Filter Results:
(492)
Show Results For
- All HBS Web
(492)
- People (1)
- News (149)
- Research (274)
- Events (1)
- Multimedia (3)
- Faculty Publications (93)
Show Results For
- All HBS Web
(492)
- People (1)
- News (149)
- Research (274)
- Events (1)
- Multimedia (3)
- Faculty Publications (93)
- 12 Jun 2018
- Research & Ideas
In a Landscape of 'Me Too' Drug Development, What Spurs Radical Innovation?
Papanikolaou, Kellogg School of Management. On balance, novel drugs with unproven chemical formulas are riskier to pursue because they are less likely to win approval from the US Food View Details
- 16 May 2019
- News
To Improve Food Inspections, Change the Way They’re Scheduled
- 16 May 2016
- HBS Case
Food Safety Economics: The Cost of a Sick Customer
Chipotle Mexican Grill’s ongoing struggle to win customers back months after a contaminated food crisis highlights the challenges companies face with keeping food safe. Chipotle has seen its shares tumble... View Details
- January 2020
- Case
Celata Bioinnovations
By: John R. Wells and Benjamin Weinstock
In December 2019, Jon Hu (HBS ‘19) and Dr. Samantha Dale Strasser, co-founders of Celata Bioinnovations, were raising $1 million to launch their company. They had founded Celata less than six months earlier with the aim of redefining the drug discovery process.... View Details
Keywords: Drug Development; Drug Discovery; Drug Trials; Pharmaceutical Companies; Pharmaceutical Company; Pharmaceuticals; Therapeutics; Biologics; Biotech; Biotechnology; Biopharmacy Company; Biochemistry; Technology Commercialization; Technology Companies; Drug Testing; Startup; Start-up; Startups; Start-ups; Startup Financing; Strategic Decision Making; Strategic Decisions; Strategic Evolution; FDA; Food And Drug Administration; Clinical Trials; Disease Management; Market Attractiveness; Market Entry; Market Opportunities; Health Disorders; Technological Innovation; Information Technology; Commercialization; Business Startups; Finance; Decision Making; Strategy; Market Entry and Exit; Opportunities; Pharmaceutical Industry; Biotechnology Industry
Wells, John R., and Benjamin Weinstock. "Celata Bioinnovations." Harvard Business School Case 720-427, January 2020.
- November 1989
- Teaching Note
H.J. Heinz Co.: The Administration of Policy (A), (B), (C), and (D), Teaching Note
By: Kenneth E. Goodpaster and Thomas R. Piper
Teaching Note for (9-382-034, 035, 036, and 037). View Details
- 09 Feb 2024
- HBS Case
Slim Chance: Drugs Will Reshape the Weight Loss Industry, But Habit Change Might Be Elusive
what may at first blush appear to be an easier fix: new drugs such as Ozempic, Wegovy, and Mounjaro, says Harvard Business School Professor Regina E. Herzlinger, who has studied the American health care... View Details
- 09 May 2018
- Research & Ideas
A Simple Way for Restaurant Inspectors to Improve Food Safety
Restaurant inspectors can be the last line of defense between you and moldy bread. (HighLaZ) Simple tweaks to the schedules of food safety inspectors could result in hundreds of thousands of currently... View Details
- 09 Jul 2015
- News
Shoppers with reusable bags buy more junk food
- 11 Jan 2017
- Research & Ideas
The Paradoxical Quest to Make Food Look 'Natural' With Artificial Dyes
chromate was used to make milk look creamier; and various poisonous ingredients were used to create bright colors for various candies, reportedly causing some children to fall ill or even die. Hisano highlights key dates in View Details
Keywords: by Carmen Nobel
- 01 Oct 2018
- Working Paper Summaries
Negative Shocks and Innovation: Evidence from Medical Device Recalls
- 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.)
- August 2008 (Revised September 2008)
- Supplement
The Flaxil Label (C): Debrief and Endnotes
This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite... View Details
Keywords: Safety; Value Creation; Negotiation; Health Care and Treatment; Sales; Pharmaceutical Industry
Barron, Greg M. "The Flaxil Label (C): Debrief and Endnotes." Harvard Business School Supplement 909-003, August 2008. (Revised September 2008.)
- 01 Mar 2014
- News
The Solution to the Global Food Crisis Just Might Come from Nigeria
these things, people look on it as the most difficult country to change." And yet, a shift appears under way. A new reformist government has started treating agriculture as a problem to be solved by industry rather than by aid. Private... View Details
- 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.
- 2023
- Working Paper
Market Exclusivity and Innovation: Evidence From Antibiotics
By: Edward Kong and Olivia Zhao
The US incentivizes drug innovation via patents as well as market exclusivity periods awarded by the US Food and Drug Administration. We estimate the causal effects of extending market exclusivity for an important drug class: antibiotics. Using a... View Details
Keywords: Health Testing and Trials; Innovation and Invention; Motivation and Incentives; Government Administration; Government Legislation; Pharmaceutical Industry; United States
Kong, Edward, and Olivia Zhao. "Market Exclusivity and Innovation: Evidence From Antibiotics." Working Paper, December 2023.
- 2024
- Working Paper
Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances
By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins
This case history describes how Magnetic Resource Imaging (MRI) came to complement – and partially replace -- computed tomography (CT) imaging of soft tissue. Specifically, we chronicle 1) the development of foundational techniques and prototypes (through the 1970s);... View Details
Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms
Datar, Srikant M., Amar Bhidé, and Katherine Stebbins. "Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-001, July 2019. (Revised May 2024.)
- 15 Jan 2019
- First Look
New Research and Ideas, January 15, 2019
forthcoming American Journal of Therapeutics Food and Drug Administration Guidance Documents and New Medical... View Details
Keywords: Dina Gerdeman
- 2007
- Book
Perspectives on Risk and Regulation: The FDA at 100
By: Arthur A. Daemmrich and Joanna Radin
Perspectives on Risk and Regulation: The FDA at 100 brings together the viewpoints of Food and Drug Administration officials and industry leaders on the future of regulating food, drugs, medical devices, and dietary supplements. In a period of rapid scientific... View Details
Keywords: Private Sector; Governing Rules, Regulations, and Reforms; Policy; Health Care and Treatment; Business and Government Relations; Risk and Uncertainty; Cooperation
Daemmrich, Arthur A., and Joanna Radin, eds. Perspectives on Risk and Regulation: The FDA at 100. Chemical Heritage Foundation, 2007. (Fulltext.)
- May 2021
- Case
The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease
By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory... View Details
Keywords: Innovation and Invention; Strategy; Business or Company Management; Society; Health; Public Administration Industry; Public Administration Industry; United States
Chandra, Amitabh, Spencer Lee-Rey, and Caroline Marra. "The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease." Harvard Business School Case 621-112, May 2021.
- 2010
- Chapter
From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance
By: Arthur A. Daemmrich
Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States
Daemmrich, Arthur A. "From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance." Chap. 13 in The Fragmentation of U.S. Health Care: Causes and Solutions, edited by Einer Elhauge, 301–322. Oxford: Oxford University Press, 2010.