Final Project Charter nine
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MilestoneOneProjectCharter-Example-2.pdf
Milestone One: Project Charter Example
Drug discovery versus drug development
Project Charter
Milestone 1 Example
3-1 Final Project Milestone One: Project Charter
Drug discovery versus drug development: Project Charter
Milestone One: Project Charter.docx Page 2 of 15
Project: Drug discovery versus drug development
Title: Project Charter
Document number:
Version 0.1
Document status: Draft
Author: Steve Coleman
Responsible:
Date created: 11-16-19
Protection class: "For internal use only"
Document history
Versio
n
Date Author Comment/Change
0.1 26.08.19 SHR Draft
Milestone One: Project Charter Example
Table of Contents
1. Background/Project Purpose or Justification ........................................................................... 3
1 Goals ........................................................................................................................................ 3
1.1 Goals ................................................................................................................................. 3
1.2 Scheduling Goals/Milestones ........................................................................................... 1
2 Project Product Description ..................................................................................................... 1
3 Delivery Units .......................................................................................................................... 2
3.1 Delivery Units/Services .................................................................................................... 2
4 Project Success Criteria ........................................................................................................... 3
5 High-Level Risks ..................................................................................................................... 3
6 Key Stakeholders ..................................................................................................................... 4
7 Assumptions, Restrictions and External Dependencies ........................................................... 5
8 Responsibility of the Customer ................................................................................................ 6
8.1 Tasks ................................................................................................................................. 6
8.2 Resources and Staffing ..................................................................................................... 6
9 Project Category ....................................................................................................................... 7
10 Project Budget (Overview) ................................................................................................... 7
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11 Project Startup ...................................................................................................................... 1
12 Project End ........................................................................................................................... 1
12.1 Signatures for Release ...................................................................................................... 1
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1. Background/Project Purpose or Justification
The pharmaceutical industry is a highly regulated market that needs managing streams of
innovation which can be better done with an improved portfolio management system. The
purpose of this project will be to create an approach that utilizes effective methodologies and
processes to ensure that the drug development process follows an efficient path. There are a lot
of challenges in deciding on how to allocate resources to these projects in order to achieve the
maximum returns. Other challenges include; how to evaluate the value and risk of each project,
how to choose new projects, how to prioritize projects to be included or removed from the
portfolio, how to setup the development team to maximize the goal of success.
2. Goals
This section describes which goals are to be realized with the project. These goals serve
as a point of reference for the project closing.
2.1. Goals
Goal Description Implementation Apply Portfolio, program and project management processes to achieve
successful projects Value Increase the value of R&D portfolios by apportioning resources to align
with strategic objectives and decrease costs associated with the R&D of new pharmaceuticals
Efficiency Increase efficiency in the overall production process of new pharmaceuticals
Closure Close the project in accordance with policies and stakeholder requirements
Milestone One: Project Charter Example
2.2. Scheduling Goals/Milestones
Schedule Description Phase 1 • Define Organization Strategy
• Establish cross function portfolio management and align the organization strategy
• Establish Program and Project Management processes
Phase 2 • Align program and project decisions with organization strategy and business objectives
• Manage resources allocations • Maximize the value of R&D portfolios
Phase 3 • Decrease operational costs • Increase efficiency in the development process
3. Project Product Description
Establishing processes can lead to successful execution of projects. Aligning with the
organization’s strategy helps ensure that portfolio management process is defined to comply with
business objectives. Through the utilization of portfolio management, strategic goals of along
with a successful project management function processes will help to increase efficiency by
determining the best approach when researching and developing new pharmaceutical products.
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4. Delivery Units
This section provides a list of all project products/deliverables whose complete and satisfactory
delivery indicate the completion of the project.
4.1. Delivery Units/Services
Delivery Unit Description/Comment
Target Product Profile (TPP)
• Process that aligns project activities between development functions, marketing and sales
• Facilitate communication of project issues and the alignment of management and stakeholder expectations
• TPP essential component of value-driven management
Stage-Gate Decision Process
• Tool to demonstrate R&D decision points, likelihoods of uncertain results at each milestone, and potential resulting decision choices
• Tool for portfolio management and project management
Financial Evaluation
• Integrates the success of milestones with the option to remove unfavorable results
• Control the future value of projects and portfolios if all milestones have been successfully completed
• Establish a financial benefit of investing in projects and identifying value in early R&D lifecycle
Sales Forecasting & Analysis
• Disclose issues that may lead a product or drug to market success or failure
• Improve the dependability of forecasts through market research • Reduce the risk of pursuing strategies that may be have market share • Align with TPP and development plan
Risk Analysis • Provide ability to select and prioritize projects within the portfolio • Deliver a project risk list by evaluating all risk opportunities
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5. Project Success Criteria
This section outlines the quantifiable criteria that must be fulfilled so that the project can be
performed successfully.
Project Success Criteria
Organization strategy and portfolio management are aligned
A TPP is created and updated for every project
Tools are setup to evaluate the potential value of each project
Effective utilization of portfolio management processes and tools
Pharmaceutical development costs are lowered
Portfolio value is raised demonstrating that a level of efficiency has been achieved
6. High-Level Risks
This section describes some of the key project risks and their potential impact on the success of
the project. This list of risks should be regarded as provisional rather than complete because risks
are usually identified and dealt with continuously during the project.
Risk Possible Impacts on the Project Compound Risk that the compound will fail due to deficiencies of the
specific molecule Mechanism Risk that the biochemical mechanism does not work in
pharmacological models and in man as expected. TPP Risk that the compound will not meet the specified
effectiveness and safety targets of the TPP Competitive Risk that the predefined TPP will not create a
differentiated product with a unique selling proposition.
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7. Key Stakeholders
This section should at least contain the key stakeholders with their names and roles in the project
context. This is your starting point for further stakeholder management and analysis.
Name Role
Ross Geller Project Sponsor
Rachel Green Project Manager
Chandler Bing Project Lead
Phoebe Buffay Development Organizer
Joey Tribiani Research & Testing Organizer
Paul Stevens Requirements Organizer
Janice Hosen Project Team Support
Emily Waltham Project Team Support
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8. Assumptions, Restrictions and External Dependencies
Assumptions are expectations that form the basis for decisions. This section lists the main assumptions
based on which appraisals, plans, and methods are defined for the project.
A R E Item
X Key project member’s availability
X Acceptance of proposed processes
X Key project team stakeholders have the appropriate skills
X Risk associated with pharmaceutical R&D
X Project resource allocations.
X Focus groups
A = Assumption R = Restriction E = External dependency
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9. Responsibility of the Customer
This section lists what the customer is to contribute in the course of the project. These
responsibilities can be split into two categories.
9.1. Tasks
Task Comment Contact Customer Representative Provide subject matter
expertise Monica Geller
Customer Representative Relay provided information to the community
Melissa Warb
Customer- Decision Maker Will make project decisions on behalf of included business units
Gunther Tuck
Customer- Decision Maker Review and approve process deliverables
Jill Green
9.2. Resources and Staffing
Resources/Staffing Comment Contact Performance issues and recognition
Ben Geller
Re-assign resource responsibilities
Kathy Smith
Staffing scheduling issues Ellen Miller
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10. Project Category
According to the relevant requirements and experiences in the company, the project is classified
based on the following predefined features.
Project Category B Project
Project Categories: C Projects: B Projects: A Projects:
Complexity Low Average High Risk & Impact on Company
Low Average High
Strategic Importance
Low Average High
Number of Persons on Project
Generally 5–10 Generally 10–20 Generally > 20
Project Duration Up to six months 6–12 months 6–24 months
11. Project Budget (Overview)
The financial framework within which the project must operate is described here. Depending on
the size of the framework, it may make sense to provide further details for individual parts.
Area Amount
Project $1,500,000
Subproject N/A
Milestone One: Project Charter Example
12. Project Startup
The project is deemed started with the following signatures:
Representative of Steering Committee
Customer Project Manager
Signature Ross Geller
Fred Flintstone Rachel Green
Name Ross Geller Fred Flintstone Rachel Green Date 08.30.2019 08.30.2019 08.30.2019
13. Project End
Planned Project End:
2020
13.1. Signatures for Release
The project manager is released with the signatures provided here following the project closing
phase:
Representative of Steering Committee
Customer Project Manager
Signature Name Ross Geller Fred Flintstone Rachel Green Date
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Annex
I. Glossary and Abbreviations
Term Explanation
II. References, Accompanying Documents
If references have been made in this document to other external documents, these documents should be
listed here.
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Reference
No.
Title Doc. No.
