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- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...
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- November 2020
- Teaching Note
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...
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- November 2020
- Case
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...
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- November 2020
- Supplement
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage...
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- October 2020
- Case
COVID-19 Testing at Everlywell
By: Jeffrey J. Bussgang and Olivia Hull
In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the...
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Keywords:
Entrepreneurship;
Business Strategy;
Venture Capital;
Health Care and Treatment;
Health Disorders;
Leading Change;
Technology Adoption;
Technology Platform;
Competitive Strategy;
Science;
Adaptation;
Corporate Social Responsibility and Impact;
Crisis Management;
Social Entrepreneurship;
Ethics;
Government Legislation;
Health;
Health Testing and Trials;
Health Pandemics;
Consumer Products Industry;
Health Industry;
Technology Industry;
Texas;
United States
- 2020
- Working Paper
Chimeric Antigen Receptor (CAR) T-Cell Therapy: 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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- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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- 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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- January 2020
- Article
The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System
By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...
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- 2020
- Working Paper
Magnetic Resonance Imaging: Case Histories of Significant Medical Advances
By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins
We describe how and why Magnetic Resource Imaging (MRI) came to complement—and partially replace—computed tomography (CT) imaging of soft tissue. Specifically we chronicle: 1) the development of foundational techniques and prototypes (through the 1970s); 2) how U.S....
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- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
- February 2018
- Article
Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience
By: Bradley R. Staats, Diwas S. KC and F. Gino
Many models in operations management involve dynamic decision making that assumes optimal updating in response to information revelation. However, behavioral theory suggests that rather than updating their beliefs, individuals may persevere in their prior beliefs. In...
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- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel Dora Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...
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- 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...
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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
- May 2016 (Revised March 2020)
- Teaching Note
Cyberdyne: A Leap to the Future
By: Doug J. Chung and Mayuka Yamazaki
Cyberdyne Inc. was a Japanese technology venture founded in 2004 by scientist Yoshiyuki Sankai to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from...
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- January 2016 (Revised July 2018)
- Case
Cyberdyne: A Leap to the Future
By: Doug J. Chung and Mayuka Yamazaki
Cyberdyne Inc. was a Japanese technology venture that wanted to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from stroke, spinal cord injury (SCI),...
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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...
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- 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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- November 2010
- Supplement
Hikma Pharmaceuticals (B)
By: John A. Quelch
By 2009, Hikma Pharmaceuticals operated 13 manufacturing plants in 8 countries of which 5 were approved by the U.S. Food and Drug Administration. Hikma tracked its sales revenues over the period to show where the largest contributors were from.
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- November 2009 (Revised March 2013)
- Case
PureCircle
By: David E. Bell and Aldo Sesia
In December 2008, the U.S. Food and Drug Administration (FDA) determined that high-purity Rebaudioside A (Reb A), a natural and calorie-free product that a young company named PureCircle manufactured from the Stevia plant, could be used in beverages, foods, and as a...
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