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

Article

Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-Five Years of Drug Lag Debate

By: Arthur A. Daemmrich

Keywords: Cost; Health; Governing Rules, Regulations, and Reforms; Communication

2009
Working Paper

Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location

By: Arthur Daemmrich

A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Health Testing and Trials; Power and Influence; Competitive Strategy; Pharmaceutical Industry; European Union; Germany; United States

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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

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

11 Sep 2007
First Look

First Look: September 11, 2007

and reveals how to recruit, nurture, and promote this special type of leader. With a healthy supply of qualified internal candidates, companies get the leadership they need—when they need it. Who Killed Health Care? America's $2 Trillion... View Details

Keywords: Martha Lagace

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

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

August 2023 (Revised May 2024)
Case

Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations

By: Satish Tadikonda and Amanda McEwen

The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details

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

2021
Working Paper

Regulatory Approval and Expanded Market Size

By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite

Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details

Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry

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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

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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

Web

Timeline - Race, Gender & Equity

Discrimination in Employment Act prohibits employers from discriminating on the basis of age An Overview of the Age Discrimination in Employment Act 1969 Neil Armstrong walks on the moon 1970 Occupational Safety and Health Act passed 1973... View Details

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

17 Jul 2017
Op-Ed

Op-Ed: As America Recedes from Global Leadership, Its CEOs are Stepping Up

That’s why they are focusing now on issues like job creation, favorable trade relations, economic growth, and corporate tax reform that are essential for sustaining earnings growth and shareholder returns. Concerned about the future of... View Details

Keywords: by Bill George

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