Project Management for the Development Transfer product:

(a) Introduction:

Project management is a discipline that can be applied to all industries and works very effectively in

the pharmaceutical industry where major shifts in recent years have significantly impacted the

way in which a pharmaceutical company brings a product to market.

In the pharmaceutical industry, project management is the key to addressing the unique regulatory,

compliance and quality related needs of the industry. The process of clinical research and drug

development, coupled with the critical issue of time to market, can capitalize on project

management techniques to effectively apply scheduling, risk management, and comprehensive

quality assurance and control to the process of bringing a drug to market in a cost-efficient way.

(b) Rationale: Importance and Significance of the Study:

Over the past decade in particular, there has been a significant increase in the use of project

management in the development transfer product in pharmaceutical industry. According to a

recent study by the Center for Business Practices (CBP), 45 percent of organizations surveyed

have implemented centers of excellence for project managers and project management.2

Companies who implemented project management improvement initiatives spent an average of

$676,000 per year on them, for an approximate ROI of 28 percent.3 Project management is

particularly helpful for providing structure and focus through the tumultuous ride from phase III

clinical trials, filing a new drug application, negotiating with and obtaining FDA approval, working

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with the Division of Drug Marketing, Advertising, and Communications (DDMAC), and navigating

the many options and choices through the early years of a product’s launch and

commercialization.

Coordinating the various processes from one phase to another, meeting timelines and dealing with

complex regulations is often challenging during the drug development process. Project managers

are able to assign the appropriate amount of time and resources to each phase of the

development, thereby ensuring that work can progress forward in a logical but controlled way.

They simultaneously manage the potential and realized risks while also focusing on the quality of

the process and product at each stage of development. By managing the process in a well-

planned and controlled manner, the Project Manager can also assure that all tasks are

completed correctly the first time so no rework has to be performed, which will delay the project

and its time to market.

Finally, more and more pharmaceutical companies that have been unable to add full-time project

management staff have turned to outsourcing to meet their project management needs.4 Key

pharmaceutical decision makers clearly recognize the impact that project management has on

their companies’ bottom lines, so despite a tough economy and competing resources, they have

increasingly found ways to bring in project management consultants to facilitate their projects.

The use of project management in the pharmaceutical industry—whether as inhouse or

outsourced expertise—has proven invaluable to help these companies manage their competing

priorities of quality and schedule.

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(c) Objectives:

Project management is a discipline that can be applied to all industries, regardless of the product or

service they are designed to deliver. Beyond its basic application across various industries,

project management has tremendous value when effectively implemented to significantly

increase the success of the product or service being delivered.

The pharmaceutical industry has encountered major shifts in recent years, both within the industry

and in its external environment. Some of the factors responsible for this shift include the rising

cost of healthcare due to an aging population, the increase in rigorous regulatory requirements,

and company mergers within the industry. These factors have led to an increased need for

restructuring, cost reduction, and culture change projects.

In the pharmaceutical industry, project management is the key to addressing the unique regulatory,

compliance and quality related needs of the industry. The process of drug development and the

critical issue of time to market can capitalize on project management techniques to effectively

apply scheduling, risk management, and comprehensive quality assurance and control to the

process of bringing a drug to market in a cost-effective but safe way.

(d) Hypotheses:

Every Pharmaceutical industry has different “stress points”—those points that are most critical to

the specific product or service being delivered. The most typical stress points are schedule, cost,

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and quality. Depending on the industry, one (sometimes more) of these stress points directly

affects that industry’s profit, thereby making that point absolutely critical to the success of the

product, and the company delivering it. It becomes, therefore, a priority in the set of processes

involved in producing the product.

Specifically in the pharmaceutical industry, there has never been a tougher time to be involved in

drug development. In recent years, the market has become much more competitive, and the

political, regulatory, social and economic pressures have become much more intense. Also, each

year at least one drug company experiences a recall of one of their drugs, lawsuits from their

customers or lawsuits from their competitors.

The most important stress point in the pharmaceutical industry is quality. Poor quality in this

industry can literally be a matter of life and death, in its worse cases. Being the first to bring a

product to market is also critical, though the course of drug development is unpredictable.

Because of the risks involved in the pharmaceutical industry, due diligence is of the utmost

importance in terms of quality control measures. So these competing priorities—quality and time

to market—must be well managed through careful process in order to reduce the risks inherent

in this industry.

Another current challenge for pharmaceutical companies is the pressure they are under to increase

their productivity, as the number of new products reaching the market has been on the decline

over the past few years. This productivity decline has led many to believe that the industry is in

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need of a new and better approach in its management of clinical research, drug development,

and product delivery.

The two key challenges in the pharmaceutical industry are quality and schedule, both of which are

directly addressed by the tools and techniques used in project management.

As mentioned above, project management is a powerful technique and it can be used to small as

well as very large projects. Project management technique is very popular in several business

activities, such as constructions, manufacturing, servicing, etc. because of multiple and useful

benefits that can be achieved from its application.

Implementation of project management technique can have significant results such as:

Cost reduction

Time reduction

Recourses allocation

Increased quality

These factors are the most important concerning the competitiveness and the profitability of any

organization.

Using project management technique we can divide one large project in many isolated tasks

(projects) and sub-tasks, so cost and time resources are more controllable, as well as quality.

Other benefits include:

Failures reduction

Reduction of inappropriate tasks

Close examination of the sub-tasks

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Scheduling

Integration

Communication

(e) Research Methodology:

The methodology for setting up projects and applying Project Management principles follows the

following guidelines:

1. Define the Objective

To minimize the risk of getting off the right track, management must clarify the objective of the

project well in advance by

a) Defining management's intent in undertaking the project

b) Outlining the scope of the project, that is, identifying the departments, companies,

Functions and staff involved and their approximate degree of their involvement

c) Describing the end results of the project and its permanent effects, if any, on the company or

division.

2. Establish a Project Organization

This includes

a) Appointment of an experienced manager to run the project full time

b) Organization of the project management function in terms of responsibilities

c) Assignment of a limited number of staff to the project team

d) Maintenance of balance of power between functional heads of departments and the project

manager.

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3. Install Project Controls

Special project controls over time, cost and quality are very different compared to routine reports.

These include:

a) Time Control: normally applied with network scheduling (Critical Path Method) which provides

the best time control for the project. Other techniques such as Program evaluation and Review

Technique (PERT) allows the use of multiple time estimates for each activity.

b) Cost Control: Project control techniques, though not formalized to the same degree as time

controls, can be followed if these steps are followed:

§ break the comprehensive cost summary into work packages

§ devise commitment reports for technical decision makers

§ act on early, approximate data

§ concentrate talent on major problems and opportunities

c. Quality Control: It comprises three elements:

§ Defining performance criteria

§ Expressing the project objective in terms of quality standards

§ Monitoring progress towards these standards

Project Management activities include:

a) Work Breakdown Structure (WBS)

Decomposes project into various levels of detailed tasks

b) Dependency Analysis

Orders the project tasks established by WBS, determining those, which must be done in sequential

order, and those, which can go on simultaneously

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c) Network Development

Portrays 'ordered' tasks graphically using a 'network' diagram

d) Resource Commitment / Allocation

Commits the appropriate individual who has the proper skills and expertise to the tasks requiring

those skills. Allocates those resources over time to determine the 'build up' and the 'phase out'

of the resources over the life of the project

e) Time Estimates

Estimates based on one of several techniques ranging from the forecast method to the quantitative

method, the constraint method, or the unit of work method. No matter which method is used,

two categories of time are considered:

Effort: Energy exerted

Calendar: Elapsed duration

f) Budgeting

Allocates the project development costs spread over the duration of the project

g) Status Reporting

Takes the baselines developed above (schedules, resource loading and budgets) and turns them into

a work-in-progress reports which track the plan against the actual.

With respect to organization, project management calls for the appointment of one man, the

project manager, who has the responsibility for the detailed planning, coordination and ultimate

outcome of the project. He is usually appointed from the middle management ranks of the

company or organization and is supplied with a team, often numbering 3 - 10 persons depending

on the budget and duration of a project.

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It is common that company staff itself implements project management principles once it adopts

project management philosophy. However, it often happens that small (and sometimes large

organizations) subcontract project management to more experienced companies or individuals

who practice project management.

ALTERNATIVES

In essence there are no alternatives to Project Management techniques. An organization would

decide to formalize and implement project management to accomplish various tasks, or it may

continue to work at random. Work done individually will be based on specific tasks assigned to

the individual and the outcome of the work would be joined by other pieces of work by other

individual.

(f) Expected contribution:

As mentioned above, project management is a powerful technique and it can be used to small as

well as very large projects. Project management technique is very popular in several business

activities, such as constructions, manufacturing, servicing, etc. because of multiple and useful

benefits that can be achieved from its application.

Implementation of project management technique can have significant results such as:

Cost reduction

· Time reduction

· Recourses allocation

· Increased quality

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These factors are the most important concerning the competitiveness and the profitability of any

organization.

Using project management technique we can divide one large project in many isolated tasks

(projects) and sub-tasks, so cost and time resources are more controllable, as well as quality.

Other benefits include:

· Failures reduction

· Reduction of inappropriate tasks

· Close examination of the sub-tasks

· Scheduling

· Integration

· Communication

(g) Chapterisation:

Contents :

1 Introduction

1.1 What is Project Management for the development transfer product in pharmaceutical

industry?

1.1.1 What is a project?

1.1.2 Examples of Projects

1.1.3 Project Attributes

1.1.4 Project Constraints

1.1.5 What Is Project Management?

1.1.6 Project Stakeholders

1.1.7 Project Management Knowledge Areas

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1.2 Objectives of the Project Management for the development transfer product in

pharmaceutical.

1.3 Description / Structure of Methodology / Alternative Solutions.

1.1.1 Define the Objective

1.3.2 Establish a Project Organization

1.3.3 Install Project Controls

1.3.4 Project Management activities include:

1.4 Expected Results / Benefits.

1.5 Characteristics of Firms/ Organizations/ Service Providers.

1.5.1 What companies Want from Project Management?

2 Application

2.1 Firms / Organizations where the technique has been applied.

2.2 Types of firms/ Organizations concerned.

2.3 Implementation cost.

2.4 Time frame for implementation.

2.5 Conditions for implementation.

2.6 Why Organizations supporting the implementation?

3 IMPLEMENTATION PROCEDURE

3.1 Steps/ Phases.

3.1.1 Milestone (MS) for effective project management followed at Sandoz Pvt. Ltd.:

3.1.2 Project Mile-stones / Phases are;

3.2 Partial Techniques & tool per Step.

3.2.1 Different Techniques used in project management are

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3.2.2 Risk Management

3.2.3 Data Collection & Data Analysis

3.2.4 Data Collection Techniques & Tools

3.2.5 Different tools for Project management are

3.3 Related software.

3.3.1 Desktop

3.3.2 Personal

3.3.3 Single user

3.3.4 Integrated

3.3.5 Non-specialized tools

3.3.6 Server-based:

3.3.7 Web based:

3.3.8 Project Management Software Benefits:

4 References:

Annex 1: Professional Project Management Organizations.

Annex 2: Glossary of Project Management terms.

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(H) References

(1) Project Management, Meredith J.R. and Mantel S.J.Jr. (1995), J. Wiley & Sons

(2) Management, Batrol K.M. and Matin, D.C. (1992), McGraw-Hill

(3) Management, Concepts and Applications, Megginson L.C. (1991), Harper Collins

Publishers Inc.

(4) Goal Directed Project Management by Kristoffer V. Grude, Tor Hague, Terry

Gibbons (Editor), E.S. Anderson - 2nd Edition - Paperback - 196 pages, Published

1997

(5) Microsoft Project for Dummies by Martin Doucette - Book & Disk Edition -

Paperback - 384 pages - Published 1997

(6) Prince: A Practical Handbook (Computer weekly Professional Series) by Colin

Bentley, Ken Bradley - 2nd Edition - Paperback - 350 pages -

(7) Published 1997

(8) Project Management Methodology: A Practical Guide for the Next Millennium by

Ralph L. Kliem, Irwin S. Ludin, Ken L. Robertson - Hardcover -Published 1997

(9) Creating an Environment for Successful Projects: The Quest to Manage Project

Management (The Jossey-Bass Business & Management Series by Robert J.

Graham, Randall L. Englund - Hardcover - 272 pages - Published Aug. 1997

(10) Project Management (ASTD Trainer's Sourcebook) by L. McLain - Paperback -

Published 1997

(11) Project Management: A Systems Approach to Planning, Scheduling and

Controlling by Harold Kerzner - 6th Edition - 1152 pages - Published Aug. 1997

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