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- All HBS Web (388)
- Faculty Publications (234)
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- 2008
- Chapter
Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation
By: Arthur A. Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details
Keywords: Geographic Location; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Demand and Consumers; Pharmaceutical Industry; European Union; Germany; United States
Daemmrich, Arthur A. "Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation." Chap. 16 in Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms. Vol. 363, edited by Jean Paul Gaudillière and Volker Hess, 271–290. Berlin, Germany: Max-Planck-Institut für Wissenschaftsgeschichte, 2008.
- 2009
- Working Paper
Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location
By: Arthur Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Health Testing and Trials; Power and Influence; Competitive Strategy; Pharmaceutical Industry; European Union; Germany; United States
Daemmrich, Arthur. "Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location." Harvard Business School Working Paper, No. 09-118, April 2009.
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging... View Details
Keywords: Machine Learning; Causal Inference; Health Care and Treatment; Safety; Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- Article
Lords of the Harvest: Symbolic Signaling and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt and Sangchan Park
Hiatt, Shon R., and Sangchan Park. "Lords of the Harvest: Symbolic Signaling and Regulatory Approval of Genetically Modified Organisms." Academy of Management Annual Meeting Proceedings (2010).
- Article
Perceptions and the Politics of Finance: Junk Bonds and the Regulatory Seizure of First Capital Life
By: S. C. Gilson, H. DeAngelo and L. DeAngelo
In May 1991, one month after seizing Executive Life, California regulators seized First Capital Life (FCLIC). Both insurers were Drexel clients with large junk bond holdings, and both had experienced 'bank runs.' FCLIC's run followed regulators' televised comments that... View Details
Gilson, S. C., H. DeAngelo, and L. DeAngelo. "Perceptions and the Politics of Finance: Junk Bonds and the Regulatory Seizure of First Capital Life." Journal of Financial Economics 41, no. 3 (July 1996): 475–511.
- Oct 2010
- Conference Presentation
How Stringent Is Private Regulatory Monitoring? The Role of Organizational Scope and Governance
- 09 May 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- spring 1976
- Article
Information, Politics and Economic Analysis: The Regulatory Decision Process in the Air Freight Cases
By: M. E. Porter and J. F. Sagansky
Keywords: Information; Government and Politics; Economics; Governing Rules, Regulations, and Reforms; Decision Making
Porter, M. E., and J. F. Sagansky. "Information, Politics and Economic Analysis: The Regulatory Decision Process in the Air Freight Cases." Public Policy 24, no. 2 (spring 1976): 263–307.
- 10 May 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- July 2011
- Article
Bringing Ethics into Focus: How Regulatory Focus and Risk Preferences Influence (Un)ethical Behavior
By: F. Gino and Joshua D. Margolis
Gino, F., and Joshua D. Margolis. "Bringing Ethics into Focus: How Regulatory Focus and Risk Preferences Influence (Un)ethical Behavior." Organizational Behavior and Human Decision Processes 115, no. 2 (July 2011): 145–156.
- 7 Nov 2010
- Conference Presentation
How Stringent Is Private Regulatory Monitoring? The Role of Organizational Scope and Governance
- 1 May 2010
- Conference Presentation
How Stringent is Private Regulatory Enforcement? The Role of Organizational Scope and Governance
- 15 Apr 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- Oct 2010
- Conference Presentation
How Stringent Is Private Regulatory Monitoring? The Role of Organizational Scope and Governance
- 1 Aug 2010
- Conference Presentation
Lords of the harvest: Symbolic signaling and regulatory approval of genetically modified organisms in the nascent U.S. agriculture-biotechnology sector
By: Shon R. Hiatt and Sangchan Park
Keywords: Science; Information Technology; Governing Rules, Regulations, and Reforms; Agribusiness; Agriculture and Agribusiness Industry; Biotechnology Industry; United States
Hiatt, Shon R., and Sangchan Park. "Lords of the harvest: Symbolic signaling and regulatory approval of genetically modified organisms in the nascent U.S. agriculture-biotechnology sector." Paper presented at the Academy of Management Annual Meeting, Montreal, Canada, August 01, 2010.
- November 2012 (Revised January 2013)
- Case
Companion Diagnostics: Uncertainties for Approval and Reimbursement
By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory... View Details
Keywords: Models Of Reimbursement; Personalized Medicine; Regulation; Healthcare Reform; Health Care and Treatment; Health Industry; United States
Hamermesh, Richard G., Norman C. Selby, and Phillip Andrews. "Companion Diagnostics: Uncertainties for Approval and Reimbursement." Harvard Business School Case 813-037, November 2012. (Revised January 2013.)
- Article
Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring
By: Jan Benedikt Brönneke, Jennifer Müller, Konstantinos Mouratis, Julia Hagen and Ariel Dora Stern
In the area of cardiac monitoring, the use of digitally driven technologies is on the rise. While the development of medical products is advancing rapidly, allowing for new use-cases in cardiac monitoring and other areas, regulatory and legal requirements that govern... View Details
Keywords: Wearables; Regulatory Changes; Medical Technology; Medical Devices; Market Access; Market Entry and Exit; Information Technology; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States; Germany; Belgium
Brönneke, Jan Benedikt, Jennifer Müller, Konstantinos Mouratis, Julia Hagen, and Ariel Dora Stern. "Regulatory, Legal, and Market Aspects of Smart Wearables for Cardiac Monitoring." Art. 4937. Sensors 21, no. 14 (July 2021).
- Article
The Harmonization of Lending Standards within Banks through Mandated Loan-Level Transparency
By: Jung Koo Kang, Maria Loumioti and Regina Wittenberg-Moerman
We explore whether the introduction of transparent reporting rules increases credit standard harmonization within a bank. We exploit the new loan-level reporting rules imposed on banks that borrow from the European Central Bank using repurchase agreements... View Details
Keywords: Transparency; External And Internal Reporting; Credit Term Harmonization; Regulatory Scrutiny; Banks and Banking; Credit; Financial Reporting; Governing Rules, Regulations, and Reforms; Learning
Kang, Jung Koo, Maria Loumioti, and Regina Wittenberg-Moerman. "The Harmonization of Lending Standards within Banks through Mandated Loan-Level Transparency." Journal of Accounting & Economics 72, no. 1 (August 2021): 101386.
- 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.
- Article
The Consumer Financial Protection Bureau: Financial Regulation for the Twenty-First Century
By: Leonard J. Kennedy, Patricia A. McCoy and Ethan S. Bernstein
After existing regulatory systems failed to prevent the recent financial crisis, Congress passed the Dodd-Frank Wall Street Reform and Consumer Protection Act, a sweeping reform designed to alleviate the crisis and prevent its recurrence. Out of this Act, the Consumer... View Details
Keywords: Consumer Financial Protection Bureau; Dodd-Frank; CFPB; Financial Crisis; Reform; New Agency; Market-based Approach; Evidence-based Analysis; Innovative Technologies And Transparency Policies; BEST Practices; Government and Politics; Government Administration; Finance; Financial History; Law; Markets; Organizations; Organizational Design; Business and Government Relations; Balance and Stability; Strategy; Financial Services Industry; Banking Industry; United States
Kennedy, Leonard J., Patricia A. McCoy, and Ethan S. Bernstein. "The Consumer Financial Protection Bureau: Financial Regulation for the Twenty-First Century." Cornell Law Review 97, no. 5 (July 2012): 1141–1176.