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- 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
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.
- 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
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.
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous... View Details
Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- 22 Feb 2021
- Working Paper Summaries
Private and Social Returns to R&D: Drug Development and Demographics
- 11 Sep 2019
- Research & Ideas
Germany May Have the Answer for Reducing Drug Prices
American lawmakers attempting to stem spiraling drug costs might find inspiration in Germany, where the government’s regulatory model has been curbing price growth without thwarting innovation or access, says research from Harvard... View Details
- 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
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.)
- 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
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.
- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details
Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- 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
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.
- 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
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.
- 20 Aug 2020
- News
The U.S. Needs an SEC for its Health Care System
- 11 Jun 2018
- News
How science can bring about a eureka moment for Indian startups
- March 2014
- Editorial
Limits on Use of Health Economic Assessments for Rare Diseases
By: Hanna I. Hyry, Ariel Dora Stern, Jonathan CP Roos and Timothy M. Cox
Funding of expensive treatments for rare ('orphan') diseases is contentious. These agents fare poorly on 'efficiency' or health economic measures, such as the QALY, because of high cost and frequently poor gains in quality of life and survival. We show that... View Details
Hyry, Hanna I., Ariel Dora Stern, Jonathan CP Roos, and Timothy M. Cox. "Limits on Use of Health Economic Assessments for Rare Diseases." hcu016. QJM: An International Journal of Medicine 107, no. 3 (March 2014): 241–245.
- 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
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.
- 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
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.
- 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
- 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
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.)
- January 2020
- Article
Assessing the Safety of Electronic Health Records: A National Longitudinal Study of Medication-related Decision Support
By: A Jay Holmgren, Zoe Co, Lisa Newmark, Melissa Danforth, David Classen and David Bates
Background Electronic health records (EHR) can improve safety via computerised physician order entry with clinical decision support, designed in part to alert providers and prevent potential adverse drug events at entry and before they reach the patient.... View Details
Keywords: Hospital; Electronic Health Records; Health Care and Treatment; Information Technology; Safety; Performance; Quality; Performance Improvement
Holmgren, A Jay, Zoe Co, Lisa Newmark, Melissa Danforth, David Classen, and David Bates. "Assessing the Safety of Electronic Health Records: A National Longitudinal Study of Medication-related Decision Support." BMJ Quality & Safety 29, no. 1 (January 2020): 52–59.