Publications

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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Other Unpublished Work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

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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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

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

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

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

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

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

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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September 2023 (Revised August 2024)
Case

Avive: Resuscitating a Defibrillator from the Regulatory Brink

By: Satish Tadikonda and William Marks

Avive Solutions set out to create a better Automatic External Defibrillator (AED) that would solve many of the problems with existing solutions, including lack of connectivity, difficulty-of-use and requiring prior training for successful use of the device, data... View Details

Keywords: Technological Innovation; Product Development; Business and Government Relations; Research and Development; Medical Devices and Supplies Industry; United States

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

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

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