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- November 2008 (Revised July 2009)
- Background Note
A Managerial Perspective on Clinical Trials
By: Arthur A. Daemmrich
This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Safety; Biotechnology Industry; Pharmaceutical Industry
Daemmrich, Arthur A. "A Managerial Perspective on Clinical Trials." Harvard Business School Background Note 709-033, November 2008. (Revised July 2009.)
- October 2024
- Article
Medicare Part D Protected-Class Policy Is Associated with Lower Drug Rebates
By: Pragya Kakani, Michael Anne Kyle, Amitabh Chandra and Luca Maini
Medicare Part D does not allow plans to exclude drugs in six protected classes from their formularies, which may limit plans’ ability to negotiate rebates and lead to higher spending. We estimated the association between protected-class status, US-level estimated... View Details
Keywords: Insurance; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States
Kakani, Pragya, Michael Anne Kyle, Amitabh Chandra, and Luca Maini. "Medicare Part D Protected-Class Policy Is Associated with Lower Drug Rebates." Health Affairs 43, no. 10 (October 2024): 1420–1427.
- 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.
- November–December 2023
- Article
Tax-Loss Harvesting with Cryptocurrencies
By: Lin William Cong, Wayne Landsman, Edward Maydew and Daniel Rabetti
We describe the taxation landscape in the cryptocurrency markets, especially concerning U.S. taxpayers, and examine how recent increases in tax scrutiny have led to changes in crypto investors' trading behavior. We argue conceptually and then empirically document that... View Details
Cong, Lin William, Wayne Landsman, Edward Maydew, and Daniel Rabetti. "Tax-Loss Harvesting with Cryptocurrencies." Art. 101607. Journal of Accounting & Economics 76, nos. 2-3 (November–December 2023).
- 2010
- Case
HeidelbergCement: Technology Choice Under Carbon Regulation
By: David F. Drake, Paul R. Kleindorfer and Luk N. Van Wassenhove
- March 2021
- Article
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
Zhuo, Ran, Bradley Huffaker, KC Claffy, and Shane Greenstein. "The Impact of the General Data Protection Regulation on Internet Interconnection." Telecommunications Policy 45, no. 2 (March 2021).
- 2011
- Book
The Fund Industry: How Your Money Is Managed
By: Robert Pozen and Theresa Hamacher
The Fund Industry explains to students and investors how to evaluate mutual funds and other collective investment vehicles. It discusses how different types of funds are managed, marketed, and regulated. It also reviews how funds invest and gather assets in countries... View Details
Keywords: Money; Financial Management; International Finance; Investment Funds; Governing Rules, Regulations, and Reforms; Financial Services Industry
Pozen, Robert, and Theresa Hamacher. The Fund Industry: How Your Money Is Managed. 3rd ed. NY: John Wiley & Sons, 2011.
- June 9, 2023
- Article
A Radical Treatment for Insulin Pricing
By: Leemore S. Dafny
In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a... View Details
Keywords: Biosimilars; Rebates; Pharmaceuticals; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States
Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
- August 2010 (Revised December 2010)
- Case
Malcolm Life Enhances Its Variable Annuities
By: Robert C. Pozen and David J. Pearlman
The case involves an insurance CEO choosing between different designs for a variable annuity product in light of hedging, marketing, and pricing issues. The case provides students with background on the economics and regulation of life insurance and variable annuities.... View Details
Keywords: Annuities; Insurance; Investment Return; Governing Rules, Regulations, and Reforms; Product Design; Insurance Industry; United States
Pozen, Robert C., and David J. Pearlman. "Malcolm Life Enhances Its Variable Annuities." Harvard Business School Case 311-041, August 2010. (Revised December 2010.)
- March 1996 (Revised June 1996)
- Case
Choices in U.S. Trade Policy
By: Louis T. Wells Jr. and Courtenay Sprague
Describes the moments leading to the conclusion of the Uruguay Round of international trade negotiations and the outcome of those negotiations. Discusses some of the options facing the Clinton Administration with respect to its international trade policy. View Details
Keywords: Trade; Governing Rules, Regulations, and Reforms; Policy; Negotiation; Outcome or Result; United States
Wells, Louis T., Jr., and Courtenay Sprague. "Choices in U.S. Trade Policy." Harvard Business School Case 796-117, March 1996. (Revised June 1996.)
- June 2023
- Article
Regulatory Limits to Risk Management
By: Ishita Sen
Variable annuities, the largest liability of U.S. life insurers, are investment products containing long-dated minimum return guarantees. I show that guarantees with similar economic risks are treated differently by regulation and these differences impact insurers’... View Details
Keywords: Interest Rate Risk; Variable Annuities; Capital Regulation; Reinsurance; Derivatives; Risk Management; Interest Rates; Governing Rules, Regulations, and Reforms
Sen, Ishita. "Regulatory Limits to Risk Management." Review of Financial Studies 36, no. 6 (June 2023): 2175–2223. (Lead Article and Editor's Choice, Winner of the RFS Rising Scholar Award 2024.)
- September 2011
- Article
How Did Increased Competition Affect Credit Ratings?
The credit rating industry has historically been dominated by just two agencies, Moody's and S&P, leading to longstanding legislative and regulatory calls for increased competition. The material entry of a third rating agency (Fitch) to the competitive landscape offers... View Details
Keywords: Credit; Governing Rules, Regulations, and Reforms; Competition; Forecasting and Prediction; Theory
Becker, Bo, and Todd Milbourn. "How Did Increased Competition Affect Credit Ratings?" Journal of Financial Economics 101, no. 3 (September 2011): 493–514.
- 1984
- Book
Prophets of Regulation: Charles Francis Adams, Louis D. Brandeis, James M. Landis, Alfred E. Kahn
By: T. K. McCraw
McCraw, T. K. Prophets of Regulation: Charles Francis Adams, Louis D. Brandeis, James M. Landis, Alfred E. Kahn. Cambridge, MA: Belknap Press of Harvard University Press, 1984.
- July 22, 1990
- Article
Japan Isn't Playing by Different Rules
By: M. E. Porter
Porter, M. E. "Japan Isn't Playing by Different Rules." New York Times (July 22, 1990).
- April 2002
- Article
If You Want Honesty, Break Some Rules
Graham, Ginger. "If You Want Honesty, Break Some Rules." Harvard Business Review 80, no. 4 (April 2002).
- February 2022 (Revised November 2022)
- Case
Fondeadora
By: Álvaro Rodríguez Arregui and Mitchell Weiss
Norman Müller and René Serrano, cofounders of Fondeadora, a Mexican “neobank,” had lined up a $12.5 million in Series A funding round in 2020 only to run into a major obstacle: The lead investor was Gradient Ventures, a venture firm launched by Alphabet, Inc., and... View Details
Keywords: Fundraising; Entrepreneurship; Venture Capital; Financial Institutions; Business Startups; Government Legislation; Governing Rules, Regulations, and Reforms; Financial Strategy; Financial Services Industry; Mexico City; Latin America
Rodríguez Arregui, Álvaro, and Mitchell Weiss. "Fondeadora." Harvard Business School Case 822-077, February 2022. (Revised November 2022.)
- November 2010 (Revised December 2010)
- Case
Mid-Missouri Energy: Ethanol from Corn
By: Forest L. Reinhardt, Noel Michele Holbrook, James Weber and Karla Sartor
Mid-Missouri Energy (MME) is a farmer-owned cooperative that produces ethanol from corn. The cooperative has performed well in comparison to other producers, but margins in the industry had declined as industry production levels neared market demand limits. MME farmers... View Details
Keywords: Agribusiness; Renewable Energy; Governing Rules, Regulations, and Reforms; Policy; Growth and Development Strategy; Cooperative Ownership; Business and Government Relations; Agriculture and Agribusiness Industry; United States
Reinhardt, Forest L., Noel Michele Holbrook, James Weber, and Karla Sartor. "Mid-Missouri Energy: Ethanol from Corn." Harvard Business School Case 711-004, November 2010. (Revised December 2010.)
- Article
A Macroprudential Approach to Financial Regulation
By: Samuel G. Hanson, Anil Kashyap and Jeremy C. Stein
Hanson, Samuel G., Anil Kashyap, and Jeremy C. Stein. "A Macroprudential Approach to Financial Regulation." Journal of Economic Perspectives 25, no. 1 (Winter 2011): 3–28.
- January 2025
- Case
COMAC - Chinese Aviation Soars to New Heights
By: William C. Kirby and Daniel Fu
COMAC's C919 manifested the first challenge to the Boeing-Airbus duopoly since it came to dominate aircraft manufacturing in the 1990s. Beijing sought to export the C919 abroad in its quest to become a "transportation superpower." Was it a wise decision for COMAC to... View Details
- fall 2007
- Article
The Design of Patent Pools: The Determinants of Licensing Rules
By: Josh Lerner, Marcin Strojwas and Jean Tirole
Patent pools are an important but little-studied economic institution. In this paper, we first make a set of predictions about the licensing terms associated with patent pools. The theoretical framework predicts that (a) pools consisting of complementary patents are... View Details
Keywords: Governing Rules, Regulations, and Reforms; Collaborative Innovation and Invention; Patents; Rights
Lerner, Josh, Marcin Strojwas, and Jean Tirole. "The Design of Patent Pools: The Determinants of Licensing Rules." RAND Journal of Economics 38, no. 3 (fall 2007): 610–625. (Earlier version distributed as National Bureau of Economic Research Working Paper No. 9680.)