Publications
Publications
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- March 2015 (Revised January 2024)
- Case
CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
- March 2015 (Revised February 2022)
- Supplement
CV Ingenuity (B): Epilogue
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen used a lea-nfunding, iconoclastic strategy for his start up for a drug eluding balloon for peripheral artery disease. His giant competitors were first movers. Did Duke obtain the funding he sought? How did his DEB fare versus that of his competitors?
The... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Strategy; Health Industry; Medical Devices and Supplies Industry; United States; Europe
- March 2015 (Revised September 2016)
- Case
Terrapin Laboratory
By: Richard G. Hamermesh and Joseph B. Fuller
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. The associated teaching materials provide students the opportunity... View Details
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- February 2005 (Revised April 2006)
- Case
Rx Depot: Importing Drugs from Canada
By: Debora L. Spar
In 2002, a handful of entrepreneurs began to ship drugs from Canada into the United States, taking advantage of regulatory and price differentials across the neighboring countries. Using the Internet and a low-cost network of Canadian pharmacies, firms like Rx Depot... View Details
- August 2003 (Revised August 2024)
- Case
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
By: Regina E. Herzlinger and John McDonough
Many health care innovations appear successful; but fail. This is the first case in the Innovating Health Care course that investigates how to create successful health care innovations. It is part of the first module in the course. This module focuses on how to... View Details
- 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
- February 2000 (Revised October 2000)
- Case
Kendle International Inc.
By: Dwight B. Crane, Paul W. Marshall and Indra Reinbergs
Candace Kendle and Christopher Bergen, the CEO and COO of Kendle International, Inc., are reviewing ways to finance the growth of their privately-owned company. Kendle is a contract research organization that conducts clinical drug trials for pharmaceutical and... View Details
- 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
- Forthcoming
- Article
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern
Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details