Global Health Communications Channel Audit

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Special Libraries Association Pharmaceutical and
Health Technology Division
Drivers of Change in Information Management
A Macro View  External Forces Shaping Change in
the Biopharmaceutical Environment
Steve Gens Principal Booz Allen
Hamilton Gens_stephen_at_BAH.com 267-614-0935
Las Vegas, Nevada April 3rd 5th, 2005
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Table of Contents

• Changing Industry Landscape
• Information Management Dynamics
• Community Systems
• Health Information Technology
• Data Explosion Complexity
• IT Labor Sourcing
• Conclusions

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Our industry is undergoing unprecedented change,
we are only witnessing the tip of the iceberg
Current Situation
Historical Situation
Implications
Drugs
Drugs, Biologics, Combinational Therapies
Increased IT Complexity
Local Standards
Global Standards (ICH, CDISC etc.)
Pricing Pressures and Dwindling Pipelines
Double Digit Growth
New approaches to regulatory interaction
Enterprise Architectures
Functional Applications
Increased Regulatory Scrutiny (Safety, SOX, etc.)
General Regulatory Guidelines
New partnerships with external owners and
miners of data
Billions in Lawsuits
Millions in Lawsuits
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Information Managers are not excluded from this
change and need to aggressively respond to
several dynamics that are currently re-shaping
the profession
Description
Dynamic
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• Information and organizational systems that serve
  a community. Can be at a divisional, company,
  sector, industry, or country level.

Community Systems
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• Technology used to collect, store, retrieve, and
  transfer clinical, administrative, and financial
  health information electronically. Seen as a key
  enabler for reducing costs and improving quality,
  access and overall public health across the
  healthcare continuum

Health Information Technology (HIT)
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Data Explosion Complexity

• The type, volume, and source of information
  through-out the information lifecycle (create,
  consume, manage, archive, and destruction)

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• How Information Technology labor is sourced
  (on-shore, near-shore, off-shore).

IT Labor Sourcing
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A new community focused model is emerging as
government, industry, and academia collaborate to
solve the most pressing healthcare issues
Community Systems
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Inward Focus
Community Focus
Industry standards bodies and enabling knowledge
workers are a critical part of this evolution
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Community Example National Cancer Institute -
Cancer Biomedical Informatics Grid (caBIG)
initiative.
Community Systems
1

• caBIG Program is
• A virtual web of interconnected data, individuals
  and organizations that redefines how research is
  conducted, care is provided and patients or
  participants interact with the biomedical
  research enterprise
• A common, widely distributed infrastructure
  permitting cancer research community to focus on
  innovation
• With shared vocabulary, data elements, data
  models facilitating information exchange
• A collection of interoperable applications
  developed to common standards
• That provides the availability of raw published
  cancer research data for mining and integration

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To be successful, Information Managers utilize
non-traditional skills to mobilize and run the
caBIG program
Community Systems
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Community Environment
Classical Environment
Challenges
Outside In Decision Making (grass roots
collaboration)
Inside Out Decision Making (Top Down )

• Negotiating standards in a community of diverse
  interest
• Applying scenarios in a grand scale
• Legacy Data Migration and Archiving

Abstract Data Modeling
Functional Data Modeling
Legacy Permutation
11 Legacy Migration
Organizational change, facilitation, and
socialization skills are key success factors
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Health Information Technology is made up of many
varied components including data standards,
infrastructure, architectures and processes.
HIT
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Patient Safety Initiatives
Adverse Event Reporting
CDISC
RFID
Electronic Clinical Data Capture
CPOE
Consolidated Health Informatics
Federal Health Architecture
NHII
Pharma
Security
PMA
Medicare Modernization
Prescription Drug Marketing Act
HIPAA
Decision Support
HLS Act (Bio-Terrorism)
IT Enterprise Initiatives
Outsourcing
HL7
Globalization
Mobile Computing
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Health Information Technology is enabling
modernization across the healthcare value chain
HIT
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Technology used to collect, store, retrieve, and
transfer clinical, administrative, and financial
health information electronically.
RD
Clinical
Administrative
Public Health

• Goal Monitor, analyze improve public health
• Representative technologies
• Laboratory information exchange networks
• Outbreak alert warning systems
• Epidemiological data repositories

• Goal Improve care delivery at point of care/
  service
• Representative technologies
• Clinical data repository
• Clinical documentation
• CPOE e-Rx
• Decision support
• Digital content
• EMR/ EHR/PHR
• PACs

• Goal Streamline/ automate admin financial
  processes
• Representative technologies
• Claims remittance systems
• Eligibility verification
• ERP
• Predictive modeling data mining
• Smart/ SwipeCards
• Websites (incl. Portals)

• Goal Streamline RD, clinical trials product
  dev.
• Representative technologies
• Clinical trials data repositories
• Bioinformatics repositories information grids
• Health outcomes evaluation systems

Information Management professionals must
service the nexus between pure technology and
data and the delivery of healthcare (bench to
bedside)
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Information Managers are dealing with the
complexity of integrating vast data sources and
applications in a validated environment and.
Data Explosion and Complexity
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maintaining corporate security as knowledge
workers need to access third party data sources
and collaborate with partners seamlessly
Data Explosion and Complexity
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Enterprise and Information Architecture skills
are critical to achieving the vision of RD
Knowledge Management
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Information Technology organizations are using a
variety of labor methods to build capabilities
and leverage global suppliers to reduce
operational cost
IT Labor Sourcing
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Type
Explanation
Insourcing

• Transferring work from an existing service
  provider to be performed within client
  organization

Outsourcing

• Transferring work from within client organization
  to a domestic service provider

Offshoring

• Transferring work from within client organization
  to an international service provider (India,
  Vietnam)

Right-shoring

• Leveraging clients global footprint to access
  labor in local low-cost geographies

• Leveraging available and proven new technology to
  reduce labor input

Automation
As commodity skills are increasingly sourced
globally, the effort and competency to manage
global development has often been underestimated
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So, what do all these dynamics mean to those who
serve the industry?

• Business leaders expect us to be business savvy
  with good change management skills!
• We need to understand the dynamics and complexity
  of managing globally with multiple partners
  (culture, time-zones, decision rights etc.)
• We must remain current with ever changing
  regulatory requirements and understand our
  companys interpretation
• Community systems and HIT requires us to
  participate and advise on key standards bodies
• Our executives expect real-time information, we
  must play the advisor/ educator to the value of
  Enterprise Information Management Architectures
• And finally, we must except that change is the
  only thing that is constant!