Publications

11 May 2010
First Look

First Look: May 11

understood, even as the United States, Germany, and the United Kingdom instituted reforms in early 2010. Presenting opportunities for cross-national policy learning, this case describes the political economy of healthcare reform. In late... View Details

Keywords: Martha Lagace

02 Jul 2015
Op-Ed

The Future of the Greek Economy

The view that "monetary sovereignty" independence could be used wisely does not take into account that the type of government that has driven Greece to the edge of the cliff is not the type of government that would enact the View Details

Keywords: by Laura Alfaro, Dante Roscini & George Serafeim; Banking

2024
Article

Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway

By: Mateo Aboy, Cristina Crespo and Ariel Stern

Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

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25 Oct 2004
Research & Ideas

Planning for Surprises

still awaits. We stick by our recommendation: Use your miles! Q: What other looming, predictable surprises have you noticed since the book manuscript was completed? A: The flu vaccine crisis is a classic example of a predictable surprise. As The New York Times noted in... View Details

Keywords: by Martha Lagace

19 Jan 2022
In Practice

7 Trends to Watch in 2022

As 2022 gets underway we asked our faculty to highlight some trends worth watching in the coming year. Ariel Stern: A new future for digital health care While 2020 and 2021 were years of rapid innovation and deployment of new health care technologies and delivery... View Details

Keywords: by HBS News

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

19 Jan 2021
In Practice

Leadership Advice for Biden: Restore a Sense of Calm

unemployed, and demands for police reform and racial justice. But in the wake of one of the most tumultuous presidential elections in US history—marked by outgoing President Donald Trump claiming the election was stolen, deadly violence... View Details

Keywords: by Dina Gerdeman

05 Jan 2016
Working Paper Summaries

The Integrity of Private Third-party Compliance Monitoring

Keywords: by Michael W. Toffel & Jodi L. Short; Manufacturing; Public Administration; Accounting; Service

August 2008 (Revised September 2008)
Case

The Flaxil Label (A)

This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Product Launch; Negotiation Process; Business and Government Relations; Safety; Pharmaceutical Industry

28 Jul 2009
First Look

First Look: July 28

report, new CEO Hank McKinnell discusses Pfizer's performance goals and its acquisition of Pharmacia, which gave it control of the anti-arthritis drug Celebrex. In the 2005 report, McKinnell discusses his decision to keep Celebrex on the market despite View Details

Keywords: Martha Lagace

July 2019
Article

The Impact of Price Regulation on the Availability of New Drugs in Germany

By: Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari

The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate... View Details

Keywords: Regulation; Pharmaceuticals; Healthcare; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Germany

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August 2008 (Revised May 2009)
Background Note

Note on Generic Drugs in the European Union

By: Robert C. Pozen and Elizabeth M. Leonard

Rules governing the introduction of generic drugs in U.S. and EU have some similarities but significant differences because of the Hatch-Waxman Act in the U.S. View Details

Keywords: Governing Rules, Regulations, and Reforms; Government Legislation; Health Care and Treatment; Trademarks; Brands and Branding; Pharmaceutical Industry; European Union; United States

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August 2001
Case

Scios, Inc.

By: Regina E. Herzlinger

Scios, filled with distinguished scientists and experienced managers, nevertheless fails to clear the FDA Phase III process for an important biotechnology drug. This case asks the students to analyze the social costs and benefits of the regulatory process. View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Cost Management; Cost vs Benefits; Social Issues; Pharmaceutical Industry; United States

January 2024 (Revised April 2024)
Case

Target Malaria: Editing Mosquitoes through Gene Drives

By: Shikhar Ghosh and Shweta Bagai

Target Malaria, a non-profit research consortium, is exploring the application of CRISPR-Cas9 gene editing technology to combat malaria in Sub-Saharan Africa. Its approach uses gene drives, a revolutionary tool, to suppress the population of malaria-carrying... View Details

Keywords: Health Disorders; Technological Innovation; Nonprofit Organizations; Business Strategy; Genetics; Ethics; Governing Rules, Regulations, and Reforms; United States; United Kingdom; Burkina Faso; Africa

January 2009 (Revised February 2009)
Case

Sydney IVF: Stem Cell Research

By: Robert L. Simons, Kathryn Rosenberg and Natalie Kindred

This case examines the strategy implementation and risk management decisions at Sydney IVF, a research-based in vitro fertilization and stem cell company based in Australia. Drs. Robert Jansen and Jock Anderson, who co-founded Sydney IVF in 1986, developed novel... View Details

Keywords: Ethics; Governing Rules, Regulations, and Reforms; Innovation and Management; Growth and Development Strategy; Risk Management; Genetics; Commercialization; Health Industry; Australia

Profile

Frank Spencer

know the details of the plan. You just have to be willing to participate with others in the work." "Real estate is the thread that's run through my career," adds Spencer, who most recently served as president of Cogdell Spencer Inc., a publicly traded... View Details

Keywords: Real Estate; Services

January 2022
Article

Global Behaviors, Perceptions, and the Emergence of Social Norms at the Onset of the COVID-19 Pandemic

By: Lukas Hensel, Marc Witte, Stefano Caria, Thiemo Fetzer, Stefano Fiorin, Friedrich M. Goetz, Margarita Gomez, Johannes Haushofer, Andriy Ivchenko, Gordon T. Kraft-Todd, Elena Reutskaja, Christopher Roth, Erez Yoeli and Jon M. Jachimowicz

We conducted a large-scale survey covering 58 countries and over 100,000 respondents between late March and early April 2020 to study beliefs and attitudes towards citizens' and governments' responses at the onset of the COVID-19 pandemic. Most respondents reported... View Details

Keywords: COVID-19; Government Regulation; Social Norms; Health Pandemics; Governing Rules, Regulations, and Reforms; Behavior; Perception; Global Range; Surveys