Graphics & Diagrams presmedic.com [email protected] (917) 856-0582.

Graphics & Diagrams

presmedic.com [email protected] (917) 856-0582

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


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.

P13K RGL2RGL RalGDS RAF PLCE

Rac PDK1 RAL MEK PKC

Akt PLD ERK

ELK JUN

Cytoskeletalorganization

Apoptosiscell survival

Celladhesion

Celltrans-

formation

Cellproliferation

Calciumsignaling

RASTP

RASGDP

GAPsGNEFs

SOSGRB2

SHC

PPP

PPP

After


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

Famotidine (Pepcid) 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 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 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

Markman M. J Cancer Res Clin Oncol (2004) 130: 25–28

Before


Another example of pre-medication

Markman M. J Cancer Res Clin Oncol. (2004) 130: 25–28.

Prednisone 50 mg PO q 6 h-3 doses beginning the day prior to chemotherapy

Famotidine 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

Zileuton 600 mg PO QID For 5 days prior to chemotherapy

Montelukast sodium 10 mg PO QD HS For 5 days prior to chemotherapy

Indomethacin 50 mg PO TID For 1 day prior to chemotherapy

Albuterol sulfate 8 mg PO BID For 1 day prior to chemotherapy

After


Before


R

GLM 100 mg + MTX GLM 100 mg + MTX Same

GLM 100 mg + MTX(n=87) GLM 100 mg + MTX GLM 100 mg + MTX Same




PBO + MTX GLM 50 mg + MTX Same

GLM 50 mg + MTX(n=86)

PBO + MTX(n=88)

Week 16EE

Week 24 Week 52

R: Randomization; EE: Early Escape

After


8

A Little About maxIT

Our Passion

IT Driven Performance Improvement

Our Focus

Healthcare IT Solutions

OutcomeMeaningful Assistance

Meaningful Use Requires Meaningful

Assistance

Engage Seasoned Professionals

+

Clear Roadmap+

Ability to Scale as Necessary

+

Value Based Pricing=

maxIT Meaningful Assistance

Before


9

A Little About maxIT

Meaningful Assistance

Outcome

IT Driven performance improvement

Our Passion

HealthcareIT Solutions

Our Focus

Meaningful Use Requires Meaningful Assistance

maxIT Meaningful Assistance

Engage Seasoned Professionals

Clear Roadmap

Ability to Scale as Necessary

Value Based Pricing

After


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 Software

Before


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 Project

After


www.maxithc.com

IMPROVED OUTCOMES

maxIT Solution Lifecycle

12

CURRENT

STATE Project Management

Implement, Operate and Optimize

Change Management Strategy

Assess and Plan

Vision and StrategyStart With

“Why?”

Governance

Before


www.maxithc.com

maxIT Solution Lifecycle

Governance and Project Management

Implement, Operate and Optimize

Change Management Strategy

Assess and Plan

Vision and Strategy

Curr

ent S

tate

Improved O

utcomes

Start With “Why?

After


(Michiels JJ et al, Hematology, 2005)

Before


(Michiels JJ et al, Hematology, 2005)

Transient or occlusive platelet

thrombi in arterioles

Aspecific inflammation

red congestion

Prostaglandin endoperoxides

increase of thromboxane A2

Prostaglandin endoperoxides

increase of thromboxane A2

Erythromelalgia

Smooth muscle cell proliferation

fibromuscular intimal proliferation

of arterioles

Platelet derived growth factor

Platelet derived growth factor

Minor stroke, transient ischemic attacks, TIA and atypical TIAs

Coronary artery disease: Angina and myocardial infarction

Adrenal microvascular thrombosis: Back pain

Erythromelalgia in skin areas of upper arm or leg. Superficial thrombophlebitis

Erythromelalgia, acrocynotic ischemia and peripheral gangrene

Thrombocythemia vera

Spontaneousplatelet

activation andaggregation

Spontaneousplatelet

activation andaggregation

After


Phase IIIb Parallel-arm Trial: Study Design

DMARD = disease-modifying antirheumatic drug

Before


Phase IIIb Parallel-arm Trial: Study Design

DMARD = disease-modifying antirheumatic drug

Short-term period Long-term extension

Patients withactive RA

???trabified basedon MTX use*

DMARDwashout period

Month 18Endpoints:

ImmunogenicitySafetyDAS28

Day 1No abatacept

IV loadingdose

administered

Month 4Primary endpoint:immunogenicity

Secondary endpoints:SafetyDAS28

SC abatacept125 mg/week

as monotherapy

SC abatacept125 mg/week

plus MTX

SC abatacept 125 mg/week continued (addition of selected DMARDs and

modifications to MTX dose permitted)

After


18

Before


19

25

16

34

Job Responsibilities

Performance Feedback

Individual NeedsWork Unit Objective Results

Vision, Mission, and Value

What ismy job?

How amI doing?

Doesanyonecare?

How is myunit doing?

Where arewe headed?

How canI help?

Empowerment

Source: D’Aprix (1996)

After


Before


BindedEE

(GLM 50 mg)n=41

PBO CO toGLM 50 mg

+ MTX

BindedEE

(MTX at BL dose)n=36

GLM may beincrease to

100 mg after DBLn=29

MTX maybe addedafter DBL

n=40

BindedEE

(no change)

BindedEE

(GLM 100 mg)n=15

GLM may beincreased to

100 mgafter DBL

n=20

SC injectionWeek 0 and q4Wks

Week 16*:Early Escape (EE)

Week 24:Placebo CO

Week 52:LTE**

Week 268

Group 1Placebo + MTX

n=133

Group 2GLM 100 mg + Placebo

n=133

Group 3GLM 50 mg + MTX

n=20

Group 4GLM 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


Thank you!Please contact us with questions or to discuss your project



Graphics & Diagrams presmedic.com [email protected] (917) 856-0582.

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Transcript of Graphics & Diagrams presmedic.com [email protected] (917) 856-0582.