Publications

2010
Chapter

From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance

By: Arthur A. Daemmrich

Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States

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01 Dec 2003
Research & Ideas

Sometimes Success Begins at Failure

In the late 1980s, scientists for New York City-based drug-maker Pfizer began testing what was then known as compound UK-92,480 for the treatment of angina. Although UK-92,480 seemed promising in the lab and in animal tests, the compound showed little benefit in... View Details

Keywords: by Henry Chesbrough; Health; Pharmaceutical

18 Dec 2018
First Look

New Research and Ideas, December 18, 2018

firms face little competition, even after the end of formal periods of patent protection and market exclusivity. Additionally, the evolving technologies of drug development—in particular, the increasingly common use of auxiliary endpoints... View Details

Keywords: Dina Gerdeman

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

August 1995 (Revised June 1997)
Case

Hillcrest Research Associates, Inc.

Hillcrest designs and administers testing procedures for drugs to determine whether they pass FDA specifications. As the company grows, it encounters problems with information technology and with the clinical research associates, who feel pressured to report more... View Details

Keywords: Growth Management; Information Technology; Health Testing and Trials; Pharmaceutical Industry

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05 Dec 2017
First Look

First Look at New Research and Ideas, December 5, 2017

the stigma of financial misconduct could reach alumni employees and need not be confined to executives and directors that oversaw the organization during the misconduct. Download working paper: https://www.hbs.edu/faculty/Pages/item.aspx?num=53547 View Details

Keywords: Sean Silverthorne

January 2020
Article

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System

By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz

Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has... View Details

Keywords: Medical Devices; Health Testing and Trials; Analysis; Sales

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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

Satish Tadikonda is a Senior Lecturer in the Entrepreneurial Management Unit at Harvard Business School. In the MBA program, Satish teaches The Entrepreneurial Manager, a required first-year MBA course, and Entrepreneurship in Life Sciences, an elective course for... View Details

June 2023 (Revised July 2024)
Case

Biogen and the Aduhelm Melee

By: Amitabh Chandra and Lauren Gunasti

Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.

This... View Details

Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry

19 Dec 2017
First Look

New Research and Ideas, December 19, 2017

Abstract—No abstract available. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53633 Characterizing the Drug Development Pipeline for Precision Medicines By: Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern... View Details

Keywords: Carmen Nobel

January 2009 (Revised July 2009)
Case

Targanta Therapeutics: Hitting a Moving Target

By: Arthur A. Daemmrich

This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful... View Details

Keywords: Decision Choices and Conditions; Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Business and Government Relations; Business Strategy; Biotechnology Industry; Pharmaceutical Industry

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

Keywords: Three Pillars; Industry Analysis; Health Care and Treatment; Innovation and Invention; Innovation and Management; Medical Specialties; Health Industry

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

Keywords: Genetics; Health Care and Treatment; Health Testing and Trials; Disruptive Innovation; Business Model; Biotechnology Industry; Health Industry

May 2023 (Revised June 2023)
Supplement

Novartis (C): Reimagining Medicine

By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi

This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,... View Details

Keywords: Health Testing and Trials; Health Care and Treatment; Business Model; Problems and Challenges; Pharmaceutical Industry; Switzerland

Web

Capstone | MBA

centuries of de-prioritization. For example, regulations barred women of reproductive age from clinical trials until the 1990s. Organoid systems, which recreate human physiology, make it possible to conduct scientific investigation far... View Details

14 Nov 2017
First Look

New Research and Ideas: November 14, 2017

authors provide numerous examples of health care organizations that are taking these steps—and seeing impressive results. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53460 forthcoming JAMA Cardiology The Central and Unacknowledged Role of the U.S.... View Details

Keywords: Carmen Nobel

October 2020 (Revised November 2023)
Case

COVID-19 Testing at Everlywell

By: Jeffrey J. Bussgang and Olivia Hull

In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the... View Details