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All HBS Web
(484)
- People (1)
- News (142)
- Research (265)
- Events (1)
- Multimedia (3)
- Faculty Publications (91)
- August 2022
- Article
Availability of New Medicines in the U.S. and Germany From 2004 to 2018
By: Katharina Blankart, Huseyin Naci and Amitabh Chandra
Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial...
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Keywords:
Market Entry and Exit;
Price;
Market Timing;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States;
Germany
Blankart, Katharina, Huseyin Naci, and Amitabh Chandra. "Availability of New Medicines in the U.S. and Germany From 2004 to 2018." e2229231. JAMA Network Open 5, no. 8 (August 2022).
- 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...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- November 1993 (Revised January 2006)
- Supplement
Beech-Nut Nutrition Corporation (B)
By: Lynn S. Paine
Officials of the U.S. Food and Drug Administration (FDA) must decide whether to refer the Beech-Nut apple juice case to the Justice Department for criminal prosecution, and if so, whether to recommend prosecution of individual executives or of the company only.
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Paine, Lynn S. "Beech-Nut Nutrition Corporation (B)." Harvard Business School Supplement 394-103, November 1993. (Revised January 2006.)
- 18 Dec 2018
- First Look
New Research and Ideas, December 18, 2018
2018 Innovation Policy and the Economy The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century By: Bagley, Nicholas, Benjamin Berger, Amitabh...
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Keywords:
Dina Gerdeman
- 04 Sep 2018
- First Look
New Research and Ideas, September 4, 2018
have been affected. Just a handful of these children were born in the U.S., where safety concerns were raised by Dr. Frances Oldham Kelsey, the medical officer handling the thalidomide application at the U.S. Food View Details
Keywords:
Dina Gerdeman
- 2021
- Working Paper
Development of CAR-T Therapies: Case Histories of Significant Medical 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)...
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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. "Development of CAR-T Therapies: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-035, August 2020. (Revised May 2021.)
- October 2012 (Revised December 2013)
- Case
Urbanizing China
By: Lakshmi Iyer and G.A. Donovan
In 2012, China attained a historic development milestone with more Chinese citizens living in cities than in the countryside. China's rapid urbanization, and the accompanying conversion of agricultural land to non-agricultural uses, raised a number of economic, social,...
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Keywords:
China;
Urbanization;
Industrialization;
Property Rights;
Local Government Finance;
Social Protest;
Business Environment;
Food Security;
Safety;
Change Management;
Food;
Urban Development;
Social Issues;
Growth and Development Strategy;
Public Administration Industry;
Public Administration Industry;
China
Iyer, Lakshmi, and G.A. Donovan. "Urbanizing China." Harvard Business School Case 713-037, October 2012. (Revised December 2013.)
- 2015
- Working Paper
Blinded by Experience: Prior Experience, Negative News and Belief Updating
By: Bradley R. Staats, Diwas S. KC and Francesca Gino
Traditional models of operations management involve dynamic decision-making assuming optimal (Bayesian) updating. However, behavioral theory suggests that individuals exhibit bias in their beliefs and decisions. We conduct both a field study and two laboratory studies...
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Keywords:
Behavioral Operations;
Egocentric Bias;
Experience;
Healthcare Operations;
Prejudice and Bias;
Behavior;
Operations;
Decision Making;
Health Care and Treatment
Staats, Bradley R., Diwas S. KC, and Francesca Gino. "Blinded by Experience: Prior Experience, Negative News and Belief Updating." Harvard Business School Working Paper, No. 16-015, August 2015.
- 22 Jun 2021
- Research & Ideas
The COVID-19 Mutiny: When Teams Leave and Take Their Clients
industrial washer in the spin cycle, putting entire industries (arts and entertainment, tourism, food and hospitality) at risk even as others (real estate, construction, View Details
- August 2008 (Revised September 2008)
- Case
The Flaxil Label (B)
This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite...
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Keywords:
Governance;
Risk and Uncertainty;
Value Creation;
Negotiation;
Attitudes;
Health Care and Treatment;
Government Administration;
Pharmaceutical Industry;
United States
Barron, Greg M. "The Flaxil Label (B)." Harvard Business School Case 909-002, August 2008. (Revised September 2008.)
- September 2013 (Revised August 2015)
- Background Note
Leadership and Teaming
By: Ethan Bernstein
Small differences in the leadership of teams can have large consequences for the success of their efforts. Many initiatives fail not because of a fatal error in judgment or insufficient ideas, knowledge, motivation, or capabilities to deliver a solution. They fail...
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Keywords:
Teams;
Teaming;
Leadership And Managing People;
Leadership;
Team Effectiveness;
Team Performance;
Team Design;
Team Leadership;
Teamwork;
Team Process;
Team Function;
Team Launch;
60/30/10 Rule;
Team Boundary;
Distribution Of Leadership Authority;
Self-Managed Teams;
Virtual Teams;
Unbounded Teams;
Acts Of Leadership;
Execution Teams;
Decision Making Teams;
Creativity Teams;
Team Size;
Task Design;
Team Timeline;
Team Roles;
Team Representation;
Diversity;
Team Familiarity;
Collective Intelligence;
Team Stages Of Development;
Team Coaching;
Performance Pressure;
X-Teams;
Team Focus;
Interaction;
Management Teams;
Managerial Roles;
Management Systems;
Management Style;
Management Skills;
Management Practices and Processes;
Organizational Design;
Organizational Structure;
Performance Effectiveness;
Performance Efficiency;
Performance Productivity;
Groups and Teams;
Networks;
Social Psychology;
Behavior;
Conflict and Resolution;
Creativity;
Social and Collaborative Networks;
Satisfaction;
Prejudice and Bias;
Power and Influence;
Personal Characteristics;
Familiarity;
Cognition and Thinking;
Attitudes;
Projects;
Organizational Culture;
Organizational Change and Adaptation;
Leadership Development;
Leadership Style;
Leading Change;
Knowledge Use and Leverage;
Knowledge Sharing;
Collaborative Innovation and Invention;
Innovation and Management;
Innovation Leadership;
Design;
Interpersonal Communication;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
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Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Agriculture and Agribusiness Industry;
Asia;
North and Central America;
South America;
Atlantic Ocean;
Central Asia;
Europe;
Latin America;
Middle East;
Oceania;
West Indies
Bernstein, Ethan. "Leadership and Teaming." Harvard Business School Background Note 414-033, September 2013. (Revised August 2015.)
- 01 Mar 2024
- News
Alumni and Faculty Books and Podcasts
Edited by Margie Kelley Alumni Books You Got This! A Straightforward, No-Nonsense Playbook for Crushing 130+ Workplace Challenges By Heidi Abelli (MBA 1993) Palmetto Publishing Stepping into the corporate world can feel like navigating a labyrinth, especially when...
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- August 2008 (Revised September 2008)
- Case
The Flaxil Label (A)
This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite...
View Details
Keywords:
Governing Rules, Regulations, and Reforms;
Health Disorders;
Product Launch;
Negotiation Process;
Business and Government Relations;
Safety;
Pharmaceutical Industry
Barron, Greg M. "The Flaxil Label (A)." Harvard Business School Case 909-001, August 2008. (Revised September 2008.)
- 05 Jun 2018
- First Look
New Research and Ideas, June 5, 2018
Mondelēz International Mondelēz International is a packaged foods company competing primarily in “snacks” around the globe. The case describes how and why the Kraft Inc. CEO, View Details
Keywords:
Dina Gerdeman
- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was...
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Keywords:
Public Health;
Genome Testing;
Health Care;
Ancestry;
23andMe;
Marketing;
Product Launch;
Health;
Health Care and Treatment;
Health Testing and Trials;
Genetics;
Strategy;
Health Industry;
United States
Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
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Keywords:
Biosimilars;
Rebates;
Pharmaceuticals;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
United States
Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
- 2024
- Working Paper
Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions
We investigate whether corporate officers should grant managers discretion to override AI-driven demand forecasts and labor scheduling tools. Analyzing five years of administrative data from a large grocery retailer using such an AI tool, encompassing over 500 stores,...
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Keywords:
AI and Machine Learning;
Forecasting and Prediction;
Working Conditions;
Performance Productivity
Kwon, Caleb, Ananth Raman, and Jorge Tamayo. "Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions." Working Paper, April 2024.
A Radical Treatment for Insulin Pricing
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a...
View Details
- 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).