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- Faculty Publications (169)
Show Results For
-
All HBS Web
(479)
- People (1)
- News (134)
- Research (317)
- Multimedia (4)
- Faculty Publications (169)
- 10 Aug 2011
- Research & Ideas
HBS Faculty Views on Debt Crisis
of perhaps $90 trillion. One side argues that we can't raise revenues, while the other asserts we can't cut entitlements. Both sides are wrong. Entitlement costs, especially health care, will eat us alive. Without real View Details
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by Staff
- 2024
- Working Paper
Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances
By: Amar Bhide and Srikant M. Datar
By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the...
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Keywords:
Health Care and Treatment;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 21-132, June 2021. (Revised May 2024.)
- 06 Oct 2015
- First Look
October 6, 2015
at the Narayana Health City Cardiac Hospital (NH) in India. The case discusses the factors driving the adoption of task shifting at NH and identifies the implications of task shifting for surgeon training, surgical capacity, and procedure...
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Sean Silverthorne
- July 2019
- Article
The Impact of Price Regulation on the Availability of New Drugs in Germany
By: Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari
The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate...
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Keywords:
Regulation;
Pharmaceuticals;
Healthcare;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
Germany
Stern, Ariel Dora, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim, and Ameet Sarpatwari. "The Impact of Price Regulation on the Availability of New Drugs in Germany." Health Affairs 38, no. 7 (July 2019): 1182–1187.
- 2023
- Article
Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control
By: Susanna Gallani
Can managers use monetary incentives to elicit cooperation from workers they cannot reward for their efforts? I study “conduit incentives,” an innovative incentive design, whereby managers influence bonus-ineligible workers’ effort by offering bonus-eligible employees...
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Keywords:
Organizational Behavior Modification;
Peer Monitoring;
Persistence Of Performance Improvements;
Crowding Out;
Implicit Incentives;
Compensation;
Healthcare;
Social Pressure;
Image Motivation;
Incentives;
Motivation;
Performance;
Behavior;
Motivation and Incentives;
Compensation and Benefits;
Governing Rules, Regulations, and Reforms;
Organizational Culture;
Health Industry;
California
Gallani, Susanna. "Conduit Incentives: Eliciting Cooperation from Workers Outside of Managers' Control." Accounting Review 93, no. 3 (2023): 1–28.
- 26 Jul 2016
- Working Paper Summaries
The Impact of the Entry of Biosimilars: Evidence from Europe
- September 2009 (Revised August 2012)
- Case
Novasys Medical
By: Richard G. Hamermesh and Lauren Barley
Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the...
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Keywords:
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Policy;
Health Care and Treatment;
Health Disorders;
Product Development;
Business and Government Relations;
Medical Devices and Supplies Industry;
United States
Hamermesh, Richard G., and Lauren Barley. "Novasys Medical." Harvard Business School Case 810-027, September 2009. (Revised August 2012.)
- 12 Dec 2018
- News
Lesson Plan
the imperative to improve school quality and its key importance to the health of a regional economy. She also cited her work in the US Treasury during the financial crisis: “I witnessed that it’s possible to address enormous problems if...
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- June 2020
- Article
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Accuracy and consistency are critical for inspections to be an effective, fair, and useful tool for assessing risks, quality, and suppliers—and for making decisions based on those assessments. We examine how inspector schedules could introduce bias that erodes...
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Keywords:
Assessment;
Bias;
Inspection;
Scheduling;
Econometric Analysis;
Empirical Research;
Regulation;
Health;
Food;
Safety;
Quality;
Performance Consistency;
Governing Rules, Regulations, and Reforms
Ibanez, Maria, and Michael W. Toffel. "How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections." Management Science 66, no. 6 (June 2020): 2396–2416. (Revised February 2019. Featured in Harvard Business Review, Forbes, Food Safety Magazine, Food Safety News, and KelloggInsight. (2020 MSOM Responsible Research Finalist.))
- 2020
- Working Paper
How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?
By: Michael Blank, Samuel G. Hanson, Jeremy C. Stein and Adi Sunderam
Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that...
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Keywords:
COVID-19;
Bank Regulation;
Recapitalization;
Health Pandemics;
Banks and Banking;
Governing Rules, Regulations, and Reforms;
Strategy;
Risk Management;
United States
Blank, Michael, Samuel G. Hanson, Jeremy C. Stein, and Adi Sunderam. "How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?" Hutchins Center Working Paper, No. 63, June 2020.
- 03 Dec 2015
- Op-Ed
How "New Nuclear" Power Could Save the Planet—If Regulators Would Allow It
driven by the fears of the past: ensuring nuclear safety and radiological health and avoiding nuclear proliferation. However, our actual experience with these issues has been far different than anticipated. Political leaders and voters...
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- 2023
- Working Paper
The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina
By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle
We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed...
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Keywords:
COVID-19;
Health Care and Treatment;
Health Pandemics;
Adoption;
Behavior;
Governing Rules, Regulations, and Reforms;
Learning
Calónico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina." NBER Working Paper Series, No. 31781, October 2023.
- November 2008 (Revised July 2009)
- Background Note
A Managerial Perspective on Clinical Trials
By: Arthur A. Daemmrich
This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Product Development;
Safety;
Biotechnology Industry;
Pharmaceutical Industry
Daemmrich, Arthur A. "A Managerial Perspective on Clinical Trials." Harvard Business School Background Note 709-033, November 2008. (Revised July 2009.)
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- 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
This... View Details
Keywords:
Health Testing and Trials;
Governing Rules, Regulations, and Reforms;
Valuation;
Product Development;
Pharmaceutical Industry
Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
- 05 Jan 2016
- Working Paper Summaries
The Integrity of Private Third-party Compliance Monitoring
- 19 Jan 2022
- In Practice
7 Trends to Watch in 2022
As 2022 gets underway we asked our faculty to highlight some trends worth watching in the coming year. Ariel Stern: A new future for digital health care While 2020 and 2021 were years of rapid innovation and deployment of new health care technologies and delivery...
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by HBS News
- November 2009 (Revised March 2010)
- Case
Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story
By: Richard G. Hamermesh, Raju Kucherlapati and Rachel Gordon
In May 2007, Amgen Inc. (Amgen) received disappointing news from the European Medicines Agency (EMEA) that its drug Vectibix, developed to fight metastatic colorectal cancer, had been rejected. This was especially surprising news given that a similar rival drug had...
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Keywords:
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Marketing Strategy;
Product Positioning;
Genetics;
Biotechnology Industry;
Europe;
United States
Hamermesh, Richard G., Raju Kucherlapati, and Rachel Gordon. "Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story." Harvard Business School Case 810-066, November 2009. (Revised March 2010.)
- 2024
- Working Paper
Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational Advances
By: Amar Bhidé and Srikant M. Datar
In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works, 2) the foundational advances and discoveries, 3) the...
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Keywords:
Immunotherapy;
Health Care and Treatment;
Innovation and Invention;
Research and Development;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, and Srikant M. Datar. "Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 21-035, August 2020. (Revised May 2024.)
- Profile
Frank Spencer
know the details of the plan. You just have to be willing to participate with others in the work." "Real estate is the thread that's run through my career," adds Spencer, who most recently served as president of Cogdell Spencer Inc., a publicly traded...
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