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Publications

Filter Results: (137) Arrow Down
Filter Results: (137) Arrow Down Arrow Up

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  • All HBS Web  (137)
    • News  (19)
    • Research  (110)
    • Events  (2)
    • Multimedia  (1)
  • Faculty Publications  (41)

Show Results For

  • All HBS Web  (137)
    • News  (19)
    • Research  (110)
    • Events  (2)
    • Multimedia  (1)
  • Faculty Publications  (41)
Page 1 of 137 Results →
  • 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
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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  • Other Unpublished Work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
Keywords: Genetics; Decision Choices and Conditions; Reputation; Agribusiness; Power and Influence; Agriculture and Agribusiness Industry; United States
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Hiatt, Shon R., and Sangchan Park. "Lords of the Harvest: Third-Party Signaling and Regulatory Approval of Genetically Modified Organisms." 2011.
  • 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
Keywords: Strategy; Government and Politics; Agriculture and Agribusiness Industry; United States
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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.
  • 22 Aug 2023
  • News

$5 Billion Intel Deal Scrapped after China Dragged Out Regulatory Approval

  • 10 May 2011
  • Conference Presentation

Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms

By: Shon R. Hiatt
Keywords: Reputation; Governing Rules, Regulations, and Reforms
Citation
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Hiatt, Shon R. "Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms." Paper presented at the Alliance for Research on Corporate Sustainability Annual Research Conference, Philadelphia, PA, May 10, 2011.
  • Article

Lords of the Harvest: Symbolic Signaling and Regulatory Approval of Genetically Modified Organisms

By: Shon R. Hiatt and Sangchan Park
Keywords: Science; Governing Rules, Regulations, and Reforms
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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
Keywords: Reputation; Governing Rules, Regulations, and Reforms
Citation
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Hiatt, Shon R. "Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms." Paper presented at the MIT-Harvard Economic Sociology Seminar, April 15, 2011.
  • 09 May 2011
  • Conference Presentation

Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms

By: Shon R. Hiatt
Keywords: Reputation; Governing Rules, Regulations, and Reforms
Citation
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Hiatt, Shon R. "Lords of the Harvest: Reputation Concerns and Regulatory Approval of Genetically Modified Organisms." Paper presented at the Strategy and the Business Environment Conference, Philadelphia, PA, May 09, 2011.
  • 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
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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
Citation
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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
Keywords: Technological Innovation; Medical Devices and Supplies Industry
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Stern, Ariel Dora. "Innovation Under Regulatory Uncertainty: Evidence from Medical Technology." Journal of Public Economics 145 (January 2017): 181–200.
  • Fast Answer

Biotech, Medical devices, and Pharmaceuticals: regulatory information

Device Regulatory Process Charts and Approval Timelines  Pharmaceuticals Pharmaceutical Patent Law European Medicines Agency FDA: Drugs portal  International Society for Pharmaceutical... View Details
  • 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
Keywords: by Kasandra Brabaw; Pharmaceutical
  • 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
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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.)
  • 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
Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry
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Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 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
Keywords: by Michael Blanding; Food & Beverage; Biotechnology; Agriculture & Agribusiness
  • 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
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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.
  • 24 Jun 2016
  • News

Health insurance mergers put consumers last

  • 01 Nov 2019
  • Video

Jaithirth Rao

Jerry Rao, serial entrepreneur and founder of India-based real estate company Value and Budget Housing Corporation, discusses the causes of corruption in the real estate sector. He blames a regulatory system... View Details
  • 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.)
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