Publications

July 2016
Case

Blue D Pharmaceuticals

By: Kevin Schulman, Emma Rasiel and Suresh Balu

Susan Durham has just been hired as the Chief Financial Officer of Blue Devil Pharmaceuticals (BDP). Her charge is to understand the optimal pathway for the development of a novel molecule, BDP-1, to understand the cost of drug development, the market opportunity, and... View Details

Keywords: Finance; Entrepreneurship

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

April 1993 (Revised October 1995)
Case

ALZA and Bio-Electro Systems (A): Technological and Financial Innovation

By: Josh Lerner and Peter Tufano

To develop the next generation of risky products, ALZA, a mature and profitable biotechnology firm specializing in drug delivery systems, must raise $40 million. Organizational constraints and competitive concerns demand that the work be done inside the firm. However,... View Details

Keywords: Risk and Uncertainty; Technological Innovation; Business Subsidiaries; Decision Choices and Conditions; Corporate Finance; Biotechnology Industry; Medical Devices and Supplies 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

September 2002 (Revised August 2003)
Case

Genzyme's Gaucher Initiative: Global Risk and Responsibility

By: Christopher A. Bartlett and Andrew N. McLean

In Egypt, Genzyme's humanitarian commitment to treat all sufferers of the rare Gaucher disease worldwide first confronts its commercial imperative to recoup the huge investment required to bring the drug Cerezyme to market. Here Tomye Tierney must decide how to balance... View Details

Keywords: Moral Sensibility; Investment; Emerging Markets; Negotiation; Corporate Social Responsibility and Impact; Business and Government Relations; Sales; Commercialization; Expansion; Value Creation

February 2007 (Revised April 2010)
Case

Wyeth Pharmaceuticals: Spurring Scientific Creativity with Metrics

By: Robert S. Huckman, Gary P. Pisano and Mark Rennella

Describes the reorganization of the drug discovery organization at Wyeth Pharmaceuticals and focuses on the decisions to: (1) centralize decision-making within drug discovery and (2) institute numerical metrics--jointly affecting all R&D scientists--for the progression... View Details

Keywords: Decision Making; Measurement and Metrics; Business Processes; Organizational Structure; Research and Development; Science-Based Business; Creativity; Pharmaceutical Industry

May 2023 (Revised June 2023)
Supplement

Novartis (C): 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 Testing and Trials; Health Care and Treatment; Business Model; Problems and Challenges; Pharmaceutical Industry; Switzerland

April 2020
Article

Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning

By: Ariel Dora Stern and W. Nicholson Price, II

In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging... View Details

Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms

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22 Feb 2016
Research & Ideas

The ‘Mother of Fair Trade’ was an Unabashed Price Protectionist

fascinating character to animate sometimes dry legalese.” Gleason’s quest for fair trade, or price protection, would not be easy. First off, the term “fair trade” in the 1930s had a different meaning than it does today when we use it to describe a social movement that... View Details

Keywords: by Dina Gerdeman; Retail; Health; Legal Services

12 Jul 2016
First Look

July 12, 2016

https://www.hbs.edu/faculty/Pages/item.aspx?num=51321 Entrepreneurship and Public Health Insurance By: Olds, Gareth Abstract—I examine the relationship between public health insurance and firm formation. Developing a variant of regression... View Details

Keywords: Sean Silverthorne

2022
Working Paper

Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern

Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to... View Details

Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development

October 2006 (Revised August 2007)
Case

Calloway Laboratory: Pee for Profit

By: Richard G. Hamermesh and David Kiron

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 treatment center business. View Details

Keywords: For-Profit Firms; Health Care and Treatment; Health Testing and Trials; Growth and Development Strategy; Market Entry and Exit; Health Industry

February 2022 (Revised September 2022)
Case

InstaDeep: AI Innovation Born in Africa (A)

By: Shikhar Ghosh and Esel Çekin

Karim Beguir and Zohra Slim were the co-founders of InstaDeep, a deep tech startup focusing on artificial intelligence (AI) solutions. Instadeep was one of the few companies globally that were partnering with DeepMind, an AI subsidiary of Google [Alphabet Inc.].... View Details

Keywords: AI; Artificial Intelligence; Entrepreneurship; Operations; Business Subsidiaries; Brands and Branding; Innovation and Invention; Growth and Development Strategy; AI and Machine Learning; Technology Industry; Africa

04 Sep 2018
First Look

New Research and Ideas, September 4, 2018

W. Feeley Abstract—Patients and providers are frustrated with seemingly endless data entry. We used our patients’ vested interest in their own health care by actively engaging them in the entry of their own medical information into the EHR. Prior to the implementation... View Details

Keywords: Dina Gerdeman

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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Forthcoming
Article

Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern

Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details

Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry

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22 Apr 2009
Working Paper Summaries

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

Keywords: by Arthur Daemmrich; Pharmaceutical

07 Dec 2010
First Look

First Look: Dec. 7

Subramanian Abstract We measure the value of shareholder proxy access by using a recent development in the ability of shareholders to nominate candidates for board seats. We use the SEC's October 4, 2010 announcement that it would... View Details

Keywords: Sean Silverthorne

February 2010
Supplement

Organization and Strategy at Millennium (B)

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 CEO Mark... View Details

Keywords: Leading Change; Transformation; Decision Choices and Conditions; Crisis Management; Competitive Advantage; Commercialization; Selection and Staffing; Product Development; Organizational Change and Adaptation; Pharmaceutical Industry