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- 2024
- Working Paper
Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational 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) the... View Details
Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms
Bhidé, Amar, and Srikant M. Datar. "Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 21-035, August 2020. (Revised May 2024.)
- 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
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).
- Article
Do We Spend Too Much on Health Care?
By: Katherine Baicker and Amitabh Chandra
Health system reforms—such as changes in insurance design, patient cost sharing, payment reform, or price regulation—should be judged by whether they move us toward higher-value use of resources, rather than by whether they reduce spending. View Details
Keywords: Health Care and Treatment; Cost; Governing Rules, Regulations, and Reforms; Value Creation
Baicker, Katherine, and Amitabh Chandra. "Do We Spend Too Much on Health Care?" New England Journal of Medicine 383, no. 7 (August 13, 2020): 605–608.
- 2024
- Working Paper
Cephalosporins—Fighting Hospital Infections: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
This case history describes the development of three generations of cephalosporins – antibiotics that have significantly reduced hospital infections. Specifically, we chronicle how: 1) Early (pre-cephalosporin) antibiotics were developed in the first half of the 20th... View Details
Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Cephalosporins—Fighting Hospital Infections: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised May 2024.)
- 2024
- Working Paper
Prozac—Controversial Blockbuster: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
This case history describes the development of Prozac, a blockbuster drug that transformed
the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we
chronicle the: 1) prior treatments for depression and the research that... View Details
Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant M. Datar, and Katherine Stebbins. "Prozac—Controversial Blockbuster: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-135, July 2020. (Revised May 2024.)
- 2024
- Working Paper
Tamoxifen—Reducing Breast Cancer Risks: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
We describe the development of tamoxifen, considered a “gold standard” treatment for
millions of breast cancer patients. Specifically, we describe breast cancer treatments before tamoxifen’s
development; the initial development of tamoxifen from 1960 to 1973;... View Details
Keywords: Health Care and Treatment; Technological Innovation; Innovation and Invention; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Tamoxifen—Reducing Breast Cancer Risks: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-134, July 2020. (Revised May 2024.)
- June 2020 (Revised February 2021)
- Case
Accounting for Leases at American Airlines (A)
By: Jonas Heese, Gerardo Pérez Cavazos and Julia Kelley
In March 2020, as coronavirus reduced demand for air travel, an analyst was forecasting American Airlines’ (American’s) first quarter financial results. To develop a forecast, she needed to familiarize herself with Accounting Standards Update (ASU) 2016-02, “Leases... View Details
Keywords: Accounting; Financial Reporting; Financial Statements; Finance; Governance; Corporate Accountability; Corporate Governance; Governing Rules, Regulations, and Reforms; Governing and Advisory Boards; Leasing; Accounting Industry; Air Transportation Industry; North and Central America; United States
Heese, Jonas, Gerardo Pérez Cavazos, and Julia Kelley. "Accounting for Leases at American Airlines (A)." Harvard Business School Case 120-069, June 2020. (Revised February 2021.)
- June 2020 (Revised February 2021)
- Supplement
Accounting for Leases at American Airlines (B)
By: Jonas Heese, Gerardo Pérez Cavazos and Julia Kelley
This is a supplement to the “Accounting for Leases at American Airlines (A)” case. The (B) case describes American Airlines’ financial results for the first quarter of 2020, as well as the continuing effects of coronavirus on the airline industry. View Details
Keywords: Accounting; Financial Reporting; Financial Statements; Finance; Governance; Corporate Accountability; Corporate Governance; Governing Rules, Regulations, and Reforms; Governing and Advisory Boards; Leasing; Health Pandemics; Accounting Industry; Air Transportation Industry; North and Central America; United States
Heese, Jonas, Gerardo Pérez Cavazos, and Julia Kelley. "Accounting for Leases at American Airlines (B)." Harvard Business School Supplement 120-113, June 2020. (Revised February 2021.)
- June 2020
- Article
How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections
By: Maria Ibanez and Michael W. Toffel
Accuracy and consistency are critical for inspections to be an effective, fair, and useful tool for assessing risks, quality, and suppliers—and for making decisions based on those assessments. We examine how inspector schedules could introduce bias that erodes... View Details
Keywords: Assessment; Bias; Inspection; Scheduling; Econometric Analysis; Empirical Research; Regulation; Health; Food; Safety; Quality; Performance Consistency; Governing Rules, Regulations, and Reforms
Ibanez, Maria, and Michael W. Toffel. "How Scheduling Can Bias Quality Assessment: Evidence from Food Safety Inspections." Management Science 66, no. 6 (June 2020): 2396–2416. (Revised February 2019. Featured in Harvard Business Review, Forbes, Food Safety Magazine, Food Safety News, and KelloggInsight. (2020 MSOM Responsible Research Finalist.))
- 2020
- Working Paper
How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?
By: Michael Blank, Samuel G. Hanson, Jeremy C. Stein and Adi Sunderam
Drawing on lessons from the 2007–2009 Global Financial Crisis (GFC) and a simple conceptual framework, we examine the response of U.S. bank regulators to the COVID-19 pandemic. We argue that the current regulatory strategy of “watchful waiting”—the same strategy that... View Details
Keywords: COVID-19; Bank Regulation; Recapitalization; Health Pandemics; Banks and Banking; Governing Rules, Regulations, and Reforms; Strategy; Risk Management; United States
Blank, Michael, Samuel G. Hanson, Jeremy C. Stein, and Adi Sunderam. "How Should U.S. Bank Regulators Respond to the COVID-19 Crisis?" Hutchins Center Working Paper, No. 63, June 2020.
- March 2020
- Article
Voluntary, Self-Regulatory, and Mandatory Disclosure of Oil and Gas Company Payments to Foreign Governments
By: Paul M. Healy and George Serafeim
Concerns about high rates of government corruption in resource-rich countries have led transparency advocates to urge oil and gas firms to disclose payments to host governments for natural resources. Transparency, they argue, can increase government accountability and... View Details
Keywords: Oil & Gas; Corruption; Transparency; Self-regulation; Industry Self-regulation; Regulation; Disclosure; Disclosure Regulation; Energy Sources; Crime and Corruption; Corporate Disclosure; Governing Rules, Regulations, and Reforms; Energy Industry
Healy, Paul M., and George Serafeim. "Voluntary, Self-Regulatory, and Mandatory Disclosure of Oil and Gas Company Payments to Foreign Governments." Accounting Horizons 34, no. 1 (March 2020): 111–129.
- February 2020 (Revised June 2020)
- Case
Shaping the Governance Debate at ISS
By: Suraj Srinivasan, Jonah S. Goldberg and Calvin O. Liou
ISS is the world’s largest provider of corporate governance research, data, analytics, and voting services. The case uses the effort of the Securities and Exchange Commission (SEC) to impose an array of new regulations that would severely restrict the functioning of... View Details
Keywords: Proxy Advisory Services; Corporate Governance; Research; Investment; Governing Rules, Regulations, and Reforms; Business and Shareholder Relations; Institutional Investing
Srinivasan, Suraj, Jonah S. Goldberg, and Calvin O. Liou. "Shaping the Governance Debate at ISS." Harvard Business School Case 120-085, February 2020. (Revised June 2020.)
- January 27, 2020
- Article
Food-Stamp Work Requirements Just Look Cruel
The rule doesn’t help beneficiaries find the steady employment that doesn’t exist. View Details
Kominers, Scott Duke. "Food-Stamp Work Requirements Just Look Cruel." Bloomberg Opinion (January 27, 2020).
- December 2019 (Revised September 2020)
- Case
Facebook Faces the Regulators
By: Debora L. Spar
In the fall of 2019, Facebook and its CEO Mark Zuckerberg are facing increased scrutiny on multiple fronts. Regulators from around the globe are threatening the company with punitive measures. Users are organizing against it. But there is little consensus around what,... View Details
Keywords: Facebook; Regulation; Media; Internet and the Web; Governance; Governing Rules, Regulations, and Reforms; Business and Government Relations; Social Media; Europe
Spar, Debora L. "Facebook Faces the Regulators." Harvard Business School Case 720-019, December 2019. (Revised September 2020.)
- December 2019 (Revised December 2022)
- Case
TXU (A): Powering the Largest Leveraged Buyout in History
By: Trevor Fetter, Erik Snowberg and Rebecca M. Henderson
This case is designed to support a lively discussion about the relative merits of shareholder vs. stakeholder perspectives in the context of a company that provides a vital public service that has important environmental implications. The 2007 purchase of TXU, the... View Details
Keywords: Leveraged Buyouts; Transformation; Insolvency and Bankruptcy; Environmental Sustainability; Business and Shareholder Relations; Business and Stakeholder Relations; Energy Generation; Non-Renewable Energy; Governing Rules, Regulations, and Reforms; Utilities Industry; Energy Industry; Texas
Fetter, Trevor, Erik Snowberg, and Rebecca M. Henderson. "TXU (A): Powering the Largest Leveraged Buyout in History." Harvard Business School Case 320-064, December 2019. (Revised December 2022.)
- 2020
- Working Paper
Capital Regulation and Product Market Outcomes
By: Ishita Sen and David Humphry
We present evidence of product market adjustments and asset reorganizations from the largest ever shift in risk regulation in a developed insurance market. Using proprietary data on insurance risk exposures from the Bank of England, we develop a measure of regulatory... View Details
Keywords: Non-traditional-non-insurance; Risk Regulation; Product Market Concentration; Small Vs. Large Insurers; Insurance Risk Exposure; Insurance; Risk and Uncertainty; Governing Rules, Regulations, and Reforms
Sen, Ishita, and David Humphry. "Capital Regulation and Product Market Outcomes." Working Paper, January 2020.
- 2020
- Working Paper
Internal Models, Make Believe Prices, and Bond Market Cornering
By: Ishita Sen and Varun Sharma
Exploiting position-level heterogeneity in regulatory incentives to misreport and novel data on regulators, we document that U.S. life insurers inflate the values of corporate bonds using internal models. We estimate an additional $9-$18 billion decline in regulatory... View Details
Keywords: Life Insurers; Capital Regulation; Internal Models; Corporate Bonds; Regulatory Supervision; Concentrated Ownership; Bonds; Capital; Governing Rules, Regulations, and Reforms; Insurance; Investment Portfolio
Sen, Ishita, and Varun Sharma. "Internal Models, Make Believe Prices, and Bond Market Cornering." Working Paper, June 2020.
- November 2019
- Case
Hapag-Lloyd AG: Complying with IMO 2020
By: Benjamin C. Esty, Mette Fuglsang Hjortshoej and Emer Moloney
A new environmental regulation known as IMO 2020 was creating what one industry analyst called “the biggest shakeup for the oil and shipping industries in decades.” According to the new regulation, all ocean-going ships would have to limit their sulfur emissions by... View Details
Keywords: Valuation; Ship Transportation; Strategic Planning; Game Theory; Pollutants; Supply Chain; Corporate Accountability; Capital Budgeting; Environmental Sustainability; Governing Rules, Regulations, and Reforms; Governance Compliance; Shipping Industry; Transportation Industry; Germany
Esty, Benjamin C., Mette Fuglsang Hjortshoej, and Emer Moloney. "Hapag-Lloyd AG: Complying with IMO 2020." Harvard Business School Case 220-003, November 2019.
- Article
Economic Principles for Medicare Reform
By: Amitabh Chandra and Craig Garthwaite
In this article, we develop an economic framework for Medicare reform that highlights trade-offs that reform proposals should grapple with but often ignore. Central to our argument is a tension in administratively set prices, which may improve short-term efficiency but... View Details
Keywords: Medicare; Value-based Care; Health Care Reform; Markets In Health Care; Health Care and Treatment; Value; Governing Rules, Regulations, and Reforms
Chandra, Amitabh, and Craig Garthwaite. "Economic Principles for Medicare Reform." Annals of the American Academy of Political and Social Science 686, no. 1 (November 2019): 63 – 92.
- 2019
- Working Paper
The Impact of the General Data Protection Regulation on Internet Interconnection
By: Ran Zhuo, Bradley Huffaker, KC Claffy and Shane Greenstein
The Internet comprises thousands of independently operated networks, where bilaterally negotiated interconnection agreements determine the flow of data between networks. The European Union’s General Data Protection Regulation (GDPR) imposes strict restrictions on... View Details
Keywords: Personal Data; Privacy Regulation; GDPR; Interconnection Agreements; Internet and the Web; Governing Rules, Regulations, and Reforms; European Union
Zhuo, Ran, Bradley Huffaker, KC Claffy, and Shane Greenstein. "The Impact of the General Data Protection Regulation on Internet Interconnection." NBER Working Paper Series, No. 26481, November 2019.