis, Current State Workflow Assessment, Interface Analysis, Outcomes Baseline Measurement, Future State Workflow Design, Order Set and Rules/Alert Development Data Configuration, Design Validation, Coded Interfaces, Computing Environment, Content Build (e.g., outlines, iforms, etc) Policy and Procedures, Project Team Training, Train-the-Trainer Training, End User Training Adoption Assessment, Adoption Strategy, Connector Strategy Communication Plan, Session Reports, Project Status, Risk Assessments, Workplan Updates Outcomes Measurement (ongoing), Turnover to Support Activation Strategy/Plan, Activation Readiness Assessment, Activation Support Test Plans, Unit Testing, Functional Testing, Integrated Testing, Volume/Stress Testing, Tested Software Project/ Program Close Program/Project Management Go-Live Testing Change Management Training System Build System/ Workflow Design Initiate ProjectAfter presmedic.com (917)

12 IMPROVED OUTCOMESIMPROVED OUTCOMES IMPROVED OUTCOMESIMPROVED OUTCOMES maxIT Solution Lifecycle 12 CURRENTSTATECURRENTSTATE CURRENTSTATECURRENTSTATE Project Management Implement, Operate and Optimize Change Management Strategy Assess and Plan Vision and Strategy Start With Why? Govern anceBefore presmedic.com (917)

13 maxIT Solution Lifecycle Governance and Project Management Implement, Operate and Optimize Change Management Strategy Assess and Plan Vision and Strategy Current State Improved Outcomes Start With Why?After presmedic.com (917)

14 (Michiels JJ et al, Hematology, 2005)Before presmedic.com (917)

15 (Michiels JJ et al, Hematology, 2005) Transient or occlusive platelet thrombi in arterioles Aspecific inflammation red congestion Prostaglandin endoperoxides increase of thromboxane A 2 Erythromelalgia Smooth muscle cell proliferation fibromuscular intimal proliferation of arterioles Platelet derived growth factor Minor stroke, transient ischemic attacks, TIA and atypical TIAs Minor stroke, transient ischemic attacks, TIA and atypical TIAs Coronary artery disease: Angina and myocardial infarction Coronary artery disease: Angina and myocardial infarction Adrenal microvascular thrombosis: Back pain Adrenal microvascular thrombosis: Back pain Erythromelalgia in skin areas of upper arm or leg. Superficial thrombophlebitis Erythromelalgia in skin areas of upper arm or leg. Superficial thrombophlebitis Erythromelalgia, acrocynotic ischemia and peripheral gangrene Erythromelalgia, acrocynotic ischemia and peripheral gangrene Thrombocythemia vera Spontaneous platelet activation and aggregation After presmedic.com (917)

16 Phase IIIb Parallel-arm Trial: Study Design DMARD = disease-modifying antirheumatic drugBefore presmedic.com (917)

17 Phase IIIb Parallel-arm Trial: Study Design DMARD = disease-modifying antirheumatic drug Short-term periodLong-term extension Patients with active RA ???trabified based on MTX use* DMARD washout period Month 18 Endpoints: Immunogenicity Safety DAS28 Day 1 No abatacept IV loading dose administered Month 4 Primary endpoint: immunogenicity Secondary endpoints: Safety DAS28 SC abatacept 125 mg/week as monotherapy SC abatacept 125 mg/week plus MTX SC abatacept 125 mg/week continued (addition of selected DMARDs and modifications to MTX dose permitted)After presmedic.com (917)

18 18Before presmedic.com (917)

19 Job Responsibilities Performance Feedback Individual NeedsWork Unit Objective Results Vision, Mission, and Value What is my job? How am I doing? Does anyone care? How is my unit doing? Where are we headed? How can I help? Empowerment Source: DAprix (1996)After presmedic.com (917)

20 Before

21 Binded EE (GLM 50 mg) n=41 PBO CO to GLM 50 mg + MTX Binded EE (MTX at BL dose) n=36 GLM may be increase to 100 mg after DBL n=29 MTX may be added after DBL n=40 Binded EE (no change) Binded EE (GLM 100 mg) n=15 GLM may be increased to 100 mg after DBL n=20 SC injection Week 0 and q4Wks Week 16*: Early Escape (EE) Week 24: Placebo CO Week 52: LTE** Week 268 Group 1 Placebo + MTX n=133 Group 2 GLM 100 mg + Placebo n=133 Group 3 GLM 50 mg + MTX n=20 Group 4 GLM 100 mg + MTX n=89 *At Week 16, any patient with <20% improvement from BL in both SJC and TJC had to enter EE in a double-blinded fashion **Dose escalation at the discretion of the PI was allowed after Week-52 DBL and unblinding Patients with active RA despite MTX therapy (n=444)After presmedic.com (917)

22 Thank you! Please contact us with questions or to discuss your project presmedic.com (917)


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