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      • Faculty Publications  (122)

      Drug DevelopmentRemove Drug Development →

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      • 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
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      Rafiq, Sana, and Max Bazerman. "Pay-for-Monopoly? An Assessment of Reverse Payment Deals by Pharmaceutical Companies." Journal of Behavioral Economics for Policy 3, no. 1 (2019): 37–43.
      • 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
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      Datar, Srikant M., Amar Bhidé, and Katherine Stebbins. "Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-001, July 2019. (Revised May 2024.)
      • 2019
      • Chapter

      Characterizing the Drug Development Pipeline for Precision Medicines

      By: Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
      BOOK ABSTRACT: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement... View Details
      Keywords: Healthcare; Precision Medicine
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      Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern. "Characterizing the Drug Development Pipeline for Precision Medicines." Chap. 5 in Economic Dimensions of Personalized and Precision Medicine, edited by Ernest R. Berndt, Dana P. Goldman, and John W. Rowe, 115–158. University of Chicago Press, 2019.
      • November 2018
      • Case

      David Hysong and SHEPHERD Therapeutics

      By: Ananth Raman, John Masko and Aldo Sesia
      In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his... View Details
      Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges
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      Raman, Ananth, John Masko, and Aldo Sesia. "David Hysong and SHEPHERD Therapeutics." Harvard Business School Case 619-012, November 2018.
      • 2018
      • Chapter

      The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century

      By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
      On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new... View Details
      Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly
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      Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
      • 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
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      Kanter, Rosabeth Moss, and Jonathan Cohen. "Sandra Brown Goes Digital." Harvard Business School Teaching Note 318-156, June 2018.
      • March 2018
      • Case

      Sandra Brown Goes Digital (A): The Promise and Perils of Social Movements in a Healthcare Company

      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 case follows her career at the company and describes the challenges she faced as a change agent,... View Details
      Keywords: Digital; Engagement; Stakeholder Engagement; Grassroots Movement; Organization Change And Adaptation; Quality; Health Care; Health Care Industry; Career Path; Leading Change; Management; Innovation and Management; Personal Development and Career; Organizational Change and Adaptation; Biotechnology Industry; Health Industry
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      Kanter, Rosabeth Moss, and Jonathan Cohen. "Sandra Brown Goes Digital (A): The Promise and Perils of Social Movements in a Healthcare Company." Harvard Business School Case 318-082, March 2018.
      • January 2018
      • Supplement

      BeiGene Supplemental PowerPoint

      By: Willy C. Shih and Jimmy Zhang
      BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window... View Details
      Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; Biotechnology Industry; China
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      Shih, Willy C., and Jimmy Zhang. "BeiGene Supplemental PowerPoint." Harvard Business School PowerPoint Supplement 618-043, January 2018.
      • January 2018
      • Teaching Note

      BeiGene

      By: Willy Shih and Jimmy Zhang
      Teaching Note for HBS No. 618-033. View Details
      Keywords: Biotechnology; Drug Development; Corporate Strategy; Business Startups; Technological Innovation; Situation or Environment; Biotechnology Industry; Pharmaceutical Industry; China
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      Shih, Willy, and Jimmy Zhang. "BeiGene." Harvard Business School Teaching Note 618-039, January 2018.
      • January 2018 (Revised January 2019)
      • Case

      ZappRx

      By: Jeffrey J. Bussgang and Olivia Hull
      In October 2015, ZappRx founder Zoe Barry is deciding between two business models for her health technology start-up. Her product, a software application that aims to expedite the prescription fulfillment process for patients with rare diseases, has attracted interest... View Details
      Keywords: Speciality Drugs; Hub Services; Pivot; Speciality Prescriptions; Health Care and Treatment; Customization and Personalization; Internet and the Web; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; Massachusetts
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      Bussgang, Jeffrey J., and Olivia Hull. "ZappRx." Harvard Business School Case 818-001, January 2018. (Revised January 2019.)
      • November 2017
      • Case

      BeiGene

      By: Willy Shih and Jimmy Zhang
      BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window... View Details
      Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Business Startups; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; China
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      Shih, Willy, and Jimmy Zhang. "BeiGene." Harvard Business School Case 618-033, November 2017.
      • 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 2017
      • Other Article

      Stepwise Distributed Open Innovation Contests for Software Development: Acceleration of Genome-Wide Association Analysis

      By: Andrew Hill, Po-Ru Loh, Ragu B. Bharadwaj, Pascal Pons, Jingbo Shang, Eva C. Guinan, Karim R. Lakhani, Iain Kilty and Scott Jelinsky
      BACKGROUND: The association of differing genotypes with disease-related phenotypic traits offers great potential to both help identify new therapeutic targets and support stratification of patients who would gain the greatest benefit from specific drug classes.... View Details
      Keywords: Crowdsourcing; Genome-wide Association Study; Logistic Regression; Open Innovation; PLINK; Collaborative Innovation and Invention
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      Hill, Andrew, Po-Ru Loh, Ragu B. Bharadwaj, Pascal Pons, Jingbo Shang, Eva C. Guinan, Karim R. Lakhani, Iain Kilty, and Scott Jelinsky. "Stepwise Distributed Open Innovation Contests for Software Development: Acceleration of Genome-Wide Association Analysis." GigaScience 6, no. 5 (May 2017).
      • April 2017
      • Case

      Imprimis (A)

      By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
      This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in... View Details
      Keywords: Strategy; Healthcare; Drug Compounding; Pharmaceuticals; Compounding; Drug Development; Decision-making; Mark Baum; Imprimis; Small Business; Decisions; Cost vs Benefits; Business Strategy; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; United States
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      Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (A)." Harvard Business School Case 717-426, April 2017.
      • April 2017
      • Supplement

      Imprimis (B)

      By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
      This case is a supplement to Imprimis (A). It describes the company’s decision to enter into the pharmaceutical compounding business in 2013–2014. Imprimis purchased a compounded ophthalmological medication called Dropless Therapy, which was injected into patients’... View Details
      Keywords: Healthcare; Drug Compounding; Drug Development; Pharmaceuticals; Small Business; Decision-making, Business Model; Mark Baum; Imprimis; Decision Making; Strategy; Health Care and Treatment; Policy; Pharmaceutical Industry; United States
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      Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (B)." Harvard Business School Supplement 717-496, April 2017.
      • April 2017
      • Supplement

      Imprimis (D)

      By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
      This case is a supplement to Imprimis (A, B, & C). It describes Imprimis’s 2015 decision to develop a $1 per pill compounded alternative to Daraprim, the branded drug that had recently undergone an extreme price hike, raising its price to $750 per pill. Imprimis also... View Details
      Keywords: Decision Choices and Conditions; Growth and Development Strategy; Pharmaceutical Industry; United States
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      Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (D)." Harvard Business School Supplement 717-498, April 2017.
      • 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
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      Fuller, Joseph B., and Andrew Otazo. "Terrapin Laboratory." Harvard Business School Teaching Plan 316-183, June 2016.
      • 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
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      Deshpande, Rohit, and Esel Çekin. "Rebranding Godiva: The Yıldız Strategy." Harvard Business School Case 515-059, January 2015. (Revised July 2019.)
      • October 2014 (Revised April 2023)
      • Case

      Gilead: Hepatitis C Access Strategy (A)

      By: V. Kasturi Rangan, Vikram Rangan and David E. Bloom
      Gilead had come up with an innovative drug for Hepatitis C, which affected 180 million people worldwide. The drug was priced at $1,000 a pill for the US market. Gilead had to decide how to price and market the pill in developing countries that bore the brunt of the... View Details
      Keywords: Healthcare; Pharmaceuticals; Pricing; Access To Care; Emerging Markets; Health Care and Treatment; Price; Strategy; Ethics; Health Industry; Pharmaceutical Industry
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      Rangan, V. Kasturi, Vikram Rangan, and David E. Bloom. "Gilead: Hepatitis C Access Strategy (A)." Harvard Business School Case 515-025, October 2014. (Revised April 2023.)
      • September 2014 (Revised February 2015)
      • Case

      Pfizer and AstraZeneca: Marketing an Acquisition (A)

      By: John A. Quelch and James Weber
      In 2014, Pfizer proposed a friendly acquisition of AstraZeneca, but the AstraZeneca board resisted over price and strategy concerns. Was this good for pharmaceutical consumers? Pfizer, like pharmaceutical companies in general, faced difficulties in growing sales due to... View Details
      Keywords: Health Care Policy; Mergers And Acquisitions; Marketing; Government Relations; Crisis Management; Decision Making; Growth and Development; Management; Markets; Strategy; Pharmaceutical Industry; United Kingdom; United States
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      Quelch, John A., and James Weber. "Pfizer and AstraZeneca: Marketing an Acquisition (A)." Harvard Business School Case 515-007, September 2014. (Revised February 2015.)
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