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  • August 2023 (Revised May 2024)
  • Case

Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations

By: Satish Tadikonda and Amanda McEwen
The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details
Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry
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Tadikonda, Satish, and Amanda McEwen. "Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations." Harvard Business School Case 824-018, August 2023. (Revised May 2024.)
  • October 2008
  • Article

Risk Frameworks and Biomonitoring: Distributed Regulation of Synthetic Chemicals in Humans

By: Arthur A. Daemmrich
The ability to detect and measure the presence of synthetic chemicals at trace levels in humans coupled to increased environmental NGO mobilization concerning chemical exposure has challenged risk and regulatory frameworks built up over the past quarter-century. This... View Details
Keywords: Chemicals; Governing Rules, Regulations, and Reforms; Risk Management; Natural Environment; Pollutants; Non-Governmental Organizations; United States
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Daemmrich, Arthur A. "Risk Frameworks and Biomonitoring: Distributed Regulation of Synthetic Chemicals in Humans." Environmental History 13, no. 4 (October 2008): 684–694.
  • October 1992 (Revised December 1992)
  • Supplement

Salomon and the Treasury Securities Auction: 1992 Update

By: Dwight B. Crane
Briefly summarizes the events that transpired after the investment bank Salomon Brothers revealed that it had repeatedly violated the rules governing the auction of new U.S. Government securities. Includes a description of the violations, the management shake-up that... View Details
Keywords: Crime and Corruption; Governing Rules, Regulations, and Reforms; Financial Instruments; Banking Industry; Financial Services Industry; United States
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Crane, Dwight B. "Salomon and the Treasury Securities Auction: 1992 Update." Harvard Business School Supplement 293-057, October 1992. (Revised December 1992.)
  • July 2024
  • Article

The Home State Effect: How Subnational Governments Shape Climate Coalitions

By: Jonas Meckling and Samuel Trachtman
Organized business interests often seek to block public interest regulations. But whether firms oppose regulation depends on institutional context. We argue that, in federal systems, sub-national policies and politics can have a home state effect on firms' national... View Details
Keywords: Local Range; Governing Rules, Regulations, and Reforms; Business and Government Relations
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Meckling, Jonas, and Samuel Trachtman. "The Home State Effect: How Subnational Governments Shape Climate Coalitions." Governance 37, no. 3 (July 2024): 887–905.
  • August 2024
  • Case

Zipline: Expanding the World's Largest Autonomous Drone Delivery Network

By: Tarun Khanna and George Gonzalez
Zipline initially established the world's largest logistics network in Rwanda and Ghana by delivering medical supplies to hospitals via automated drones from a centralized hub. The company is now looking to expand to the U.S. home delivery market and designed a... View Details
Keywords: Governing Rules, Regulations, and Reforms; Growth and Development Strategy; Logistics; Expansion; Air Transportation; Business Model; Rwanda; Ghana; United States
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Khanna, Tarun, and George Gonzalez. "Zipline: Expanding the World's Largest Autonomous Drone Delivery Network." Harvard Business School Case 725-381, August 2024.
  • Article

Red Light States: Who Buys Online Adult Entertainment?

By: Benjamin Edelman
This paper studies the adult online entertainment industry, particularly the consumption side of the market. In particular, it focuses on the demographics and consumption patterns of those who subscribe to adult entertainment websites. On the surface, this business... View Details
Keywords: Online Technology; Segmentation; Film Entertainment; Demographics; Web Sites; Competition; Governing Rules, Regulations, and Reforms; Demand and Consumers; Legal Liability; Culture; Religion; Entertainment and Recreation Industry; United States
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Edelman, Benjamin. "Red Light States: Who Buys Online Adult Entertainment?" Journal of Economic Perspectives 23, no. 1 (Winter 2009): 209–220.
  • 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
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Dafny, Leemore S. "A Radical Treatment for Insulin Pricing." New England Journal of Medicine 386, no. 23 (June 9, 2023): 2157–2159.
  • July 2013
  • Case

Sample6: Innovating to Make Food Safer

By: Robert F. Higgins and Kirsten Kester
Tim Curran, CEO of Sample6, a start-up biotechnology company developing a novel food safety diagnostics platform, must decide how to partner with food industry players. How can he best convince leaders in this mature industry to adopt a new technology and improve food... View Details
Keywords: Data Analytics; Food Safety; Biotechnology; Nutrition; Entrepreneurship; Product; Partners and Partnerships; Food; Technological Innovation; Business Startups; Governing Rules, Regulations, and Reforms; Product Development; Agribusiness; Information Technology; Globalization; Performance Improvement; Safety; Technology Adoption; Agriculture and Agribusiness Industry; Food and Beverage Industry; Biotechnology Industry; Information Industry; United States; Boston; Massachusetts
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Higgins, Robert F., and Kirsten Kester. "Sample6: Innovating to Make Food Safer." Harvard Business School Case 814-014, July 2013.
  • Article

Optimizing Organic Waste to Energy Operations

By: Baris Ata, Deishin Lee and Mustafa H. Tongarlak
A waste-to-energy firm that recycles organic waste with energy recovery performs two environmentally beneficial functions: it diverts waste from landfill and it produces renewable energy. At the same time, the waste-to-energy firm serves and collects revenue from two... View Details
Keywords: Business Ventures; Energy Generation; Renewable Energy; Revenue; Customers; Strategy; Corporate Governance; Wastes and Waste Processing; Environmental Sustainability; Governing Rules, Regulations, and Reforms; Cost Management; Urban Scope
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Ata, Baris, Deishin Lee, and Mustafa H. Tongarlak. "Optimizing Organic Waste to Energy Operations." Manufacturing & Service Operations Management 14, no. 2 (Spring 2012): 231–244.
  • August 1991 (Revised March 1993)
  • Case

Champion International Corp.: Timber, Trade, and the Northern Spotted Owl

By: Forest L. Reinhardt
Champion's forest products division owns timberlands, sawmills, and plywood mills in the Pacific Northwest. The listing of the northern spotted owl as an endangered species, and restrictions on exports of logs from state-owned lands, have disrupted the stumpage, log... View Details
Keywords: Science-Based Business; Natural Environment; Product Marketing; Governing Rules, Regulations, and Reforms; Government and Politics; Environmental Sustainability; Corporate Strategy; Trade; Decisions; Management Teams; Forest Products Industry; North and Central America
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Reinhardt, Forest L. "Champion International Corp.: Timber, Trade, and the Northern Spotted Owl." Harvard Business School Case 792-017, August 1991. (Revised March 1993.)
  • 14 Mar 2011
  • Research & Ideas

Keeping Credit Flowing to Consumers in Need

The credit crunch and subsequent collapse of the nonprime mortgage market claimed many victims, including hundreds of thousands of low- and moderate-income Americans who lost their homes and savings. Today, regulators and policymakers are debating ways to View Details
Keywords: by Sean Silverthorne; Financial Services; Construction; Real Estate
  • October 2009 (Revised November 2016)
  • Case

Generation Health: A Pioneer in Genetics Benefit Management (A)

By: Robert F. Higgins, Jeffrey D. Marrazzo and Rachel Gordon
Generation Health, a pioneer in the new field of genetics benefit management and a newly formed company, faces many strategic issues. CEO Per Lofberg is in the midst of negotiating a partnership with a major pharmacy benefit management company. As part of these... View Details
Keywords: Business Startups; Entrepreneurship; Governing Rules, Regulations, and Reforms; Growth and Development Strategy; Partners and Partnerships; Genetics; Health Industry; Insurance Industry
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Higgins, Robert F., Jeffrey D. Marrazzo, and Rachel Gordon. "Generation Health: A Pioneer in Genetics Benefit Management (A)." Harvard Business School Case 810-007, October 2009. (Revised November 2016.)
  • May 2024
  • Article

Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms

By: Caroline Marra and Ariel D. Stern
Digital health technologies (DHTs) can enable more patient-centric therapeutic development by generating evidence that captures how patients feel and function, enabling decentralized trial designs that increase participant inclusivity and convenience, and collecting... View Details
Keywords: Health Care and Treatment; Technological Innovation; Product Development; Health Testing and Trials; Governing Rules, Regulations, and Reforms
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Marra, Caroline, and Ariel D. Stern. "Tepid Uptake of Digital Health Technologies in Clinical Trials by Pharmaceutical and Medical Device Firms." Clinical Pharmacology & Therapeutics 115, no. 5 (May 2024): 988–992.
  • February 2025
  • Article

Disclosure, Humanizing, and Contextual Vulnerability of Generative AI Chatbots

By: Julian De Freitas and I. Glenn Cohen
In the wake of recent advancements in generative AI, regulatory bodies are trying to keep pace. One key decision is whether to require app makers to disclose the use of generative AI-powered chatbots in their products. We suggest that some generative AI-based chatbots... View Details
Keywords: AI and Machine Learning; Governing Rules, Regulations, and Reforms; Applications and Software; Well-being
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De Freitas, Julian, and I. Glenn Cohen. "Disclosure, Humanizing, and Contextual Vulnerability of Generative AI Chatbots." New England Journal of Medicine AI 2, no. 2 (February 2025).
  • September 1991 (Revised February 1993)
  • Case

Burroughs Wellcome and AZT (A)

By: Willis M. Emmons III
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S.... View Details
Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London
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Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
  • 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
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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.)
  • 23 Dec 2008
  • First Look

First Look: December 23, 2008

they experienced from growth prior to the 1960s. Download the working paper from SSRN ($5): http://papers.nber.org/papers/w14539 The Supply Side of Innovation: H-1B Visa Reforms and U.S. Ethnic Invention Authors:William R. Kerr and... View Details
Keywords: Martha Lagace
  • Article

Is It Time for Auditor Independence Yet?

By: M. H. Bazerman and D. A. Moore
Well before the collapse of Enron and Arthur Andersen, we argued that the auditing system had been corrupted by the incentives auditors face to please their clients. We stated that even honest auditors were incapable of independence within the current regulatory... View Details
Keywords: Accounting Audits; Change; Crime and Corruption; Customer Satisfaction; Governing Rules, Regulations, and Reforms; Failure; Motivation and Incentives
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Bazerman, M. H., and D. A. Moore. "Is It Time for Auditor Independence Yet?" Accounting, Organizations and Society 36, nos. 4-5 (May–July 2011): 310–312.
  • 2011
  • Article

Bias in Search Results?: Diagnosis and Response

By: Benjamin Edelman
I explore allegations of search engine bias, including understanding a search engine's incentives to bias results, identifying possible forms of bias, and evaluating methods of verifying whether bias in fact occurs. I then consider possible legal and policy responses,... View Details
Keywords: Prejudice and Bias; Motivation and Incentives; Outcome or Result; Markets; Legal Liability; Policy; Search Technology; Performance Evaluation; Governing Rules, Regulations, and Reforms
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Edelman, Benjamin. "Bias in Search Results?: Diagnosis and Response." Indian Journal of Law and Technology 7 (2011): 16–32.
  • January 2024 (Revised January 2025)
  • Case

Huawei: Resilience amid Autarky and Adversity

By: William C. Kirby and Daniel Fu
In September 2023, Huawei made a dramatic return to the global smartphone space with the launch of its Mate 60 Pro smartphone, equipped with an indigenously designed, 7nm chip. This came despite a myriad of export controls and restrictions imposed against the company... View Details
Keywords: International Strategy; Semiconductors; Smartphone; Government And Politics; Government And Business; Digital Infrastructure; 5G; Political Risk; Business and Government Relations; Global Strategy; Multinational Firms and Management; Governing Rules, Regulations, and Reforms; AI and Machine Learning; Mobile and Wireless Technology; Leadership; Retirement; Corporate Strategy; Technology Industry; China; United States; Europe; Asia; Middle East
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Kirby, William C., and Daniel Fu. "Huawei: Resilience amid Autarky and Adversity." Harvard Business School Case 324-069, January 2024. (Revised January 2025.)
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