Publications

2018
Book

Rebel Talent: Why It Pays to Break the Rules at Work and Life

By: F. Gino

The world’s best chef.
An airline captain who brought his flight to safety in a daring water landing.
A magician known for his sensational escape acts.
A computer scientist who founded a world-renowned animation studio.
What do all of these... View Details

Keywords: Talent and Talent Management; Personal Characteristics; Success; Behavior

December 2016 (Revised March 2017)
Case

Beingmate

By: David E. Bell, Juan Ma and Natalie Kindred

Founded in 2002, Hangzhou, China–based Beingmate was a major producer of infant formula and related products in the high-demand Chinese market. After an infamous 2008 food safety episode in China, in which toxic infant formula sickened thousands of babies and led to... View Details

Keywords: Marketing Strategy; Competitive Strategy; Partners and Partnerships; Food and Beverage Industry; China

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... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States

10 Feb 2009
First Look

First Look: February 10, 2009

b01/en/common/item_detail.jhtml?id=809095 GLOBALGAP: Food Safety and Private Standards Harvard Business School Case 509-004 In response to new laws governing liability and several View Details

Keywords: Martha Lagace

November 2017
Case

The 'Wonder Drug' That Killed Babies

By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble

In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children... View Details

Keywords: Regulation; Business and Government Relations; Business and Community Relations; Business and Stakeholder Relations; Product Marketing; Corporate Social Responsibility and Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe

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... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States

Read Now

07 Oct 2014
First Look

First Look: October 7

comparative advantages of intermediate versus final disclosure policies in fostering innovation. Publisher's link: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2288746 October 2014 The Compass (Newsletter of the American Society of View Details

Keywords: Sean Silverthorne

21 Jun 2011
First Look

First Look: June 21

refrigerated food products, primarily poultry, it begins by describing broad patterns about the use of alternative financing terms. These patterns help discipline a model in which the trade finance mode is shaped by the risk that an... View Details

Keywords: Sean Silverthorne

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... View Details

Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms

Read Now

August 2009 (Revised August 2009)
Case

Swire Beverages: Implementing CSR in China

By: Christopher Marquis, G.A. Donovan and YiKwan Chu

Swire Beverage, the largest Coca-Cola bottler in China, recently created a corporate social responsibility (CSR) organization to oversee environmental, community, health and safety initiatives at the companies' nine bottling plants in China. The case considers... View Details

Keywords: Brands and Branding; Corporate Social Responsibility and Impact; Organizational Design; Business and Stakeholder Relations; Partners and Partnerships; Non-Governmental Organizations; Food and Beverage Industry; China

20 Nov 2012
First Look

First Look: November 20

lifestyle and food choices of its employees or customers. But Boyan and his team thought differently. Purchase this case:http://hbr.org/search/512034-PDF-ENG The Product Manager Jeffrey Bussgang, Thomas Eisenmann, and Robert GoHarvard... View Details

Keywords: Sean Silverthorne

Program

Agribusiness Seminar

Summary Climate extremes, economic shifts, geopolitical conflict, environmental constraints, new technologies, regulatory changes, consumer expectations—these and many other forces are creating pressures, uncertainties, and opportunities across global and local View Details

Keywords: Agriculture; Agriculture

July 2000 (Revised April 2001)
Case

Agricultural Biotechnology and its Regulation

By: Forest L. Reinhardt

In the United States, genetically modified corn and soybeans are now widely grown and consumed. In Europe, however, they have been dubbed "Frankenstein foods," shunned by packaged food manufacturers, and subjected to a host of governmental restrictions. This case... View Details

Keywords: Agribusiness; Genetics; Governing Rules, Regulations, and Reforms; Corporate Strategy; Trade; Law; Goods and Commodities; Safety; Environmental Sustainability; Government and Politics; Agriculture and Agribusiness Industry; Biotechnology Industry; Europe; United States

November 2020
Case

Truebird—An AlleyCorp Venture

By: Shikhar Ghosh and Shweta Bagai

In December 2018, Kevin Ryan and Wendy Tsu faced an important decision – to finalize the CEO candidate for Truebird, an innovative, automated coffee café concept. Like many of AlleyCorp and Ryan’s companies, Truebird started with the observation of an unmet need – an... View Details

Keywords: Startup; Hiring; Staffing; Recruiting; Business Startups; Finance; Leadership; Management Skills; Management Teams; Jobs and Positions; Job Interviews; Human Resources; Recruitment; Selection and Staffing; Food and Beverage Industry; Food and Beverage Industry; United States