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- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was... View Details
Keywords: Public Health; Genome Testing; Health Care; Ancestry; 23andMe; Marketing; Product Launch; Health; Health Care and Treatment; Health Testing and Trials; Genetics; Strategy; Health Industry; United States
Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
- October 2013
- Case
FasterCures: Removing Barriers to Treatments
By: Richard G. Hamermesh and James Weber
In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit... View Details
Keywords: Health Care; Health Care Industry; Health Care Policy; Health Services; Healthcare; Healthcare Reform; Healthcare Ventures; Nonprofit; Non-profit Management; Not-for-profit; Incubator; Accelerator; Venture Philanthropy; Medical Services; Medical Solutions; Medical Research; Medical Treatment; Clinical Trials; Drug Reimbursement; Early Stage; Early Stage Research Funding; Early Stage Funding; Milken Institute; Michael Milken; David Baltimore; Partnering For Cures; National Institutes Of Health; Cancer Care In The U.S.; Cancer Care Services; Policy-making; Health Care and Treatment; Health; Health Testing and Trials; Entrepreneurship; Social Entrepreneurship; Nonprofit Organizations; Policy; Health Industry; United States; District of Columbia
Hamermesh, Richard G., and James Weber. "FasterCures: Removing Barriers to Treatments." Harvard Business School Case 814-003, October 2013.
- November 2009
- Case
The Explosion of Genetic Testing: Opportunities and Challenges
By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon
This case study invites the reader to consider genetic testing in several different lights. First, can the business of genetic testing be considered a disruptive innovation to the current drug therapy model as defined by Harvard Business School Professor Clay... View Details
- 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... View Details
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.)
- April 2009 (Revised May 2010)
- Case
Partners In Health: HIV Care in Rwanda
By: Michael E. Porter, Scott S. Lee, Joseph Rhatigan and Jim Yong Kim
In 2005, Partners in Health (PIH) was invited by the Rwandan Ministry of Health to assume responsibility for the management of public health care in two rural districts in Eastern Rwanda and create an HIV treatment program at these sites. PIH successfully implemented a... View Details
Keywords: Developing Countries and Economies; Health Care and Treatment; Health Testing and Trials; Medical Specialties; Service Delivery; Nonprofit Organizations; Expansion; Health Industry; Rwanda
Porter, Michael E., Scott S. Lee, Joseph Rhatigan, and Jim Yong Kim. "Partners In Health: HIV Care in Rwanda." Harvard Business School Case 709-474, April 2009. (Revised May 2010.)
- November 2007
- Case
Antegren: A Beacon of Hope
By: Joshua D. Margolis, Thomas J. DeLong and Terence Heymann
The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series focuses on operational decisions triggered by the drive for early approval. Sparks discussion... View Details
Keywords: Demand and Consumers; Leadership; Ethics; Corporate Social Responsibility and Impact; Decision Choices and Conditions; Crisis Management; Health Testing and Trials; Biotechnology Industry; Pharmaceutical Industry
Margolis, Joshua D., Thomas J. DeLong, and Terence Heymann. "Antegren: A Beacon of Hope." Harvard Business School Case 408-025, November 2007.
- October 2006 (Revised August 2007)
- Case
Calloway Laboratory: Pee for Profit
By: Richard G. Hamermesh and David Kiron
Describes the formation and rapid growth of a drug-testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug treatment center business. View Details
Keywords: For-Profit Firms; Health Care and Treatment; Health Testing and Trials; Growth and Development Strategy; Market Entry and Exit; Health Industry
Hamermesh, Richard G., and David Kiron. "Calloway Laboratory: Pee for Profit." Harvard Business School Case 807-040, October 2006. (Revised August 2007.)
- March 2006 (Revised July 2006)
- Supplement
Drug Testing in Nigeria (B)
By: Debora L. Spar
Spar, Debora L., and Adam Day. "Drug Testing in Nigeria (B)." Harvard Business School Supplement 706-042, March 2006. (Revised July 2006.)
- January 2006 (Revised July 2006)
- Case
Drug Testing in Nigeria (A)
By: Debora L. Spar
In 1996, a meningitis epidemic swept across Nigeria. Thousands of children were struck and, lacking appropriate medicine, were liable to die from the disease. Doctors at Pfizer had an antibiotic that could probably save most of these children's lives. The drug was new,... View Details
Keywords: Risk and Uncertainty; Health Pandemics; Health Testing and Trials; Developing Countries and Economies; Pharmaceutical Industry; Nigeria
Spar, Debora L., and Adam Day. "Drug Testing in Nigeria (A)." Harvard Business School Case 706-033, January 2006. (Revised July 2006.)
- August 2005 (Revised December 2006)
- Case
Procter & Gamble: Electronic Data Capture and Clinical Trial Management
By: Robert S. Huckman and Mark J. Cotteleer
Considers whether the management of Procter & Gamble (P&G) Pharmaceuticals should adopt Web-based electronic data capture (EDC) as the default standard for the management of its clinical drug trials. Provides a detailed description of the existing paper-based process... View Details
Keywords: Health Testing and Trials; Internet and the Web; Information Technology; Adoption; Business Processes; Industry Structures; Technological Innovation; Service Operations; Pharmaceutical Industry; United States
Huckman, Robert S., and Mark J. Cotteleer. "Procter & Gamble: Electronic Data Capture and Clinical Trial Management." Harvard Business School Case 606-033, August 2005. (Revised December 2006.)
- April 2003 (Revised October 2004)
- Case
Novartis: The Challenge of Success (A)
By: Sandra J. Sucher and Stacy McManus
Preliminary results from Phase 1 clinical trials of a newly developed compound, STI571, showed that 31 out of 31 patients with chronic myelogenous leukemia (CML) had their blood counts return to normal. In the world of oncology, this was unheard of. This was the... View Details
Keywords: Decision Making; Health Testing and Trials; Innovation and Invention; Markets; Distribution; Product Development; Production; Problems and Challenges; Research; Research and Development; Complexity; Biotechnology Industry; Pharmaceutical Industry
Sucher, Sandra J., and Stacy McManus. "Novartis: The Challenge of Success (A)." Harvard Business School Case 603-043, April 2003. (Revised October 2004.)
- 1996
- Chapter
The Determinants of Research Productivity in Ethical Drug Discovery
By: Rebecca M. Henderson and Ian Cockburn
- 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,... View Details
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.)