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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://www.hbs.edu/faculty/Pages/item.aspx?num=53460 forthcoming JAMA Cardiology The Central and... View Details

Keywords: Carmen Nobel

01 Sep 2007
News

Riding It Out

is beginning to understand the importance of the issue,” says Gisholt. The country’s former head of the State Food and Drug Administration, Zheng Xiaoyu, was executed for... View Details

Keywords: Julia Hanna; dog food; pets; Food Manufacturing; Food Manufacturing; Food Manufacturing; Food Manufacturing

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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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. View Details

Keywords: Crime and Corruption; Decisions; Cases; Law; Management; Food and Beverage Industry

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... View Details

Keywords: Dina Gerdeman

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... View Details

Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms

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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... View Details

Keywords: Behavioral Operations; Egocentric Bias; Experience; Healthcare Operations; Prejudice and Bias; Behavior; Operations; Decision Making; Health Care and Treatment

SSRN

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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,... View Details

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

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

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... View Details

Keywords: Governance; Risk and Uncertainty; Value Creation; Negotiation; Attitudes; Health Care and Treatment; Government Administration; Pharmaceutical Industry; United States

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... View Details

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

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

Keywords: by Robin Abrahams, Boris Groysberg, and Steven L. Manchel

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... View Details

Keywords: Publishing Industries (except Internet); Information

News

How to End the Plasma Shortage for Coranavirus Patients

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... View Details

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

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... View Details

Keywords: Biosimilars; Rebates; Pharmaceuticals; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States