A Project Analysis of Drug Development in the Pharmaceutical Industry

The project statement aims to provide a high-level overview of the different project stakeholders on the key highlights of the project. Hence the aim is to shed light on the scope of the project, the deliverables together with the different roles that the stakeholders will play to ensure the successful execution of the project.

Project Purpose and Justification

The purpose of the project is to identify the procedures that drive the successful development of the drug in the pharmaceutical industry while effectively linking the business strategies with the business goals. Hence, the purposes of the project are mainly categorised into two;

• To give a clear focus on the processes of drug development including the expenditure that is involved

• To expound on how organisations can utilise research and development as a tool for efficient allocation of resources while developing the drugs in the pharmaceutical industry.

Scope Description

The project focused on analysing the pharmaceutical life cycle of four different candidates with the emphasis on the different phases of drug development. Moreover, the financial aspects of the four candidates were also analysed regarding the annual expenses, profit margins and the peak sales. The project aims to equip the stakeholders with the knowledge of processes that will lead to the development of quality drugs which will improve the quality of healthcare that the patients receive.

Also, the foundation of the project is that it incorporates the ideas of different stakeholders to ensure that quality drugs are manufactured. As a result, the tools that have been applied in the product development include; stage-gate decision, budget management, target product profile and sales forecasting. Hence, the desired outcome is to determine a drug development process that will ensure the patients get quality as well as enabling organisations to manage their resources efficiently.

High-Level Project Requirements

The requirements of the project are as below;

The skilled personnel who will be involved in the project

The relevant technology for conducting the research

The financial resources to support the research process

The four drug candidates to be engaged in the research process

Project Boundaries

The boundaries of the project will be as below;

• The market research of drugs which may need for specific illness

• Identify the gap analysis based on the poor quality of drugs which exist in the market

• Delivers the practicality of specific medical therapies which have been identified through different studies

• Identifies the efficient operational process for producing new drugs

• Provides the compliance guidelines which consumers need to follow the various drugs

• Identifies the prototypes of how to package different drugs based on the findings

Project Strategy

The strategy that has been applied to ensure the successful execution of the project is to divide the project into subprojects A, B and C. Through the division, the project management officer has allocated the personnel and the required budget including the expected timeline of completion. As a result, by dividing the project into subproject, the team can successfully execute the project by managing the risks, resources and constraints.

Project Deliverables

The deliverable of the project will be assessed on;

• The level of technical innovativeness of the recommended processes

• The termination of the project based on the set timelines

• The improved performance of the organisation on completion of the project

• The professional growth of the different stakeholders who have been involved in the project

Acceptance Criteria

The project will be accepted when it is agreed that the drug development phase has produced quality drugs which will improve the medical condition of patients while the organisations are also saving their costs and maximising on revenue during the drug production phase.

Project Constraints

The constraints of the project are as shown below;

Poor leadership and conflict between the stakeholders

Insufficient definition of the scope leading to missing of key activities

Inaccurate forecasts of the different costs

Insufficient communication between the stakeholders leading to poor execution

Insufficient resources to effectively conduct the project

Project Assumptions

The assumptions of the project include;

The estimated work and duties required will be sufficient to complete the project

The number of people listed will enable the successful completion of the project

The estimated cost will be enough to run the project to the end

The performance of the suppliers and contractors is expected to be at the highest standards

Cost Estimates

The estimates of the expenses of the project are outlined below;

Drug Candidate

Expense

Estimated Budget

Expended to Date

Estimate to Complete

Variance

LC-1

Development Costs

$100 MM

$40 MM

$65 MM

$5 MM

LC-2

Development Costs

$300 MM

$180 MM

$150 MM

$30 MM

LC-3

Development Costs

$600 MM

$360 MM

$360 MM

$120 MM

LC-4

Development Costs

$220 MM

$110 MM

$165 MM

$55 MM

Cost Benefit Analysis

The cost benefit analysis of the project reveals that overally the benefits exceed the costs of the project. As a result, cumulatively, the organisation will gain a net profit of $ 1,205 Million once all the four different cycles are completed as shown below;

Drug Candidate

Peak Sales ($M)

Profit Margins

Profit

Annual Expenses($M)

Development Costs

Net Profit

LC-1

600

90%

540

40

100

400

LC-2

800

90%

720

65

300

355

LC-3

1000

80%

800

80

600

120

LC-4

750

82%

615

65

220

330

Total

2675

250

1220

1205

Sponsor Acceptance

Approved by the Project Sponsor:

__________________________________________ Date:___________________