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Commercializing Successful Biomedical Technologies: Basic Principles for the Development of Drugs, Diagnostics and Devices [Pehme köide]

  • Formaat: Paperback / softback, 360 pages, kõrgus x laius x paksus: 244x170x19 mm, kaal: 570 g, Worked examples or Exercises
  • Ilmumisaeg: 03-Mar-2011
  • Kirjastus: Cambridge University Press
  • ISBN-10: 0521205859
  • ISBN-13: 9780521205856
Teised raamatud teemal:
  • Formaat: Paperback / softback, 360 pages, kõrgus x laius x paksus: 244x170x19 mm, kaal: 570 g, Worked examples or Exercises
  • Ilmumisaeg: 03-Mar-2011
  • Kirjastus: Cambridge University Press
  • ISBN-10: 0521205859
  • ISBN-13: 9780521205856
Teised raamatud teemal:
Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.

An indispensable guide for professionals, entrepreneurs and students in biomedical technology development, teaching how to translate technology into useful patentable inventions and commercial products. Guiding the reader through the practical aspects of the commercialization process, it is an ideal accompaniment to a capstone design course in engineering and biotechnology.

Arvustused

Review of the hardback: 'This text covers the commercialization of life science technologies in the areas of pharmaceuticals, biotechnologies, medical devices, and diagnostics, and spanning the development process from invention through marketing and sales. Shreefal Mehta writes clearly and with a practical bent, using case examples and drawing on his own substantial industry experience to help chart a path through the complex landscape of new product development.' Paul Yock Director of the Stanford Program in Biodesign and Professor at Stanford Graduate School of Business and School of Medicine Review of the hardback: 'The book looks like it will be very important and interesting. The outline lists all the sorts of things that matter but are never written down in a comprehensive text.' Carmichael Roberts Vice Chairman, WMR Biomedical and cofounder of Surface Logix (a private company in Boston) Review of the hardback: 'Shreefal Mehta's book is very timely for it provides insights and important information regarding the major steps entrepreneurs must take as an idea progresses through the various steps of commercialization Consequently this text is a must for anyone developing a new medical product.' Joseph Bronzino Editor-in-Chief of The Biomedical Engineering Handbook (2006) and President of Biomedical Engineering Alliance and Consortium Review of the hardback: 'Dr Mehta covers the evolution of products in the biomedical industry from ideas to income. The book is a comprehensive and practical overview of all the steps and challenges required to successfully develop and commercialize a product from ideas to income. Throughout the text he illustrates his points with real life examples. This is a text that should be broadly read by students and professionals alike!' Jim Mullen CEO of Biogen Idec Review of the hardback: 'Launching a new biomedical company is a complex undertaking, and this book is packed with useful details on all aspects of the startup process. I highly recommend it to anyone contemplating a new venture.' Hanson Gifford Biomedical device entrepreneur and co-founder of The Foundry Review of the hardback: 'This book is a must for starters in the industry and for people who have collected different pieces of the puzzle through scattered sources and need to organize it in their minds to put it in perspective.' Atul Gupta MIT Sloan School MBA candidate and Kauffman Foundation intern Review of the hardback: 'Real life issues experienced by life sciences product development teams are described in the book. Key hurdles along the commercialization path are clearly organized and will help the reader navigate multiple business functions and disciplines to take a product to market. Dr Mehta's book is on my table as a handy reference and overview of the business and product development challenges involved in the health care industry. Young scientists, engineers and even experienced executives involved in the health care industry should read this book.' Christoph Hergersberg Global Technology Leader, Biosciences, General Electric Global Research Center Review of the hardback: 'Venture philanthropists, venture capitalists, state organizations, and angel investors involved in building new life sciences-based ventures can use this book to inform their investment decision making process. Dr Mehta's comprehensive book helps funding organizations and entrepreneurs identify the companies and technologies most likely to succeed.' Lesa Mitchell Vice President, Advancing Innovation, the Ewing Marion Kauffman Foundation Review of the hardback: 'Dr Mehta's book is an excellent guide on how to overcome obstacles in commercializing innovative medical technologies. It covers market research, intellectual property rights, business models, and regulatory affairs. Of note are the real life examples, the extensive discussion of Intellectual Property Rights in relation to business models, and that of interaction with the FDA for innovative projects.' Henk van Houten Senior Vice President Philips Research, Program Manager Healthcare Review of the hardback: 'The 'How-To Bible' for launching a product - If I had to recommend one great book to get you started on the road to launching a product, then begin with Commercializing Successful Biomedical Technologies.' Joe Sasenick Washington Biotechnology & Biomedical Association Review of the hardback: 'Shreefal Mehta's book highlights the right questions to ask in order to truly understand the impact of reimbursement and health economics, too often ignored in product development, on new devices, drugs, and biologicals.' Parashar Patel Vice President, Health Economics & Reimbursement, Boston Scientific Review of the hardback: ' Mehta does an excellent job of identifying and organising the major issues associated with biomedical technology commercialisation in a framework that students, researchers and entrepreneurs can understand.' Nature America, Inc.

Muu info

An indispensable guide to the commercialization process of drug, diagnostic and device biomedical technology.
Foreword xv
F. L. Douglas
Preface xix
Acknowledgements xxii
1 The biomedical drug, diagnostic, and devices industries and their markets
1(35)
1.1 The healthcare industry
1(1)
1.2 Biomedical technology - definition and scope; applications
2(2)
1.3 Drugs and biotechnology - definition and scope
4(4)
1.4 Devices and diagnostics - definition and scope
8(2)
1.4.1 Medical devices industry
8(1)
1.4.2 Diagnostics - IVD industry
9(1)
1.5 Industry analysis
10(1)
1.6 Biomedical industry clusters
11(2)
1.6.1 Biopharmaceutical and biotechnology concentration in clusters
11(2)
1.6.2 Biomedical device clusters
13(1)
1.7 Competitive analysis of an industry or sector with Porter's five forces model
13(4)
1.7.1 Competitiveness summary for the pharmaceutical industry
14(1)
1.7.2 Competitiveness summary for the biomedical devices industry
15(1)
1.7.3 Competitiveness summary for the diagnostics market
15(2)
1.8 Industrial value chains
17(7)
1.8.1 Drug development process
20(3)
1.8.2 Biomedical device and diagnostic development process
23(1)
1.9 Technology trends in biomedical device and drug development
24(5)
1.9.1 Drug development technology trends
24(3)
1.9.2 Medical device and diagnostics technology trends
27(1)
1.9.3 Emerging technologies and materials in the nucleic acid diagnostics field
27(2)
1.10 Convergence of technologies in biotechnology
29(2)
1.11 Summary
31(5)
Appendix 1.1 Industry classification system for government and other databases
33(3)
2 Markets of interest and market research steps
36(27)
2.1 Introduction
36(1)
2.2 General market research methodology
37(3)
2.2.1 Reports, projections, and historical data
37(1)
2.2.2 Experimental
37(1)
2.2.3 Observational
38(1)
2.2.4 Survey
39(1)
2.2.5 Primary sources of information in biomedical market research
39(1)
2.2.6 Secondary sources of information
40(1)
2.3 Sizing and segmenting the markets (a stepwise approach)
40(4)
2.3.1 Market size segmented by application
40(1)
2.3.2 Market size segmented by geography for drugs, devices, and IVD
41(1)
2.3.3 How big is the market for my technology or innovation?
42(2)
2.4 Drivers and hurdles
44(3)
2.4.1 Drivers
45(1)
2.4.2 Hurdles
46(1)
2.5 The referral chain - developing market context and understanding customer needs
47(13)
2.5.1 Market context - insight into biology or disease pathology
47(1)
2.5.2 Market context - the referral chain
48(2)
2.5.3 What competitive or alternate products exist?
50(1)
2.5.4 Defining the end user
50(3)
2.5.5 Defining the indication
53(7)
2.6 Market research in the context of medical device design and development
60(3)
3 Intellectual property, licensing, and business models
63(41)
3.1 Types of intellectual property
63(1)
3.2 Patents and patent rights
64(1)
3.2.1 Patent rights
64(1)
3.3 Types of patent
65(1)
3.3.1 Utility patents
65(1)
3.3.2 Design patents
66(1)
3.3.3 Plant patents
66(1)
3.4 What can and cannot be patented?
66(2)
3.4.1 What cannot be patented (from the US PTO website)
66(1)
3.4.2 Can living things be patented?
66(2)
3.4.3 What type of invention or discovery is patentable?
68(1)
3.5 Protecting intellectual property by filing a patent
68(10)
3.5.1 How long do issued patents last in the USA?
68(1)
3.5.2 How much does it cost to get a patent?
68(1)
3.5.3 Considerations before filing a patent
69(1)
3.5.4 Steps to prepare a patent filing
70(1)
3.5.5 What is in a patent? How to read an issued patent
70(3)
3.5.6 Provisional patent application
73(1)
3.5.7 Priority date and publicizing inventions
73(3)
3.5.8 International patent filings and the Patent Cooperation Treaty (PCT) process
76(1)
3.5.9 Patent prosecution process
76(2)
3.5.10 Rough estimate of patent costs for project budgets
78(1)
3.6 Patent infringement and freedom to operate
78(4)
3.6.1 Patent infringement and protecting your rights
78(2)
3.6.2 "Freedom to practice" or "freedom to operate"
80(2)
3.7 Trademarks
82(2)
3.7.1 Why register your trademark?
83(1)
3.7.2 Filing a trademark with the US PTO
83(1)
3.7.3 International filing of trademarks
84(1)
3.8 Copyrights
84(1)
3.9 Trade secrets
84(1)
3.10 Intellectual property commercialization and technology transfer
85(3)
3.10.1 Commercial use of intellectual property
85(1)
3.10.2 Technology transfer in academic research institutions
86(1)
3.10.3 The Bayh-Dole Act
86(2)
3.11 Licensing
88(7)
3.11.1 Key non-financial terms of license agreements
88(2)
3.11.2 Financial terms in a license
90(5)
3.11.3 "Boilerplate" clauses in the license agreement
95(1)
3.12 Biotech business models and IP management strategies
95(6)
3.12.1 What is a business model?
97(1)
3.12.2 Practical note on business models for drug, device, and diagnostic innovator companies
98(1)
3.12.3 Emergent dominant business models among biotechnology (drug) companies
99(2)
3.13 Summary
101(3)
4 New product development (NPD)
104(68)
4.1 Why have a new product development (NPD) process just get it done!
105(1)
4.2 Planning and preparing an NPD process for biomedical technologies (drugs, devices, and diagnostics)
106(4)
4.2.1 The project proposal document
106(1)
4.2.2 Strategy and competency of the company and goal of the project
107(1)
4.2.3 Product life cycle planning
108(1)
4.2.4 Market research
108(1)
4.2.5 Identify key unknowns and risks
109(1)
4.2.6 Build a milestone-based plan for product development
109(1)
4.2.7 Specific risks known to occur frequently during the development of biomedical products
109(1)
4.3 Kill the project early or try some more?
110(5)
4.3.1 Early failure is better than late failure in biomedical product development
110(3)
4.3.2 When to kill a project
113(2)
4.4 Uncertainty-based view of product development processes
115(3)
4.5 Stage-gate approach
118(2)
4.5.1 Stages and gates
118(1)
4.5.2 How to configure a stage-gate process plan for my biomedical product
119(1)
4.5.3 Unique features of biomedical development
119(1)
4.6 Ethical requirements in biomedical product development
120(1)
4.6.1 Institutional Animal Care and Use Committee (IACUC)
121(1)
4.6.2 Institutional Review Board (IRB)
121(1)
4.7 Define the product and process - indications and endpoints
121(3)
4.8 Typical drug development process
124(14)
4.8.1 Discovery and pre-clinical testing
124(8)
4.8.2 Distinctions in pre-clinical development of biotechnology drugs (large molecule biologics)
132(1)
4.8.3 Drug candidate clinical testing to market approval
132(5)
4.8.4 Manufacturing, marketing, sales, and reimbursement
137(1)
4.8.5 Keeping a record for the FDA
138(1)
4.8.6 General stage-gate process for new drug development
138(1)
4.9 Typical diagnostics development process
138(6)
4.10 Typical device development process
144(10)
4.10.1 Discovery, feasibility, and optimization - design and pre-clinical testing
145(5)
4.10.2 Special considerations for device clinical trial design
150(3)
4.10.3 Device manufacturing
153(1)
4.10.4 Keeping records for the FDA
154(1)
4.10.5 Device development stage-gate process
154(1)
4.11 A few general notes on biomedical product development
154(2)
4.12 Project management
156(4)
4.12.1 Project management tools - Gantt charts and critical path
156(2)
4.12.2 Team composition
158(1)
4.12.3 Team management in a matrix environment
159(1)
4.13 Formulating budgets
160(2)
4.14 How to get your project funded in a larger organization
162(4)
4.14.1 The art of persuasion
162(1)
4.14.2 Business case
162(1)
4.14.3 Valuation decision - net present value (NPV)
162(2)
4.14.4 Stakeholders
164(2)
4.15 Outsourcing product development
166(2)
4.16 Summary of pre-clinical certifications and laboratory regulations
168(2)
4.17 Summary
170(2)
5 The regulated market: gateway through the FDA
172(54)
5.1 The FDA: its role and significance for biomedical product development
172(2)
5.1.1 Introduction and history
172(2)
5.1.2 Role of the FDA and significance for product development
174(1)
5.2 Organization and scope of the FDA
174(5)
5.2.1 Divisions of the FDA
174(1)
5.2.2 What the FDA does not regulate
175(1)
5.2.3 What does the FDA regulate?
176(1)
5.2.4 Friends not foe
176(2)
5.2.5 Science rules - most of the time
178(1)
5.2.6 International harmonization
179(1)
5.3 Regulatory pathways for drugs (biologicals or synthetic chemicals)
179(17)
5.3.1 Pre-clinical studies regulated by the FDA
181(2)
5.3.2 Filing an investigational new drug application (IND; or form FDA 1571)
183(2)
5.3.3 Working with the FDA in formally arranged meetings
185(1)
5.3.4 New drug application submission
185(2)
5.3.5 Clinical trials done in foreign countries
187(1)
5.3.6 Drug master files
187(1)
5.3.7 Regulatory pathway for copies of already approved drugs (generic or biosimilar drugs)
188(1)
5.3.8 Regulatory pathway for OTC (over-the-counter) drugs
188(1)
5.3.9 Post-market clinical studies (Phase IV) and safety surveillance by FDA
189(1)
5.3.10 Schematics of IND, NDA, and ANDA review processes
190(2)
5.3.11 Speeding up access to drugs
192(3)
5.3.12 Market exclusivity for new drugs and the Hatch Waxman Act 1984
195(1)
5.3.13 Drugs: helpful FDA websites and the Electronic Orange Book
195(1)
5.4 Orphan drugs
196(1)
5.5 Devices: regulatory pathways and NPD considerations
196(11)
5.5.1 Step 1 Determine the jurisdiction of the FDA center - is it a device?
197(1)
5.5.2 Step 2 classify the medical device - what controls and regulations apply?
198(1)
5.5.3 Step 3 determine marketing application required to be submitted
199(1)
5.5.4 Working with the FDA in formal meetings
200(1)
5.5.5 General controls and exempt devices
201(1)
5.5.6 Pre-clinical considerations - special controls and QSR for Class II and III devices
201(3)
5.5.7 The use of master files (MAF)
204(1)
5.5.8 510(k) submission type and content
204(2)
5.5.9 PMA submission content
206(1)
5.5.10 Types of PMA submission
206(1)
5.5.11 Humanitarian use devices (HUDs)
207(1)
5.6 Diagnostics: regulatory pathways and NPD considerations
207(8)
5.6.1 In vitro devices - regulatory clearance or approval steps to market
209(1)
5.6.2 Pre-clinical and clinical considerations for in vitro devices
210(2)
5.6.3 Clinical Laboratory Improvement Amendments program
212(1)
5.6.4 Analyte-specific reagents or "home-brew" tests
212(3)
5.7 Emerging regulatory guidelines for co-development of pharmacogenomic diagnostic tests and drugs
215(2)
5.8 Combination products, genetic material, and tissues
217(7)
5.8.1 Cellular, tissue, and gene therapies
219(5)
5.9 Summary
224(2)
6 Manufacturing
226(38)
6.1 Introduction
226(1)
6.2 Technology transfer to manufacturing operations (drugs, devices, and diagnostics)
227(1)
6.3 Regulatory compliance in manufacturing
228(5)
6.3.1 Current good manufacturing practices
228(2)
6.3.2 Validation
230(1)
6.3.3 Drug manufacture regulations - control systems reviewed for compliance
230(1)
6.3.4 Device and diagnostic manufacture regulations - control systems reviewed for compliance
231(2)
6.4 Manufacturing standards
233(4)
6.4.1 What are standards and what is their purpose?
233(2)
6.4.2 Who sets standards?
235(1)
6.4.3 Which of the thousands of standards apply to my product?
236(1)
6.4.4 What are "clean room" standards?
236(1)
6.5 Manufacturing in drug development
237(8)
6.5.1 Process validation before approval
240(2)
6.5.2 Bulk drug scale-up and production stages
242(1)
6.5.3 Commercial manufacturing planning
243(2)
6.6 Manufacturing in devices and diagnostics
245(2)
6.6.1 Design for manufacturability
247(1)
6.6.2 Design for assembly
247(1)
6.7 Manufacturing in diagnostics
247(3)
6.7.1 Labeling requirements for in vitro devices
250(1)
6.8 Buy or build
250(2)
6.9 Summary
252(12)
Appendix 6.1 Compliance to pharmaceutical GMP
254(4)
Appendix 6.2 Compliance to device and diagnostic GMP
258(6)
7 Reimbursement, marketing, sales, and product liability
264(53)
7.1 Introduction
264(1)
7.2 Healthcare system in the USA
265(4)
7.2.1 Economic impact of the healthcare system
265(1)
7.2.2 Insurance coverage of the US population
265(1)
7.2.3 Who pays for the national healthcare costs?
266(3)
7.3 Flow of payments and distribution models for products and services
269(2)
7.4 Distribution and payment flow for biomedical product types
271(3)
7.4.1 Drugs and biologics: product payment and distribution model
271(2)
7.4.2 Devices and diagnostics: product payment and distribution model
273(1)
7.5 Components of the reimbursement process
274(17)
7.5.1 Coverage
276(6)
7.5.2 Coding
282(2)
7.5.3 Payment
284(7)
7.6 Reimbursement planning activities
291(1)
7.7 Reimbursement path for self-administered drugs (mostly pills)
292(1)
7.8 Reimbursement path for devices and infused drugs
293(9)
7.8.1 Reimbursement path for physician-administered drugs (continued)
294(2)
7.8.2 Reimbursement path for devices (continued)
296(6)
7.9 Reimbursement pathway for in vitro diagnostics (IVDs)
302(2)
7.10 Major differences among selected national healthcare and reimbursement systems
304(1)
7.11 Marketing
305(2)
7.12 Sales
307(2)
7.13 Product liability
309(8)
Appendix 7.1 Technology assessment center for coverage determination
313(4)
Glossary and acronyms 317(13)
Index 330