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  • 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
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Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (A): Reimagining Medicine." Harvard Business School Case 723-443, May 2023. (Revised June 2023.)
  • February 2002 (Revised August 2002)
  • Case

Inhale Therapeutics: Executing and Growing the Business Model

Inhale is about to bring a novel technology to market that uses inhalation to administer drugs that formerly required injection. Inhale must now decide which way to evolve its business model. This will determine the future direction of growth for the company. View Details
Keywords: Business Model; Technological Innovation; Health Care and Treatment; Growth and Development Strategy; Medical Devices and Supplies Industry
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Chesbrough, Henry W., and Gillian Morris. "Inhale Therapeutics: Executing and Growing the Business Model." Harvard Business School Case 602-132, February 2002. (Revised August 2002.)
  • September 1993
  • Supplement

Manufacturing at ALZA: The Right Prescription? (C)

By: Dorothy A. Leonard
ALZA, a drug delivery company, considers marketing its own and other companies' products. The primary issue is whether to build an internal sales force focused on a few niche markets, to finance a sales force through alliances, or to acquire a marketing company. View Details
Keywords: Mergers and Acquisitions; Product Marketing; Alliances; Research and Development; Salesforce Management; Business Strategy; Pharmaceutical Industry
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Leonard, Dorothy A. "Manufacturing at ALZA: The Right Prescription? (C)." Harvard Business School Supplement 694-021, September 1993.
  • 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
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Ofek, Elie, and Amanda Dai. "MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work." Harvard Business School Case 518-031, August 2017. (Revised July 2018.)
  • 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
Citation
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Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (C): Reimagining Medicine." Harvard Business School Supplement 723-445, May 2023. (Revised June 2023.)
  • 01 Aug 2023
  • Cold Call Podcast

Can Business Transform Primary Health Care Across Africa?

Keywords: Re: Regina E. Herzlinger; Pharmaceutical; Health
  • 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
  • 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
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Ghosh, Shikhar, and Esel Çekin. "InstaDeep: AI Innovation Born in Africa (A)." Harvard Business School Case 822-104, February 2022. (Revised September 2022.)
  • 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
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Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (B): Reimagining Medicine." Harvard Business School Supplement 723-444, May 2023. (Revised June 2023.)
  • 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
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Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
  • 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
  • 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
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Bowen, H. Kent, and Courtney Purrington. "Novartis AG: Science-Based Business." Harvard Business School Case 608-136, March 2008.
  • 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
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Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
  • 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

  • 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
  • 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
Citation
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Daemmrich, Arthur A. "Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation." Chap. 16 in Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms. Vol. 363, edited by Jean Paul Gaudillière and Volker Hess, 271–290. Berlin, Germany: Max-Planck-Institut für Wissenschaftsgeschichte, 2008.
  • 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
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Daemmrich, Arthur A. "Targanta Therapeutics: Hitting a Moving Target." Harvard Business School Case 709-002, January 2009. (Revised July 2009.)
  • 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
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Pisano, Gary P., Daniela Beyersdorfer, and Ruth Dittrich. "Innovation and Growth at Actelion Ltd." Harvard Business School Case 611-065, March 2011. (Revised February 2012.)
  • 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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Daemmrich, Arthur. "Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location." Harvard Business School Working Paper, No. 09-118, April 2009.
  • 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
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Tadikonda, Satish. "Atomwise: Strategic Opportunities in AI for Pharma." Harvard Business School Case 824-043, September 2023. (Revised April 2024.)
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