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(139)
- News (19)
- Research (110)
- Events (2)
- Multimedia (1)
- Faculty Publications (41)
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- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality... View Details
Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- 2011
- Other Unpublished Work
Lords of the Harvest: Third-Party Signaling and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt and Sangchan Park
Little is known about the factors that influence regulatory agencies' decision making. We posit that regulatory agencies are influenced by the firms they regulate, but not exclusively via political influence as is argued in the traditional regulatory-capture... View Details
- August 2013
- Article
Lords of the Harvest: Third-party Influence and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt and Sangchan Park
Little is known about the factors that influence regulatory-agency decision making. We posit that regulatory agencies are influenced by the firms they regulate, but not exclusively via dyadic exchanges as is traditionally argued in the regulatory capture and... View Details
Hiatt, Shon R., and Sangchan Park. "Lords of the Harvest: Third-party Influence and Regulatory Approval of Genetically Modified Organisms." Academy of Management Journal 56, no. 4 (August 2013): 923–944.
- 10 May 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- 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).
- 15 Apr 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- 09 May 2011
- Conference Presentation
Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms
By: Shon R. Hiatt
- 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.)
- 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.
- January 2017
- Article
Innovation Under Regulatory Uncertainty: Evidence from Medical Technology
By: Ariel Dora Stern
This paper explores how the regulatory approval process affects innovation incentives in medical technologies. Prior studies have found early mover regulatory advantages for drugs. I find the opposite for medical devices, where pioneer entrants spend 34% (7.2 months)... View Details
Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.
- 28 Mar 2023
- Research & Ideas
The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation
“The findings of our study suggest that regulatory innovation can support more efficient drug development—in particular, in settings where we have unmet medical needs. ” In the first comprehensive analysis of its kind, Harvard Business... View Details
- March 2015 (Revised January 2024)
- Case
CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies
By: Regina E. Herzlinger and Andrew Otazo
Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details
Keywords: CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised January 2024.)
- 09 Apr 2012
- Research & Ideas
Who Sways the USDA on GMO Approvals?
subtle difference in perspective also has the potential to distort the agency's reliance on pure science in its approval of GMOs. In his working paper "Lords of the Harvest: Third-Party Signaling and View Details
- June 2023 (Revised July 2024)
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry
Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details
Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- December 2003
- Case
Antitrust Regulations in a Global Setting: The EU Investigation of the GE/Honeywell Merger
By: Mihir A. Desai, Belen Villalonga and Mark Veblen
Helps students understand the principles underlying competition and antitrust policy in the context of the proposed GE-Honeywell merger. The U.S. Department of Justice has already approved the transaction and it is being considered by the European Commission. The... View Details
Keywords: Mergers and Acquisitions; Decisions; Economy; Fairness; Governing Rules, Regulations, and Reforms; Competition; Aerospace Industry
Desai, Mihir A., Belen Villalonga, and Mark Veblen. "Antitrust Regulations in a Global Setting: The EU Investigation of the GE/Honeywell Merger." Harvard Business School Case 204-081, December 2003.
- August 2022
- Article
Availability of New Medicines in the U.S. and Germany From 2004 to 2018
By: Katharina Blankart, Huseyin Naci and Amitabh Chandra
Importance: Germany's unique approach to coverage determination and pricing has ensured that effective medicines remain on the market, often at prices reduced through negotiation. However, less is known about trade-offs of this approach with regard to initial... View Details
Keywords: Market Entry and Exit; Price; Market Timing; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States; Germany
Blankart, Katharina, Huseyin Naci, and Amitabh Chandra. "Availability of New Medicines in the U.S. and Germany From 2004 to 2018." e2229231. JAMA Network Open 5, no. 8 (August 2022).
- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
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
Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
- 10 Aug 2015
- Research & Ideas
New Medical Devices Get To Patients Too Slowly
implantable defibrillators or transcatheter heart valves, the FDA's regulatory approval process appears to delay those approvals, which in turn adds to development costs borne by device manufacturers,... View Details
- 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.