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      • Faculty Publications  (209)

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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 (Revised January 2023)
      • Case

      Cann: High Hopes for Cannabis Infused Beverages

      By: Ayelet Israeli and Anne V. Wilson
      Founded in 2018 by Jake Bullock and Luke Anderson, Cann sold “social tonics,” or cannabis-infused beverages. By 2022, the company had several notable celebrity investors and talent partners, had sold over 10 million beverages to consumers, was distributing in six...  View Details
      Keywords: Stigma; Product Innovation; Product Introduction; Product Differentiation; New Products; New Product Marketing; New Product Management; Brand Management; Branding; Packaging; Positioning; Growth Strategy And Execution; Growth; Cannabis Industry; Purpose; Purpose Brands; LGBTQ; Direct-to-consumer; DTC; Regulations; Channels Of Distribution; Product Development; Product Marketing; Product Positioning; Product; Innovation and Invention; Brands and Branding; Marketing; Marketing Communications; Marketing Channels; Advertising; Advertising Campaigns; Digital Marketing; Market Entry and Exit; Governing Rules, Regulations, and Reforms; Consumer Products Industry; Food and Beverage Industry; United States; Canada; North America
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      Israeli, Ayelet, and Anne V. Wilson. "Cann: High Hopes for Cannabis Infused Beverages." Harvard Business School Case 523-074, December 2022. (Revised January 2023.)
      • December 2022
      • Supplement

      Freelancer, Ltd. Case Supplement

      By: Christopher Stanton, Karim R. Lakhani, Jin Hyun Paik and Nina Cohodes
      Over the course of the 2010s, the rapid advancement of mobile technologies and the rise of online freelancing platforms seemed to portend a radical transformation of labor markets into on-demand, flexible talent pools. Even though several Fortune 500 companies,...  View Details
      Keywords: Labor Markets; Freelancers; Change Management; Corporate Entrepreneurship; Globalized Firms and Management; Human Capital; Employment; Digital Platforms; Global Range; Adoption; Governing Rules, Regulations, and Reforms; Growth and Development Strategy; Computer Industry; Electronics Industry; Employment Industry; Information Industry; Australia; United States; Philippines
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      Stanton, Christopher, Karim R. Lakhani, Jin Hyun Paik, and Nina Cohodes. "Freelancer, Ltd. Case Supplement." Harvard Business School Multimedia/Video Supplement 823-707, December 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.
      • December 2022
      • Article

      Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics

      By: Cheng Gao and Rory McDonald
      In nascent industries—whose new technologies are often poorly understood by regulators—contending with regulatory uncertainty can be crucial to organizational survival and growth. Prior research on nonmarket strategy has largely focused on established firms in mature...  View Details
      Keywords: Technological Change; Innovation; Qualitative Methods; New Categories; Entrepreneurship; Technological Innovation; Governing Rules, Regulations, and Reforms; Risk and Uncertainty; Strategy
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      Gao, Cheng, and Rory McDonald. "Shaping Nascent Industries: Innovation Strategy and Regulatory Uncertainty in Personal Genomics." Administrative Science Quarterly 67, no. 4 (December 2022): 915–967.
      • November 2022
      • Case

      The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales

      By: Regina E. Herzlinger and Tiffany Farrell
      Can an online pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous technological innovation...  View Details
      Keywords: DTC; Internet and the Web; Marketing Channels; Customer Value and Value Chain; Governing Rules, Regulations, and Reforms; Competitive Strategy; Service Delivery; Growth and Development Strategy; Pharmaceutical Industry; Health Industry; Retail Industry
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      Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
      • 2022
      • Chapter

      The Origins of the Developmental State: The European Experience

      By: Sophus A. Reinert
      Book Abstract: There has been a major revival of interest in State Capitalism: what it is, where it is found, and why it is seemingly becoming more ubiquitous. As a concept, it has evolved from radical critiques of the Soviet Union, to being deployed by neo-liberals to...  View Details
      Keywords: State Capitalism; History; Macroeconomics; Developing Countries and Economies; Economic Systems; Europe
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      Reinert, Sophus A. "The Origins of the Developmental State: The European Experience." Chap. 3 in The Oxford Handbook of State Capitalism and the Firm, edited by Mike Wright, Geoffrey T. Wood, Alvaro Cuervo-Cazurra, Pei Sun, Ilya Okhmatovskiy, and Anna Grosman, 53–77. Oxford University Press, 2022.
      • September 2022 (Revised December 2022)
      • Case

      Navya: Steering Toward a Driverless Future

      By: Julian De Freitas, Elie Ofek, Shaun Ingledew and Tonia Labruyere
      In 2022, Sophie Desormière arrived at French roboshuttle producer Navya, tasked with charting a new course in a challenging sector. The company, which had recently listed on the Paris Stock Exchange, was burning through cash reserves and needed to transform the promise...  View Details
      Keywords: Autonomous Vehicles; Market Entry and Exit; Opportunities; Governing Rules, Regulations, and Reforms; Consumer Behavior; Business Model; Auto Industry; Transportation Industry; France; United States
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      De Freitas, Julian, Elie Ofek, Shaun Ingledew, and Tonia Labruyere. "Navya: Steering Toward a Driverless Future." Harvard Business School Case 523-046, September 2022. (Revised December 2022.)
      • September 2022 (Revised November 2022)
      • Case

      The Uyghur Forced Labor Prevention Act: Forced Labor and Genocide in U.S.-China Relations

      By: Jeremy Friedman and David Lane
      On June 21, 2022, the Uyghur Forced Labor Prevention Act (UFLPA) went into effect, requiring companies to prove that goods imported from the People’s Republic of China were not made with forced labor. The bill was a reaction to reports of products being made with...  View Details
      Keywords: Ethics; Multinational Firms and Management; Globalized Markets and Industries; Governing Rules, Regulations, and Reforms; Policy; Government Legislation; International Relations; Labor; Wages; Law Enforcement; Law; Rights; Operations; Supply Chain Management; Business and Government Relations; Agriculture and Agribusiness Industry; Manufacturing Industry; Mining Industry; China; United States
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      Friedman, Jeremy, and David Lane. "The Uyghur Forced Labor Prevention Act: Forced Labor and Genocide in U.S.-China Relations." Harvard Business School Case 723-001, September 2022. (Revised November 2022.)
      • 2022
      • Article

      Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response

      By: Alexander MacKay and Samuel N. Weinstein
      Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...  View Details
      Keywords: Competition Policy; Regulation; Algorithmic Pricing; Dynamic Pricing; Economics; Law And Economics; Law And Regulation; Consumer Protection; Antitrust Law; Industrial Organization; Antitrust Issues And Policies; Technological Change: Choices And Consequences; Competition; Policy; Price; Governing Rules, Regulations, and Reforms; Microeconomics; Duopoly and Oligopoly; Law
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      MacKay, Alexander, and Samuel N. Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Washington University Law Review 100, no. 1 (2022): 111–174. (Direct download.)
      • August 2022
      • Case

      SuperRare: Turning an NFT Marketplace into a DAO

      By: Jeffrey J. Bussgang, Scott Duke Kominers and Amy Klopfenstein
      In June 2021, John Crain and Jonathan Perkins, the founders of SuperRare, a marketplace for non-fungible tokens (NFTs), contemplate whether to transform their company into a decentralized autonomous organization (DAO). Crain and Perkins founded SuperRare in 2018 to...  View Details
      Keywords: NFTs; Crypto Economy; Alternative Assets; DAOs; Arts; Governance; Governance Controls; Governing Rules, Regulations, and Reforms; Information Technology; Technology Adoption; Internet and the Web; Digital Platforms; Innovation and Invention; Technological Innovation; Disruptive Innovation; Finance; Currency; Investment; Markets; Auctions; Bids and Bidding; Demand and Consumers; Network Effects; Market Design; Market Transactions; Market Timing; Web Services Industry; North and Central America; United States
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      Bussgang, Jeffrey J., Scott Duke Kominers, and Amy Klopfenstein. "SuperRare: Turning an NFT Marketplace into a DAO." Harvard Business School Case 823-027, 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

      Calling All Issuers: The Market for Debt Monitoring

      By: Huaizhi Chen, Lauren Cohen and Weiling Liu
      A substantial fraction of local governments refinance their long-term debt with significant delays—resulting in sizable losses. Using data from 2001 to 2018, we estimate that U.S. municipals lost over $31 billion from this delayed refinancing, whereas the entire U.S....  View Details
      Keywords: Debt Monitoring; Financial Institutions; Governing Rules, Regulations, and Reforms; Government Administration; Financing and Loans
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      Chen, Huaizhi, Lauren Cohen, and Weiling Liu. "Calling All Issuers: The Market for Debt Monitoring." NBER Working Paper Series, No. 29790, February 2022.
      • 2022
      • Working Paper

      Consumer Reviews and Regulation: Evidence from NYC Restaurants: Evidence from NYC Restaurants

      By: Chiara Farronato and Georgios Zervas
      We investigate the informativeness of hygiene signals in online reviews, and their effect on consumer choice and restaurant hygiene. We first extract signals of hygiene from Yelp. Among all dimensions that regulators monitor through mandated restaurant inspections, we...  View Details
      Keywords: Restaurants; Reviews; Hygiene; Yelp; Regulation; Food; Governing Rules, Regulations, and Reforms; Consumer Behavior
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      Farronato, Chiara, and Georgios Zervas. "Consumer Reviews and Regulation: Evidence from NYC Restaurants: Evidence from NYC Restaurants." NBER Working Paper Series, No. 29715, February 2022.
      • January 2022
      • Background Note

      Common Prosperity? China Shifts Left

      By: William C. Kirby and Noah B. Truwit
      Since the founding of the People’s Republic of China in 1949, the ruling Chinese Communist Party (CCP) has been mistrustful of entrepreneurs and the private sector that operates outside the government’s authority. In its first decades under Mao Zedong, the CCP...  View Details
      Keywords: Market Reform; Gdp; Government Administration; Government and Politics; Private Sector; Governing Rules, Regulations, and Reforms; Economy; Globalized Economies and Regions; Entrepreneurship; Business and Government Relations; Globalized Markets and Industries; Social Issues; Society; Economic Growth; China
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      Kirby, William C., and Noah B. Truwit. "Common Prosperity? China Shifts Left." Harvard Business School Background Note 322-069, January 2022.
      • January 2022
      • Case

      FIFA and The World Cup: The Future of Football

      By: Anita Elberse, Oliver Band and Howard Johnson
      Should FIFA host its biggest event—the FIFA World Cup—every two years instead of every four, as it has been doing since the event’s inception in the 1930s? In September 2021, Gianni Infantino, the president of the International Federation of Association Football...  View Details
      Keywords: Sports; Soccer; Football; Entertainment; Media; Talent Development; Globalization; Marketing; Strategy; General Management; Governance; Decision Making; Governing and Advisory Boards; Problems and Challenges; Brands and Branding; Sports Industry; Entertainment and Recreation Industry
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      Elberse, Anita, Oliver Band, and Howard Johnson. "FIFA and The World Cup: The Future of Football." Harvard Business School Case 522-076, January 2022.
      • 2021
      • Working Paper

      Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response

      By: Alexander J. MacKay and Samuel Weinstein
      Pricing algorithms are rapidly transforming markets, from ride-sharing apps, to air travel, to online retail. Regulators and scholars have watched this development with a wary eye. Their focus so far has been on the potential for pricing algorithms to facilitate...  View Details
      Keywords: Competition Policy; Regulation; Algorithmic Pricing; Dynamic Pricing; Law And Economics; Law And Regulation; Consumer Protection; Competition; Policy; Price; Governing Rules, Regulations, and Reforms; Economics
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      MacKay, Alexander J., and Samuel Weinstein. "Dynamic Pricing Algorithms, Consumer Harm, and Regulatory Response." Harvard Business School Working Paper, No. 22-050, January 2022. (Direct download.)
      • 2021
      • Working Paper

      Who Benefits from Online Gig Economy Platforms?

      By: Christopher Stanton and Catherine Thomas
      This paper estimates the magnitude and distribution of surplus from the knowledge worker gig economy using data from an online labor market. Labor demand elasticities determine workers’ wages, and buyers’ past market experience shapes both their job posting frequency...  View Details
      Keywords: Gig Economy; Knowledge Workers; Online Platforms; Employment; Internet and the Web; Governing Rules, Regulations, and Reforms; Wages; Digital Platforms
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      Stanton, Christopher, and Catherine Thomas. "Who Benefits from Online Gig Economy Platforms?" NBER Working Paper Series, No. 29477, November 2021.
      • October 2021 (Revised November 2022)
      • Case

      The 2012 Spanish Labor Reform: Lifting All Boats, or Leveling Down?

      By: Vincent Pons, Rafael Di Tella, Santiago Botella and Elena Corsi
      Since 1978, Spain had struggled to control unemployment. The country’s labor law was protective of employees hired long-term and companies used temporary contracts as buffers. In 2012, amid economic recession and a 23.6% unemployment rate, a center-right government of...  View Details
      Keywords: COVID-19 Pandemic; Labor Market; Unemployment; Recession; Globalized Markets and Industries; Government Legislation; International Relations; Working Conditions; Employment; Labor Unions; Contracts; Social Issues; Public Opinion; Governing Rules, Regulations, and Reforms; Spain; European Union
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      Pons, Vincent, Rafael Di Tella, Santiago Botella, and Elena Corsi. "The 2012 Spanish Labor Reform: Lifting All Boats, or Leveling Down?" Harvard Business School Case 722-008, October 2021. (Revised November 2022.)
      • 2021
      • Working Paper

      The Business of K-12 Education in China

      By: Geoffrey Jones and Yuhai Wu
      This working paper examines the evolution of K-12 education in China, especially between 1985 and the present day, drawing extensive interviews with participants in the educational sector. China has been hugely successful in reaching almost 100 percent literacy,...  View Details
      Keywords: K-12 Education; China; Real Estate; Early Childhood Education; Performance Evaluation; Teaching; Governing Rules, Regulations, and Reforms; Personal Development and Career; Social Issues; Nonprofit Organizations; Private Sector; Education Industry; Real Estate Industry; China
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      Jones, Geoffrey, and Yuhai Wu. "The Business of K-12 Education in China." Harvard Business School Working Paper, No. 22-022, October 2021.
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