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Contents

Preface

Introduction
The Biotechnology Industry
The Development of Biotechnology
Knowledge and Skills
Application
Commercialization
Industry Trends

Science
Information Flow in Molecular Biology
The Big Picture
Drug Development
Biotechnology vs. Pharmaceutical Drug Development
The Five Basic Steps of Drug Development
Qualities of a “Good” Drug
Tools and Techniques
Bioinformatics
Combinatorial Chemistry
Functional Genomics
Microarrays
Proteomics
Manufacturing
Drug Delivery
Nanotechnology
Applications
Green Biotechnology: Agriculture
White Biotechnology: Industrial Processes and Bio-based Products
Red Biotechnology: Medical Applications

Laws, Regulations, and Politics
Intellectual Property
Patents
When Patents Expire
Patent Infringement, Challenge, and Exemptions
Patent Licensing
Trade Secrets
Trademark
Copyright
The Role of Intellectual Property in Biotechnology
Regulation
Food and Drug Administration
Department of Agriculture
Environmental Protection Agency
Securities and Exchange Commission
Politics
Supporting Biotechnology Innovation
Balancing Innovation Incentives with Economic Constraints

The Business of Biotechnology
Biotechnology Company Fundamentals
Company Formation
Business Model
Team
Company Characteristics
Finance
Development Stages and Funding
Private Equity
Public Markets
Other Funding Sources
Valuation
Research and Development
R&D Stages
Project Selection
Outsourcing Innovation
Marketing
Marketing as a Guide for R&D
Market Structure and Marketing Environment
Reimbursement
Marketing Planning and Strategy
Licensing, Alliances, and Mergers
Licensing and Outsourcing
Alliance Partnerships
Mergers and Acquisitions
Selecting Partnership Options
Managing Biotechnology
Starting Up
Managing R&D
Intellectual Property Protection
Management Changes with Growth
Dealing with Failure
Communications and Public Relations
International Biotechnology
Benchmarking Against the United States
Intellectual Property Protection
Regulation
Operations
Finance

Conclusion
Business Models
First Steps
Selecting Opportunities and Business Planning
Investing
Caveat Emptor
Investing in Biotechnology
Strategy
Conclusion
Career Development
Job Descriptions
Ph.D., MBA, or Both?
Final Words

Appendices
Internet Resources
News and Information
Investing and Competitive Intelligence
Angel Funding
Federal Funding
Industry Organizations
Annotated Bibliography
Science
Intellectual Property and Regulation
Business
Sciene
Legal
Regulatory
Commercial
Index

Biotech Blog

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