Publications

19 Apr 2023
Video

How Martine Rothblatt Started a Company to Save Her Daughter

August 2017 (Revised July 2018)
Case

MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work

By: Elie Ofek and Amanda Dai

In June 2014, MannKind Corporation announced that after years of development and billions of dollars in expenses, the FDA had finally approved its drug, Afrezza. MannKind would thus be the only company with an inhalable insulin on the market. As an alternative to... View Details

Keywords: Health Care and Treatment; Product Launch; Product Positioning; Marketing Strategy; Adoption; Pharmaceutical Industry

01 Aug 2023
Cold Call Podcast

Can Business Transform Primary Health Care Across Africa?

Keywords: Re: Regina E. Herzlinger; Pharmaceutical; Health

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

Satish Tadikonda is a Senior Lecturer in the Entrepreneurial Management Unit at Harvard Business School. In the MBA program, Satish teaches The Entrepreneurial Manager, a required first-year MBA course, and Entrepreneurship in Life Sciences, an elective course for... View Details

24 Sep 2007
Research & Ideas

The FDA: What Will the Next 100 Years Bring?

The U.S. Food and Drug Administration, which was created by the passage of the 1906 Federal Food and Drugs Act, regulates companies and industries accounting for one-quarter of all consumer spending, roughly... View Details

Keywords: by Sean Silverthorne; Biotechnology; Consumer Products; Food & Beverage; Health

May 2023 (Revised June 2023)
Supplement

Novartis (B): 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; Production; Business Strategy; Pharmaceutical Industry

March 2008
Case

Novartis AG: Science-Based Business

By: H. Kent Bowen and Courtney Purrington

Novartis is a science-based drug company, which has important implications for its business strategy. It is one of the largest pharmaceutical companies in the world with over $38B in sales in 2007. Pharmaceuticals account for slightly over $24B of that total. In 2007,... View Details

Keywords: Innovation and Invention; Resource Allocation; Product Development; Partners and Partnerships; Research and Development; Science-Based Business; Pharmaceutical Industry

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

Find at Harvard

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

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

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

Research Summary

Health-care Applications

Active postmarketing drug surveillance. There is substantial interest within the U.S. health community and among health policymakers in developing a surveillance system that scans public health databases in order to proactively detect potential drug safety... View Details

2008
Chapter

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

By: Arthur A. 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: Geographic Location; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Demand and Consumers; Pharmaceutical Industry; European Union; Germany; United States

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

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

March 2011 (Revised February 2012)
Case

Innovation and Growth at Actelion Ltd.

By: Gary P. Pisano, Daniela Beyersdorfer and Ruth Dittrich

In late 2010, Jean-Paul Clozel, CEO of the Swiss biotech pharmaceuticals firm Actelion, looks back on a successful decade. The small venture that he had started with a few of his scientist colleagues in the late 1990s to discover novel medicine in a research-driven... View Details

Keywords: Business Model; Talent and Talent Management; Innovation and Management; Leadership; Growth and Development Strategy; Product Development; Organizational Culture; Research and Development; Biotechnology Industry; Pharmaceutical Industry; Switzerland

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

Read Now

September 2023 (Revised April 2024)
Case

Atomwise: Strategic Opportunities in AI for Pharma

By: Satish Tadikonda

Abraham Heifets and his co-founder, Izhar Wallach, had founded Atomwise to develop i) an AI engine to transform drug discovery by creating better medicines faster, and ii) a machine learning-based discovery engine that combined the power of convolutional neural... View Details

Keywords: Business Model; Business Startups; AI and Machine Learning; Science-Based Business; Technological Innovation; Biotechnology Industry; Pharmaceutical Industry