Faculty
Professor Michael T. Horvath
Objectives
This mini-course will cover topics relevant to the management of the life science enterprise. Companies engaged in developing products and services in the life sciences area face a myriad of unique factors and challenges. This course will focus on the strategic and practical aspects of management in this rapidly growing and changing sector. No specific technical knowledge of the “science” behind life sciences is required. The mini-course will cover: (1) an overview of the life sciences sector—the major players and recent trends that are likely to shape the operating environment over the coming decade; (2) the business models common to the industry; (3) a close look at the Food and Drug Administration (FDA) and how the regulatory environment impacts life sciences companies; and (4) the financing of life sciences ventures. The course will make use of readings, case studies, and invited speakers in a workshop environment.
Requirements
Class Presentation
Student groups of 3-5 (depending on class enrollment) will make presentations to the class on selected topics.
Final Exam
There will be a take-home 1.5 hour final exam at the conclusion of the term.
Materials
A course packet containing reading materials to be used during the course is available electronically in the P:\Course-Files\Winter\T06 folder. If additional materials will be used during the term they will be distributed in class or via this public access folder.
Attendance and Class Participation
You should come to class having read the assigned material and be well-prepared engage in discussion on the topics raised in the readings. If you have to miss a class, please inform me ahead of time if possible or get in touch with me by e-mail after the missed class with an explanation.
Grading
Class Participation 25%
Prepared Presentation 25%
Final Exam 50%
Schedule
Thursday 02/02
Agarwal, S. S. Desai, and M. Holcomb. “Unlocking the value in Big Pharma,” McKinsey Quarterly 2001(2).
George, C. and J. M. Pearson. “Riding the pharma roller coaster,” McKinsey Quarterly 2002(4).
Biotechnology Industry Organization (2005). “Guide to Biotechnology”, pp. 1-70.
Goozner, Merrill (2004). The $800 Million Pill; University of California Press, read Introduction only.
Wednesday 02/08
Goozner, Merrill (2004). The $800 Million Pill; University of California Press, read chs 1-3.
Momenta Pharmaceuticals (2004). “SEC S-1 Registration Statement”
Thursday 02/09
Alnylam Pharmaceuticals (2004). “SEC S-1 Registration Statement”
Alnylam Pharmaceuticals (2005). “BIO-CEO Presentation” (powerpoint slide deck)
Wednesday 02/15
Sylvie Grégoire, PharmD, former EVP Technical Operations at Biogen speaking on "Management Careers in Life Sciences"
Thursday 02/16
Goozner, Merrill (2004). The $800 Million Pill; University of California Press, read chs 4-7.
Rowe, J.C, Elling, M.E., Hazlewood, J.G., and Zakhary R. “A cure for clinical trials,” McKinsey Quarterly 2002(2).
Wednesday 02/22
FDA (1998). “Guidance for the Industry: General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products” (skim only)
Food & Drug Administration Org Chart
Thursday 02/23
Kaplan AV, Baim DS, Smith JJ, Feigal DA, Simons MS, Jefferys D, Fogarty TJ, Kuntz RE, Leon MB. (2004) “Medical Device Development: From Prototype to Regulatory Approval.” Circulation 109:3068-3072
Wednesday 03/01
Horvath, M. (1999) “Venture Capital Flows to Biotechnology Companies.” Prepared testimony presented to the U.S. House Committee on Science, subcommittee on Technology, hearing on "Competing in the New Millennium: Challenges Facing Small Biotechnology Firms."
Thursday 03/02
Andrew Palmer TU’94, Senior Vice President, Organization and Operations, Infinity Pharmaceuticals speaking on “The Future of Biotech”
Thursday 03/02
