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Project Planning for Clinical Supplies: New Technologies for Facilitating Clinical Supplies Operatio

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Large scale, one-of-a-kind (or few-of-a-kind) effort. Definite beginning and end (Phase I IV) ... Technology and Irrational Exuberance: Lessons Learned ... – PowerPoint PPT presentation

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Title: Project Planning for Clinical Supplies: New Technologies for Facilitating Clinical Supplies Operatio


1
Project Planning for Clinical Supplies New
Technologies for Facilitating Clinical Supplies
Operations
  • Presented by
  • Nitin Pathak PhD, MBA
  • Richard C Hwang PhD, MBA
  • Pfizer Global Research Development

2
Outline
  • A. Introduction
  • B. Project Management
  • C. Technologies IT
  • D. Clinical Supply Chain Technologies
  • F. Take Away

3
A. Introduction
4
The Three Chains of Enterprise Design
Fulfillment, Development, Technology Chains
Technology Supply Chain (Support Focus)
IT Infrastructure Hardware Software Database
Telecommunication
Pre-formulation R D
Formulation R D
Development Value Chain (enabling dosage form
focus)
Analytical R D
Voice of
IS Architecture Software Business process
application
the Customer
Regulatory
Warehouse Inventory Mgmt.
DP Mfg. and Clinical Packaging
Clinical Trial Sites
DS Mfg.
Fulfillment Supply Chain (on time CTM delivery
focus)
5
Scope
Warehouse Inventory mgmt.
DP Mfg. and Clinical Packaging
Clinical Trial Sites
DS Mfg.
  • Fulfillment Supply Chain (on time CTM delivery
    focus)

6
B. Project Management
7
Project Characteristics
  • Large scale, one-of-a-kind (or few-of-a-kind)
    effort
  • Definite beginning and end (Phase I IV)
  • Can be subdivided into discrete activities with
    definite beginnings and ends
  • Known precedence relationships among activities
  • Time estimates available for activities

8
Project Flow Chart
Event 1, 2, 3, 5, 6, and 7 critical path
3
5
D
Beginning
F
End
B
1
2
6
7
A
G
C
Activities E and F must both be completed before
G may start
E
4
Activity E has slack
Event
Activity
9
Project Management Issues
  • Understand the structure of the project
  • Estimate project duration
  • Identify critical activities
  • Identify which activities have slack
  • Establish schedule for activities
  • (and associated resources)
  • Identify most effective ways to reduce project
    duration, if necessary

10
Project Duration
  • Project duration is determined by the longest
    (time) path of activities through the project
    network
  • This longest path is the critical path
  • Identify all of the paths through the network in
    the previous slide
  • Which is the critical path, and what is its
    length?

11
Slack Time
  • Slack is the time an individual activity might be
    delayed without delaying completion of the
    project
  • Activities on the critical path have zero slack
  • Sometimes slack is shared between adjacent
    activities -- if slack is used up early in the
    project, flexibility is lost later
  • Free Slack refers to the amount of time an
    individual activity might be delayed without
    delaying any immediate follower activity

12
Allocating Resources and Reducing Project Duration
  • Estimate project duration based on expected
    activity times for critical activities
  • May sometimes want to reduce project duration
  • Meet a deadline
  • Effectively compete in the market
  • To reduce project duration, reduce time for
    critical activities
  • Allocate more resources
  • Use more expensive, but faster resources

13
Allocating Resources and Reducing Project Duration
  • Not necessarily a good idea to crash every
    activity
  • Guidelines for crashing a project
  • Apply resources to reducing only critical
    activities
  • Monitor length of non-critical paths -- what was
    originally considered non-critical may become
    critical
  • Crash activities only as long as the benefit of
    crashing exceeds the cost

14
Project Optimization
Quality
Project Management
Time
Resource/
15
Business Technology IT
16
Business Technology
  • Business Technology is the application of
    scientific knowledge to improve business
    efficiency, quality or flexibility
  • Not just machines or electronics
  • May include novel raw materials or bio-tech

17
Classifying Business Technologies
  • Processing
  • Industrial Robots
  • Automated Materials Handling
  • Flexible Manufacturing Systems
  • Design
  • Computer-aided Design (CAD)
  • Computer-aided Engineering (CAE)
  • Computer-aided Process Planning (CAPP)
  • Administrative
  • Material Requirements Planning (MRP)
  • Enterprise Resource Planning (ERP)
  • Electronic Data Interchange (EDI)
  • Internet

18
Clinical Supply Chain Objectives
  • Reduce Lead Times
  • Minimize Waste
  • Maintain and Improve Quality
  • Reduce Cost
  • On-time Delivery of CTM

19
Typical Benefits of New Technologies
  • Cost Reductions
  • Increased Product Variety (Economies of Scope)
  • Improved Quality
  • Faster Cycle Times

20
Risks Associated with New Technologies
  • Technological
  • Higher investment, compatibility issues, downside
    of too much information, protection of IP,
    technology and product life cycles
  • Organizational
  • Challenges in global market environment
  • Market
  • Volatile market price, uncertain demand

21
Because it is there, is NOT a good reason!
  • Too many organizations develop or buy new
    technologies based on the reasoning applied by
    George Leigh Mallory when asked why he sought to
    climb Mt. Everest in 1924 Because it is
    there.
  • We must carefully think about the goals dictating
    our usage of technology.

22
IT
  • Information
  • Do you agree with the following statement
  • We have more data and information now, but not
    necessarily more KNOWLEDGE?

Data
Information
Knowledge
23
Technology and Irrational Exuberance Lessons
Learned
Hype
Reality
  • The Internet complements rather than cannibalizes
    existing means of competing.
  • New economics of information must be integrated
    with existing economics of physical things.
  • Manage information and physical value chains
  • Construct extended enterprise networks
  • The Internet is a revolutionary force that will
    upend all conventional wisdom about strategy and
    competition.
  • New economics of information will drive strategy.
  • Deconstruct physical and information value chains
  • First-mover advantages combined with network
    externalities and lock-in effects will enable
    scalable growth

24
Aligning IT and Business Capabilities
  • Understand the intangible benefits of IT.
  • Aligning investments in IT with value creating
    processes.

25
The Functionality of Advanced Information
Technologies
  • Speed
  • Capacity or Throughput
  • Efficiency
  • Ubiquity
  • Ease of Use
  • Transparency or Complexity Hiding

26
Monetizing IT Value
  • How information technologies enhance the quality
    of ongoing transactions
  • Transaction Capital
  • Example
  • E-Procurement of raw material packaging
    components

27
Monetizing IT Value
  • How information technologies enhance the quality
    of ongoing decisions
  • Decision Capital
  • Examples
  • Data warehousing, data mining, and online
    analytic processing (OLAP) technologies
    facilitate greater insights into data
  • Online monitoring of critical process parameters
    (trend analysis, PAT)
  • Smart scheduling of CS operations
  • Monitoring product flow in CS value chain

28
Monetizing IT Value
  • How information technologies enhance the quality
    of organizational intelligence
  • Intellectual Capital
  • Example
  • Intranets and portals enabling knowledge
    management and continuously monitoring
    competitive intelligence

29
Monetizing IT Value
  • How information technologies enhance the quality
    of a firms relations with its extended
    enterprise (suppliers, contract manufacturers,
    strategic partners, etc.)
  • Relational Capital
  • Examples
  • Extranets and virtual private networks, XML, WML
  • Lean supply chain Information sharing with
    external vendors and SC partners for effective
    execution of company strategy

30
The IT Response
31
D. Clinical Supply Chain Technologies
32
Supply Chain Technologies
  • Objectives
  • Understand technologys potential impact on
    performance
  • Overview of types of technologies
  • Planning
  • Processing
  • Communications

33
Clinical Supply Chain Information Infrastructure
ERP Enterprise Resource Planning
APS Advanced Planning Scheduling
Information Flow
SCE Supply Chain Execution Software
ERP http//www.erpcentral.com/
34
Three Layers of Information Technology
ERP/Legacy Systems Extension Systems Planning
Systems
Layer 3
Business Application
Identification Codes Bar Coding Electronic Data
Interchange
Infrastructure, Core Technologies, and
Standards
Layer 2
Transaction Processing Architecture Data
Architecture Communication Architecture
Layer 1
Hardware and Software System
35
Types of Clinical Supply Chain Technologies
  • 1. Decision Support Technologies
  • (Planning and Scheduling)
  • Strategic planning
  • Operational planning and control
  • 2. Processing Technologies
  • Product/process design
  • Manufacturing
  • Transportation and materials handling
  • Automated data capture
  • 3. Communication Technologies
  • Collaborative and coordination-oriented
  • Transaction-based integrative

36
1. Decision Support Technologies
  • Strategic (Supply Chain Planning DSS)
  • Location, size and number of plants, distribution
    centers, and suppliers
  • Sourcing and deployment plans for each plant,
    distribution center, and customer
  • Flow of goods through the network
  • Tactical (Resource Planning, Order Management
    Systems)
  • Operations planning
  • Manufacturing and sourcing planning
  • Distribution planning
  • Operational
  • Manufacturing Execution System
  • Transportation Execution System
  • Warehouse Execution System

Advanced Planning and Scheduling Systems
37
Application Definitions
  • Planning
  • Term weeks or months in advance
  • Deals with aggregate data of demand and capacity
  • Balances the load and capacities of different
    resources over time
  • Scheduling
  • Term hours or days in advance
  • Deals with individual jobs and tasks, specific
    tools and capabilities
  • Generates assignment of specific tasks to
    specific tools at specific times

38
2. Processing Technologies
  • Manufacturing
  • Automated materials handling
  • Warehouse management systems (WMS)
  • Transport management systems (TMS)
  • Automated data capture

39
Manufacturing
  • Supervisory Control and Data Acquisition (SCADA)
  • Programmable logic controller (PLC)
  • Material resource planning systems (MRPII)
  • Electronic batch record systems (EBR)
  • Statistical process control (SPC)
  • Laboratory information management systems
    (LIMS)
  • Business application software (word processors,
    spreadsheet computational software etc.)

40
Manufacturing Process Analytical Technology (PAT)
  • Application Development value chain
  • Multivariate data acquisition and analysis tools
  • Process analyzers or process analytical chemistry
    tools (offline, at-line, on-line, in-line,
    noninvasive)
  • Process monitoring, control, end point
  • Continuous improvement knowledge management
  • Tools
  • Near IR spectroscopy
  • Statistical process control
  • Raman spectroscopy

Source http//www.fda.gov/cder/ops/pat.htm
41
Benefits of Mfg. Automation
  • Reduced start-up costs for similar new products
  • Smaller batch sizes, lead times, and inventories
  • Improved productivity
  • Capital for labor
  • Reduced downtime
  • Reduced supervision required
  • Reduced manufacturing waste

42
Risks of Mfg Automation
  • Big capital expenditures required
  • Requires changes in operating policies,
    standards, and employment
  • Relative inflexibility to radical new product
    introduction or major shifts in drug product
  • Vulnerable to business conditions
  • Sensitive to capital markets
  • Sensitive to demand and price instability

43
Automated Materials Handling
  • Robots
  • Conveyances
  • Automated Storage and Retrieval Systems (AS/RS)
  • Automated Guided Vehicle (AGV)
  • Vision Systems

44
Warehouse Management System Functionality
  • Labor equipment productivity
  • Responsiveness to customers

45
Transportation Management Systems (TMS)
AutoStage
Order Database
Shipment Consolidation
Planning
Optimized Shipping Plans

Optimized Assignment / EDI
Continuous Moves
Last Minute Changes / Exceptions
Operations
In-Transit Visibility
Freight Bill Payment
46
Transport Management System Functionality
  • EDI links with carriers
  • Internet based shipment tracking
  • Integrated POD and claims management
  • Most economical mode
  • Calculates best route for multiple stops
  • Carrier selection based on cost, and service
    (including performance factor)

47
Automated Data Capture
  • Bar Coding Systems
  • Radio Frequency Communication
  • Voice Recognition
  • Global Positioning Systems

48
Radio Frequency
  • RF Identification (RFID)
  • Carton/pallet identification
  • Shipment tracking
  • RF Data Communications (RFDC)
  • Real time execution instructions
  • Location assignment/tracking

49
3. Communication Technologies
  • Collaboration and Coordination
  • Electronic Data Interchange
  • Satellites

The Internet
50
Supply Chain Information Flows
Procurement Plan/BOM
Logistics Plan
Coordination Flows
Strategic Plan
Capacity Plan
Mfg./Prod Plan
Inventory Mgmt. Deployment
Forecast
Operating Flows
LIS Operations
Order Management
Order Processing
Ware- housing
Transportation
Material Resource Planning Systems (MRP)
51
EDI Components
Trading Partner 1
Trading Partner 2
Business Applications
Business Applications
EDI Utility
EDI Utility
Translation/Communications -Value Added Network
(VAN) -Direct connect -Other
Processing Techniques -Batching -Real
time -Interactive
Transaction Sets (Standardizes exchange)
Cycle Time
52
F. Take Away
53
Aligning IT and Business Value
  • Think of a Clinical Supply Chain unit as a
    portfolio of digital value streams
  • What are the performance metrics for that digital
    value stream?
  • What are the leverage points where IT can impact
    the digital value stream?
  • How should the impacts be monetized?

54
Project Management, Planning Scheduling
Challenges
Product Volume
Low Volume High Variety
High Volume Low Variety
Phase I
Customized Batch Mixed Repetitive Dedicated Repe
titive Optimized
Process Variety
Phase IV
55
Acronyms
MRP - Material Requirements Planning MRPII -
Manufacturing Resource Planning OMS-
Operations Management System RFDC - Radio
Frequency Data Communications RFID - Radio
Frequency Identification SCADA- Supervisory
Control and Data Acquisition SFDC - Shop
Floor Data Collection SPC - Statistical
Process Control TMS - Transportation
Management System WMS - Warehouse Management
System
AGV - Automatically Guided Vehicle AMHS -
Automatic Material Handling System APS -
Advanced Planning/Scheduling System AS/RS -
Automated Storage / Retrieval System CAPP -
Computer Aided Process Planning CIM -
Computer Integrated Manufacture CRP -
Capacity Requirements Planning CRM -
Customer Relationship Management EDI -
Electronic Data Interchange ERP -
Enterprise Resource Planning GPS - Global
Positioning System MES - Manufacturing
Execution System
56
Acknowledgement
  • Mark Aills
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