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      • Faculty Publications  (55)

      Regulatory Environment Remove Regulatory Environment →

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      • October 2021
      • Article

      Can Self-Regulation Save Digital Platforms?

      By: Michael A. Cusumano, Annabelle Gawer and David B. Yoffie
      This article explores some of the critical challenges facing self-regulation and the regulatory environment for digital platforms. We examine several historical examples of firms and industries that attempted self-regulation before the Internet. All dealt with similar...  View Details
      Keywords: Self-regulation; Government Regulation; Digital Platforms; Governing Rules, Regulations, and Reforms
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      Cusumano, Michael A., Annabelle Gawer, and David B. Yoffie. "Can Self-Regulation Save Digital Platforms?" Industrial and Corporate Change 30, no. 5 (October 2021): 1259–1285.
      • July 2021 (Revised February 2022)
      • Technical Note

      RegTech: A New Way to Manage Risks

      By: Aiyesha Dey, Jonas Heese and James Barnett
      A note on regulatory technology (RegTech) describing its evolution, use cases, and the competitive environment in 2021.  View Details
      Keywords: Regulatory Technology; Change; Financial Management; Governance Compliance; Governance Controls; Technology; Banking Industry; Financial Services Industry; Technology Industry
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      Dey, Aiyesha, Jonas Heese, and James Barnett. "RegTech: A New Way to Manage Risks." Harvard Business School Technical Note 122-004, July 2021. (Revised February 2022.)
      • March 2021 (Revised October 2021)
      • Teaching Note

      Afterpay U.S.: The Omnichannel Dilemma

      By: Antonio Moreno and Anibha Singh
      Teaching Note for HBS Case No. 519-086. In 2018, Nick Molnar, the founder of the Australia-based online payment service Afterpay began its expansion to the U.S. market. The service had gained a loyal following in Australia by enabling customers to pay for online...  View Details
      Keywords: Omnichannel Retail; Digital Marketing; Business Startups; Business Growth and Maturation; Business Model; Business Organization; For-Profit Firms; Change Management; Customer Value and Value Chain; Customer Relationship Management; Customer Satisfaction; Financing and Loans; Microfinance; Global Strategy; Marketing Strategy; Market Entry and Exit; Digital Platforms; Product Development; Supply Chain Management; Business and Stakeholder Relations; Networks; Network Effects; Internet and the Web; Financial Services Industry; Technology Industry; United States; Australia
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      Moreno, Antonio, and Anibha Singh. "Afterpay U.S.: The Omnichannel Dilemma." Harvard Business School Teaching Note 521-074, March 2021. (Revised October 2021.)
      • September 2020
      • Article

      Regulatory Sandboxes: A Cure for mHealth Pilotitis?

      By: Abhishek Bhatia, Rahul Matthan, Tarun Khanna and Satchit Balsari
      Mobile health (mHealth) and related digital health interventions in the past decade have not always scaled globally as anticipated earlier despite large investments by governments and philanthropic foundations. The implementation of digital health tools has suffered...  View Details
      Keywords: COVID-19; mHealth; Digital Health; Design Thinking; Regulation; Intervention; Regulatory Sandbox; Health Care and Treatment; Technological Innovation; Design; Governing Rules, Regulations, and Reforms; India
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      Bhatia, Abhishek, Rahul Matthan, Tarun Khanna, and Satchit Balsari. "Regulatory Sandboxes: A Cure for mHealth Pilotitis?" Journal of Medical Internet Research 22, no. 9 (September 2020).
      • March–April 2020
      • Article

      An Institutional Approach to Gender Diversity and Firm Performance

      By: Letian Zhang
      This study examines data from 35 countries and 24 industries to understand the relationship between gender diversity and firm performance. Previous studies report conflicting evidence: some find that gender-diverse firms experience more positive performance and others...  View Details
      Keywords: Institutional Theory; Cross-cultural; Diversity; Gender; Organizations; Performance; Situation or Environment; Cross-Cultural and Cross-Border Issues
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      Zhang, Letian. "An Institutional Approach to Gender Diversity and Firm Performance." Organization Science 31, no. 2 (March–April 2020): 439–457.
      • September 2019
      • Case

      Bill & Melinda Gates Foundation: Shaping the Vaccine Manufacturing Ecosystem

      By: Willy C. Shih
      Vaccines for children has been a long-standing focus for the Bill & Melinda Gates Foundation, and its critical role in public health made its production an important economic and political issue. This case describes the Foundation's investment in a breakthrough vaccine...  View Details
      Keywords: Vaccine; Production; Supply Chain; Product; Biotechnology Industry; Pharmaceutical Industry; Manufacturing Industry; Belgium
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      Shih, Willy C. "Bill & Melinda Gates Foundation: Shaping the Vaccine Manufacturing Ecosystem." Harvard Business School Case 620-021, September 2019.
      • 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).
      • 2019
      • Report

      U.S. Nuclear Energy Leadership: Innovation and the Strategic Global Challenge

      By: Joseph B. Lassiter III
      Throughout 2018, the Atlantic Council Global Energy Center convened a “Task Force on US Nuclear Energy Leadership,” which comprised civilian and military experts in foreign policy, defense, and nuclear energy. Senators Mike Crapo (R-ID) and Sheldon Whitehouse (D-RI)...  View Details
      Keywords: Nuclear Energy; Environment; Energy Sources; Energy; Energy Generation; Energy Conservation; Energy Policy; Global Range; Energy Industry
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      "U.S. Nuclear Energy Leadership: Innovation and the Strategic Global Challenge." Report, Atlantic Council, 2019.
      • April 2019
      • Case

      Afterpay U.S.: The Omnichannel Dilemma

      By: Antonio Moreno, Donald Ngwe and George Gonzalez
      In 2018, Nick Molnar, the founder of the Australia-based online payment service Afterpay began its expansion to the U.S. market. The service had gained a loyal following in Australia by enabling customers to pay for online purchases through four interest-free...  View Details
      Keywords: Omnichannel Retail; Multi-sided Platforms; Value Creation; Business Model Innovation; Fintech; Digital Marketing; Disruptive Innovation; Business Startups; Business Growth and Maturation; Business Model; Business Organization; For-Profit Firms; Change Management; Customer Value and Value Chain; Customer Relationship Management; Customer Satisfaction; Financing and Loans; Microfinance; Global Strategy; Marketing Channels; Brands and Branding; Marketing Strategy; Market Entry and Exit; Digital Platforms; Product Development; Supply Chain Management; Business and Stakeholder Relations; Networks; Network Effects; Internet and the Web; Financial Services Industry; Retail Industry; Technology Industry; United States; Australia
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      Moreno, Antonio, Donald Ngwe, and George Gonzalez. "Afterpay U.S.: The Omnichannel Dilemma." Harvard Business School Case 519-086, April 2019.
      • 2018
      • Working Paper

      Corporate Sustainability: A Strategy?

      By: George Serafeim
      We explore the conditions under which firms maintain their competitive advantage through sustainability-based differentiation when faced with imitation pressures by industry peers. We document growing intraindustry convergence on sustainability actions over time for...  View Details
      Keywords: Sustainability; Corporate Performance; Industry Analysis; CSR; ESG; ESG (Environmental, Social, Governance) Performance; Environment; Social Responsibility; Strategy And Execution; Corporate Social Responsibility and Impact; Environmental Sustainability; Strategy; Performance; Corporate Strategy
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      Ioannou, Ioannis, and George Serafeim. "Corporate Sustainability: A Strategy?" Harvard Business School Working Paper, No. 19-065, January 2019. (Revised April 2021.)
      • September 2018
      • Article

      An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India

      By: Budhaditya Gupta and Stefan Thomke
      Recent research has studied innovation in emerging economies. However, microlevel product development processes in these economies are relatively unexplored, and the mechanisms by which the emerging economy context might affect such processes are still unclear. In this...  View Details
      Keywords: India; Product Development; Emerging Markets; Situation or Environment; Medical Devices and Supplies Industry; India
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      Gupta, Budhaditya, and Stefan Thomke. "An Exploratory Study of Product Development in Emerging Economies: Evidence from Medical Device Testing in India." R&D Management 48, no. 4 (September 2018): 485–501.
      • July 2018 (Revised August 2018)
      • Case

      Project Helios: Harvesting the Sun

      By: Mark Egan and E. Scott Mayfield
      Aware of the impact that modern society was having on the environment, Ashley Telkes had always tried to be cognizant of her own impact on the environment and to take reasonable steps to mitigate her own effects. Having already implemented a number of passive measures...  View Details
      Keywords: Renewable Energy; Personal Finance; Decision Making; Environmental Sustainability
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      Egan, Mark, and E. Scott Mayfield. "Project Helios: Harvesting the Sun." Harvard Business School Case 219-009, July 2018. (Revised August 2018.)
      • March 2018
      • Case

      Lufax: FinTech and the Transformation of Wealth Management in China

      By: Christopher J. Malloy, Lauren H. Cohen and Anthony K. Woo
      This case examines the rise and competitive positioning of Lufax, an online marketplace headquartered in Shanghai, China, and a pioneer in the origination and trading of financial assets. The company had grown at a remarkable rate, and was awarded “Trading Platform of...  View Details
      Keywords: Asset Management; Internet and the Web; Competitive Strategy; Situation or Environment; Product Positioning; Financial Services Industry; China
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      Malloy, Christopher J., Lauren H. Cohen, and Anthony K. Woo. "Lufax: FinTech and the Transformation of Wealth Management in China." Harvard Business School Case 218-088, March 2018.
      • January 2018
      • Supplement

      BeiGene Supplemental PowerPoint

      By: Willy C. Shih and Jimmy Zhang
      BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window...  View Details
      Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; Biotechnology Industry; China
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      Shih, Willy C., and Jimmy Zhang. "BeiGene Supplemental PowerPoint." Harvard Business School PowerPoint Supplement 618-043, January 2018.
      • November 2017
      • Case

      BeiGene

      By: Willy Shih and Jimmy Zhang
      BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window...  View Details
      Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Business Startups; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; China
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      Shih, Willy, and Jimmy Zhang. "BeiGene." Harvard Business School Case 618-033, November 2017.
      • 2017
      • Chapter

      High Stakes Negotiation: Indian Gaming and Tribal/State Compacts

      By: Gavin Clarkson and James K. Sebenius
      Although Indian tribes and the surrounding states were often bitter enemies throughout much of the history of the United States, recently tribes and states have been able to work cooperatively in a number of areas. In some instances, Congress has mandated such...  View Details
      Keywords: Indian Gaming; Negotiation; Regulation; Tribal Sovereignty; Sovereign Finance; Negotiation Participants; Relationships; Cooperation; Connecticut
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      Clarkson, Gavin, and James K. Sebenius. "High Stakes Negotiation: Indian Gaming and Tribal/State Compacts." Chap. 8 in American Indian Business: Principles and Practices, edited by Deanna M. Kennedy, Charles Harrington, Amy Klemm Verbos, Daniel Stewart, Joseph Gladstone, and Gavin Clarkson, 130–161. Seattle: University of Washington Press, 2017.
      • March 2017 (Revised March 2019)
      • Case

      Ant Financial (A)

      By: Feng Zhu, Ying Zhang, Krishna G. Palepu, Anthony K. Woo and Nancy Hua Dai
      Headquartered in Hangzhou (China), Ant Financial has grown into a fintech “Unicorn.” The fintech empire that the company established spanned verticals such as mobile and online payment (Alipay), money market fund (Yu’e Bao), wealth management (Ant Fortune),...  View Details
      Keywords: Growth and Development Strategy; Global Strategy; Finance; Opportunities; Financial Services Industry; Technology Industry
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      Zhu, Feng, Ying Zhang, Krishna G. Palepu, Anthony K. Woo, and Nancy Hua Dai. "Ant Financial (A)." Harvard Business School Case 617-060, March 2017. (Revised March 2019.)
      • January 23, 2017
      • Article

      Trump Has a Great Opportunity to Save Our Environment

      By: Vanessa Burbano, Magali Delmas, Marian Chertow, Glen W. S. Dowell, Rodolphe Durand, Andrew J. Hoffman, Guy Holburn, Andrew A. King, Michael Lenox, Lin Lerpold, Thomas Lyon, John W. Maxwell, Eric Orts, N. Craig Smith, John Sterman, Michael W. Toffel, L. Beril Toktay, David Vogel, Judith Walls, Frank Wijen, Jeff York and Maurizio Zollo
      Keywords: Environment; Regulation; Regulator Leniency; Regulatory Enforcement; Environmental Policy; Environmental Regulations; United States
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      Burbano, Vanessa, Magali Delmas, Marian Chertow, Glen W. S. Dowell, Rodolphe Durand, Andrew J. Hoffman, Guy Holburn, Andrew A. King, Michael Lenox, Lin Lerpold, Thomas Lyon, John W. Maxwell, Eric Orts, N. Craig Smith, John Sterman, Michael W. Toffel, L. Beril Toktay, David Vogel, Judith Walls, Frank Wijen, Jeff York, and Maurizio Zollo. "Trump Has a Great Opportunity to Save Our Environment." The Hill (January 23, 2017).
      • Fall 2016
      • Article

      The Integrity of Private Third-party Compliance Monitoring

      By: Jodi L. Short and Michael W. Toffel
      Government agencies are increasingly turning to private, third-party monitors to inspect and assess regulated entities’ compliance with law. The integrity of these regulatory regimes rests on the validity of the information third-party monitors provide to regulators....  View Details
      Keywords: Regulation; Compliance; Compliance Policies; Conflict Of Interest; Independent Third Party; Inspection; Audit Quality; Auditor; Audit; Environment; Safety; Conflict of Interests; Working Conditions; Labor; Corporate Social Responsibility and Impact; Governance Compliance; Accounting Audits
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      Short, Jodi L., and Michael W. Toffel. "The Integrity of Private Third-party Compliance Monitoring." Administrative & Regulatory Law News 42, no. 1 (Fall 2016): 22–25.
      • September 2016 (Revised September 2016)
      • Case

      The Tavistock Group and the Australian Agricultural Company

      By: Dante Roscini and Matthew Preble
      In late 2015, Dr. Shehan Dissanayake, a managing director and board member of Bahamian investment firm The Tavistock Group (Tavistock), the largest shareholder in the Australian Agricultural Company (AACo), one of the country's largest agribusinesses, faces a...  View Details
      Keywords: Agribusiness; Foreign Direct Investment; Cross-Cultural and Cross-Border Issues; Business and Government Relations; Agriculture and Agribusiness Industry; Australia; Bahamas
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      Roscini, Dante, and Matthew Preble. "The Tavistock Group and the Australian Agricultural Company." Harvard Business School Case 717-009, September 2016. (Revised September 2016.)
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