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      • Faculty Publications  (252)

      Courts and Trials Remove Courts and Trials →

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      • January 2023
      • Case

      Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery

      By: Regina Herzlinger and Brian Walker
      How can a successful executive assess her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to find a therapeutic window for Cleave Therapeutics oncology drug was on track but faced an uncertain future. Overseeing the...  View Details
      Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry
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      Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
      • 2022
      • Working Paper

      Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data

      By: Alexander O. Everhart and Ariel D. Stern
      Medical devices increasingly include software components, which facilitate remote patient monitoring. The introduction of software into previously analog medical devices as well as innovation in software-driven devices may introduce new safety concerns—all the more so...  View Details
      Keywords: Technological Innovation; Safety; Governing Rules, Regulations, and Reforms; Health Care and Treatment; Medical Devices and Supplies Industry
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      Everhart, Alexander O., and Ariel D. Stern. "Post-market Surveillance of Software Medical Devices: Evidence from Regulatory Data." Harvard Business School Working Paper, No. 23-035, November 2022.
      • 2022
      • Working Paper

      Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

      By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
      Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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      Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
      • 2022
      • Working Paper

      The Ties That No Longer Bind: Inventor Mobility and Patent Litigation

      By: Daniel Jay Brown and Maria Roche
      The retention of inventor-employees represents a core strategic concern for firms in innovative industries. In this paper, we examine the impact of reduced patent enforceability on the mobility of inventor-employees and explore the related influence on firms’...  View Details
      Keywords: Mobility; Inventors; Patent Enforceability; Skills; Strategic Human Capital; Retention; Innovation and Invention; Intellectual Property
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      Brown, Daniel Jay, and Maria Roche. "The Ties That No Longer Bind: Inventor Mobility and Patent Litigation." Harvard Business School Working Paper, No. 23-021, October 2022.
      • Working Paper

      Representation and Extrapolation: Evidence from Clinical Trials

      By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
      This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and patients when it...  View Details
      Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
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      Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." NBER Working Paper Series, No. 30575, October 2022. (Revise and resubmit, Quarterly Journal of Economics.)
      • 2022
      • Book

      Corporate Criminal Investigations and Prosecutions

      By: Leo R. Tsao, Daniel S. Kahn and Eugene F. Soltes
      Over the past two decades, corporate criminal liability has developed into one of the fastest-growing and most dynamic areas of legal practice. The growth of corporate criminal enforcement has correlated with a broad shift in how the government investigates and...  View Details
      Keywords: Criminal Investigations; Crime and Corruption; Legal Liability
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      Tsao, Leo R., Daniel S. Kahn, and Eugene F. Soltes. Corporate Criminal Investigations and Prosecutions. Aspen Publishing, 2022.
      • August 2022
      • Case

      Rocket Learning: Evidence in Action

      By: Brian Trelstad, Tomas Rosales and Malini Sen
      Founders of Rocket Learning, an India-based nonprofit which focused on early childhood education (ECE), received an invitation from MIT’s Abdul Latif Jameel Poverty Action Lab (JPAL), a development research organization, to test its intervention for ECE with a...  View Details
      Keywords: Social Entrepreneurship; Early Childhood Education; Nonprofit Organizations; Literacy; Values and Beliefs; Social and Collaborative Networks; Education Industry; India; Asia
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      Trelstad, Brian, Tomas Rosales, and Malini Sen. "Rocket Learning: Evidence in Action." Harvard Business School Case 323-002, August 2022.
      • August 2022
      • Article

      The U.S. Approach to Antitrust Policy in Technology Markets

      By: Shane Greenstein
      This report illustrates the strengths and weaknesses of the U.S. approach to antitrust policy by drawing lessons from three cases: United States v. AT&T, United States v. Microsoft, and United States v. Google. The cases against AT&T and Microsoft are historical cases,...  View Details
      Keywords: Antitrust; Lawsuits and Litigation; Information Technology; Competition
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      Greenstein, Shane. "The U.S. Approach to Antitrust Policy in Technology Markets." AEI Digital Platforms and American Life Project (August 2022).
      • 2022
      • Working Paper

      Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina

      By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
      Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its...  View Details
      Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina
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      Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
      • Article

      Do the Right Firms Survive Bankruptcy?

      By: Samuel Antill
      In U.S. Chapter 11 bankruptcy cases, firms are either reorganized, acquired, or liquidated. I show that decisions to liquidate often reduce creditor recovery, costing creditors billions of dollars every year. I exploit the within-district random assignment of...  View Details
      Keywords: Bankruptcy; Bankruptcy Reorganization; Recovery Rate; Structural Estimation; Roy Model; 363 Sales; Insolvency and Bankruptcy; Governing Rules, Regulations, and Reforms
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      Antill, Samuel. "Do the Right Firms Survive Bankruptcy?" Journal of Financial Economics 144, no. 2 (May 2022): 523–546.
      • April 2022
      • Teaching Note

      CVS Health: Prescription for Transformation

      By: Rosabeth Moss Kanter and Catarina Martinez
      In 2021, new CEO Karen Lynch (named the most powerful woman in business) considered the next transformation phase for CVS Health (a Fortune 5 corporate giant). The 2018 acquisition of Aetna insurance brought her to the company as part of its long evolution from a...  View Details
      Keywords: Health; COVID-19 Pandemic; Primary Care; Leadership; Change Management; Women Executives; Retail; Pharmacy; Pharmacy Benefit Manager; Clinical Trials; Vaccination; Acquisition; Innovation and Invention; Transformation; Retail Industry; Pharmaceutical Industry; Health Industry; United States
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      Kanter, Rosabeth Moss, and Catarina Martinez. "CVS Health: Prescription for Transformation." Harvard Business School Teaching Note 322-122, April 2022.
      • February 2022 (Revised December 2022)
      • Case

      Jaypee Infratech and the Indian Bankruptcy Code

      By: Kristin Mugford, William Vrattos and Radhika Kak
      In 2016, India passed a new bankruptcy law (IBC) to counter a brewing bank crisis and increased corporate distress. Homebuilder Jaypee Infratech, one of India largest distressed companies (the “dirty dozen”) began restructuring under the IBC in 2017. Two years later,...  View Details
      Keywords: Restructuring; Decisions; Judgments; Voting; Developing Countries and Economies; Financial Crisis; Public Sector; Asset Pricing; Borrowing and Debt; Corporate Finance; Credit; Insolvency and Bankruptcy; Debt Securities; Bonds; Investment Return; Price; Government Legislation; Laws and Statutes; Bids and Bidding; Business and Stakeholder Relations; Risk and Uncertainty; Valuation; Real Estate Industry; India; Delhi
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      Mugford, Kristin, William Vrattos, and Radhika Kak. "Jaypee Infratech and the Indian Bankruptcy Code." Harvard Business School Case 222-071, February 2022. (Revised December 2022.)
      • February 2022
      • Case

      Leading The UK Vaccine Task Force

      By: Amy C. Edmondson and Claudia Pienica
      This case describes the first six months of the UK Vaccine Taskforce, under the leadership of Kate Bingham. With a career spent in the private sector as a biotech investor, Bingham’s appointment within the government was considered unusual. The overarching brief given...  View Details
      Keywords: COVID-19; Vaccine; Government; Health Pandemics; Health Care and Treatment; Science; Innovation and Invention; Groups and Teams; Leadership; Decision Making; Government and Politics; Health; Innovation and Management; Governance; Change; Government Administration; Health Industry; Financial Services Industry; Public Administration Industry; Europe; United Kingdom
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      Edmondson, Amy C., and Claudia Pienica. "Leading The UK Vaccine Task Force." Harvard Business School Case 622-079, February 2022.
      • February 15, 2022
      • Article

      How Managers Can Build a Culture of Experimentation

      By: Frank V. Cespedes and Neil Hoyne
      Testing in business presents qualitatively different challenges than those in clinical trials and most scientific research. There are very few opportunities for randomized control experiments in a changing, competitive market. Yet, change and competition make testing a...  View Details
      Keywords: Experimentation; Management; Decision Making
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      Cespedes, Frank V., and Neil Hoyne. "How Managers Can Build a Culture of Experimentation." Harvard Business Review Digital Articles (February 15, 2022).
      • February 2022 (Revised November 2022)
      • Case

      Nuritas

      By: Mitchell Weiss, Satish Tadikonda, Vincent Marie Dessain and Emer Moloney
      Nora Khaldi had built a technology “to unlock the power of nature” in the service of extending human lifespan and improving health, and now in April 2020 was debating telling her Board of Directors she wanted to put on ice some of her discoveries. Nuritas, the company...  View Details
      Keywords: Cash Burn; Cash Flow Analysis; Pharmaceutical Companies; Founder; Artificial Intelligence; AI; Entrepreneurship; Health Testing and Trials; Health Care and Treatment; Decision Making; Market Entry and Exit; AI and Machine Learning; Pharmaceutical Industry
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      Weiss, Mitchell, Satish Tadikonda, Vincent Marie Dessain, and Emer Moloney. "Nuritas." Harvard Business School Case 822-080, February 2022. (Revised November 2022.)
      • January 17, 2022
      • Article

      Reducing Racial Disparities in Cancer Outcomes

      By: Kathy Giusti and Richard G. Hamermesh
      A disproportionate number of Black patients die from cancer in the United States. A key to addressing this problem is enrolling more Black patients in clinical trials. A strategy consisting of these three parts can help accomplish this goal: 1) centralize information...  View Details
      Keywords: Cancer Trials; Racial Disparity; Health Testing and Trials; Race; Strategy
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      Giusti, Kathy, and Richard G. Hamermesh. "Reducing Racial Disparities in Cancer Outcomes." Harvard Business Review (website) (January 17, 2022).
      • 2022
      • Book

      Ripe for Revolution: Building Socialism in the Third World

      By: Jeremy Friedman
      A historical account of ideology in the Global South as the postwar laboratory of socialism, its legacy following the Cold War, and the continuing influence of socialist ideas worldwide.

      In the first decades after World War II, many newly independent...  View Details
      Keywords: Socialism; Economic Systems; Globalization; Government and Politics; Developing Countries and Economies
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      Friedman, Jeremy. Ripe for Revolution: Building Socialism in the Third World. Cambridge, MA: Harvard University Press, 2022.
      • December 2021
      • Case

      Should I Stay or Should I Go? Assessing Risk in Carlos Ghosn's International Escape

      By: Eugene F. Soltes, Grace Liu and Muneeb Ahmed
      In 2018, automotive tycoon Carlos Ghosn was arrested in Japan on financial misreporting charges, followed later by charges of improper payments and misappropriation of funds. Over a year later, still awaiting trial, Ghosn organized his escape from house arrest in Tokyo...  View Details
      Keywords: Crime and Corruption; Decision Making; Cost vs Benefits; Decision Choices and Conditions; Ethics; Cross-Cultural and Cross-Border Issues; Law; Courts and Trials; Rights; Risk and Uncertainty; Auto Industry; Japan
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      Soltes, Eugene F., Grace Liu, and Muneeb Ahmed. "Should I Stay or Should I Go? Assessing Risk in Carlos Ghosn's International Escape." Harvard Business School Case 122-051, December 2021.
      • December 2021
      • Article

      Negativity Spreads More Than Positivity on Twitter after Both Positive and Negative Political Situations

      By: Jonas Paul Schöne, Brian Parkinson and Amit Goldenberg
      What type of emotional language spreads further in political discourses on social media? Previous research has focused on situations that primarily elicited negative emotions, showing that negative language tended to spread further. The current project extends existing...  View Details
      Keywords: Negative Emotions; Emotional Influence; Emotional Resonance; Political Discourse; Emotion Contagion; Intergroup; Interactive Communication; Emotions; Government and Politics; Social Media
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      Schöne, Jonas Paul, Brian Parkinson, and Amit Goldenberg. "Negativity Spreads More Than Positivity on Twitter after Both Positive and Negative Political Situations." Affective Science 2, no. 4 (December 2021): 379–390.
      • October 2021 (Revised January 2022)
      • Supplement

      Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)

      By: Linda A. Hill and Emily Tedards
      This case is the third installment in a series about the 10-year cultural and digital transformation of Pfizer’s Global Clinical Supply organization. In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone...  View Details
      Keywords: Clinical Supply Chain; COVID-19; Vaccine; Agile; Innovation and Invention; Change Management; Organizational Culture; Transformation; Leadership; Corporate Strategy; Health Pandemics; Crisis Management; Mission and Purpose; Health Care and Treatment; Supply Chain Management; Digital Transformation
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      Hill, Linda A., and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)." Harvard Business School Supplement 422-041, October 2021. (Revised January 2022.)
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