Capital Technology Information Services, Inc.

1
Capital Technology Information Services, Inc.
Presented to
2
Table of Content

1. Disease management Informatics market, purpose
   and commitment Slides 3 to 17
2. Informatics framework, technologies, architects
   and processes Slides 18 to 35
3. Disease management informatics for the cancer
   program Slides 36 to 55
4. Disease management informatics for the HIV/AIDS
   program Slides 56 to 68
5. Disease management Informatics for the Heart
   Program slides 69 to 73
6. Disease management Informatics for business
   intelligence Program slides 74 to 82
7. Disease management Informatics for the
   International Program slides 83 to 100

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3
Solution to the Global Public Health Requirements
with the use of End to End Health Informatics
Framework
4
Disease Management Challenges
Dramatic Disease Growth
Not Enough Awareness
Limited and Disparate Resources
Fragmented Connectivity
Incomplete Public Policy
Incompatible Informatics Frameworks
5
Disease Management Informatics Priorities based
on the Industry CIOs
Under 1,000 employees
Over 1,000 employees
CIO Priorities for the year 2003
All
Use IT to improve business (patient Safety)
purpose 38.8
38.5
39.0
Developing strategies that increase (net revenue)
ROI 35.9
30.3
39.6
Meeting the regulatory compliance and standards
29.6
28.7
30.2
Improve productivity and efficiencies (Reducing
costs) 24.7
29.1
18.0
Improving security and privacy requirements
19.4
17.6
22.1
Ensuring major projects are completed on time and
budget 17.6
15.9
18.0
Ensuring enterprise wide stakeholder
connectivity 16.4
18.9
14.8
Developing proper organization framework 15.1
14.8
15.4
Helping the enterprise improve customer service
14.5
17.2
12.6
Identifying appropriate investment levels for
technology 13.5
13.9
13.2
Increase capacity utilization 12.8
18.0
9.3
Other 0.7
1.6
0.0
Primary source - CIO Insight
6
Disease Management Challenges and Informatics
Solutions
and the primary tool is information
Value of CTIS Good Clinical
Informatics (GCI)
7
Disease Management Informatics Requirements

• The Disease Management Informatics purpose is to
  improve the lives of patients by finding better
  ways to prevent, treat, control, cure and care
  for the disease. CTIS utilizing its IT capacity
  and builds GCI based Informatics solutions and
  attempts to forge broad collaborations within the
  Health Industry stakeholders to effectively
  promote awareness, support patient care, support
  research, enable development of new drugs,
  support treatment, provide surveillance,
  participate in disease control and provides
  support for the patient care.
• The mission critical elements of Disease
  Management Informatics are
• Safety for the Patients
• Efficacy (and Effectiveness) of the Drug
• Productivity of the People
• Efficiencies of the Processes
• Sustainability of the Applications
• Reliability of the Information
• Scalability of the Technologies
• Collaboration between the Stakeholders

8
End to End Disease Management Process Enabled
Through Informatics
Connect
Control
Cure
Care
Phase
Connect the population to prevent the disease
before it may happen
Control the disease process in the population as
it happens
Provide the cure through treatment for the
disease when it happens
Provide care after the outcome for comfort and
continuum
Goal

• Surveillance
• Epidemiology
• Oversight
• Interventions
• Patterns
• Education
• Therapy
• Integration

• Awareness
• Promotion
• Registration
• Screening
• Profiling
• Assessment
• Regimen
• Research

• Diagnostics
• Protocol
• Treatment
• Drugs/Devices
• Laboratory
• Process
• Collaboration
• Results

• Program
• Connectivity
• Comfort
• Association
• Reminders
• Maintenance
• Updates
• Monitoring

Activities

• Genetic
• Life style
• Behavior
• Social
• Diet
• Exercise
• Spiritual
• Therapeutic

• Record Keeping
• Participation
• Communication
• Collaboration
• Practice
• Alerts
• Feedback
• Vital signs

• Preparation
• Participation
• Follow-through
• Environment
• Coordination
• Event-management
• Critical-path
• Alignment

• Family
• Work-place
• Community
• Environment
• Setting
• Workflow
• Sharing
• Training

Components
9
Disease Management Science Elements
VBI Graphic
10
Disease Management Informatics Growth
Bioinformatics Management Gene, Protein,
Phenotype and Translational Data Management,
Computational, Patterns, Pathways
Clinical Management Phase II and III
Protocol Trial Setup Trial Conduct Trial
Tracking Trial Outcome
Outcome Management FDA Approval Phase IV Market
Phase Post Patent
Discovery Management Design Phase In vivo and In
vitro Pre-Clinical Early Discovery
Medical Management Awareness, Prevention,
Behavior and Social Treatment, Electronic Medical
Record and Post Treatment
11
Expand the clinical informatics to end to end
informatics through Bioinformatics - Research,
development, or application of computational
tools and approaches for expanding the use of
biological, medical, clinical, behavioral or
health data. where Genotype profile of tumor
provides the probability of response and
genotype profiling of patient provides the
probability of tolerance. From Giga to Terabytes
trillions of bytes of storage. Use Global IT
networks for Integration. Integrate Computational
capacity to add data mining for the data
management Process - The development and
application of data-analytical and theoretical
methods, mathematical modeling and computational
simulation techniques to the study of biological,
behavioral, and social systems. Petaflops of
super computing power - thousands of trillions of
floating points operations per second. Use global
IT capacity for distributed super
computing. Expand the human genome project
alphabet to become the Disease Communication
language. Develop the language that has right
vocabulary and the ability to communicate. This
will happen through computing power (SVMs) to
build pattern recognition, pathways and phenotype
traits and Translation research. Use Global
networks that speedup the process from bench to
the bedside through the bridge of computing
environment and optimized clinical trials
process. Movement of a laboratory discovery into
a patient or population research setting and the
movement of an observation in a patient or
population setting into a laboratory research
environment. Improve the health industry
declining research productivity. The engine of
growth in the industry remains innovation (new
product discovery, design, development and
deployment). To build a sustained and perpetual
growth the industry needs to take full advantage
of the new technologies that is driving drug
delivery (i.e., genomic, proteomics one side and
information technology on the other). The
industry should leverage Global capability by
structuring themselves around specific diseases
and families of molecular targets and maintain
compliance with regulatory imperatives and
engineer optimization with complex economic
framework. Build end to end informatics from the
beginning of the pipe (prevention) to the end of
the pipe (care).
Disease Management Informatics Strategy
12
CTIS Disease Management Legacy Platform
35 years - Information Outreach, Communication
and Science 20 Years Information Analysis,
Decision Support and Business Intelligence 15
Years Information Management and
Infrastructure 10 Years Disease Management
Informatics
13
Disease Management Market

• The total worldwide disease management
  informatics market in 2004 is estimated at over
  40 billion with distribution between
• discovery informatics (5 billion),
• clinical informatics (5 billion),
• bioinformatics (15 billion),
• medial informatics (10 billion) and
• decision support informatics (5 billion)
• The overall market is growing at annual rate of
  over 15 with distribution between
• discovery informatics (10),
• clinical informatics (10),
• bioinformatics (25),
• medial informatics (10) and
• decision support informatics (10).

14
Disease Management Market customers and needed
services
Industries

• National Institute of Health and disease specific
  institutes
• Academic medical Institutes, Hospital and disease
  centers
• Biotech, genomic and proteomic organizations
• Pharmaceutical corporations
• Contract research organizations and site
  management organizations
• Life science consulting and IT companies
• Agricultural business and sciences companies
• Non-profit institutions and associations

Informatics requirements Building of the data
warehouse with application, enterprise
integration web services layers and providing
end to end information tracking and exchange with
specific functions such as

• Source and acquire information and perform
  information curation
• Extract and Integrate the information and
  validate information integrity
• Handle and manage information and optimize
  information workflow
• Comply with regulatory requirements and meet
  information standards
• Build repositories with information assurance
  and provide information security
• Develop information applications and deliver
  information reporting
• Provide High performance computing and build
  information pattern recognition
• Analyze and communicate information and
  connect information stakeholders
• Publish Interchange information and enhance
  information collaboration
• Mine information develop business
  intelligence and provide information decision
  support

15

• NIH Roadmap plans to support through informatics
  the requirements of important challenges in
  biomedical research to include
• Integration of clinical research networks
• Integrating critical insights relating to
  genomics, proteomics, other biomarkers and
  prognostic indicators into the clinical research
  process
• Development of enabling technologies for improved
  assessment of clinical outcomes
• Harmonization of clinical research regulatory
  processes

NIH Disease Management Strategy
CTIS is committed to creating informatics tools
and optimized processes for moving biomedical
discoveries rapidly from clinical testing into
clinical practice.
16
Disease Management Opportunity Framework
ICOG International

DSS (Business Intelligence)
Bio-Informatics (Computational)
TrialBridge Development Framework
NIAID/DAIDS HIV/AIDS
NHLBI Heart
Applications (Data Mgmt.)
Connectivity (IT Network)
Cancer NCI/CTEP
Collaboration Governmental, International,
Institutes AMIs, Universities, Hospitals,
Centers Networks, Community Organizations CROs,
SMOs
CTIS Business Platform 150 million current
backlog for the next five years. Expected to
grow to 500 million in five years
17
Disease Management Priorities - CTIS Corporate
Commitment
Impact Strategy - The Use Of Informatics For
Diseases Management Start with Chronic disease -
Cancer, Heart, Diabetes, AIDS..
Client (Patient) Focus - Underserved, Minority,
developing world, Women Children Training,
Care, Support, Allegiance, Compassion, Respect
Purpose Commitment - Highest Patient Safety And
Most Drug Efficacy On demand, end to end,
Integrity, workflow, compliance, security
Product/Service Components - Total Solutions
For All Stakeholders (Eight Tracks) Prevention,
Registry, Epidemiology, Outreach, Control,
Treatment, Trials, Research..
IT Solution Framework - Infrastructure,
Transaction, Mgmt. And Intelligence Clinical,
Regulatory, organization Development, Business
Processes, HR Integration..
Technology Platform - Sustainable, Appropriate,
Pervasive And Persuasive Scalable, interoperable,
reliable, predictable, repeatable and Fault
Tolerance
Investment Value - Highest Return On Investment
In Terms Of Human Value HR Productivity, Process
Efficiency, Organization Effectiveness. Financial
Engineering
Service Delivery Requirements - On time, Cost
Effective and Best Quality Standards,
Performance, Tools, Change Management, QASP
based.
Information Availability - On demand, as
required and as necessary Anytime, Any place,
through any device and in any environment.
18
End to End Health Informatics Framework Technology
, Solution and Architectural Processes
19
Disease Management Sustainability Paradigm
20
Disease Management Informatics Solution building
- Six Elements
Why information will enable disease management
process
FEAF RUP ZACHMAN
Purpose
What are the program logistics in the management
of the information
Compliance
Product
Plan
How is the Information Transformed to knowledge
and Knowhow
Standards-GCP
Critical Path
Integrity
Performance-AQL
Value-KPA
Tools-eEnable
Platform-SOP
Reliability
Infrastructure-IA
Productivity
Security
People
Process
Who are the stakeholders that will be the
custodian of the Information
How is the information collected, managed and
communicated
Practice
Where and When the information environment is
Managed and maintained
21
Disease Management Products ad Services Standards
Framework
IT Standards
Data Standards
IT Standards
Data Standards
Trial Bridge
NASA/OMB ISO/CMM SDLC/FEED RUP/ZACHMAN
MedDRA SnoMed ICD CTC
Good Clinical Informatics
Practice Standards
Protection Standards
Protection Standards
Clinical Standards
Practice Standards
HIPAA 508 IA Assurance EM - Recovery
GPRA FEAF SIX SIGMA BEST PRACTICE
Clinical Standards
GCP/ICH CFR CDISC HL7
22
Disease Management Informatics Development
Approach
Process Disciplines
Supporting Workflow
RUP Methodology
23
Disease Management Informatics Development
Approach
Zachman Framework
24
Disease Management Informatics Development
Approach
25
DMI Good Clinical Informatics Framework

• GCI is a convergence of GCP and CTRM informatics
  where the basic data transforms into good
  clinical information by providing
• Data curation and integrity at the data
  collection step,
• Business rules integration and the processes
  connectivity at transaction management step,
• Regulatory compliances and organization workflow
  at the application reporting step, and
• Information security and privacy at the solution
  delivery step.

26
Disease Management Informatics Generic Components
Clinical
Information Services
Relational
Database
Standards Services
Portal Explorer
Page Builder
Multi
-
Dimensional
Application Services
Sub
-
Portal Builder
Database
Publishing
Security
Organization Services
Flat File
System
Custom
Hooks
APIs
Logic
Collaboration Services
Web Sites
Infrastructure Services
Foundation Server
Data Sources
27
Disease Management Architectural Framework
Application
Enterprise
Global
28
Disease Management Architectural Layers
29
DIM Application Framework (DAF)
The break down of any component, areas, processes
or functions into 3 key areas
Document Management Enterprise wide document
management Y1 Application Document
Management Y2 DW Document and Process
Management Y3 Stakeholders Collaboration
Management
Y axis
Content Management Overall content collaboration
and management X1 Target Application Data
Management X2 Enterprise Data warehousing
Management X3 Web Services (external) data
sources Management
X axis
Environment Management Overall vitals and
performance management Z1 Reference/Links and
other connectivity Management Z2 Standards,
sources and other Interfaces Management Z3
Audit and Performance (Values) Framework
Management
Capital Technology Information Services, Inc.
30
Disease Management Digital Dash Board Framework
31
Disease Management Informatics Project Management
workflow
Client SM
Client PO
CTIS PD
CTIS PM
CTIS PLs
32
Disease Management Reuse Framework
Reuse Organization Framework Sponsors National
Institute
25
50
Reuse Knowledge Management Process
Reuse Infrastructure Platform
Reuse Development Approach Methods RUP
Reuse Program Structure Disease
Segment Clinical Trials
Reuse Program Processes
Reuse Components Library
35
25
Reuse Work Product Knowledge Working
Applications Adverse Events
33
Disease Management Informatics Focus
Reuse Replicate
Guiding Principles
Train Transfer
Connect Collaborate
Research Translate
34
TrialBridgeTM
35
Security / Privacy / Authentication Adapter
TrialBridgeTM
GCI Process and Coding Verification
Trial BridgeTM Front End

• Client-Customized Transactional Component
  Assembly
• Off-the-Shelf Integration
• Clinical References, Libraries

OUTPUTS
WORKFLOW COMMUNICATION
INPUTS
Data uploads Direct data entry Electronic data
capture Wireless electronic data capture Business
process tools Guided regulatory compliance
Document Management Scheduling Alerts Workflow
Management Communication and Collaboration
36
Disease Management Cancer Program
Clinical Trial Research and Management Informatics
Cancer Program
37
Cancer Informatics Foundation Significant
CTEP/NCI experience
Business Profile

• Over 15 years with NCI
• Over 100 million performed business
• Over 100 professionals with current expertise
• Over 1,000 years of direct experience
• Over six years in future contracts
• Over 75 million in business backlog
• Over 15 departments and branches connectivity
• Over 50 cancer centers connectivity
• Over 15 Pharma companies connectivity

• Technical Profile
• End to End Clinical Trial Research and
  Management Informatics 15 years
• Full service communication and outreach support
  15 years
• Web sites, portals and web services support
  10 years
• Business Intelligence Informatics support 5
  years
• Regulatory Compliance Informatics support 10
  years
• Information assurance and CIT support 10
  years
• Systems Integration and Enterprise Application
  Integration Support 5 years.

38
Cancer Disease Management Program National
Cancer Institute
39
Cancer Informatics Foundation Over 10 year
CTEP/NCI experience
Cancer Therapy Evaluation Program (CTEP)
Initiative at National Cancer Institute (NCI)
Organizational Profile

• Considered worlds largest pharmaceutical
  company and clinical trials sponsor
• Cancer Therapy Evaluation Program (CTEP)
  consists of 15 clinical trials Applications.
• Tracking of Protocols, Drugs, INDs, Sites,
  Patients, Treatment, SAEs, Regulations.
• Encompass 150 INDs, 2000 protocols 6,000
  sites, 50,000 documents.
• Connects 6000 sites, 10,000 physicians,
  600,000 patients Information
• Data Warehouse size Over 100 Giga bytes
• Investment over 100 million

• Results of System Implementation
• Increased Drug discovery capacity by over 20
• Increased Administrative capacity by 25 per
  Administrator
• Generated gt 30 ROI

40
Cancer Informatics Foundation Over 10 year
CTEP/NCI experience
Cancer Therapy Evaluation Program (CTEP)
Initiative Performance History
Metric Before Today Letter of Intent to Concept
Review 45 days 10 days Concept Review to Protocol
Receipt 300 days 30 days Protocol Receipt to
Protocol Approval 75 days 40 days Protocol
Approval to Protocol Activation 100 days lt30
days Days before patient data received 360
days lt30 days Accuracy of Patient
Data lt40 gt99 Avg. days to generate report gt2
weeks online, real-time of adverse events
reported 1000 10,000 days before adverse
event received 10-45 days lt3 days of
non-reportable adverse events received 880 lt100
Government Agencies
CTIS has developed the CTEP Cancer Trials
Enterprise System (CTES)
My favorite thing about the Clinical Trials
Enterprise System (CTES) is that it allows the
program staff to directly access mission critical
information at their desktops. We can make sure
our time is used to the best effect, so were not
just busy, but efficient. Dr. Michael Montello,
Chief of the Protocol and Information
Office Cancer Therapy Evaluation Program,
National Cancer Institute
41
CTEP Environment in 1997/98 - The Leaky Pipe
Protocol Authorization
42
CTEP Environment in 2002 onwards an end-to-end
Tracking System
CTEP Business Enterprise
CTEP - Enterprise Database
43
CTES Informatics

• A Case Study The CTEP Enterprise System
• CTES Applications Overview
• CTES applications are tracking and inventory
  systems that allow the sponsors and regulators to
  monitor, measure and manage the clinical trials
  process. The system supports CTEPs mission
  critical equipment with specific emphasis on
  human subject safety requirements and associated
  drug efficacy, data integrity, process
  efficiency and people productivity.
• The solutions is scalable and reliable and
  provides all necessary informatics support for
  data curation, regulatory compliance, treatment
  workflow and information assurance.
• The applications have been developed in two
  primary formats
• Client-server applications used solely by CTEP
  professional staff and their local extramural
  support staff
• Web-based applications used primarily by
  extramural support staff (i.e., Cancer
  Cooperative Groups Consortia, Networks, etc.) and
  other Single Institutions (i.e. universities,
  hospitals, private practice offices, etc.)

44
CTES Informatics

• CTES Applications Areas
• CTES applications include
• Address Maintenance Module (AMM)
• Address Query Module (AQM)
• Protocol Authorization and Tracking System (PATS)
• Enterprise Query Module (EQW)
• Drug Authorization and Review Tracking System
  (DARTS)
• Dose Regimen System (Dose-Reg)
• Common Toxicity Criteria Tool (CTC Tool)
• Clinical Data Update System (CDUS)
• Clinical Data Update Reports (CDU Reports)
• Adverse Event Expedited Reporting System (AdEERS)
• AdEERS Backend System (ABS)
• ABS-Do Not Process (ABS-DNP)
• CTEP-Enterprise Information System (CTEP-EIS)
• Enterprise Maintenance Module (EMS)
• Clinical Trials Monitoring Branch-Audit
  Information System (CTMB-AIS)
• Scientific Management of Agents Reporting and
  Tracking System (SMARTS)

45
CTES Informatics

• CTES Applications Overview AdEERS
• Benefits (AdEERS ABS)
• Streamlined the adverse event reporting process
• Helped to ensure adherence to clinical best
  practices and adverse event reporting guidelines
• Allowed for accurate data analysis that helps
  ensure patient safety
• Eliminated the need for the processing of Adverse
  Events that are assessed as not serious
  resulted in a 40 reduction of reports that need
  immediate processing
• Helped reduce the number of unnecessary adverse
  event to less than 10
• Key Features
• Processing Module tracks the processing stages
  of the AE report
• Assessment allows the assessment and
  reassessment of the adverse event data submitted
  by the investigator
• IDB DNP Module facilitates reviewing and/or
  activating all AE report(s)
• Built-in security through the use of a key based
  mechanism consisting
• Standards-based including NCIs Common Toxicity
  Criteria (CTC) and MedDRA
• Workflow-based
• Emailing alerts and notifications
• A built-in assessment module
• Allowing adverse event reporting for all trials

46
CTES Informatics

• CTES Applications Overview CTMB-AIS
• Benefits
• Streamlined the clinical trials audit reporting
  process
• Helped to ensure adherence to clinical best
  practices and compliance with the federal code of
  regulations
• Allowed for accurate data analysis that helps
  ensure scheduling, performing, tracking and
  reporting audits.
• Eliminated the need for duplicate or organization
  specific audit process requirements
• Helped reduce the number of audit delays to less
  than 5
• Key Features
• A web-based system to report clinical trial audit
  information to CTMB
• Allow electronically schedule audits, report
  audit findings, and submit roster updates
• Give online access to Roster and Audit data,
  maintain the audit schedule, and remind audits
  are due
• Provide regulatory reporting capability
• Provide role-based security at the database level

47
CTES Informatics

• CTES Applications Overview CTEP-EIS
• Comprise the following tools
• Enterprise Query Wizard (EQW) enables users to
  gain immediate access to information.
• CTEP-Enterprise Information System (CTEP-EIS)
  enables users to perform ad hoc queries, analyze
  data, and format query results
• Key Features
• Has exhaustive query criteria Allows for the
  design of custom reports based on criteria
• Assists in determining if a document exists in
  the database by accessing all data with specific
  criteria
• Permits electronic access to document for related
  documentation and correspondences
• Generating output of the query in Excel or PDF
  format
• Provide logical All, Any, and NOT functions
  for for query construction
• Provide
• Customized drill down hierarchies
• Easy to understand Data filters
• Item classes (List of Values)
• Extensive graphical capabilities
• Focus primarily on three business areas 1)
  Complete Document Information, 2) Protocol
  Accruals and 3) Toxicity
• An Online Analytical Processing (OLAP) tool
• Organized in the form of business areas and
  collection of folders
• Has pre-built report templates

48
CTES Informatics

• CTES Applications Overview CTEP-EIS
• Benefits
• Enabled the implementation of new audit
  guidelines and procedures
• Eliminated data redundancy and discrepancy issues
• Allowed users to perform a variety of queries on
  demand and as necessary from anywhere
• Allowed users to run statistics and related
  graphical analysis
• Assured site compliance
• Ensured more efficient audit scheduling and
  reporting process
• Increased improvement in audit scheduling,
  reviewing and reporting efficiency
• Electronic access to documents and associated
  correspondences
• Reducing training costs
• Facilitate agent and disease development plans
• Number of help desk requests and queries for data
  reduced by over 25
• Enhanced data quality and integrity
• Facilitate identification of bottlenecks and
  inefficiencies in the clinical trials process
• Enable data mining to support decision making
• Supports more INDs to go through the clinical
  trials process

49
CTES Informatics

• CTES Applications Overview DARTS
• Key Features
• Standard Order Screen
• Special Exception Order screen
• Blinded Order Screen
• E-Loader
• Remote Order Entry System
• Benefits
• Increased in efficiency (2x drug requests and 4x
  blinded shipments) with no change in the level of
  effort
• Enabled NCI to support simple and complex blinded
  study designs and assures integrity of blinded
  studies
• Provided NCI with a full drug accountability from
  acquisition, receipt, and shipping to returns,
  transfers, and destructions
• Streamlined drug distribution procedures thereby
  reducing reduce distribution errors
• Promoted registration, management and tracking of
  over 10000 investigators to assure compliance
  with FDA policies
• Increase quality of data, streamline the
  workflow, and result in regulatory compliance
• Reduce PMB administrative efforts and reduce
  shipment errors
• Facilitated transfers and returns of drug,
  thereby reducing drug wastage
• Resulted in a quadrupling in the number of
  blinded shipments without any increase in
  administrative effort

50
CTES Informatics

• A Case Study The CTEP Enterprise System
• CTES Applications Overview PATS
• Key Features
• Document evaluation, creation and abstraction
• Document tracking and workflow
• Correspondence Module
• FDA Module
• Extensive Reporting
• Benefits
• Standardized the protocol abstraction process and
  eliminate data redundancies and need for multiple
  abstractions
• Improved data quality with over 400 validations
• A 25 increase in the number of documents
  processed per year with no change in the level of
  effort
• Improved document processing and tracking
• Improved adherence to protocol development
  timelines by reducing administrative delays

51
Cancer Therapy Evaluation Program (CTEP)
Initiative Performance History
Overall savings of 25 to 30 of Clinical Trial
time
DAYS

400
Patient Data Received
350
300
250
200
Protocol Receipt to Protocol Approval
150
Letter Of Intent to Concept Review
100
Report Generations
50
0
Concept Review To Protocol Receipt
Protocol Approval to Protocol Activation
Adverse Event Reporting
Non Reported Adverse Events
52
Cancer Therapy Evaluation Program (CTEP)
Initiative Performance History
1999
2000
2001
2002
1996 Benchmark before CTEP Reengineering Process
16,148
A 350 increase in Productivity without increase
in FTE
53
Cancer Therapy Evaluation Program (CTEP)
Initiative Performance History
1999
2000
2001
2002
1996 Benchmark before CTEP Reengineering Process
586
A 125 increase in Productivity without increase
in FTE
54
Client ROI Framework
CTEP Reuse Model Provides Potential Savings
Across Building, Operations, Technology and Data
Components of a Clinical Trials Informatics
Framework
55
CTES Informatics Proliferations
NIH Institutes
AMIs Centers
Pharma CROs
Others
56
Disease Management HIV/AID Program
Clinical Trial Research and Management Informatics
HIV/AID Program
57
HIV/AID Informatics Foundation
Business Profile

• Over 3 years with NIAID/DAIDS
• Over 10 million performed business
• Over 70 professionals with current expertise
• Over 250 years of direct experience
• Over six years in future contracts
• Over 60 million in business backlog
• Over 15 departments and branches connectivity
• Over 24 countries connectivity
• Over 15 Pharma companies connectivity

• Technical Profile
• End to End Clinical Trial Research and
  Management Informatics 15 years
• Full service communication and outreach support
  15 years
• Web sites, portals and web services support
  10 years
• Business Intelligence Informatics support 5
  years
• Regulatory Compliance Informatics support 10
  years
• Information assurance and CIT support 10
  years
• Systems Integration and Enterprise Application
  Integration Support 5 years.

58
HIV/AID Disease Management Program - NIAID
59
HIV/AID Informatics Foundation
Division of AID Enterprise System (DAIDS - ES)
Initiative at National Institute of Allergy and
Infectious Diseases
Organizational Profile

• Considered worlds largest pharmaceutical
  company and clinical trials sponsor
• Division of AID Enterprise System (DAIDS-ES)
  consists of 10 clinical trials Applications.
• Tracking of Protocols, Drugs, INDs, Sites,
  Patients, Treatment, SAEs, Regulations.
• Encompass 50 INDs, 500 protocols 1,000
  sites, 20,000 documents.
• Connects 1000 sites, 3,000 physicians,
  50,000 patients Information
• Data Warehouse size Over 50 Giga bytes
• Investment over 10 million

• Results of System Implementation
• Stakeholder connectivity increase by over 20
• Administrative capacity increased by 25 per
  Administrator
• ROI over 30

60
DAIDS Current Organization Information Landscape
61
DAIDS-ES Enterprise Architecture Framework
62
DAIDS ES Background

• The mission of DAIDS/NIAID is to help end the
  HIV/AIDS epidemic
• gt96 of the 40M cases of HIV/AIDS is occurring in
  resource-poor developing countries (RPDC)
• An international research agenda will require
  both scientific and administrative adjustments
  and maintain the strong basic and applied
  research agenda to feed new concepts into the
  clinical evaluation pipeline
• By necessity, one cannot conduct research in RPDC
  without a comprehensive care, treatment and
  prevention approach and this requires attention
  to building infrastructure/capability first in
  the host countries and use of IT will be central
  to achieving success in maintaining scientific
  quality

CTIS Contract 60 Million - 2008
63
DAIDS HIV/AID Solution Management Plan

• Has established
• Office for Policy in Clinical Research Operations
• International Research Branch
• Has initiated the Partnership for AIDS Vaccine
  Evaluation (PAVE)
• Is reorganizing the major clinical research
  networks for FY05/06
• Is developing the DAIDS Enterprise Database
  System (DAIDS-ES)

64
Partnership for AIDS Vaccine Evaluation (PAVE)

• A partnership, established under the auspices of
  NIAID, between 3 U.S. governmental agencies
  involved in clinical HIV/AIDS vaccine research
• The purpose is to serve as a forum and clearing
  house to achieve better harmony, increased
  efficiencies and cost effectiveness for all
  vaccines evaluated under its auspices
• The contribution and unique identity of each
  cooperating entity will be maintained and
  recognized

65
Reorganization of the Major HIV/AIDS Clinical
Trials Networks
(AACTG, CPCRA, AIEDRP,ESPRIT, PACTG, HPTN, HVTN)

• Network Priorities
• Continue effective priorities in basic research,
  prevention, treatment and vaccines
• Operational research necessary to build RPDC
  infrastructure
• Long-term sustainable strategies in RPDC settings

66
DAIDS International HIV/AIDS Research Sites
DAIDS in 24 countries Network costs 285
Million Support contracts 31 Million DAIDS ES
10 million International Travel costs -
International Clinical Activities 0.46 Million
67
DAIDS Enterprise System (DAIDS-ES) Update
Accomplishments

• SAE Reporting System
• Initiated pilot for AACTG
• Pediatric version in development
• CIPRA Tracking System
• Tracks applications and action items
• Provides summary data on CIPRA program
• Site Seer
• Web-based travel tracking system
• Project website
• Tracks progress of DAIDS-ES
• Archives meeting schedules, minutes and other
  documents

68
DAIDS Enterprise System (DAIDS-ES) Update
Near Term Plans

• Business area analysis
• Complete DAIDS-wide As-Is process maps
• Major projects underway
• Protocol tracking
• Clinical site monitoring
• DAIDS master contract system
• Hardware software infrastructure
• Define IT architecture for DAIDS-ES
• Compliance with security and application
  interfaces with NIAID

69
Disease Management Heart Program
Clinical Trial Research and Management Informatics
Heart Program
70
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71
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74
Disease Management Business Intelligence
Providing business intelligence to improve the
disease management decision making process for
all of the stakeholders
75
Business Intelligence Framework
Business Intelligence is the ability to perform
data mining function across the application,
enterprise and web services layer for both
structured and unstructured information and
applying of the visualization and analytical
techniques that transform information to
knowledge and provide stakeholders necessary
decisions support.
76
BI Architecture
77
Business Intelligence Dashboard
78
Business Intelligence Dashboard
79
Business Intelligence Dashboard
80
Business Intelligence Dashboard
81
Business Intelligence Dashboard
82
Business Intelligence Dashboard
83
Disease Management International Program
Formation of International Cooperative Group
(ICOG) to make a difference in the fight against
Cancer
84
International Cooperative Group (ICOG)
What should be obvious, is never obvious, until
you make it obvious.
The Consortium Prime, INCTR
An Implementation Leader
An Awareness Leader
An Information Leader
International Network For Cancer Treatment And
Research
Consortium Members Johns Hopkins International
Health Washington Cancer Institute Lombardi
Cancer Center Medstar Research Institute Fox
chase Cancer Center National Cancer Institute
through CTEP American Cancer Society Life With
Cancer WWA GINI SAIC DIFZ and IBM
85
Why The ICOG Formation? Governance and Fairness
Worldwide Rough Order Of Magnitude (ROM)
Population Level, Cancer Cases, Economic Burden
Distribution. GDP Level, Drug Usage and RD
Investments Comparison as a .
Dollar per dollar 65 to 100 times more drug
availability or RD investment for a patient in
USA than the LDW and 7 to 10 times more than MDW
86
Why The ICOG Formation? Economic Impact
Burden as a of GDP will double between 2002 and
2020 Impact of cancer in the LDW will have an
effect on all of us due to global economic
connectivity.
Disease Forecast Source WHO
As the impact of AIDs (Infectious Disease) is
like punctuated equilibrium and Cancers
(Chronic Disease) is like plate tectonics one
is obvious and the other is not, especially in
terms of economic impact. Historically, effect of
a 10 burden on any economy for a sustained
period or one time is devastation across the
board as a comparison with a stock market crash
or the impact of plague, war or a massive
earthquake.
87
Why The ICOG Formation? - Patient
As carcinogenesis is a multiphase and progressive
process
Cancer control needs to be a multiphase and
progressive process
This means Cancer commitment has to be continuous
and everywhere
De Vita VT, Hellman S, Rosemberg SA. Cancer
Principles Practice of Oncology
Sources Dr.Huerta
88
Why The ICOG Formation? - Sponsors

• ICOG-Driven Drug
• Development Process Can
• Increase the approval process
• Increase the Filing
• Increase Phase I Accruals
• Increase Phase II Accruals
• Increase the Phase III Accruals

• ICOG Sponsored CTRM Informatics
• Based on NCI, NHLBI and DAIDS experience can save
  in the application development cost.
• Save in people productivity
• Save in trial/application components time line.
• Overall getting to market time line can be by
  months. Monthly savings to the sponsors.

Sources ACS
89
What is The ICOG Plan?

• Action Plan
• Write Proposals
• Build IT infrastructure
• Support Demonstration Projects
• Build Models and Systems
• Transfer Programs
• Build Value Proposition

Screening and Detection
Treatment and Care
Surveillance and Control
Prime INCTR
Education and Training

• Technical Plans
• Build an Information Acquisition Hub
• Establish a Loosely Coupled Network
• Establish Global Library
• Create a Centralized Portal
• Establish Defined Tracks/Programs
• Build a Virtual Clinical Content Center
• Set up a Training Program
• Create a Tailoring Mechanism
• Develop a Transition Process
• Build a Test Process
• Establish Transfer Mechanisms
• Maintain Feedback Mechanism
• Maintain an Oversight Program
• Monitor and Measure Outcome
• Connect with the Value and ROI

Prevention and Nutrition
ICOG
Resources CTIS
Promotion ISOLF
Studies And Epidemiology
Communication and Outreach
Research and Trials
90
ICOG Foundation, Archetypes and Core Elements
91
ICOG Communication Connectors
Information, Technologies, Programs and Resources
1001 1101 0010
1001 1101 0010
1001 1101 0010
1001 1101 0010
Information Technology Portals/Data Warehouses
Broadcast Media Video Conference/Television
Telephony Telecommunication Medium
Telemedicine Collaboration, Oversight and
Intervention
Tel-education Global Virtual Public health
training
92
ICOG Communication convergence

digital imaging sciences
computing
telephony
digital healthcare networks support services
digital imaging applications
broadcasting
...telecommunications, or the convergence of
PCs, phones, and TVs.
93
ICOG Communication benefits
educational
immediacy
efficiency
accessibility
interactivity
quality
second opinion on pancreatic cancer without
having to see another physician
child uploading respiratory quality rate data
to her doctor during an asthma attack
paper records are lost, misfiled and cost a lot
to transport
specialists supplementing the expertise of a
rural physician
rural patient in medically underserved area gets
treatment at a TM kiosk
interactive homecare will serve an increasingly
greying population
cost-effectiveness
94
DM Clinical Trials community access

• Dedicated mobile clinical trials unit designed to
  increase access to underserved populations with
  the goal to improve accrual and retention in
  these populations.
• Complete SOPs for staffing, training and
  operation of unit. Applications and workflow
  interactive for guided regulatory compliance.
  Complete audit trail of all operations and
  clinical trials data in a closed, validated
  system.
• Turn-key clinical trials functionality for
  complete electronic data capture and real-time
  wireless transmittal of data. Utilizes reuse of
  CTEP developed CTRM applications.
• Interface through community outreach groups,
  human subjects protection through central and
  local IRB, increase health literacy and provide a
  bridge to community outreach services and
  healthcare resources.
• Provides access to patient populations presently
  underserved and inaccessible to public health
  research efforts.
• Prototype for self-contained clinical trials
  units to be deployed domestically or globally
  (can be installed, validated and operated in the
  same manner as a free-standing Class 10,000 clean
  room manufacturing environment or mobile surgical
  unit).

95
ICOG Urban Framework
Hospitals
Telecom Connectivity
Telemedicine stations
96
ICOG Rural Framework
Appalachia
Satellite link
sick person
Telecom Connectivity
10 feet of snow
telemedicine technician
97
ICOG Asia profile
Standards Regulatory Licensing IT
Infrastructure Current Penetration
Competition Score
17 12 TBD 12 4 TBD 16 TBD 1 0
Low
48.8
Japan
High
46
Singapore
TBD
Low
41
South Korea
Low
43
Taiwan
East coast
Low
3.3
China
TBD
TBD
Medium
5.8
Thailand
Medium
16.7
Malaysia
TBD
TBD
Low
1.7
Indonesia
N/A
N/A
Low
2.1
Philippines
N/A
N/A
Low
1.3
India
98
ICOG Possibilities
IT Communications Industry

• Few industries are more critical to the
  development of a country.
• A convergence of two industries can alleviates
  chronic shortage of physicians and patient
  care.
• One industry builds on the other.
• Global support needed for the improvements and
  native participation in both industries are
  a must.

Healthcare Industry
99
Who is ICOG?

• ICOG is a Union of
• Cancer Content Providers Groups
• Cancer Connectivity Groups
• Cancer Communication Groups
• Information Technology Platform Groups
• Cancer Program Implementers Groups
• Cancer Knowledge Source Groups
• Cancer Advocacy Groups

• Process
• Been There Done ThatExtension of the Proven
  Platform (CTIS.INCTR..JHU)
• Content Capacity, Capability, Credentials,
  Commitment..
• (JHU AMI and centers)
• Reuse programs, Recycle technologies, realign
  knowledge, reengineer solutions, retrofit
  regulations, replicate applications(CTIS)
• Connect, Bridge, Share, Optimize, Leverage and
  Collaborate INCTR
• Train, Tailor, Transition, Test and Transfer
  (CTIS)

100
When and Where Will ICOG Begin Its Operation?
Y 2008
Y 2007
Y 2006
Europe and Russia
Y 2005
Y 2004
Middle East
Asia
Africa
5
15
Americas
25
40
Number of Countries programs, trials, patients
60
101
Thank You