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 products 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 wellplanned 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 industrywhether as inhouse or outsourced expertisehas 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 pointsthose 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 industrys 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 marketmust 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 What is Project Management for the development transfer product in pharmaceutical industry?

1.1

1.1.1 1.1.2 1.1.3 1.1.4 1.1.5 1.1.6 1.1.7

What is a project? Examples of Projects Project Attributes Project Constraints What Is Project Management? Project Stakeholders Project Management Knowledge Areas
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1.2

Objectives of the Project Management for the development transfer product in pharmaceutical.

1.3 1.1.1 1.3.2 1.3.3 1.3.4 1.4 1.5 1.5.1 2 2.1 2.2 2.3 2.4 2.5 2.6 3 3.1 3.1.1 3.1.2 3.2 3.2.1

Description / Structure of Methodology / Alternative Solutions. Define the Objective Establish a Project Organization Install Project Controls Project Management activities include: Expected Results / Benefits. Characteristics of Firms/ Organizations/ Service Providers. What companies Want from Project Management? Application Firms / Organizations where the technique has been applied. Types of firms/ Organizations concerned. Implementation cost. Time frame for implementation. Conditions for implementation. Why Organizations supporting the implementation? IMPLEMENTATION PROCEDURE Steps/ Phases. Milestone (MS) for effective project management followed at Sandoz Pvt. Ltd.: Project Mile-stones / Phases are; Partial Techniques & tool per Step. Different Techniques used in project management are
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3.2.2 3.2.3 3.2.4 3.2.5 3.3 3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6 3.3.7 3.3.8 4

Risk Management Data Collection & Data Analysis Data Collection Techniques & Tools Different tools for Project management are Related software. Desktop Personal Single user Integrated Non-specialized tools Server-based: Web based: Project Management Software Benefits: 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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