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      • Faculty Publications  (43)

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      • 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; 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.)
      • 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 Technology; 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).
      • 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
      Keywords: Digital; Medicine; FDA; Health Care and Treatment; Applications and Software; Safety; Cybersecurity; Medical Devices and Supplies Industry
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      Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
      • February 2019 (Revised September 2019)
      • Case

      Theranos: The Unicorn That Wasn't

      By: Joseph B. Fuller and John Masko
      In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains...  View Details
      Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry
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      Fuller, Joseph B., and John Masko. "Theranos: The Unicorn That Wasn't." Harvard Business School Case 319-068, February 2019. (Revised September 2019.)
      • December 2018 (Revised May 2019)
      • Case

      Bord Bia: Strategically Growing Irish Exports

      By: Jose B. Alvarez, Forest L. Reinhardt and Emer Moloney
      Agriculture was Ireland’s largest indigenous industry. Its agri-food sector was export driven, with almost 90% of production exported. Bord Bia was the Irish government agency charged with the promotion, trade development, and marketing of the Irish food, drink, and...  View Details
      Keywords: Agribusiness; Trends; Disruption; Communication Strategy; Experience and Expertise; Talent and Talent Management; Public Sector; Trade; Education; Food; Geography; Geographic Location; Rural Scope; Corporate Governance; Government Administration; Information; Knowledge Dissemination; Marketing Channels; Brands and Branding; Marketing Communications; Marketing Strategy; Planning; Business and Government Relations; Environmental Sustainability; Public Opinion; Business Strategy; Diversification; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Agriculture and Agribusiness Industry; Republic of Ireland; United Kingdom; Europe
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      Alvarez, Jose B., Forest L. Reinhardt, and Emer Moloney. "Bord Bia: Strategically Growing Irish Exports." Harvard Business School Case 519-043, December 2018. (Revised May 2019.)
      • 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...  View Details
      Keywords: Information; Announcements; Service Operations; Decision Making; Medical Specialties; Experience and Expertise; Medical Devices and Supplies Industry
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      Staats, Bradley R., Diwas S. KC, and F. Gino. "Maintaining Beliefs in the Face of Negative News: The Moderating Role of Experience." Management Science 64, no. 2 (February 2018): 804–824.
      • 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...  View Details
      Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States
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      Kaplan, Aaron V., and Ariel Dora Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
      • 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; Public Administration Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe
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      Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
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