Biotechnology Business, Law, and Science
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Learn the business of biotechnology, how to start and manage biotechnology companies, and how to better service the needs of biotechnology companies.
Going beyond simple 'science for non-scientists' or 'mini MBA' offerings, this course describes the convergence of scientific, political, regulatory, and commercial factors that drive the biotechnology industry and define its scope.
This course is based on the leading business-of-biotechnology text, "Building Biotechnology," which has been adopted by more than 50 schools, and is taught by Yali Friedman, Ph.D., chief editor of the Journal of Commercial Biotechnology and a former instructor of biotechnology management at the National Institutes of Health.
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|Section 1: Welcome and overview|
|Section 2: Introduction|
|Section 3: The Development of Biotechnology|
Knowledge and Skills Enabling Biotechnology
Biotechnology Industry Trends
Case Study: Company Examples
|Section 4: Science|
The Science of Biotechnology
|Section 5: Introduction to Molecular Biology|
The Roles of DNA, Genes, and Protein
The Big Picture
|Section 6: Drug Development|
Biotechnology vs. Pharmaceutical Methods
5 Basic Steps of Drug Development
Desirable Qualities of a Good Drug
|Section 7: Biotechnology Tools and Techniques|
Genomics and Proteomics
Biologic Drug Delivery and Nanotechnology
|Section 8: Biotechnology Applications|
Green Biotechnology: Agriculture
White Biotechnology: Industrial Processes and Bio-based Products
Red Biotechnology: Medical Applications
|Section 9: Laws, Regulations, and Policy|
Patents, Regulation, and Policy
Intellectual Property - Overview
|Section 10: Intellectual Property|
Patent Challenge and Exemptions
The Role of Intellectual Property in Biotechnology
|Section 11: Regulation|
Food and Drug Administration: Clinical Trials
Food and Drug Administration: Incentives and Other Regulations
Department of Agriculture and Environmental Protection Agency
|Section 12: Policy|
Balancing Innovation Incentives with Economic Constraints
|Section 13: The Business of Biotechnology|
The Business of Biotechnology
|Section 14: Biotechnology Company Fundamentals|
Biotechnology Business Models
Biotechnology Company Team
Biotechnology Company Characteristics
|Section 15: Finance|
Development Stages and Financing
Other Funding Sources
|Section 16: Marketing, Marketing Environment, and Reimbursement|
Marketing as a Guide for R&D
Market Structure and Marketing Environment
|Section 17: Managing Biotechnology|
Managing Research and Development
Overcoming Setbacks and Dealing with Failure
|Section 18: Conclusion|
Yali Friedman, Ph.D. is chief editor of the Journal of Commercial Biotechnology, and publisher of DrugPatentWatch.com. His first book, Building Biotechnology, is used as a course text in dozens of biotechnology programs. His other books include Best Practices in Biotechnology Education and Best Practices in Biotechnology Business Development. He also serves on the science advisory board of Chakra Biotech, and is a judge for the Maryland Incubator Company of the Year Award.
Yali has strong exposure to leading issues in international biotechnology. He is lead editorial consultant for Scientific American's worldVIEW, a global biotechnology perspective profiling biotechnology industries and innovation capacity in dozens of countries since 2009, and has been invited to participate in biotechnology industry development forums for international groups such as APEC and for individual countries such as Japan, Canada, Germany, the Philippines, Turkey, and Taiwan.
Yali taught biotechnology management at the National Institutes of Health for many years and regularly guest-lectures for other biotechnology education programs. He writes and speaks on diverse topics such as biotechnology entrepreneurship, strategies to cope with a lack of management talent and capital when developing companies outside of established hubs, and new paradigms in technology-based economic development.
Yali has a long history in biotechnology media. He created the first blog on the business of biotechnology for a NY Times company, which was named to Forbes "Best of the Web". His other projects include the Student Guide to DNA Based Computers, sponsored by FUJI Television, BiotechBlog.com, and DrugPatentWatch.com, a pharmaceutical industry competitive intelligence service based on a business plan that was awarded second place in the Panasci Entrepreneurial Awards Competition.