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(487)
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Show Results For
- All HBS Web
(487)
- People (1)
- News (152)
- Research (274)
- Events (3)
- Multimedia (3)
- Faculty Publications (93)
- 2024
- Working Paper
Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions
By: Caleb Kwon, Ananth Raman and Jorge Tamayo
We investigate whether corporate officers should grant managers discretion to override AI-driven demand forecasts and labor scheduling tools. Analyzing five years of administrative data from a large grocery retailer using such an AI tool, encompassing over 500 stores,... View Details
Keywords: AI and Machine Learning; Forecasting and Prediction; Working Conditions; Performance Productivity
Kwon, Caleb, Ananth Raman, and Jorge Tamayo. "Human-Computer Interactions in Demand Forecasting and Labor Scheduling Decisions." Working Paper, April 2024.
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Technology Adoption; Technological Innovation; Safety; Medical Devices and Supplies Industry; United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- November 2020
- Case
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage... View Details
Keywords: Mergers and Acquisitions; Value; Valuation; Judgments; Decision Making; Cash Flow; Financial Instruments; Cognition and Thinking; Pharmaceutical Industry; Biotechnology Industry; United States
Esty, Benjamin C., and Daniel Fisher. "Valuing Celgene's CVR." Harvard Business School Case 221-031, November 2020.
- 01 Apr 2014
- News
FDA Moves to Regulate E-Cigarettes
- October 2020 (Revised November 2023)
- Case
COVID-19 Testing at Everlywell
By: Jeffrey J. Bussgang and Olivia Hull
In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the... View Details
Keywords: Entrepreneurship; Business Strategy; Venture Capital; Health Care and Treatment; Health Disorders; Leading Change; Technology Adoption; Digital Platforms; Competitive Strategy; Science; Adaptation; Corporate Social Responsibility and Impact; Crisis Management; Social Entrepreneurship; Ethics; Government Legislation; Health; Health Testing and Trials; Health Pandemics; Consumer Products Industry; Health Industry; Technology Industry; Texas; United States
Bussgang, Jeffrey J., and Olivia Hull. "COVID-19 Testing at Everlywell." Harvard Business School Case 821-001, October 2020. (Revised November 2023.)
- 25 Sep 2018
- First Look
New Research and Ideas, September 25, 2018
operations. Product failures are, therefore, likely to impact firms’ subsequent innovation activities. Using 13 years of Food and Drug View Details
Keywords: Dina Gerdeman
- November 2010
- Supplement
Hikma Pharmaceuticals (B)
By: John A. Quelch
By 2009, Hikma Pharmaceuticals operated 13 manufacturing plants in 8 countries of which 5 were approved by the U.S. Food and Drug Administration. Hikma tracked its sales revenues over the period to show where the largest contributors were from. View Details
Quelch, John A. "Hikma Pharmaceuticals (B)." Harvard Business School Supplement 511-075, November 2010.
- 19 Dec 2017
- First Look
New Research and Ideas, December 19, 2017
Abstract—No abstract available. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53633 Characterizing the Drug Development Pipeline for Precision Medicines By: Chandra, Amitabh, Craig Garthwaite, View Details
Keywords: Carmen Nobel
- November 2020
- Supplement
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA) approved three of Celgene’s late stage... View Details
- 31 Oct 2017
- First Look
New Research and Ideas, October 31, 2017
developed new product categories such as organic food and wind and solar energy, which explicitly focused on sustainability. Again this process has been traced back to the... View Details
Keywords: by Sean Silverthorne
- 23 Jun 2015
- Video
Innovations Wanted: Beating Brain Disease
- 24 Sep 2007
- Research & Ideas
The FDA: What Will the Next 100 Years Bring?
The U.S. Food and Drug Administration, which was created by the passage of the 1906 Federal Food and View Details
- September 1991 (Revised August 1994)
- Background Note
Note on Pharmaceutical Industry Regulation
Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,... View Details
Keywords: Safety; Industry Growth; Marketing; Research and Development; Health Testing and Trials; Economics; Pharmaceutical Industry; United States
Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
- November 2020
- Teaching Note
Valuing Celgene's CVR
By: Benjamin C. Esty and Daniel Fisher
Teaching Note for HBS Case No. 221-031. When Bristol-Myers Squibb (BMS) acquired Celgene Corporation in November 2019, Celgene shareholders received cash, BMS stock, and a contingent value right (CVRs) that would pay $9 if the U.S. Food and Drug Administration (FDA)... View Details
- 01 Dec 2022
- News
December 2022 Alumni and Faculty Books and Podcasts
Westminster, Bingham juggled vaccine suppliers, Whitehall, the media circus—and her daughter’s exams. Political maneuvering, miscommunications, and administrative meddling nearly jeopardized the project, but... View Details
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices... View Details
Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- 01 Dec 2015
- News
Leading Boston and Beyond
(MBA 2002), served as the city’s CFO from 2010 to 2014 after working as an advisor to the mayor and serving in the department of administration and finance. Mitch Weiss (MBA... View Details
- 15 Dec 2024
- News
Alumni and Faculty Books
Edited by Margie Kelley Alumni Books The Power of Imperfect Eating By Kavita Bhatnagar (SELP 11, 2022) Penguin Enterprise Rather than dictating which foods are good or bad, this book weaves together stories that mirror the intricate,... View Details
- 21 Aug 2007
- First Look
First Look: August 21, 2007
http://www.hbsp.harvard.edu/b01/en/common/item_detail.jhtml?id=807074 PublicationsPerspectives on Risk and Regulation: The FDA at 100 Author:Arthur A. Daemmrich Publication:Chemical Heritage Press, 2007 Abstract Perspectives on Risk... View Details
Keywords: Martha Lagace