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    • All HBS Web  (152)
      • Faculty Publications  (13)

      Drug QualityRemove Drug Quality →

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      • 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.
      • November 2022
      • Case

      The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales

      By: Regina E. Herzlinger and Tiffany Farrell
      Can an online, direct-to-consumer pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous... View Details
      Keywords: DTC; Internet and the Web; Marketing Channels; Customer Value and Value Chain; Governing Rules, Regulations, and Reforms; Competitive Strategy; Service Delivery; Growth and Development Strategy; Pharmaceutical Industry; Health Industry; Retail Industry
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      Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
      • 2022
      • Working Paper

      Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina

      By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
      Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its... View Details
      Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina
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      Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
      • Summer 2021
      • Article

      The Cost and Evolution of Quality at Cipla Ltd, 1935–2016

      By: Muhammad H. Zaman and Tarun Khanna
      This article examines the evolution of Indian pharmaceutical manufacturer Cipla towards producing drugs that met the quality standards of European and U.S. regulators. It employs new research in Cipla’s corporate archives, the Creating Emerging Markets database, and... View Details
      Keywords: Cipla; Pharmaceuticals; Drug Quality; Generics; Quality; Standards; Information Technology; Cost; Organizational Culture; Business History; Pharmaceutical Industry; India
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      Zaman, Muhammad H., and Tarun Khanna. "The Cost and Evolution of Quality at Cipla Ltd, 1935–2016." Business History Review 95, no. 2 (Summer 2021): 249–274.
      • 2021
      • Working Paper

      Regulatory Approval and Expanded Market Size

      By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
      Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details
      Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
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      Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
      • May 2021
      • Case

      The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease

      By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
      This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory... View Details
      Keywords: Innovation and Invention; Strategy; Business or Company Management; Society; Health; Public Administration Industry; Health Industry; United States
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      Chandra, Amitabh, Spencer Lee-Rey, and Caroline Marra. "The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease." Harvard Business School Case 621-112, May 2021.
      • May 2021
      • Article

      Private and Social Returns to R&D: Drug Development and Demographics

      By: Efraim Benmelech, Janice Eberly, Dimitris Papanikolaou and Joshua Krieger
      Investment in intangible capital such as R&D has increased dramatically since the 1990s. However, productivity growth remains sluggish in recent years. One potential reason is that a significant share of the increase in intangible investment is geared toward consumer... View Details
      Keywords: Drug Development; Research and Development; Investment Return; Demographics; Pharmaceutical Industry
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      Benmelech, Efraim, Janice Eberly, Dimitris Papanikolaou, and Joshua Krieger. "Private and Social Returns to R&D: Drug Development and Demographics." AEA Papers and Proceedings 111 (May 2021): 336–340.
      • August 2020
      • Article

      Do Physician Incentives Increase Patient Medication Adherence?

      By: Edward Kong, John Beshears, David Laibson, Brigitte Madrian, Kevin Volpp, George Loewenstein, Jonathan Kolstad and James J. Choi
      We conducted a randomized experiment (911 primary care practices and 8,935 nonadherent patients) to test the effect of paying physicians for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. We measured... View Details
      Keywords: Health Economics; Medication Adherence; Physician Payment Incentives; Primary Care; Quality Improvement; Health Care and Treatment; Motivation and Incentives; Behavior
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      Kong, Edward, John Beshears, David Laibson, Brigitte Madrian, Kevin Volpp, George Loewenstein, Jonathan Kolstad, and James J. Choi. "Do Physician Incentives Increase Patient Medication Adherence?" Health Services Research 55, no. 4 (August 2020): 503–511.
      • 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.)
      • 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.
      • August 2004 (Revised July 2006)
      • Case

      PROPECIA TM: Helping Make Hair Loss History

      By: Marta Wosinska and Youngme E. Moon
      In late 1997, Tom Casola, brand manager for Propecia, debates the best approach to market this breakthrough one-a-day pill for hair loss. This launch would be atypical for a prescription drug because of the key position of the consumer. As a result, the team's... View Details
      Keywords: Advertising; Communication Strategy; Customers; Marketing Communications; Marketing Strategy; Product Launch; Product; Performance Effectiveness; Problems and Challenges; Quality; Pharmaceutical Industry
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      Wosinska, Marta, and Youngme E. Moon. "PROPECIA TM: Helping Make Hair Loss History." Harvard Business School Case 505-035, August 2004. (Revised July 2006.)
      • 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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      Chandra, Amitabh, Jennifer Kao, Kathleen L. Miller, and Ariel Dora Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." Review of Economics and Statistics (forthcoming). (Pre-published online March 18, 2024.)
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