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How to Create and Conduct Real-Life Reusable Case Studies with Industry Employer Alliances and Projects Written and Endorsed by Science and Business Professionals in the Research Triangle Park in North Carolina, USA. Many students and university teachers are unfamiliar with the industry environment. Case studies developed in collaboration with working professionals can help students and professors bridge the gap between universities and industry. This book provides guidance on how to approach industry professionals and create educational alliances. The strategy of establishing contact with industry employers and the process of developing and teaching case-studies are described. Among the case-studies are examples of how to identify biomarkers and new drugs simultaneously, prioritize and develop products in compliance with rules and regulations, commercialize products and protect and manage the intellectual property, optimize processes and technologies for manufacturing, and minimize human errors in production.
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Seitenzahl: 342
Veröffentlichungsjahr: 2011
Contents
Copyright
Preface
Disclaimer
1 Principles of Industry Immersion Learning
Contents
Abbreviations
1.1 Introduction
1.2 Building a University – Industry Alliance
1.3 Design, Format, and Model Examples of Case Studies
1.4 Basics of Industry Immersion Learning
1.5 Predicted Learning Outcomes
1.6 Assessment of Actual Learning Outcomes
1.7 Overview of Selected Case Studies
1.8 Logistics of Industry Immersion Teaching
1.9 Publishing of Industry Immersion Case Studies
2 Integration of Pharmaceutical and Diagnostic Co-Development and Commercialization: Adding Value to Therapeutics by Applying Biomarkers
Contents
2.1 Mission
2.2 Goals
2.3 Predicted Learning Outcomes
2.4 Introduction
2.5 Case Scenario
2.6 Timeline
2.7 Study Plan and Assignments
Resources
3 Product Portfolio Planning and Management in the Pharmaceutical Industry
Contents
3.1 Mission
3.2 Goals
3.3 Predicted Learning Outcomes
3.4 Introduction
3.5 Case Scenario
3.6 Timeline
3.7 Study Plan and Assignments
Appendix A: Method for Net Present Value Calculations
Appendix B: Glossary of Abbreviations and Terms
4 Entrepreneurship: Establishing a New Biotechnology Venture
Contents
4.1 Mission
4.2 Goals
4.3 Predicted Learning Outcomes
4.4 Introduction
4.5 Timeline
4.6 Study Plan and Assignments
Resources
5 Introduction to US Patent Law1)
Contents
5.1 Mission
5.2 Goals
5.3 Predicted Learning Outcomes
5.4 Introduction
5.5 Timeline
5.6 Study Plan and Assignments
Resources
6 Intellectual Property Management
Contents
6.1 Mission
6.2 Goals
6.3 Predicted Learning Outcomes
6.4 Introduction
6.5 Timeline
6.6 Study Plan and Assignments
7 Operational Excellence in Pharmaceutical Manufacturing
Contents
7.1 Mission
7.2 Goals
7.3 Introduction
7.4 Part I – Operational Excellence: Implementing Process Improvements
7.5 Predicted Learning Outcomes
7.6 Case Scenario
7.7 Timeline
7.8 Study Plan and Assignments
7.9 Company Supervised Practicum
7.10 Part II – Optimizing Existing Technologies
7.11 Predicted Learning Outcomes
7.12 Case Scenario
7.13 Timeline
7.14 Study Plan and Assignments
7.15 Company Supervised Practicum
7.16 Conclusion
8 Aligning Behaviors and Standards in a Regulated Industry: Design and Implementation of a Job Observation Program
Contents
8.1 Mission
8.2 Goals
8.3 Predicted Learning Outcomes
8.4 Introduction
8.5 Case Scenario
8.6 Timeline
8.7 Study Plan and Assignments
8.8 Items Needed for a Widely Applicable Job Observation Program
8.9 Job Observation Program Evaluation
Appendix A: Job Observation Program for a Commercial Kitchen
Appendix B: Job Observation Program for GMP Documentation in a Manufacturing Facility
Appendix C: Test
Resources
Subject Index
Lisbeth Borbye, Michael Stocum,
Alan Woodall, Cedric Pearce,
Elaine Sale, William Barrett,
Lucia Clontz, Amy Peterson,
and John Shaeffer
Industry Immersion Learning
The Authors
Dr. Lisbeth Borbye
Michael Stocum
Alan Woodall
Cedric Pearce
Elaine Sale
William Barrett
Lucia Clontz
Amy Peterson
John Shaeffer
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ISBN 978-3-527-32408-8
Preface
Graduates who secure their first jobs in industry typically spend a significant amount of time adjusting to the new environment because it is so different from the traditional university setting. Together with multiple industry professionals in the Research Triangle Park, North Carolina, I have introduced a learning method called “industry immersion learning” with the goal of easing the transition from the university to the workplace (here, the biotechnology industry).
The industry immersion method is characterized by need-based, innovationoriented, and proactive acquisition of knowledge. The education is coordinated and supervised by academic and industry professionals in concert and promotes a high level of interaction between students and industry professionals. As the name of the method implies, students are immersed in the industry environment and tasked to excel in matters of high relevance to the company in which the training takes place. Students must adapt quickly to the new environment, create a professional network on site, become knowledgeable about the topic of study, employ innovative thinking, and meet or exceed expectations in their deliverables in a timely manner in order to succeed.
The industry immersion method has been received with enthusiasm among students and both university and industry leaders. It provides a means for the students to graduate with an industry-relevant education, and the university to provide industry with a better prepared, industry-ready workforce while simultaneously creating important university–industry networks and empowering employers to participate in curriculum design.
In an attempt to disseminate the method to a larger audience, employer alliance building and the industry immersion method are described in detail in this book, and seven industry projects, the so-called “case studies”, have been compiled and transposed to a format useful in both industry and classroom settings. Each of these sample industry case studies focuses on a particular trend and together they provide a nonexhaustive view into selected, timely topics. The logistics of teaching by immersion are outlined and a variety of parameters can be customized to match the environment in which they are taught. By consolidating these examples of industry case studies in this book, I encourage their “re-use” while simultaneously hoping to inspire the creation of many new case studies and much new collaboration between universities and industry.
Disclaimer
The content of this book is based on the individual authors’ personal knowledge and experiences. This book presents selected topics in the biotechnology and pharmaceutical industries. Mentioned laws, regulations, and guidelines are based on current status at the time of the authors’ experience or writing. Each author is solely responsible for the content of his or her own chapter. The authors and editor disclaim any liability or loss in connection with use of the information herein. Use of the information is at own risk.
The contents of this publication and related links do not constitute legal or professional advice. Readers should not act or rely on any information in this book without first seeking the advice of an attorney or other relevant expert.
No part of this publication and the web presentations may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publisher and relevant author(s).
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Lesen Sie weiter in der vollständigen Ausgabe!
Lesen Sie weiter in der vollständigen Ausgabe!
Lesen Sie weiter in der vollständigen Ausgabe!
Lesen Sie weiter in der vollständigen Ausgabe!
Lesen Sie weiter in der vollständigen Ausgabe!
Lesen Sie weiter in der vollständigen Ausgabe!