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All HBS Web
(500)
- People (1)
- News (142)
- Research (262)
- Events (1)
- Multimedia (3)
- Faculty Publications (91)
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- 09 Feb 2024
- HBS Case
Slim Chance: Drugs Will Reshape the Weight Loss Industry, But Habit Change Might Be Elusive
what may at first blush appear to be an easier fix: new drugs such as Ozempic, Wegovy, and Mounjaro, says Harvard Business School Professor Regina E. Herzlinger, who has studied the American health care...
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- 09 May 2018
- Research & Ideas
A Simple Way for Restaurant Inspectors to Improve Food Safety
Restaurant inspectors can be the last line of defense between you and moldy bread. (HighLaZ) Simple tweaks to the schedules of food safety inspectors could result in hundreds of thousands of currently...
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- 11 Jan 2017
- Research & Ideas
The Paradoxical Quest to Make Food Look 'Natural' With Artificial Dyes
chromate was used to make milk look creamier; and various poisonous ingredients were used to create bright colors for various candies, reportedly causing some children to fall ill or even die. Hisano highlights key dates in View Details
Keywords:
by Carmen Nobel
- 01 Oct 2018
- Working Paper Summaries
Negative Shocks and Innovation: Evidence from Medical Device Recalls
- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S....
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Keywords:
Governing Rules, Regulations, and Reforms;
Ethics;
Business and Government Relations;
Communication Strategy;
Health Care and Treatment;
Monopoly;
Intellectual Property;
Research and Development;
Price;
Pharmaceutical Industry;
London
Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
- August 2008 (Revised September 2008)
- Supplement
The Flaxil Label (C): Debrief and Endnotes
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:
Safety;
Value Creation;
Negotiation;
Health Care and Treatment;
Sales;
Pharmaceutical Industry
Barron, Greg M. "The Flaxil Label (C): Debrief and Endnotes." Harvard Business School Supplement 909-003, August 2008. (Revised September 2008.)
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- 2007
- Book
Perspectives on Risk and Regulation: The FDA at 100
By: Arthur A. Daemmrich and Joanna Radin
Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific...
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Keywords:
Private Sector;
Governing Rules, Regulations, and Reforms;
Policy;
Health Care and Treatment;
Business and Government Relations;
Risk and Uncertainty;
Cooperation
Daemmrich, Arthur A., and Joanna Radin, eds. Perspectives on Risk and Regulation: The FDA at 100. Chemical Heritage Foundation, 2007. (Fulltext.)
- 15 Jan 2019
- First Look
New Research and Ideas, January 15, 2019
forthcoming American Journal of Therapeutics Food and Drug Administration Guidance Documents and New Medical...
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Keywords:
Dina Gerdeman
- 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...
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Keywords:
Innovation and Invention;
Strategy;
Business or Company Management;
Society;
Health;
Public Administration Industry;
Public Administration 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.
- 2010
- Chapter
From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance
By: Arthur A. Daemmrich
Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Business and Government Relations;
Risk and Uncertainty;
Safety;
Pharmaceutical Industry;
United States
Daemmrich, Arthur A. "From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance." Chap. 13 in The Fragmentation of U.S. Health Care: Causes and Solutions, edited by Einer Elhauge, 301–322. Oxford: Oxford University Press, 2010.
- 14 Nov 2017
- First Look
New Research and Ideas: November 14, 2017
authors provide numerous examples of health care organizations that are taking these steps—and seeing impressive results. Publisher's link: https://pubwww.hbs.edu/faculty/Pages/item.aspx?num=53460 forthcoming JAMA Cardiology The Central and...
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Keywords:
Carmen Nobel
- 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).
- 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.)
- 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.
- 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.)
- 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
- 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.