What is Project Management? NIH Principles of Clinical Research

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What is Project Management? NIH Principles of
Clinical Research

• Charles Grudzinskas, Ph.D.
• NDA Partners LLC
• Center for Drug Development Science (CDDS)
• UCSFWashington Center
• Drug Development Consultant
• Annapolis

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WHAT IS PROJECT MANAGEMENT ?

• What Is A Project ?
• Process Content
• 7 Elements Of Project Management
• Evolution Of Project Management

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Cost of Poor Management

• 899 MM/Each New Drug
• Opportunity Costs
• Failed Drugs
• Marketing Sales Costs
• The Patients are Still Waiting

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Benefit of Good Management

• Higher NPVs
• More Products per
• Identify Losers Sooner
• More Successful Projects
• Faster Reviews

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Washington Post January 5, 2003 When Business
Plans Go Bust Automobiles Airlines Fast
Food Pharmaceuticals
Many Are Treated, but Few Are Cured From within
the ranks of the Pharmaceutical Industry,
Statistics on the Low Percentage of Individuals
Helped by Medications Drugs.  The solution? 
Pharmacogenomics Glaxo chief Our Drugs do not
Work on Most Patients
The New Drug Approvals of 1996, 1997 and
1998 Drug development Trends in the User Fee
Era, Kaitin, K. and Healy, E., Drug Information
Journal, 34, pages 1-14, 2000 800-899 M per
each new drug
June 16, 2003, NY Times New York Region 22
States Limiting Doctors' Latitude in Medicaid
Drugs In an effort to rein in the fast-rising
cost of Medicaid, states are limiting which drugs
doctors can prescribe for Medicaid patients
An effectiveness increase of 33 would represent
a savings of 242M of the cost of a drug
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US-IND (not all FIHs) to NDA
J. DiMasi (Tufts) Clinical Pharmacology
Therapeutics May 2001
7
Shrinking time to second in class requires
that you get out of the gates fast hard
Years Between Drug Launch and First Competitor
Years 0 2 4 6 8 10
Inderal 1968 (hypertension) Tagamet
1977 (ulcer) Capoten 1980 (hypertension)
Source A.T. Kearney, The Economist 09/20/97
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Shrinking time to second in class requires
that you get out of the gates fast hard
Years Between Drug Launch and First Competitor
Years 0 2 4 6 8 10
Inderal 1968 (hypertension) Tagamet
1977 (ulcer) Capoten 1980 (hypertension) Seldane
1985 (hayfever) AZT 1987 (AIDS) Mevacor
1987 (cholesterol) Prozac 1988 (depression)
Source A.T. Kearney, The Economist 09/20/97
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Shrinking time to second in class requires
that you get out of the gates fast hard
Years Between Drug Launch and First Competitor
Years 0 2 4 6 8 10
Inderal 1968 (hypertension) Tagamet
1977 (ulcer) Capoten 1980 (hypertension) Seldane
1985 (hayfever) AZT 1987 (AIDS) Mevacor
1987 (cholesterol) Prozac 1988 (depression) Difluc
an 1990 (fungal infections) Recombinant
1992 (hemophilia)
Source A.T. Kearney, The Economist 09/20/97
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Differentiation Oncology

• Better effectiveness profile
• Imatinib Mesylate (Gleevec)
• Better safety profile
• Epirubicin (Ellence)
• Better patient compliance
• Less chair-time?
• Oral paclitaxel?

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Tools for Success

• Target Product Profile (TPP)
• Target Package Insert (TPI)
• Comparative PI elements
• Marketed
• In development

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Target Product Profile

• Meets ICH guidances
• The Optimal target
• The Threshold-
• Below which we will not launch
• Must be measurable

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A PROJECT IS...
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A PROJECT IS...
SPECIFICATIONS (QUALITY AND QUANTITY)
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PROJECT OBJECTIVES

• GO / NO GO Criteria
• Barn Door Forecasting ?

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Barn Door Forecasting
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Barn Door Forecasting
BANG!
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Barn Door Forecasting
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Barn Door Forecasting
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Barn Door Forecasting
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Barn Door Forecasting
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Barn Door Forecasting
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A PROJECT IS...
RESOURCES (PEOPLE, EQUIP., )
SPECIFICATIONS (QUALITY AND QUANTITY)
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A PROJECT IS...
RESOURCES (PEOPLE, EQUIP., )
TIME (SCHEDULES, DEADLINES)
SPECIFICATIONS (QUALITY AND QUANTITY)
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A PROJECT IS...
SPECIFICATIONS (QUALITY AND QUANTITY)
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A PROJECT IS...

• Unique Chemical (or Combo), Biological, or
  Device
• Single Indication(s)
• Single Formulation
• Single Package Style

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A PROJECT IS...

• Unique Chemical (or Combo), Biological, or
  Device
• Single Indication(s)
• Single Formulation
• Single Package Style

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INTERNAL FORCES
YOUR PROJECT
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INTERNAL FORCES
Team
YOUR PROJECT
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INTERNAL FORCES
Team
Turf
YOUR PROJECT
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INTERNAL FORCES
Team
Turf
Strategic Intent
YOUR PROJECT
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INTERNAL FORCES
Team
Turf
Strategic Intent
YOUR PROJECT
Marketing
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INTERNAL FORCES
Team
Turf
Strategic Intent
YOUR PROJECT
Marketing
Selection
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INTERNAL FORCES
Team
Turf
Strategic Intent
YOUR PROJECT
Decision Making
Marketing
Selection
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INTERNAL FORCES
Team
Turf
Strategic Intent
YOUR PROJECT
Time
Decision Making
Marketing
Selection
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INTERNAL FORCES
Team
Turf
Quality
Strategic Intent
YOUR PROJECT
Time
Decision Making
Marketing
Selection
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INTERNAL FORCES
Team
Evaluation
Turf
Quality
Strategic Intent
YOUR PROJECT
Time
Decision Making
Marketing
Selection
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EXTERNAL FORCES
YOUR PROJECT
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EXTERNAL FORCES
Commercial Potential
YOUR PROJECT
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EXTERNAL FORCES
Commercial Potential
YOUR PROJECT
FDA/BoH
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EXTERNAL FORCES
Commercial Potential
YOUR PROJECT
FDA/BoH
Congress
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EXTERNAL FORCES
Commercial Potential
YOUR PROJECT
FDA/BoH
Congress
Reimbursement
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EXPANDED REIMBURSEMENTHCFA Reimbursement For
Epogen, Takeover Talk Help Amgen Grow in June

• A second increase in the Health Care Financing
  Administration reimbursement rates for Epogen has
  aided in increasing the valuation of Amgen in the
  financial community.
• On June 19, HCFA issued a program memorandum to
  payors that directed payment of claims for Epogen
  (erythropoietin alfa) in patients whose
  hematocrit levels reach as high as 37.5

The Pink Sheet 7/6/98 page 20
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EXPANDED REIMBURSEMENTHCFA Reimbursement For
Epogen, Takeover Talk Help Amgen Grow in June

• On June 24, Gruntal Co. analyst David Saks
  predicted that the new reimbursement policy could
  result in a 10 increase in use Epogen sales in
  1997 were about 1.07 bil. And Amgens total
  revenues were 2.4 bil. Gruntal upgrades Amgen
  from buy to strong buy.

The Pink Sheet 7/6/98 page 20
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EXTERNAL FORCES
Commercial Potential
YOUR PROJECT
FDA/BoH
Activists
Congress
Reimbursement
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EXTERNAL FORCES
Commercial Potential
Time
YOUR PROJECT
FDA/BoH
Activists
Congress
Reimbursement
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EXTERNAL FORCES
Commercial Potential
Competition
Time
YOUR PROJECT
FDA/BoH
Activists
Congress
Reimbursement
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What is Project Management?

• PMBOK
• Project management is the application of
  knowledge, skills, tools, and techniques to
  project activities in order to meet or exceed
  stakeholder needs and expectations from a
  project.

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What is Project Management?Knowledge

• Drug development process benchmarking
• Science/Medicine (therapeutic area)
• Regulations
• Business
• Portfolio management
• Alliance Management

• Risk management
• Project time management
• Project cost management
• Organizational dynamics
• International corporate culture

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What is Project Management?Skills

• Interpersonal
• Network planning
• Strategic thinking
• Negotiation
• Meeting management

• Communication (written oral)
• Conflict management
• Issue resolution
• Monitoring
• Contractor management

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What is Project Management?Tools

• Planning software
• PERT charts
• Gantt (bar) charts
• Dashboards

• Decision trees network
• Meeting minutes
• Spreadsheets
• e-Mail
• Word processor
• Teleconference
• Videoconference

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What is Project Management?Techniques

• What if analyses
• Critical path analyses
• Brainstorming
• Challenging (devils advocate)

• Cajoling
• Nagging
• Begging

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OBJECTIVES(Results)
CONTENT
PROCESS

• Communicate Strategy
• White Space
• Integrate Plan
• Facilitate
• Resolve Conflicts
• Report on Progress
• Business Decisions

• Establish Strategy
• Science/Technology
• Study Design/ Execution
• Report/Recommend
• Scientific Decisions
• Business Decisions

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WHAT IS PROJECT MANAGEMENT ?

• Portfolio Design, Planning Management
• Planning
• Scheduling
• Resource Allocation
• Human Factors (Teams)
• Decision Making Process
• Process Leadership Benchmarking

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Sure, we need more research in alchemy,
necromancy, and sorcery, but where is the money
going to come from?
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WHAT IS PROJECT MANAGEMENT ?

• PORTFOLIO DESIGN, PLANNING MANAGEMENT
• Doing the Right Research
• Doing the Research Right

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WHAT IS PROJECT MANAGEMENT ?

• PORTFOLIO DESIGN, PLANNING MANAGEMENT
• Design and Plan
• Vision
• Design
• Plan

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WHAT IS PROJECT MANAGEMENT ?

• PORTFOLIO DESIGN, PLANNING MANAGEMENT
• Manage
• Prioritize
• Decision Effectiveness

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Suddenly, a heated exchange took place
between the king and the moat contractor!
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WHAT IS PROJECT MANAGEMENT ?

• PLANNING
• Objectives
• Strategy
• Tactics
• Go/No Go Criteria prespecified
• Integration
• Budgeting (Finance)

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3
10 weeks
4 weeks
Analyze Blood Samples
Lock PK DB
H
G
D
B
4 weeks
2
2 weeks
Finalize Analysis
Finalize Report
F
C
A
6 weeks
4 weeks
4 weeks
Collect CRFs
Lock Safety DB
LPLV
1 week
5 weeks
Finalize 1st Draft Report
1
D
Critical Path
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WHAT IS PROJECT MANAGEMENT ?

• SCHEDULING
• Deadlines
• Velocity
• Acceleration
• Tradeoffs

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Critical Path Analysis GANTT Chart
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Im sorry, Mr. Funucci, but we decided to award
the ceiling project to Michelangelo.
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WHAT IS PROJECT MANAGEMENT ?

• RESOURCE ALLOCATION
• Capacity
• Relative to timing needs?
• Financial
• Budget (Forecast)
• Accounting (Status)

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WHAT IS PROJECT MANAGEMENT ?

• HUMAN FACTORS (TEAMS)
• Communication
• Transformation
• Leadership

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WHAT IS PROJECT MANAGEMENT ?

• HUMAN FACTORS (TEAMS)
• Team Building
• Team Leadership
• Matrix Teams Core Teams
• High Performance
• Heavy-weight Teams
• Education Core Competencies

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WHAT IS PROJECT MANAGEMENT ?

• FACILITATING DECISIONS
• Selecting Clinical Candidates
• Implementing
• Tracking
• Reporting
• Completing /Terminating

Adapted from How to Keep RD Projects on
Track!--Robert Szakonyi
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WHAT IS PROJECT MANAGEMENT ?

• FACILITATING DECISIONS

Report
Decide
Monitor/Track
Implement
Complete/ Terminate
Initiate
Adapted from How to Keep RD Projects on
Track!--Robert Szakonyi
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WHAT IS PROJECT MANAGEMENT ?

• PROCESS LEADERSHIP AND BENCHMARKING
• Knowledge of the Overall Process
• Knowing What is Needed Next
• Knowing How Long it Should Take How Much It
  Costs

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PM EVOLUTION
PROJECT DRIVEN
LINE DRIVEN
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
PROJECT DRIVEN
LINE DRIVEN
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
PROJECT DRIVEN
LINE DRIVEN
Resource Constraints
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
PROJECT DRIVEN
Plan/Integrate
LINE DRIVEN
Resource Constraints
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
Facilitate
PROJECT DRIVEN
Plan/Integrate
LINE DRIVEN
Resource Constraints
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
Resource Allocation
Facilitate
PROJECT DRIVEN
Plan/Integrate
LINE DRIVEN
Resource Constraints
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
Portfolio P/M
Resource Allocation
Facilitate
PROJECT DRIVEN
Plan/Integrate
LINE DRIVEN
Resource Constraints
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
Project/Venture
Portfolio P/M
Resource Allocation
Facilitate
PROJECT DRIVEN
Plan/Integrate
LINE DRIVEN
Resource Constraints
Track Monitor Status
Notes
1975 1980 1985 1990 1995 2000
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PM EVOLUTION
Planning/ Scheduling (Engineer)
Late 1980s
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PM EVOLUTION
Directing (Architect)
Planning/ Scheduling (Engineer)
Late 1980s
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Project Initiation

• What are the expected outcomes?
• When are they needed?
• How much will they cost?
• What resources will you need?
• Who do you need?
• What the project isnt (out of scope)

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Project Initiation

• What are the expected outcomes?
• Deliverable
• Results (work product)
• Measurable
• Target Product Profile
• Target Package Insert
• Emerging Draft Package Insert

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Project Initiation

• Weight reduction drug
• To generate the data needed to support global
  registrations for the weight reduction drug.
• The product will be a once/week formulation.

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Project Initiation

• Weight reduction drug
• The development program will be designed to
  demonstrate a sustainable (24 months) 20
  reduction in weight.

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Project Initiation

• Weight reduction drug
• The development plan will support a 12/05 NDA
  submission and 03/06 European submissions.

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Project Initiation

• Weight reduction drug
• The projected budgets are
• Proof of concept 20M
• Dose and dose regimen 50M
• Animal safety for NDA 45M
• Phase 3 clinical program 75M
• TOTAL 190M

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Project Initiation

• When are objectives needed?
• Timing drives resources?
• Resources drive timing?
• Deadline driven?
• Competition driven?

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Project Initiation

• What resources will you need?
• People
• Facilities
• Equipment
• Supplies
• Animals, receptors, etc.

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Project Initiation

• Who do you need?
• In your area
• In collaborative areas
• In other areas of the government
• Collaborators (JV)
• Outsourcing (contracts)

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Project Initiation

• How much will it cost?
• Green dollars
• Grants
• Equipment
• Supplies
• Animals/receptors/etc.
• Blue dollars
• People
• Facilities

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Project Initiation

• What the project is NOT
• Out of scope
• Defines the bounds (triangle)
• Used to track project modifications

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WHAT IS PROJECT MANAGEMENT ?

• 1. PORTFOLIO
• Design Planning
• Management

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WHAT IS PROJECT MANAGEMENT ?

• 2. PLANNING
• Objectives
• Strategy
• Tactics
• Integration
• Budgeting/Finance

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WHAT IS PROJECT MANAGEMENT ?

• 3. SCHEDULING/TIMING
• Deadlines
• Velocity
• Acceleration
• Tradeoffs

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WHAT IS PROJECT MANAGEMENT ?

• 4. RESOURCE ALLOCATION
• Capacity
• Financial
• Budget (Forecast)
• Accounting (Status)

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WHAT IS PROJECT MANAGEMENT ?

• 5. FACILITATE DECISIONS
• Selection
• Initiation
• Tracking
• Reporting
• Completion/Termination

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WHAT IS PROJECT MANAGEMENT ?

• 6. HUMAN FACTORS
• Leadership
• Team Building
• Matrix/ Heavy-weight Teams
• Communication
• High Performance
• Education

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WHAT IS PROJECT MANAGEMENT ?

• 7. PROCESS LEADERSHIP AND BENCHMARKING
• Knowledge of the Overall Process
• Knowing What is Needed Next
• Knowing How Long it Should Take How Much It
  Costs

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WHAT IS PROJECT MANAGEMENT ?

• Portfolio Planning Management
• Planning
• Scheduling
• Resource Allocation
• Human Factors (Teams)
• Decision Making Process
• Process Leadership Benchmarking

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WHAT IS PROJECT MANAGEMENT ?

• What Is A Project ?
• Process And Content
• Evolution Of Project Management
• 7 Elements Of Project Management

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Ha, ha, ha, Biff. Guess What? After we go to
the drugstore and the post office, Im going to
the vets to get tutored.
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Ha, ha, ha, Biff. Guess What? After we go to
the drugstore and the post office, Im going to
the vets to get tutored.
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