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Pharmaceutical and Biomedical Project Management in a Changing Global Environment (Wiley Series on Technologies for the Pharmaceutical Industry) [Kindle Edition]

Scott D. Babler
5.0 von 5 Sternen  Alle Rezensionen anzeigen (1 Kundenrezension)

Kindle-Preis: EUR 73,96 Inkl. MwSt. und kostenloser drahtloser Lieferung über Amazon Whispernet

  • Sprache: Englisch
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Produktbeschreibungen

Rezension

"The book is an excellent primer and "hands on" reference text focused on the unique aspects of managing projects in the life sciences. Practical tips and tools are offered for wide ranging topics relevant to those working in both large pharma and small biotech, in both US focused and global settings."
--Barbara Rosengren, Vice President, Strategic Product Development, Momenta Pharmaceuticals Inc
 
"I love this book and absolutely want to keep a copy on my shelf. It feels like a PMO in a box - I will be able to open it up and get my questions answered, confirm what I am thinking, and look for other ways to approach and solve problems. The writing across the board is consistently strong, the organization makes sense and it reads well - almost like a fast-paced fiction novel!"
--Kathleen Monroe, Vice President, Imaging Services, Synarc
 
"I found the book to be practical and timely in providing up-to-date information for project managers in this evolving area of practice. The book provides a good view of the broad landscape of current project management challenges in a quickly evolving industry. It is an excellent grounding for project managers in the biomedical industry and a highly recommended text for those who want hands-on advice from professionals that are actively engaged in the field. This book is valuable for project management practitioners as well as for senior managers who seek a better understanding of the complexities of project management in the current biomedical environment."
--Elaine Alexander, Sr Project Manager, Global Medical Company

Rezension

"The book is an excellent primer and "hands on" reference text focused on the unique aspects of managing projects in the life sciences. Practical tips and tools are offered for wide ranging topics relevant to those working in both large pharma and small biotech, in both US focused and global settings."
Barbara Rosengren, Vice President, Strategic Product Development, Momenta Pharmaceuticals Inc

"I love this book and absolutely want to keep a copy on my shelf. It feels like a PMO in a box I will be able to open it up and get my questions answered, confirm what I am thinking, and look for other ways to approach and solve problems. The writing across the board is consistently strong, the organization makes sense and it reads well almost like a fast–paced fiction novel!"
Kathleen Monroe, Vice President, Imaging Services, Synarc

"I found the book to be practical and timely in providing up–to–date information for project managers in this evolving area of practice. The book provides a good view of the broad landscape of current project management challenges in a quickly evolving industry. It is an excellent grounding for project managers in the biomedical industry and a highly recommended text for those who want hands–on advice from professionals that are actively engaged in the field. This book is valuable for project management practitioners as well as for senior managers who seek a better understanding of the complexities of project management in the current biomedical environment."
Elaine Alexander, Sr Project Manager, Global Medical Company


Produktinformation

  • Format: Kindle Edition
  • Dateigröße: 2168 KB
  • Seitenzahl der Print-Ausgabe: 400 Seiten
  • Verlag: Wiley; Auflage: 1 (9. Mai 2011)
  • Verkauf durch: Amazon Media EU S.à r.l.
  • Sprache: Englisch
  • ASIN: B0050PJ8ZI
  • Text-to-Speech (Vorlesemodus): Aktiviert
  • X-Ray:
  • Word Wise: Nicht aktiviert
  • Erweiterte Schriftfunktion: Nicht aktiviert
  • Durchschnittliche Kundenbewertung: 5.0 von 5 Sternen  Alle Rezensionen anzeigen (1 Kundenrezension)
  • Amazon Bestseller-Rang: #1.061.214 Bezahlt in Kindle-Shop (Siehe Top 100 Bezahlt in Kindle-Shop)

  •  Ist der Verkauf dieses Produkts für Sie nicht akzeptabel?

Kundenrezensionen

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Die hilfreichsten Kundenrezensionen
5.0 von 5 Sternen Excellent book to take us from theory to practice 15. September 2013
Von bernie
Format:Kindle Edition
I worked in a company that both designed and produces IV Pumps and complex drug delivery products. The company was so global that if a war broke out anywhere we would be on both sides.

When I studied Project management in at the local University it was more of a process that did not adapt well to the real world; it was being taught as an independent discipline. When I joined the professional groups I found myself surrounded in many fields but no colleges in the biomedical field.

This is a fantastic book for people with a future in a growing field. It makes a good crossover for people from ether discipline. I will not go through most of the details as that is why you are buying the book. However is did find the section on abbreviations useful and read them before tackling the main body. The book its self has some good suggestions but will need to be adapted to your needs. The book is well lad out and flows well from front to back with just the correct diagram for just when you need it. I was surprised to see they paid attention to the incorporation of the different regulatory agencies and their guidelines. We used carry our personal copy of 21 CRF Part 820 around with us.

Where was this book when I needed it? Obtain it now and save a lot of time reinventing the wheel.
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Die hilfreichsten Kundenrezensionen auf Amazon.com (beta)
Amazon.com: 4.8 von 5 Sternen  10 Rezensionen
1 von 1 Kunden fanden die folgende Rezension hilfreich
5.0 von 5 Sternen Excellent overview, good for stakeholder and project managers transitioning roles 12. März 2012
Von LMS - Veröffentlicht auf Amazon.com
Format:Gebundene Ausgabe|Vine Kundenrezension eines kostenfreien Produkts (Was ist das?)
Project management in Pharma and Biotech has its own unique challenges. There is a host of regulatory, fda, iso, etc style issues that are unique to these types of projects. As a disclosure, I am not a project manager, but I am a stakeholder in biotechnology product development projects. I work on the product management/marketing and operations side of these types of products so I am very familiar with the unique challenges of bringing these types of products to market. This book would serve as an overview for someone in project management but would be a very good guide to a project manager who was moving from one aspect of biomedical project management to another (for example, from drug development to in vitro diagnostics). This would also be a very good guide to someone who is a stakeholder in these types of projects because it would provide a good overview of whats at stake on a systems level (because it is very easy to get lost in the weeds).

The authors put a lot of emphasis on the importance of viewing the project on a systems level instead of as a collection of individual contributions (or silos). This is a critical point to keep in mind, one problem with these types of projects is that one groups metrics may not always be in line with what is best for the system as a whole (a reliance on cost cutting measures for procurement may be disastrous for quality management downstream) or people fail to see the forest for the trees. The role of stakeholders is discussed as is the importance of product concept design (distinguishing the must haves from the nice-to-have features of a new product) and risk assessment. There are chapters devoted to specific types of projects:
in vitro diagnostics
drug development (both for profit and non for profit)
strategic alliances
outsourcing and managing contract manufacturers (and a very good case study)
technology transfers
international team management
clinical trial management
setting a plan for managing through the product lifecycle
regulatory strategies for international projects

The book finishes with a section devoted to portfolio management which includes managing R&D pipelines, stage gating, and resource management. This book does a good job of providing an overview of all the basics. It was written by professionals from within the various industries covered. This book will not "teach" you project management in these industries, it provides a useful set of guidelines and examples. I would definitely recommend this book to anyone who is seeking a more in-depth understanding of bringing pharma or biomedical products to market.
1 von 1 Kunden fanden die folgende Rezension hilfreich
4.0 von 5 Sternen Well-edited essays in pharmaceutical project management 17. September 2012
Von Afia - Veröffentlicht auf Amazon.com
Format:Gebundene Ausgabe|Vine Kundenrezension eines kostenfreien Produkts (Was ist das?)
I think the advantage offered in this book is to get multiple perspectives in the field of pharmaceutical project management. This book offers the perspectives of many authors concerning the future of medicines and medical devices, the globalized production of these products and marketing concerns.

The essays are filled with examples that illustrate the goodness of systems approaches. Pharmaceutical companies operate in a highly networked environment with many types of high-level specialists. These authors made me realize how easy it must be to get captured by any area of the project and consequentially lose the systems perspective required to be an effective project manager (PM).
5.0 von 5 Sternen Brilliant job of providing insider's view of biomedical project management 1. August 2013
Von Amazon Customer - Veröffentlicht auf Amazon.com
Format:Gebundene Ausgabe|Vine Kundenrezension eines kostenfreien Produkts (Was ist das?)
Occasionally, Amazon VINE offerings become a family affair at my house. With a husband who spent 15 years working in the pharmaceutical industry and now runs his own executive search firm for the pharmaceutical and biotech industries, I figured this title was one that would be right up his alley. So I'll turn this review over to him:

Chapters include:

· Project Leadership for Biomedical Industries

· Medical Devices - Components, Systems and their Integration

· The Role of Project Management in the Development of In Vitro Diagnostics

· Drug Development Project Management

· Outsourcing of Project Activities

· The Unique Aspects of Alliance Projects

· Managing of Outsourcing for Biomedical Companies

· A Roadmap for Successful Technology Transfers

· Lessons Learned from Inter-organizational Collaboration Projects

· Case Study: Project Management in Non-Profit Drug Development

· Clinical Trials and Project Management

· Role of Project Management in Quality Planning and Functions Throughout the Product Lifecycle

· Regulatory Strategies and Submissions in an International Product Environment

· Risk Management - A Practical Approach

· Managing Successful Product Portfolio Creation and R&D Pipelines

· Effective Strategies for Project Resource Planning and Utilization

· Stage Gate Product Development Processes and Lifecycle Management

· The Future of Medical Devices

· The Next Wave of Managing Biomedical Projects

Scott Babler and his industry savvy co-authors have done an absolutely brilliant job of providing the readers with an insiders' view of biomedical project management.

The project management professional (PMP) has one of the most difficult, challenging and rewarding jobs in the biomedical industry. PMPs must be experts at all aspects of drug, diagnostic and/or medical device development. They are responsible for getting a team of individuals to work as a team, develop a product development plan, execute the plan, deal with contingencies and all the while working with a team that does not directly report to them. PMPs must by nature be extremely logical, down-to-earth with the persuasive skills of an experienced diplomat. Babler and Ekins (editors) have called on numerous industry professionals to thoroughly cover all these aspects of pharmaceutical project management.

This book will allow the following readers to more fully understand how PMP professionals play a vital role in the commercialization of technology.

· Industry professionals involved in the commercialization of biomedical products need to understand the whole process of taking technology to the point of commercialization on a global basis
· Undergraduate and graduate students who are contemplating a biomedical career in industry need to gain an understanding of career options that combine their love of science with a strong desire to bring products to the marketplace
· Academicians and other biomedical professionals who create scientific discoveries need to understand and respect the role that other disciplines such as project management have on bringing their discovery to the point of commercialization
· Consumer advocates who think that every product should be a "generic" need to understand the time, effort and costs associated with the commercialization of scientific discoveries
· Investors who buy stock in biomedical companies and analysts who recommend stocks will gain insight into the biomedical commercialization process; a company with an excellent PMP will be a much better horse to bet on

In addition the editor has written a Study Guide for Pharmaceutical and Biomedical Project Management in a Changing Global Environment. Cram101; First Edition (2011)

Review by Don Fraser, PharmD, MBA
Career Novations
5.0 von 5 Sternen Terrific Source of Information 9. März 2012
Von Groovin' guy - Veröffentlicht auf Amazon.com
Format:Gebundene Ausgabe|Vine Kundenrezension eines kostenfreien Produkts (Was ist das?)
The author begins with an overview of product management for biomedical industries and ends with chapter "The Next Wave of Managing Biomedical Projects." In between are 16 chapters written by professionals working in the various industries giving great insight into issues faced by today's biomedical companies.

All managerial and supporting activities are covered in depth for a project.

This book is an excellent source of information for guiding a project from start to finish with constant insights into how the project manager through planning, communication, etc... can give a "best effort" while avoiding cost overruns, time delays and other pitfalls.

I enjoyed reading about the regulatory process and in particular for use with medical devices. The best way to satisfy the FDA's design control requirements in 21 CFR 820.30 are discussed. Medical device classifications are there to protect us all. The design control guidance for a Class II or III device and managerial implications could be applied to a Class I device (just remove any unnecessary steps) for a carefully thought out project management plan.

The IVD (in vitro diagnostics) was written by consultants. Since this market is so vast, having consultants write it was perhaps a brainstorm. A great job was done of covering all aspects of IVD project management.

The tables and graphics are wonderfully prepared and very useful.

I recommend this book to anyone with a great interest in this field.
5.0 von 5 Sternen Good Resource 5. April 2012
Von V. Hutson - Veröffentlicht auf Amazon.com
Format:Gebundene Ausgabe|Vine Kundenrezension eines kostenfreien Produkts (Was ist das?)
While the book is primarily intended for individuals interested in using effective project management skills to reduce the cost of drug development it also provides insight into why pharmaceutical drugs are so expenseive. For example, according to this book a drug development project "may last eight to twelve years, cost significantly more than $100 million, with strict regulations on quality of the final product and its characteristics, and may have an initial probability of success in the range of 5%."

The focus of this book is on ways to use effective project management to help reduce those costs. This book is intended by the authors to be an educational source that can be references by those already working in the field, as well as students of the biomedical industry and project management.

The book's 18 chapters are divided into six main Parts. They include:

Part 1: Overview
Part 2: Managing Medical and Pharmaceutical Projects
Part 3: Effect of Business Relationships on Managing Large Projects
Part 4: Managing Unique Project Complexities
Part 5: Portfolio Management and Resource Planning
Part 6: Trends in BMI Project Management

In a way, this is two books in one. It provides unique insight into the Medical/Pharmaceutical area as well as project management skills that could be used in any area.
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