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May 6, 2020
Article

We Shouldn't Wait for a Breakthrough in the COVID-19 Pandemic

By: Gary P. Pisano

The ultimate solutions to the COVID-19 crisis may be big breakthroughs in building massive test and trace capacity and developing vaccines and drug remedies. But in the meantime, we should not ignore the potential cumulative impact of the many small things we already... View Details

Keywords: COVID-19; Health Pandemics; Strategy; Leadership

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2007
Book

Perspectives on Risk and Regulation: The FDA at 100

By: Arthur A. Daemmrich and Joanna Radin

Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific... View Details

Keywords: Private Sector; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Business and Government Relations; Risk and Uncertainty; Cooperation

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January 2003 (Revised May 2003)
Case

Heineken NV: Workplace HIV/AIDS Programs in Africa (A)

This case is the first in a three-part series that explores the multifaceted organizational and strategic choices that companies now face as a result of the global AIDS epidemic. Heineken is considering becoming one of the first companies to offer AIDS drugs... View Details

Keywords: Health Disorders; Corporate Social Responsibility and Impact; Employees; Food and Beverage Industry; Africa

November 2024
Teaching Note

Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams

By: Debora L. Spar and Julia M. Comeau

Teaching Note for HBS Case No. 323-039. In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At... View Details

Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Pharmaceutical Industry; Medical Devices and Supplies Industry; United States; District of Columbia

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

October 1992 (Revised September 1993)
Case

Nopane Advertising Strategy

By: David E. Bell

Nopane is a proprietary drug that sells in much of the United States. It faces substantial competition. The brand manager is undertaking an experiment to determine whether ad copy should be emotional-based or rational-based. The data and associated regression results... View Details

Keywords: Competition; Intellectual Property; Advertising; Health Care and Treatment; Brands and Branding; Product Marketing; Pharmaceutical Industry; United States

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

2024
Working Paper

Prozac—Controversial Blockbuster: Case Histories of Transformational Advances

By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins

This case history describes the development of Prozac, a blockbuster drug that transformed the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we chronicle the: 1) prior treatments for depression and the research that... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms

April 18, 2022
Article

Will mRNA Technology Companies Spawn Innovation Ecosystems?

By: Christoph Grimpe, Timo Minssen, W. Nicholson Price, II and Ariel Dora Stern

The mRNA technologies that helped rapidly create effective COVID-19 vaccines could become technology platform businesses, which has tremendous implications for players in the world of drug development. These platforms could attract other companies interested in... View Details

Keywords: Health Care; Digital Health; Technology; Innovation; Health Care and Treatment; Technological Innovation; Digital Transformation; Health Industry; United States

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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

Article

The Rise of Synthetic Colors in the American Food Industry, 1870–1940

By: Ai Hisano

This article examines how, starting in the 1870s, food manufacturers in the United States began to use standardized color, achieved by synthetic dyes, as part of their marketing strategies. The emergence of the synthetic dye industry paralleled the growth of mass... View Details

Keywords: Safety; Food; Health; Brands and Branding; Manufacturing Industry; Food and Beverage Industry; United States

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November 2007 (Revised October 2009)
Case

Ligand Pharmaceuticals Incorporated

In an activist role, the hedge fund Third Point LLC has three board seats and an ownership stake of 9.5% in Ligand Pharmaceuticals, Inc., a specialty pharmaceutical company. Third Point believed that Ligand had a strong drug portfolio and pipeline but that it was... View Details

Keywords: Mergers and Acquisitions; Private Equity; Investment Activism; Investment Funds; Governing and Advisory Boards; Bids and Bidding; Ownership Stake; Pharmaceutical Industry; United States

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Working Paper

Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S.

By: Pragya Kakani, Michael Chernew and Amitabh Chandra

Rising list prices are often used to illustrate the burden of prescription drug spending, but payers routinely negotiate rebates from manufacturers that generate differences between list and net prices. List prices are easily available and affect patient cost-sharing,... View Details

Keywords: Pharmaceuticals; Rebates; Health Care and Treatment; Markets; Price; Analysis; Pharmaceutical Industry

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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

June 2016
Case

Alnylam: Building a Biotechnology Powerhouse

By: Kevin Schulman

Alnylam is an early stage biomedical technology focused on commercial development of a novel technology platform, siRNA. This technology offered promise to treat rare genetic disorders that could not be treated with other technologies. Alnlyam's development entailed... View Details

Keywords: Technological Innovation; Commercialization; Health Disorders; Intellectual Property; Biotechnology Industry

February 2010 (Revised April 2010)
Case

Organization and Strategy at Millennium (A)

By: Julie M. Wulf and Scott Waggoner

This case examines Millennium's strategic and organizational responses to the rapid evolution of the biopharmaceutical industry. In the early 2000s, as Millennium's competitive advantage in early-stage research slipped away and its losses mounted, founder and CEO Mark... View Details

Keywords: Transformation; Leading Change; Management Succession; Organizational Change and Adaptation; Competitive Strategy; Competitive Advantage; Biotechnology Industry; Pharmaceutical Industry

2019
Article

Pay-for-Monopoly?: An Assessment of Reverse Payment Deals by Pharmaceutical Companies

By: Sana Rafiq and Max Bazerman

Abstract Over the past eighteen years, pharmaceutical firms have developed a blueprint to impede competition in order to maintain their monopoly profits. This scheme, termed pay-for-delay, involves direct or indirect payment of money from a branded-drug manufacturer... View Details

Keywords: Monopoly; Policy; Competition; Agreements and Arrangements; Pharmaceutical Industry

April 2002
Case

In vivo to in vitro to in silico: Coping with Tidal Waves of Data at Biogen

By: Juan Enriquez-Cabot, Gary P. Pisano and Gaye Bok

Biogen is a successful biotech company facing a critical juncture. CEO John Mullen ponders how technological changes introduced into the research function will shape larger corporate decisions. This world in which biotechnology companies operated had changed... View Details

Keywords: Change; Decisions; Product Development; Research and Development; Expansion; Technology; Biotechnology Industry

May 2023 (Revised June 2023)
Case

Novartis (A): 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 Care and Treatment; Business Model; Leadership; Pharmaceutical Industry; Switzerland

November 2006 (Revised July 2008)
Case

Eli Lilly: Developing Cymbalta

By: Elie Ofek and Ron Laufer

Anticipating the expiration of its Prozac patent, Eli Lilly has to make tough decisions regarding the development of its next-generation antidepressant drug. In particular, the company needs to decide whether to first establish that once-a-day dosing for Cymbalta... View Details

Keywords: Decision Choices and Conditions; Marketing Strategy; Product Launch; Product Development; Research and Development; Pharmaceutical Industry

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