Publications

September 1991 (Revised February 1993)
Case

Burroughs Wellcome and AZT (A)

By: Willis M. Emmons III

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.... View Details

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

August 2022
Article

Availability of New Medicines in the U.S. and Germany From 2004 to 2018

By: Katharina Blankart, Huseyin Naci and Amitabh Chandra

Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial... View Details

Keywords: Market Entry and Exit; Price; Market Timing; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States; Germany

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In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a... View Details

June 9, 2023
Article

A Radical Treatment for Insulin Pricing

By: Leemore S. Dafny

In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a... View Details

Keywords: Biosimilars; Rebates; Pharmaceuticals; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States

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10 Aug 2015
Research & Ideas

New Medical Devices Get To Patients Too Slowly

implantable defibrillators or transcatheter heart valves, the FDA's regulatory approval process appears to delay those approvals, which in turn adds to development costs borne by device manufacturers,... View Details

Keywords: by Michael Blanding; Health; Technology

Article

Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries

By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer

Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details

Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry

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December 2008 (Revised October 2013)
Case

Amylin Pharmaceuticals: Diabetes and Beyond (A)

By: Richard G. Hamermesh and Rachel Gordon

Ginger Graham, CEO of Amylin Pharmaceuticals, joined the company with the expectation of taking the company's signature drug, Symlin, to market. However, unforeseen regulatory challenges have put the approval process in jeopardy. At the same time, the company has a... View Details

Keywords: Regulations; Drug Regulations; Symlin; Negotiation; Governing Rules, Regulations, and Reforms; Resource Allocation; Negotiation Deal; Product Development; Research and Development; Commercialization; Pharmaceutical Industry; United States

February 2025
Case

Abiomed: A Change of Heart

By: Satish Tadikonda, Faith Robertson and William Marks

After acquiring Impella CardioSystems AG in May 2005, Abiomed Inc., a company focused on cardiac care, ran into a dilemma. Its Impella 2.5 device was approved for use in the European Union, but CEO Michael Minogue had seemingly bet the company's future on the ability... View Details

Keywords: Mergers and Acquisitions; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Business and Government Relations; Medical Devices and Supplies Industry; European Union; United States

April 2021 (Revised December 2021)
Case

The Carlyle Group: Carving Out Atotech

By: Rosabeth Moss Kanter

On January 31, 2017, The Carlyle Group ("Carlyle") closed its $3.2 billion acquisition of Atotech, an international Specialty Chemicals and Equipment company. In Carlyle's Washington, DC headquarters, the US-based deal team—Martin Sumner, Greg Nikodem, Tanaka Maswoswe... View Details

Keywords: Oil ＆ Gas; Deal; International Acquisition; International; Acquisition; Negotiation Deal; Transformation; Chemicals; Chemical Industry; United States; Europe; Asia; Germany

December 2019
Technical Note

Technical Note on Bayesian Statistics and Frequentist Power Calculations

By: Amitabh Chandra and Ariel Dora Stern

This Technical Note provides an introduction to Bayes’ Rule and the statistical intuition that stems from it. In this note, we review the concepts that underlie Bayesian statistics, and we offer several simple mathematical examples to illustrate applications of Bayes’... View Details

Keywords: Bayesian Statistics; Mathematical Methods

February 2025
Case

Abiomed: Clinical Trials and Tribulations

By: Satish Tadikonda, Faith Robertson and William Marks

After receiving 510(k) clearance for the Impella 2.5 device, Abiomed had proceeded to conduct a premarket approval (PMA) process as well to prove clinical superiority, earn greater protection, and extend commercial runway. However, in the middle of the clinical trial... View Details

Keywords: Corporate Disclosure; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Launch; Medical Devices and Supplies Industry

20 Dec 2016
First Look

December 20, 2016

to creating your own model. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=52002 January 2017 Journal of Public Economics Innovation Under Regulatory Uncertainty: Evidence from Medical Technology By: Stern, Ariel Dora... View Details

Keywords: Carmen Nobel

2012
Other Unpublished Work

The Efficacy of Shareholder Voting: Evidence from Equity Compensation Plans

By: Ian D. Gow, Christopher S. Armstrong and David F. Larcker

This study examines the effects of shareholder support for equity compensation plans on subsequent chief executive officer (CEO) compensation. Using cross-sectional regression, instrumental variable, and regression discontinuity research designs, we find little... View Details

Keywords: Voting; Equity; Executive Compensation; Rights; Performance Effectiveness; Business and Shareholder Relations; Mathematical Methods; Motivation and Incentives

May 2024
Article

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

By: Caroline Marra and Ariel D. Stern

Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting... View Details

Keywords: Health Care and Treatment; Technological Innovation; Product Development; Health Testing and Trials; Governing Rules, Regulations, and Reforms

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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

July 2021
Teaching Note

The Carlyle Group: Carving Out Atotech

By: Rosabeth Moss Kanter

Teaching Note for HBS Case No. 321-153. On January 31, 2017, The Carlyle Group ("Carlyle") closed its $3.2 billion acquisition of Atotech, an international Specialty Chemicals and Equipment company. In Carlyle's Washington, DC headquarters, the US-based deal... View Details

Keywords: Oil ＆ Gas; Deal; International Acquisition; International; Acquisition; Negotiation; Negotiation Deal; Transformation; Chemicals; Markets; Bids and Bidding; Globalized Markets and Industries; Standards; Chemical Industry; United States; Europe; Asia; Germany