A Guide That Perplexes - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

A Guide That Perplexes
Despite its flaws, a recent release fills a need for books about pharmaceutical project management.


Pharmaceutical Technology
Volume 32, Issue 8


Roger Dabbah
Project management is a useful aid to the pharmaceutical industry, but not because it ensures the success of every project. Rather, it increases the probability of success. Project management is a tool that offers a systematic approach to the development of pharmaceutical products. This tool is influenced by technical, regulatory, supplier, and organizational considerations.

Pharmaceutical Project Management, edited by Tony Kennedy, is one of only a few books about this subject that are intended for the pharmaceutical industry. Although the book helps to fill a void, it contains notable shortcomings.


DORLING KINDERSLEY/GETTY IMAGES
The book starts with an unlabeled list of 182 books that I assume the authors consulted. The list should have been included at the end of the book and properly labeled as "Interesting Books" or "Reference Books."

The book's chapters were written by various authors, and there is a lack of continuity from chapter to chapter.

For example, concepts are repeated numerous times for different types of products, and this repetition distracts from the book's objective.


Pharmaceutical Project Management, Tony Kennedy, Ed., Informa Healthcare, New York, 2008, 280 pp., ISBN-13: 978-0849340246
In Chapters 1 and 10, Kennedy valiantly attempts to unify the other chapters under a common theme. Chapter 1 reviews strategy at the project level, and Chapter 10 describes the projectmanagement function in a pharmaceutical organization. These two chapters should have been combined as an introduction to the book because they would set the stage for what follows.

The book has a lot of information that a project manager must know to successfully bring a product to market.

The book includes so much information that a new project manager (who would need the book most) would be overwhelmed and would not be able to use the book as a guide. The book appears to be directed toward seasoned project managers who might benefit from the experience of the various contributing authors.

Project management encompasses more than the technical aspects of a project; its scope includes human interactions that ensure the success of a project. The rule of thumb in project management is that 80% of the problems that a project manager will encounter are people problems. Yet, aside from the chapter about managing teams, none of the book's chapters is devoted to managing interactions between employees.

In addition, project management depends on a risk-management plan, which should be integrated with the project-management plan early in its development. A chapter entirely devoted to risk management would have been welcome. Instead, the book discusses risk management briefly in a chapter about project management in exclusive synthesis.

The lack of a chapter about project management for biotechnologyderived products is another curious omission, especially considering that the future of the pharmaceutical industry depends on biological drugs. A chapter that discussed them would have been valuable to the book because project management for biotechnology products has a different emphasis and different features than it does for other pharmaceutical products.

Similarly, project management for medical devices and for combination products present specific challenges that deserve chapters of their own. The book fails to address these areas, which are a large part of the pharmaceutical industry.

The book's graphics and tables summarize some of the aspects of pharmaceutical project management. They provide a measure of relief from the large passages of text that appear throughout the book.

Despite its faults, Pharmaceutical Project Management is a valuable addition to the literature. The book is surprisingly easy for a US audience to read and understand, considering the fact that most, if not all, of the authors are European. I know that I will use the book as a reference and I suspect that many other scientists will also do so.

Roger Dabbah is the principal consultant for Tri-Intersect Solutions and an associate professor of technology and engineering management at the University of Maryland, University College, Graduate School, College Park, MD 20742, tel. 301.762.9258, fax 301.762.5356,
He is also a member of Pharmaceutical Tehcnology's Editorial Advisory Board.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
8%
All of the above.
41%
No government involvement in patient treatment or drug development.
11%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Source: Pharmaceutical Technology,
Click here