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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

January 2005 (Revised March 2006)
Case

Molecular Insight Pharmaceuticals, Inc.

By: Richard G. Hamermesh and Edwin W. Parkinson III

Molecular Insight has developed a novel biopharmaceutical to detect heart attacks. The company's unique approach to intellectual property protection uses the Hatch Waxman Act and the Orphan Drug Act. The company is struggling to raise $7 million in Series B financing.... View Details

Keywords: Intellectual Property; Health Care and Treatment; Pharmaceutical Industry; Health Industry

February 2024
Case

Compass Pathways: Pioneering Psychedelic Treatment

By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu

This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no... View Details

Keywords: Commercialization; Corporate Strategy; Competitive Strategy; Product Launch; Health Testing and Trials; Research and Development; Laws and Statutes; Pharmaceutical Industry; Europe; United States; United Kingdom

September 1991 (Revised August 1994)
Background Note

Note on Pharmaceutical Industry Regulation

By: Willis M. Emmons III

Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,... View Details

Keywords: Safety; Industry Growth; Marketing; Research and Development; Health Testing and Trials; Economics; Pharmaceutical Industry; United States

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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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2023
Working Paper

Evaluation and Learning in R&D Investment

By: Alexander P. Frankel, Joshua L. Krieger, Danielle Li and Dimitris Papanikolaou

We examine the role of spillover learning in shaping the value of exploratory versus incremental R&D. Using data from drug development, we show that novel drug candidates generate more knowledge spillovers than incremental ones. Despite being less likely to reach... View Details

Keywords: Research and Development; Forecasting and Prediction; Valuation; 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

January 2015 (Revised July 2019)
Case

Rebranding Godiva: The Yıldız Strategy

By: Rohit Deshpande and Esel Çekin

This case concerns Yıldız Holding’s acquisition of Godiva Chocolatier from its previous owner, Campbell Soup, and its salient strategy in preserving Godiva’s “made in Belgian” brand position. Provenance Paradox, a problem faced by companies in emerging countries trying... View Details

Keywords: Branding; Internationalization; Provenance Paradox; Acquisitions; Positioning; Innovation; Customer-centricity; Brands and Branding; Marketing Strategy; Emerging Markets; Product Positioning; Change Management; Innovation and Management; Customer Focus and Relationships; Food and Beverage Industry; North America; Turkey; Japan

January 2009
Case

When Supply is of Public Interest: Roche & Tamiflu

The case focuses on the challenges of Roche maintaining a supply network for a global influenza pandemic response initiative based on its antiviral drug Tamiflu. The Roche group is a 40 billion CHF company consisting of a pharmaceutical division and a diagnostic... View Details

Keywords: Global Strategy; Health Pandemics; Distribution; Logistics; Production; Supply Chain Management; Performance Capacity; Pharmaceutical Industry

14 Dec 2020
Research & Ideas

What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?

Pharmaceutical regulators around the world tend to speed through drug applications in December and before major national holidays, according to new research that might raise questions about COVID-19 vaccines and other treatments under... View Details

Keywords: by Danielle Kost; Pharmaceutical; Health

October 2023
Case

Vida Health: Transforming Chronic Disease Treatment

By: William Sahlman and Nicole Tempest Keller

San Francisco based Vida Health, founded by Stephanie Tilenius, former vice president of Commerce and Payments at Google, was a B2B digital health startup focused on the treatment of cardiometabolic conditions, such as diabetes and obesity. Its innovative digital... View Details

Keywords: Corporate Strategy; Growth and Development Strategy; Demand and Consumers; Health Care and Treatment; Product Marketing; Risk and Uncertainty; Technological Innovation; Health Industry; Technology Industry; United States; California; San Francisco

February 2003 (Revised April 2004)
Case

Pharmaceutical Industry, The: Challenges in the New Century

By: Stephen P. Bradley and James Weber

Provides a broad overview of the numerous internal and external forces that were driving change in the global pharmaceutical industry in 2003. These forces--including downward price pressures, political and social pressures, increased development costs, new... View Details

Keywords: Business Model; Change; Cost; Price; Globalization; Government and Politics; Brands and Branding; Industry Growth; Society; Competition; Consolidation; Technology; Pharmaceutical Industry

September 2020
Case

Minerva 2010: Turbulent Times

By: John R. Wells and Benjamin Weinstock

In 2010, amid a flurry of new discoveries, Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), raised $6.6 million to test her new cancer drugs in mice. It had been more than 6 years since she had announced that she and her small team at... View Details

Keywords: Biotechnology; Research; Product Development; Commercialization; Strategy

June 2016
Teaching Plan

Terrapin Laboratory

By: Joseph B. Fuller and Andrew Otazo

This teaching plan accompanies the case "Terrapin Laboratory," HBS No. 315-098. That case 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... View Details

Keywords: Business Growth; Entrepreneurial Management; Growth Strategy; Market Entry; Venture Capital; Market Entry and Exit; Entrepreneurship; Health Testing and Trials; Growth and Development Strategy; Pharmaceutical Industry

01 Dec 2003
Research & Ideas

Sometimes Success Begins at Failure

that eventually resulted in a historic windfall for the drug maker soon after it began marketing UK-92,480 under the brand name Viagra. Pfizer was able to develop and launch a wildly successful and... View Details

Keywords: by Henry Chesbrough; Health; Pharmaceutical

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

November 2008 (Revised July 2009)
Background Note

A Managerial Perspective on Clinical Trials

By: Arthur A. Daemmrich

This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70... View Details

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

2024
Working Paper

Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances

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

This case history describes how Magnetic Resource Imaging (MRI) came to complement – and partially replace -- computed tomography (CT) imaging of soft tissue. Specifically, we chronicle 1) the development of foundational techniques and prototypes (through the 1970s);... 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

June 2018
Teaching Note

Sandra Brown Goes Digital

By: Rosabeth Moss Kanter and Jonathan Cohen

As a middle manager at a biotechnology company, Sandra Brown harnessed digital tools and social media to engage others and build campaigns for change in the company. This Teaching Note presents strategies for teaching the Sandra Brown case series, which follows Brown's... View Details

Keywords: Change Leadership; Change Management; Digital; Engagement; Stakeholder Engagement; Grassroots Movement; Health Care Industry; Career Path; Innovation; Leading Change; Management; Innovation and Management; Personal Development and Career; Organizational Change and Adaptation; Quality

February 2001 (Revised July 2006)
Case

Discovering the Future: R&D Strategy at Merck

By: Gary P. Pisano

Given explosive growth in technologies for drug discovery, how does Merck remain competitive in an industry that is fragmented and continues to consolidate? View Details

Keywords: Competitive Strategy; Research and Development; Pharmaceutical Industry

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