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      • 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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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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....  View Details
      Keywords: Feedback; Helping; Prosocial Behavior; Misprediction; Relationships; Interpersonal Communication; Perspective
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      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...  View Details
      Keywords: Healthcare; Utilization; Financial Assistance; Health Care and Treatment; Social Issues; Poverty; Health Industry
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      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.
      • 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...  View Details
      Keywords: Food Safety; Adulteration; Malnutrition; Supply Chain; Health; Government Administration; Food and Beverage Industry
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      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....  View Details
      Keywords: Feedback; Helping; Prosocial Behavior; Relationships; Social Psychology; Theory; Perception
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      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...  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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      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...  View Details
      Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology
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      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...  View Details
      Keywords: Innovation and Invention; Strategy; Business or Company Management; Society; Health; Public Administration Industry; Public Administration Industry; United States
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      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...  View Details
      Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards
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      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
      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...  View Details
      Keywords: Mergers and Acquisitions; Valuation; Value; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Teaching Note 221-036, November 2020.
      • 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...  View Details
      Keywords: Mergers and Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Spreadsheet Supplement 221-705, November 2020.
      • 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...  View Details
      Keywords: Mergers and Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
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      Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Case 221-031, November 2020.
      • October 2020 (Revised June 2021)
      • 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...  View Details
      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
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      Bussgang, Jeffrey J., and Olivia Hull. "COVID-19 Testing at Everlywell." Harvard Business School Case 821-001, October 2020. (Revised June 2021.)
      • 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...  View Details
      Keywords: Food Deserts; Food Access; Food Policy; Causal Inference; Food; Nutrition; Poverty; Government Administration
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      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)...  View Details
      Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms
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      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...  View Details
      Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework
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      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).
      • May 2020 (Revised March 2022)
      • Case

      The Coronavirus (COVID-19) Pandemic and the Global Economy (A)

      By: Alberto Cavallo and Christian Godwin
      In April 2020, the world struggled to contain the exponential escalation of the coronavirus (COVID-19) pandemic. Dozens of countries had imposed restrictions on travel, work, and social gatherings. A large share of the global population was under lockdowns and...  View Details
      Keywords: COVID-19 Pandemic; Demand and Consumers; Supply and Industry; Finance; Central Banking; Financial Markets; International Finance; Globalization; Government and Politics; Health Pandemics; Decision Making; Macroeconomics; Employment; Crisis Management; Supply Chain; Risk and Uncertainty; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Food and Beverage Industry; Asia; China; Europe; Latin America; Africa; United States
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      Cavallo, Alberto, and Christian Godwin. "The Coronavirus (COVID-19) Pandemic and the Global Economy (A)." Harvard Business School Case 720-031, May 2020. (Revised March 2022.)
      • 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
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      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.
      • 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...  View Details
      Keywords: Medical Devices; Health Testing and Trials; Analysis; Sales
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      Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
      • 2019
      • Working Paper

      Optimal Interventions for Increasing Healthy Food Consumption Among Low Income Households

      By: Retsef Levi, Elisabeth Paulson and Georgia Perakis
      The federal government currently spends over $100 billion per year on policies aimed to increase fruit and vegetable (FV) consumption among low income households. These include price-, nutrition education-, and access-related interventions. Currently, the government...  View Details
      Keywords: Bi-level Optimization; Optimal Subsidies; Public Policy; Food Policy; Central Planner; Government Administration; Poverty; Food; Nutrition
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      Levi, Retsef, Elisabeth Paulson, and Georgia Perakis. "Optimal Interventions for Increasing Healthy Food Consumption Among Low Income Households." MIT Sloan Research Paper, No. 6053-19, November 2019.
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