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ProjectScope.docx

Project Scope Statement

Beyond the pill: Lifecycle Pharmaceuticals

May 4, 2017

Project Scope Statement - Beyond the Pill: Lifecycle Pharmaceuticals

7

Table of Contents

Introduction 3

Project Purpose and Justification 3

Scope Description 3

High Level Requirements 3

Boundaries 3

Strategy 4

Deliverables 4

Acceptance Criteria 4

Constraints 4

Assumptions 4

Cost Estimate 4

Cost Benefit Analysis 5

Introduction

Disciplined project management usually starts at the start of the portfolio in which the strategic vision of the organization usually drives the initial investment of a company and where there is establishment of the measures. In an organization, it is observed that a fully aligned management strategy should take into account the entire innovation aspects of the organization which dictates the execution strategy of the project which aims at ensuring that there is deliver of the project at every stage.

At the lifecycle Pharmaceuticals, Beyond the Pills is set to make an establishment of a portfolio management system which enhances the effectiveness through the application of greater emphasis of efficiency in the entire process in order to increase the level of the level of efficiency and add some value for research and development process for drug development.

Project Purpose and Justification

As the cost for drug development increase, the Research and Development Organizations in the field of pharmaceutical industry have felt a need to make an improvement of the overall productivity in the process of drug development.

The main purpose for the project is to come up with an implementation plan which is in a position to incorporate the entire strategic objective and mission of the organization. It is also aimed at maximizing the value and minimizing the risk as well as increase the efficiency during the entire process of research and development of new drugs.

Scope Description

Improvement of the business process is quite essential when it comes to successful execution of project which fits the needs of the lifecycle pharmaceuticals. It is quit essential to align the organization strategic goals and the newly expanded functions are aimed at determining the best approach which can be applied in the earlier stages of drug development in order to increase the entire productivity and products development on the new and existing drugs and also decreased costs of healthcare.

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High-Level Project Requirements

It is observed that successful project usually have SMART goals. I.e. Specific, Measurable, and Realistic and time Bound goals which are congruent to both continuous and Functional improvement and implementation plans for Lifecycle Pharmaceutical industries.

Some of the High Level project requirements that should be met include;

· It should be in a position to align the business strategies with the entire organization goals

· It should have the essential capability to make constant updates on Target Product Profile for each individual project.

· It should have essential tools that make analysis of the potential value derived from all project.

· It should have the capability for the application of effective portfolio management within the organization.

· It should also ensure that it is in a position to achieve low drug development cost

· Finally the Lifecycle Pharmaceuticals should be in a position to increase the portfolio value

Project Boundaries

The new project underway should be implemented against the four listed drug candidates under the development process. The other thing is that the remaining drugs under the research will also continue to continually to make adherence to the original drug development process hence creating a boundary and placing them out of the project scope.

Project Strategy

With the utilization of the of the portfolio management, the Beyond Pills allows for the management is aimed at aligning the strategic goals and objectives of the pharmaceutical business units upon the successful project management process. There is need for the project teams to make adherence to the established charter of the organization so that they are in a position to stay with the established project budget as well as the key milestones for the project. It is also essential for setting the goals through the improvements of business process and it is key in identifying and resolving any possible risks that might face a project from the initiation stage all the way to the project closure.

Project Deliverables

· It is key to define to the business strategy and make alignments with the business process.

· Defining the essential criterion for every business milestone

· Discovery of new drugs or improvement of the existing drugs.

· Development and constantly make an improvement of an updated of a TPP for each project.

· Lowering the entire development costs incurred for drug development

· Improving the entire business process essential for drug development.

· Ensuring that there is proper maximization of the research and development portfolios upon proper resource allocation.

· Implementation of an effective portfolio management plan

· Ensuring that there are effective portfolio decisions in place

Acceptance Criteria

The project is going to be considered complete for acceptance by the management in the case that all the requirements and deliverables in the project scope by ensuring that they have been successfully executed by all the project teams on schedules and within the projected budget. Through successful executing the portfolio management process during the process of development and application of the new drugs in the market being developed by the Lifecycle Pharmaceuticals and have them tested and approved by the FDA to ensure the following acceptance criterion have been met.

· The first thing is to ensure that the TPP for each and every project has been developed and updated constantly.

· There are key essential tools to check on the potential value derived from the project.

· There should be installation of capacity management system.

· There should be improvement of current drugs.

· There should be successful implementation of portfolio management for the organization.

Project Constraints

· Scope – The project statement for this project for this document is defined has been already defined and cannot be easily changed unless through an Integrated Change Control Process.

· Cost- The services provided this project is part of the fixed contract, it is also limited to funding and also with the contingency.

· Schedule: The project is set to be completed within the set timeframe. The critical milestone for the project milestones are clearly identified should be met.

· Quality – For this project, the quality is not to be compromised.

Project Assumptions

· It is assumed that there are adequate resources obtained for the company.

· The project teams will remain in place in the entire execution of the project.

· The stakeholders for the projects are interested for the improvement of the business process.

· The deliverables for the Likewise Pharmaceutical are well defined in the project scope.

· Project objectives will be obtained at the closure of the project.

Cost Estimates

The estimated costs for these projects are included in the table below. As the company continually proceed during the execution phase, some of the costs associated with it can be easily identified which at the long run are communicated to the all the project stakeholders,

Expense

Estimated Budget

Expended to Date

Estimate to Complete

Variance

Labor

$350,000

$150,000

$200,000

+/- $25,000

Research

$500,000

$175,000

$325,000

N/A

Development

$750,000

$225,000

$525,000

N/A

Materials

$400,000

$75,000

$325,000

N/A

Other

$250,000

$25,000

$225,000

+/- $10,000

Total

$2,250,000

$650,000

$1,600,000

Cost Benefit Analysis

In the current times, it is observed that the Healthcare costs are continually rising which is continually becoming a concern to many business within the pharmaceutical industry. The development costs associated with new drug development in the market can be essentially being reduced through the improved portfolio management system. The cost benefit analysis is therefore essential in the development of the project. Upon the completion of the project, it is projected that is going to have greater benefits for the Lifecycle Pharmaceutical upon its completion. It is quiet essential for the project stakeholders to have a better understanding of the essential benefits that are going to be derived at completion of the project. The new system developed to monitor and make essential performance of the new drugs in the market which have a 50% pass rate and are estimated to generate a profit margin of 90%. It is therefore observed that the profit for this project outweighs the estimated costs.

Sponsor Acceptance

Approved by the Project Sponsor:

Lessie Artis Date: 5/6/2018

Lessie Artis Project Sponsor

Director of Pharmaceutical Development

References

Bode-greuel, K., & Nickisch, K. J. (2008). Value-driven project and portfolio management in the pharmaceutical industry: Drug discovery versus drug development - commonalities and differences in portfolio management practice. Journal of Commercial Biotechnology, 14(4), 307-325. doi:http://dx.doi.org.ezproxy.snhu.edu/10.1057/jcb.2008.6