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Show Results For
- All HBS Web
(230)
- People (2)
- News (74)
- Research (151)
- Multimedia (1)
- Faculty Publications (57)
- January 2009 (Revised July 2009)
- Case
Targanta Therapeutics: Hitting a Moving Target
By: Arthur A. Daemmrich
This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful... View Details
Keywords: Decision Choices and Conditions; Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Business and Government Relations; Business Strategy; Biotechnology Industry; Pharmaceutical Industry
Daemmrich, Arthur A. "Targanta Therapeutics: Hitting a Moving Target." Harvard Business School Case 709-002, January 2009. (Revised July 2009.)
- 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.
- Profile
Avi Kremer
millions of dollars into research, and removed critical barriers to the development of treatments. “Our focus was to get drug companies to invest money in ALS,” says Kremer, who was diagnosed in 2004, just weeks into his first year at... View Details
- August 2017 (Revised July 2018)
- Case
MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work
By: Elie Ofek and Amanda Dai
In June 2014, MannKind Corporation announced that after years of development and billions of dollars in expenses, the FDA had finally approved its drug, Afrezza. MannKind would thus be the only company with an inhalable insulin on the market. As an alternative to... View Details
Keywords: Health Care and Treatment; Product Launch; Product Positioning; Marketing Strategy; Adoption; Pharmaceutical Industry
Ofek, Elie, and Amanda Dai. "MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work." Harvard Business School Case 518-031, August 2017. (Revised July 2018.)
- May 6, 2020
- Article
We Shouldn't Wait for a Breakthrough in the COVID-19 Pandemic
By: Gary P. Pisano
The ultimate solutions to the COVID-19 crisis may be big breakthroughs in building massive test and trace capacity and developing vaccines and drug remedies. But in the meantime, we should not ignore the potential cumulative impact of the many small things we already... View Details
Pisano, Gary P. "We Shouldn't Wait for a Breakthrough in the COVID-19 Pandemic." Harvard Business Review Digital Articles (May 6, 2020).
- 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.)
- September 2017
- Case
Dr. William Carson— Intrapreneurial Innovation in the Pharmaceutical Industry
By: Steven Rogers and Alyssa Haywoode
Dr. William Carson, an African-American alum of Harvard University became the President and CEO of a multi billion dollar division of Otsuka, a Japan based pharmaceutical company. His ascension to this leadership position followed a thriving career in academic medicine... View Details
Keywords: Dr. Williams Carson; Otsuka America Pharmaceutical; Harvard; Abilify; Aripiprazole; Health Testing and Trials; Globalized Firms and Management; Globalized Markets and Industries; Cross-Cultural and Cross-Border Issues; Decision Choices and Conditions; Pharmaceutical Industry; Japan
Rogers, Steven, and Alyssa Haywoode. "Dr. William Carson— Intrapreneurial Innovation in the Pharmaceutical Industry." Harvard Business School Case 318-005, September 2017.
- October 2013
- Case
FasterCures: Removing Barriers to Treatments
By: Richard G. Hamermesh and James Weber
In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit... View Details
Keywords: Health Care; Health Care Industry; Health Care Policy; Health Services; Healthcare; Healthcare Reform; Healthcare Ventures; Nonprofit; Non-profit Management; Not-for-profit; Incubator; Accelerator; Venture Philanthropy; Medical Services; Medical Solutions; Medical Research; Medical Treatment; Clinical Trials; Drug Reimbursement; Early Stage; Early Stage Research Funding; Early Stage Funding; Milken Institute; Michael Milken; David Baltimore; Partnering For Cures; National Institutes Of Health; Cancer Care In The U.S.; Cancer Care Services; Policy-making; Health Care and Treatment; Health; Health Testing and Trials; Entrepreneurship; Social Entrepreneurship; Nonprofit Organizations; Policy; Health Industry; United States; District of Columbia
Hamermesh, Richard G., and James Weber. "FasterCures: Removing Barriers to Treatments." Harvard Business School Case 814-003, October 2013.
- September 2020
- Case
Minerva 2010: Turbulent Times
By: John R. Wells and Benjamin Weinstock
In 2010, amid a flurry of new discoveries, Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), raised $6.6 million to test her new cancer drugs in mice. It had been more than 6 years since she had announced that she and her small team at... View Details
Wells, John R., and Benjamin Weinstock. "Minerva 2010: Turbulent Times." Harvard Business School Case 721-390, September 2020.
- 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.
- April 2003 (Revised October 2004)
- Case
Novartis: The Challenge of Success (A)
By: Sandra J. Sucher and Stacy McManus
Preliminary results from Phase 1 clinical trials of a newly developed compound, STI571, showed that 31 out of 31 patients with chronic myelogenous leukemia (CML) had their blood counts return to normal. In the world of oncology, this was unheard of. This was the... View Details
Keywords: Decision Making; Health Testing and Trials; Innovation and Invention; Markets; Distribution; Product Development; Production; Problems and Challenges; Research; Research and Development; Complexity; Biotechnology Industry; Pharmaceutical Industry
Sucher, Sandra J., and Stacy McManus. "Novartis: The Challenge of Success (A)." Harvard Business School Case 603-043, April 2003. (Revised October 2004.)
- April 2009 (Revised May 2010)
- Case
Partners In Health: HIV Care in Rwanda
By: Michael E. Porter, Scott S. Lee, Joseph Rhatigan and Jim Yong Kim
In 2005, Partners in Health (PIH) was invited by the Rwandan Ministry of Health to assume responsibility for the management of public health care in two rural districts in Eastern Rwanda and create an HIV treatment program at these sites. PIH successfully implemented a... View Details
Keywords: Developing Countries and Economies; Health Care and Treatment; Health Testing and Trials; Medical Specialties; Service Delivery; Nonprofit Organizations; Expansion; Health Industry; Rwanda
Porter, Michael E., Scott S. Lee, Joseph Rhatigan, and Jim Yong Kim. "Partners In Health: HIV Care in Rwanda." Harvard Business School Case 709-474, April 2009. (Revised May 2010.)
- 04 Sep 2018
- First Look
New Research and Ideas, September 4, 2018
individuals have the choice to enact a variety of communication styles. We test the differential impact of being “warm and friendly” versus “tough and firm” in a distributive negotiation, when first offers are held constant and concession... View Details
Keywords: Dina Gerdeman
- Research Summary
Health-care Applications
Active postmarketing drug surveillance. There is substantial interest within the U.S. health community and among health policymakers in developing a surveillance system that scans public health databases in order to proactively detect potential drug safety... View Details
- February 2024
- Case
Compass Pathways: Pioneering Psychedelic Treatment
By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no... View Details
Keywords: Commercialization; Corporate Strategy; Competitive Strategy; Product Launch; Health Testing and Trials; Research and Development; Laws and Statutes; Pharmaceutical Industry; Europe; United States; United Kingdom
Zuzul, Tiona, Kisha Lashley, and Gamze Yucaoglu. "Compass Pathways: Pioneering Psychedelic Treatment." Harvard Business School Case 724-412, February 2024.
- Profile
Arjun Goyal
Trust Centre for Human Genetics, a new door opened for Arjun. “It was my first exposure to research,” he says. “It fascinated me that the test tube in my hand could hold a new cure or the next new therapy for controlling a disease.”... 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.)
- 18 Aug 2011
- Lessons from the Classroom
Business Plan Contest: 15 Years of Building Better Entrepreneurs
in 2001 with Alec Machiels (MBA '01) at the helm, its plan hinged on a mechanism created by a team of Harvard and MIT scientists that used atomic force microscopy in drug research. "A number of the scientists decided that being part of a... View Details
- Article
A Feasibility Study Using Time-driven Activity-based Costing as a Management Tool for Provider Cost Estimation: Lessons from the National TB Control Program in Zimbabwe in 2018
By: J. Chirenda, B. Nhlema Simwaka, C. Sandy, K. Bodnar, S. Corbin, P. Desai, T. Mapako, S. Shamu, C. Timire, E. Antonio, A. Makone, A. Birikorang, T. Mapuranga, M. Ngwenya, T. Masunda, M. Dube, E. Wandwalo, L. Morrison and R. S. Kaplan
Background: This study used process maps and time-driven activity-based costing to document TB service delivery processes. The analysis identified the resources required to sustain TB services in Zimbabwe, as well as several opportunities for more effective and... View Details
Keywords: Time-Driven Activity-Based Costing; Provider Cost; Health Care and Treatment; Cost Management; Activity Based Costing and Management; Zimbabwe
Chirenda, J., B. Nhlema Simwaka, C. Sandy, K. Bodnar, S. Corbin, P. Desai, T. Mapako, S. Shamu, C. Timire, E. Antonio, A. Makone, A. Birikorang, T. Mapuranga, M. Ngwenya, T. Masunda, M. Dube, E. Wandwalo, L. Morrison, and R. S. Kaplan. "A Feasibility Study Using Time-driven Activity-based Costing as a Management Tool for Provider Cost Estimation: Lessons from the National TB Control Program in Zimbabwe in 2018." BMC Health Services Research 21, no. 242 (2021).
- August 2023 (Revised May 2024)
- Case
Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations
By: Satish Tadikonda and Amanda McEwen
The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical... View Details
Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry
Tadikonda, Satish, and Amanda McEwen. "Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations." Harvard Business School Case 824-018, August 2023. (Revised May 2024.)