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- 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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Kwon, Caleb, Ananth Raman, and Jorge Tamayo. "Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions." Working Paper, April 2024.
- 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).
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- December 2022
- Article
'Just Letting You Know…': Underestimating Others' Desire for Constructive Feedback
By: Nicole Abi-Esber, Jennifer E. Abel, Juliana Schroeder and Francesca Gino
People often avoid giving feedback to others even when it would help fix a problem immediately. Indeed, in a pilot field study (N=155), only 2.6% of individuals provided feedback to survey administrators that the administrators had food or marker on their faces....
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Keywords:
Feedback;
Helping;
Prosocial Behavior;
Misprediction;
Relationships;
Interpersonal Communication;
Perspective
Abi-Esber, Nicole, Jennifer E. Abel, Juliana Schroeder, and Francesca Gino. "'Just Letting You Know…': Underestimating Others' Desire for Constructive Feedback." Journal of Personality and Social Psychology 123, no. 6 (December 2022): 1362–1385.
- September 2022
- Article
The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente
By: Alyce S. Adams, Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong and Wesley Yin
Most hospitals have financial assistance programs for low-income patients. We use administrative data from Kaiser Permanente to study the effects of financial assistance on health care utilization. Using a regression discontinuity design based on an income threshold...
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Keywords:
Healthcare;
Utilization;
Financial Assistance;
Health Care and Treatment;
Social Issues;
Poverty;
Health Industry
Adams, Alyce S., Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong, and Wesley Yin. "The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente." American Economic Review: Insights 4, no. 3 (September 2022): 389–407.
- 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).
- 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.
- 2021
- Article
Public Health Risks Arising from Food Supply Chains: Challenges and Opportunities
By: Lu Chen, Donovan Guittieres, Retsef Levi, Elisabeth Paulson, Georgia Perakis, Nicholas Renegar and Stacy Springs
Safe, healthy, and resilient food supply chains are essential to ensuring the livelihood and well-being of humans and societies, as well as local and global economies. However, the ability to provide and sustain access to nutritious and safe food continues to be a...
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Keywords:
Food Safety;
Adulteration;
Malnutrition;
Supply Chain;
Health;
Government Administration;
Food and Beverage Industry
Chen, Lu, Donovan Guittieres, Retsef Levi, Elisabeth Paulson, Georgia Perakis, Nicholas Renegar, and Stacy Springs. "Public Health Risks Arising from Food Supply Chains: Challenges and Opportunities." Special Issue on OR Models for Developmental Studies. Naval Research Logistics Quarterly 68, no. 8 (2021): 1098–1112.
- 2021
- Working Paper
'Just Letting You Know…': Underestimating Others' Desire for Constructive Feedback
By: Nicole Abi-Esber, Jennifer Abel, Juliana Schroeder and Francesca Gino
People often avoid giving feedback to others even when it would help fix a problem immediately. Indeed, in a pilot field study (N=155), only 2.6% of individuals provided feedback to survey administrators that the administrators had food or marker on their faces....
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Keywords:
Feedback;
Helping;
Prosocial Behavior;
Relationships;
Social Psychology;
Theory;
Perception
Abi-Esber, Nicole, Jennifer Abel, Juliana Schroeder, and Francesca Gino. "'Just Letting You Know…': Underestimating Others' Desire for Constructive Feedback." Harvard Business School Working Paper, No. 22-009, August 2021.
- 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.
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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Keywords:
Connected Digital Products;
Telehealth;
Remote Monitoring;
Health Testing and Trials;
Research;
Governing Rules, Regulations, and Reforms;
Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).
- 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.
- 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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Keywords:
Medical Devices;
FDA;
Health Care and Treatment;
Government Administration;
Information;
Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- November 2020
- Teaching Note
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
Teaching Note for HBS Case No. 221-031. 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)...
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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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- 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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Keywords:
Mergers and Acquisitions;
Value;
Valuation;
Judgments;
Decision Making;
Cash Flow;
Financial Instruments;
Cognition and Thinking;
Pharmaceutical Industry;
Biotechnology Industry;
United States
Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Case 221-031, November 2020.
- October 2020 (Revised November 2023)
- 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;
Digital Platforms;
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
Bussgang, Jeffrey J., and Olivia Hull. "COVID-19 Testing at Everlywell." Harvard Business School Case 821-001, October 2020. (Revised November 2023.)
- 2020
- Working Paper
Fresh Fruit and Vegetable Consumption: The Impact of Access and Value
By: Retsef Levi, Elisabeth Paulson and Georgia Perakis
The goal of this paper is to leverage household-level data to improve food-related policies aimed at increasing the consumption of fruits and vegetables (FVs) among low-income households. Currently, several interventions target areas where residents have limited...
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Keywords:
Food Deserts;
Food Access;
Food Policy;
Causal Inference;
Food;
Nutrition;
Poverty;
Government Administration
Levi, Retsef, Elisabeth Paulson, and Georgia Perakis. "Fresh Fruit and Vegetable Consumption: The Impact of Access and Value." MIT Sloan Research Paper, No. 5389-18, October 2020.
- 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.)
- 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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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).