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Industry Immersion Learning: Real-Life Industry Case-Studies in Biotechnology and Business [Kõva köide]

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  • Formaat: Hardback, 220 pages, kõrgus x laius x paksus: 244x176x15 mm, kaal: 538 g
  • Ilmumisaeg: 28-Jan-2009
  • Kirjastus: Blackwell Verlag GmbH
  • ISBN-10: 3527324089
  • ISBN-13: 9783527324088
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Industry Immersion Learning: Real-Life Industry Case-Studies in Biotechnology and BusinessSuurem pilt
  • Formaat: Hardback, 220 pages, kõrgus x laius x paksus: 244x176x15 mm, kaal: 538 g
  • Ilmumisaeg: 28-Jan-2009
  • Kirjastus: Blackwell Verlag GmbH
  • ISBN-10: 3527324089
  • ISBN-13: 9783527324088
Teised raamatud teemal:
Püsilink: https://www.kriso.ee/db/9783527324088.html
Märksõnad:
Students are often surprised about the differences between the university and industry work environments when adjusting to their first job in the biotechnology and pharmaceutical industry. This book aims to facilitate the transition from university to industry by presenting real-life study cases that span a broad range of important topics. Amongst these are examples of innovation, management or optimization of products, processes, and intellectual property.

Many university teachers are also unfamiliar with the industry environment. This book provides guidance on how to approach industry professionals and create educational alliances. The strategy of establishing contact to industry employers and the process of developing study cases are outlined. Each study includes a description of the topic, mission and goals, learning outcomes, study plan, student deliverables, and teacher’s instructional materials.

Few textbooks are available that contain hands-on training for students aiming to work in industry and instructions for university teachers interested in collaborating with industry. This book is ideal for professional science and MBA students, as well as university teachers and industry professionals.

Preface xv
Disclaimer xvii
Principles of Industry Immersion Learning
1(16)
Lisbeth Borbye
Introduction
2(1)
Building a University --- Industry Alliance
3(3)
Educational Needs Assessment
3(1)
Establishing Contact
3(2)
Marketing Incentives
5(1)
Obtaining Commitment
5(1)
Alliance Dynamics
5(1)
Design, Format, and Model Examples of Case Studies
6(2)
Example 1: Technology Development
6(1)
Example 2: Product Assessment
7(1)
Example 3: Business Development
7(1)
Basics of Industry Immersion Learning
8(1)
Definition and Characterization
8(1)
The Immersion Environment
8(1)
Sample Work Flow of an Immersion Case Study
8(1)
Interactive Agents
8(1)
Predicted Learning Outcomes
9(1)
Assessment of Actual Learning Outcomes
10(1)
Overview of Selected Case Studies
10(1)
Logistics of Industry Immersion Teaching
11(4)
Topic Selection
11(1)
Instructor and Instructor Affiliation
11(2)
Timeline
13(1)
Location
13(1)
Teaching Format
14(1)
Student Deliverables
14(1)
Legal Requirements
15(1)
Publishing of Industry Immersion Case Studies
15(2)
Integration of Pharmaceutical and Diagnostic Co-Development and Commercialization: Adding Value to Therapeutics by Applying Biomarkers
17(24)
Michael Stocum
Mission
18(1)
Goals
18(1)
Predicted Learning Outcomes
19(1)
Introduction
19(14)
Current Environment for Pharmaceutical and Diagnostic Product Development
21(4)
Potential Solutions to the Challenges Confronting Pharma
25(1)
Genomics and Proteomics, Metabolomics, and ``Other -omics''
25(1)
Translational Research
26(1)
Biomarkers
26(1)
Drug Development for Targeted Cancer Therapies
27(1)
Tamoxifen in Estrogen-Receptor-Positive Breast Cancer
27(1)
Trastuzumab (Herceptin) in Breast Cancers Overexpressing Her2
28(1)
Imatinib (Gleevec) in Chronic Myelogenous Leukemia and Gastrointestinal Stromal Tumors
29(1)
Other Targeted Therapies
30(1)
Specific Example of Lapatinib (Tykerb)
30(1)
Leveraging Biomarkers and Diagnostics to Accelerate Drug Development
30(2)
Potential to Enhance Commercial Success with Companion Diagnostics
32(1)
Personalized Medicine
33(1)
Case Scenario
33(1)
Timeline
34(1)
Study Plan and Assignments
34(7)
Session 1
34(1)
Session 2
35(1)
Session 3
35(1)
Session 4
36(3)
Session 5
39(1)
Session 6
39(1)
Acknowledgment
39(1)
Resources
39(2)
Product Portfolio Planning and Management in the Pharmaceutical Industry
41(20)
Alan Woodall
Mission
42(1)
Goals
42(1)
Predicted Learning Outcomes
43(1)
Introduction
43(3)
Preclinical Phase
44(1)
Phase I
44(1)
Phase II
44(1)
Phase III
44(1)
Marketing Application
44(1)
Phase IV
44(2)
Case Scenario
46(1)
Timeline
47(1)
Study Plan and Assignments
47(14)
Session 1
47(2)
Session 2
49(2)
Session 3
51(1)
Session 4
52(3)
Session 5
55(1)
Session 6
55(1)
Session 7
55(1)
Session 8
55(3)
Appendix A: Method for Net Present Value Calculations
58(1)
Appendix B: Glossary of Abbreviations and Terms
59(2)
Entrepreneurship: Establishing a New Biotechnology Venture
61(18)
Cedric Pearce
Mission
62(1)
Goals
62(1)
Predicted Learning Outcomes
62(1)
Introduction
62(13)
Characteristics of an Entrepreneur
63(1)
Twenty Questions to Determine How Entrepreneurial You Are
64(1)
From Idea to Concept Evaluation
65(3)
Assessing Opportunity and Writing a Business Plan
68(3)
Organizing the Venture
71(1)
Financing the Business
72(2)
Start-Up Dynamics
74(1)
Timeline
75(1)
Study Plan and Assignments
75(4)
Session 1
75(1)
Session 2
76(1)
Session 3
76(1)
Session 4
76(1)
Session 5
77(1)
Session 6
77(1)
Session 7
77(1)
Session 8
77(1)
Resources
78(1)
Introduction to US Patent Law
79(38)
Elaine T. Sale
Mission
80(1)
Goals
80(1)
Predicted Learning Outcomes
80(1)
Introduction
81(32)
Brief Description of US Patents
81(2)
Patentable Subject Matter
83(1)
Utility
84(1)
Novelty
85(3)
Nonobviousness
88(2)
Enablement
90(1)
Written Description
91(1)
Best Mode
92(1)
Claim Drafting
92(4)
Invention and Inventorship
96(3)
The Patent Process: Obtaining and Maintaining a Patent
99(7)
Patent Infringement
106(4)
Patent Ownership and Intellectual Property Agreements
110(3)
Timeline
113(1)
Study Plan and Assignments
113(4)
Session 1
113(1)
Session 2
113(1)
Session 3
113(1)
Session 4
114(1)
Session 5
114(1)
Session 6
114(1)
Session 7
114(1)
Session 8
115(1)
Resources
115(2)
Intellectual Property Management
117(24)
William Barrett
Mission
118(1)
Goals
118(1)
Predicted Learning Outcomes
119(1)
Introduction
119(16)
Economics of IP
120(1)
Globalization of Innovation
121(1)
Creating an IP Strategy
122(1)
IP Vision
123(1)
IP Plan
124(1)
IP Team
124(1)
Invention Assessment
125(1)
Novelty
125(1)
Probability of Technological Success (Technology Risk)
126(1)
Invention Type
126(1)
Mapping the Competitive Patent Landscape
127(1)
Conducting a Search
128(1)
Indentification of Relevant Patent Documents
129(1)
Mapping of Relevant Patent Documents
129(3)
Screening Out Clearly Noninfringing Patents
132(1)
Analyzing Potentially Infringing Patents
132(2)
Analyzing Clearly Infringing Patents
134(1)
Conclusion
135(1)
Timeline
135(1)
Study Plan and Assignments
135(6)
Session 1
135(1)
Session 2
136(1)
Session 3
137(1)
Session 4
138(1)
Session 5
139(1)
Session 6
140(1)
Session 7
140(1)
Session 8
140(1)
Operational Excellence in Pharmaceutical Manufacturing
141(34)
Lucia Clontz
Mission
143(1)
Goals
143(1)
Introduction
143(2)
Overview of the Drug Manufacturing Process
143(1)
A Change in Paradigm for the Pharmaceutical Industry
144(1)
Part I --- Operational Excellence: Implementing Process Improvements
145(3)
Introduction to Lean Manufacturing
145(3)
Predicted Learning Outcomes
148(1)
Case Scenario
149(1)
Timeline
149(1)
Study Plan and Assignments
150(7)
Session 1
150(1)
Session 2
151(2)
Session 3
153(1)
Session 4
154(1)
Session 5
154(2)
Session 6
156(1)
Session 7
156(1)
Session 8
157(1)
Company Supervised Practicum
157(4)
Part II - Optimizing Existing Technologies
161(1)
Introduction to Quality Control
161(1)
Predicted Learning Outcomes
161(1)
Case Scenario
162(1)
Timeline
163(1)
Study Plan and Assignments
163(6)
Session 1
163(1)
Session 2
164(1)
Session 3
165(1)
Session 4
166
Session
5(163)
Session 6
168(1)
Session 7
168(1)
Session 8
168(1)
Company Supervised Practicum
169(4)
Conclusion
173(2)
Aligning Behaviors and Standards in a Regulated Industry: Design and Implementation of a Job Observation Program
175(9)
Amy Peterson
John Shaeffer
Mission
176(1)
Goals
176(1)
Predicted Learning Outcome
177(1)
Introduction
177(2)
Human Error and Human Error Prevention by Job Observation
177(1)
Procedural Adherence and Human Behavior
178(1)
The Necessity for Job Observation
178(1)
Case Scenario
179(2)
Timeline
181(1)
Study Plan and Assignments
181(2)
Session 1
181(1)
Assignment #1
181(1)
Session 2
181(1)
Presentations
181(1)
Assignment #2
181(1)
Session 3
182(1)
Assignment #3
182(1)
Session 4
182(1)
Assignment #4
182(1)
Session 5
182(1)
Assignment #5
182(1)
Session 6
182(1)
Assignment #6
182(1)
Session 7
182(1)
Assignment #7
182(1)
Session 8
183(1)
Presentations
183(1)
Items Needed for a Widely Applicable Job Observation Program
183(1)
Job Observation Program Evaluation
184(1)
Appendix A: Job Observation Program for a Commercial Kitchen
184(6)
Behavior Standards
185(1)
Metrics
185(1)
Example Form: Job Observation --- Commercial Cooking
186(1)
Items for the basis of an observation program
187(3)
Appendix B: Job Observation Program for GMP Documentation in a Manufacturing Facility
190(5)
Behavior Standards
190(1)
Metrics
190(1)
Example Form: Job Observation for GMP Documentation in a Manufacturing Facility
191(1)
Comparison: Manufacturing Observation Program vs. Standards
191(1)
Items for the basis of an observation program
191(4)
Appendix C: Test
195(2)
Test and Test Answers
195(1)
Resources
196(1)
Subject Index 197
Lisbeth Borbye received a PhD in Genetics at the University of Copenhagen and was a post-doctoral fellow in the Human Genome Project. Since 1995 Dr. Borbye has held appointments in both academic and industry settings involving a range of technological, managerial, editorial and educational disciplines. The most prominent of these is the establishment and directorship of the professional Master's program in Microbial Biotechnology at North Carolina State University, a new type of education which seeks to integrate business and science to meet industry and society's needs. Dr. Borbye is a pioneer in establishing alliances between industry and academia. She has published numerous journal articles and holds several patents. In addition, she recently published the book entitled "Secrets to Success in Industry careers - Essential Skills in Science and Business" (Academic Press).