Fluent Essays

Projects that start with effective planning have a better chance of finishing strong. The creation of a good project charter will help the team coalesce around clarified objectives and will help guide the team to a successful conclusion.In Module One, you wrote an overview of the case study you will be using for your final project. Your next step in this milestone will be to create a project charter continuing with the same case study. QSO 680 Milestone One Guidelines and Rubric Overview: For the final project in the course, you will analyze the case study Value-Driven Project and Portfolio Management in the Pharmaceutical Industry and additional course resources to create a program performance report for a hypothetical organization. The completion of this project will allow you to demonstrate your knowledge of program-level management and your ability to develop key executive reporting following standard frameworks. Prompt: In Module One, you wrote an overview of the case study you will be using for your final project. In this milestone, using the project charter template provided, you will now dig more deeply into the case study information to create a project charter, which gives you a high-level perspective of the project. A data set for this case study has also been provided for your benefit. You are expected to complete each section of the charter template. When you complete your final project program report, you will pull the information you need from your charter to complete your program report. For the project charter, specifically, the following critical elements must be addressed: I. Discuss the project purpose and background. Here you will provide the organization’s justification for taking on the project. II. Identify the project’s goals, objectives, and expectations. Be sure that your goals are measurable. III. Discuss the end product or service to be supplied. Here you will discuss the scope of the end product or service and the business need that the project will address. IV. Identify milestones/estimated deliverables. Note the relationship between the project deliverables and the project objectives. The deliverables should meet the objectives. V. Discuss the success criteria. How will “success” be measured? VI. Identify the high-level risks. How do the risks potentially impact the project? VII. Identify the key stakeholders. What is the role of each stakeholder in the project? VIII. Identify any assumptions, restrictions, and external dependencies. What are the assumptions on which decisions are being made? IX. Identify any customer responsibilities. Will the customer be doing any tasks or contributing any resources to the project? X. Complete a project category table allowing a high-level view of the project. XI. Specify a high-level budget. Guidelines for Submission: Your project charter must be submitted using the provided project charter template. Critical Elements Proficient (100\%) Needs Improvement (75\%) Not Evident (0\%) Value Purpose and Background Discusses project purpose, background and justification Discusses project purpose, background, and justification but with gaps in detail and relevance Does not discuss project purpose, background, and justification 8.5 Goals, Objectives, and Expectations Identifies measurable goals, objectives, and expectations Identifies goals, objectives, and expectations but some or all are not measurable Does not identify measurable goals, objectives, and expectations 8.5 http://search.proquest.com.ezproxy.snhu.edu/docview/232912662?pq-origsite=summon&accountid=3783 http://snhu-media.snhu.edu/files/course_repository/graduate/qso/qso680/qso680_project_charter_template.docx http://snhu-media.snhu.edu/files/course_repository/graduate/qso/qso680/qso680_final_project_case_study_data_set.xlsx End Product or Service Discusses end product or services to be supplied Discusses end product or services to be supplied but with gaps in detail Does not discuss end product or services to be supplied 8.5 Deliverables Identifies major milestones and deliverables aligned with project objectives Identifies major milestones and deliverables, but they are not clearly aligned with project objectives Does not identify major milestones and deliverables 8.5 Success Criteria Identifies and discusses quantifiable success criteria Identifies and discusses success criteria but with gaps in detail and/or they are not quantifiable Does not identify and discuss success criteria 8.5 High-Level Risks Identifies high-level risks and potential impact Identifies high-level risks but with gaps in details of potential impact Does not identify high-level risks and potential impact 8.5 Key Stakeholders Identifies key stakeholders and their roles Identifies key stakeholders but with gaps in detail of roles Does not identify key stakeholders and their roles 8.5 Assumptions Identifies assumptions on which key decisions are based Identifies assumptions on which key decisions are based but with gaps in detail and/or logic Does not identify assumptions on which key decisions are based 8.5 Customer Responsibilities Identifies the customer responsibilities to the project Identifies the customer responsibilities to the project but with gaps in detail Does not identify the customer responsibilities to the project 8.5 Project Category Completes the project category table Works on the project category table but table is incomplete or illogical Does not complete the project category table 8.5 Budget Specifies a high-level budget Specifies a high-level budget but with gaps in detail and/or logic Does not specify a high-level budget 8.5 Articulation of Response Submission has no major errors related to citations, grammar, spelling, syntax, or organization Submission has major errors related to citations, grammar, spelling, syntax, or organization that negatively impact readability and articulation of main ideas Submission has critical errors related to citations, grammar, spelling, syntax, or organization that prevent understanding of ideas 6.5 Total 100\% 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 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 2 of 15 11 Project Startup ...................................................................................................................... 1 12 Project End ........................................................................................................................... 1 12.1 Signatures for Release ...................................................................................................... 1 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 3 of 15 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. 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 2 of 15 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 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 3 of 15 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. 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 4 of 15 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 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 5 of 15 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 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 6 of 15 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 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 7 of 15 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 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 2 of 15 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. 3-1 Final Project Milestone One: Project Charter Drug discovery versus drug development: Project Charter Milestone One: Project Charter.docx Page 3 of 15 Reference No. Title Doc. No. Sheet1 Lifecycle Pharmaceutical Interest Rate = 5\% Assumptions for Valuation Drug Candidate Current Stage Complete Phase I Complete Phase II Complete Phase III Drug Approval Remaining Development Costs LC-1 Phase II NA Q2 2004 Q1 2006 Q2 2007 $100 MM LC-2 Phase II NA Q2 2006 Q2 2008 Q1 2009 $300 MM LC-3 Phase II Q1 2004 Q4 2007 Q2 2008 Q2 2008 $600 MM LC-4 Preclinical Q2 2005 Q4 2007 Q1 2009 Q2 2009 $220 MM PTC-Ph 1 PTC-Ph 2 PTC Ph-3 Probability of Approval PTC = Probability of Technical Success LC-1 100\% 40\% 65\% 75\% LC-2 100\% 60\% 50\% 50\% LC-3 80\% 60\% 60\% 75\% LC-4 70\% 50\% 75\% 80\% Clinical Phase Durations (estimates) Phase I 1 year Peak Sales Profit Margins Annual Expenses Phase II 730 days LC-1 $600 MM 90\% $40 MM Phase III 3 years LC-2 $800 MM 90\% $65 MM Drug Regulatory Submission 0.5 year LC-3 $1,000 MM 80\% $80 MM LC-4 $750 MM 82\% $65 MM Sheet1 Lifecycle Pharmaceutical Interest Rate = 5\% Assumptions for Valuation Drug Candidate Current Stage Complete Phase I Complete Phase II Complete Phase III Drug Approval Remaining Development Costs LC-1 Phase II NA Q2 2004 Q1 2006 Q2 2007 $100 MM LC-2 Phase II NA Q2 2006 Q2 2008 Q1 2009 $300 MM LC-3 Phase II Q1 2004 Q4 2007 Q2 2008 Q2 2008 $600 MM LC-4 Preclinical Q2 2005 Q4 2007 Q1 2009 Q2 2009 $220 MM PTC-Ph 1 PTC-Ph 2 PTC Ph-3 Probability of Approval PTC = Probability of Technical Success LC-1 100\% 40\% 65\% 75\% LC-2 100\% 60\% 50\% 50\% LC-3 80\% 60\% 60\% 75\% LC-4 70\% 50\% 75\% 80\% Clinical Phase Durations (estimates) Phase I 1 year Peak Sales Profit Margins Annual Expenses Phase II 730 days LC-1 $600 MM 90\% $40 MM Phase III 3 years LC-2 $800 MM 90\% $65 MM Drug Regulatory Submission 0.5 year LC-3 $1,000 MM 80\% $80 MM LC-4 $750 MM 82\% $65 MM