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- November 2009 (Revised March 2010)
- Case
Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story
By: Richard G. Hamermesh, Raju Kucherlapati and Rachel Gordon
In May 2007, Amgen Inc. (Amgen) received disappointing news from the European Medicines Agency (EMEA) that its drug Vectibix, developed to fight metastatic colorectal cancer, had been rejected. This was especially surprising news given that a similar rival drug had...
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Keywords:
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Marketing Strategy;
Product Positioning;
Genetics;
Biotechnology Industry;
Europe;
United States
Hamermesh, Richard G., Raju Kucherlapati, and Rachel Gordon. "Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story." Harvard Business School Case 810-066, November 2009. (Revised March 2010.)
- January 2007 (Revised January 2007)
- Background Note
Note on the U.S. Food and Drug Administration
By: Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller
Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure.
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Keywords:
Health;
Governance Compliance;
Policy;
Product Development;
Government and Politics;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
Medical Devices and Supplies Industry;
United States
Higgins, Robert F., Richard G. Hamermesh, and Virginia Fuller. "Note on the U.S. Food and Drug Administration." Harvard Business School Background Note 807-050, January 2007. (Revised January 2007.)
- November 2000 (Revised March 2001)
- Case
Iggy's Bread of the World
By: Kathleen L. McGinn and Alexis Lefort
In January 1994, Igor and Ludmilla Ivanovic opened the doors of their bakery, Iggy's Bread of the World. This case describes their unusual mission statement and the way in which they try to bring a social consciousness mentality to a for-profit business. Six years...
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Keywords:
Growth Management;
Mission and Purpose;
Organizational Culture;
Restructuring;
Family Business;
Power and Influence;
Food and Beverage Industry;
Food and Beverage Industry;
Massachusetts
McGinn, Kathleen L., and Alexis Lefort. "Iggy's Bread of the World." Harvard Business School Case 801-282, November 2000. (Revised March 2001.)
- September 1996
- Case
Food and Drug Administration: Business as Unusual at CDER
By: Steven C. Wheelwright and James Leonard
Wheelwright, Steven C., and James Leonard. "Food and Drug Administration: Business as Unusual at CDER." Harvard Business School Case 697-022, September 1996.
- November 1993 (Revised January 2006)
- Supplement
Beech-Nut Nutrition Corporation (B)
By: Lynn S. Paine
Officials of the U.S. Food and Drug Administration (FDA) must decide whether to refer the Beech-Nut apple juice case to the Justice Department for criminal prosecution, and if so, whether to recommend prosecution of individual executives or of the company only.
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Paine, Lynn S. "Beech-Nut Nutrition Corporation (B)." Harvard Business School Supplement 394-103, November 1993. (Revised January 2006.)
- September 1991 (Revised August 1994)
- Background Note
Note on Pharmaceutical Industry Regulation
Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,...
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Keywords:
Safety;
Industry Growth;
Marketing;
Research and Development;
Health Testing and Trials;
Economics;
Pharmaceutical Industry;
United States
Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S....
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Keywords:
Governing Rules, Regulations, and Reforms;
Ethics;
Business and Government Relations;
Communication Strategy;
Health Care and Treatment;
Monopoly;
Intellectual Property;
Research and Development;
Price;
Pharmaceutical Industry;
London
Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
- November 1989
- Teaching Note
H.J. Heinz Co.: The Administration of Policy (A), (B), (C), and (D), Teaching Note
By: Kenneth E. Goodpaster and Thomas R. Piper
Teaching Note for (9-382-034, 035, 036, and 037).
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- Research Summary
Overview
The focus of my research is on the systems of social innovation. How small groups of individuals come up with new products and services targeting important problems; how they finance these initial efforts, and convert prototypes into viable organizational strategies;...
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Keywords:
(General) Management;
Social Business;
Non-profit Management;
Entrepreneur;
Entrepreneurial Ecosystems;
Entrepreneurial Finance;
System Dynamics;
Non-profit;
Evaluation;
Impact Investing;
Venture Philanthropy;
Social Enterprise Initiative;
Advanced Leadership Initiative;
Investment;
Innovation and Invention;
Organizations;
Social Enterprise;
Civil Society or Community;
System;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry;
Food and Beverage Industry