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- All HBS Web
(242)
- People (2)
- News (74)
- Research (150)
- Multimedia (1)
- Faculty Publications (57)
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- 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.)
- 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 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.
- 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.
- 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.
- 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
- 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.
- 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
- 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
- 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.)
- 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.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (C): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,... View Details
Keywords: Health Testing and Trials; Health Care and Treatment; Business Model; Problems and Challenges; Pharmaceutical Industry; Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (C): Reimagining Medicine." Harvard Business School Supplement 723-445, May 2023. (Revised June 2023.)
- August 2005 (Revised December 2006)
- Case
Procter & Gamble: Electronic Data Capture and Clinical Trial Management
By: Robert S. Huckman and Mark J. Cotteleer
Considers whether the management of Procter & Gamble (P&G) Pharmaceuticals should adopt Web-based electronic data capture (EDC) as the default standard for the management of its clinical drug trials. Provides a detailed description of the existing paper-based process... View Details
Keywords: Health Testing and Trials; Internet and the Web; Information Technology; Adoption; Business Processes; Industry Structures; Technological Innovation; Service Operations; Pharmaceutical Industry; United States
Huckman, Robert S., and Mark J. Cotteleer. "Procter & Gamble: Electronic Data Capture and Clinical Trial Management." Harvard Business School Case 606-033, August 2005. (Revised December 2006.)
- 15 Jan 2019
- First Look
New Research and Ideas, January 15, 2019
December 19, 2018 NEJM Catalyst It's Time to Reform the Orphan Drug Act By: Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern Abstract—No abstract available. Publisher's link:... View Details
Keywords: Dina Gerdeman
- 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).
- September–October 2020
- Article
The Past, Present, and (Near) Future of Gene Therapy and Gene Editing
By: Julia Pian, Amitabh Chandra and Ariel Dora Stern
Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the likely trajectory of genetically focused... View Details
Keywords: Gene Therapy; Gene Editing; Impact; Health Care and Treatment; Technological Innovation; Health Testing and Trials; Venture Capital; Change
Pian, Julia, Amitabh Chandra, and Ariel Dora Stern. "The Past, Present, and (Near) Future of Gene Therapy and Gene Editing." NEJM Catalyst Innovations in Care Delivery 1, no. 5 (September–October 2020).
- November 2007
- Case
Antegren: A Beacon of Hope
By: Joshua D. Margolis, Thomas J. DeLong and Terence Heymann
The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series focuses on operational decisions triggered by the drive for early approval. Sparks discussion... View Details
Keywords: Demand and Consumers; Leadership; Ethics; Corporate Social Responsibility and Impact; Decision Choices and Conditions; Crisis Management; Health Testing and Trials; Biotechnology Industry; Pharmaceutical Industry
Margolis, Joshua D., Thomas J. DeLong, and Terence Heymann. "Antegren: A Beacon of Hope." Harvard Business School Case 408-025, November 2007.
- 14 Nov 2017
- First Look
New Research and Ideas: November 14, 2017
authors provide numerous examples of health care organizations that are taking these steps—and seeing impressive results. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53460 forthcoming JAMA Cardiology The Central and Unacknowledged Role of the U.S.... View Details
Keywords: Carmen Nobel
- January–February 2023
- Article
Data-Driven COVID-19 Vaccine Development for Janssen
By: Dimitris Bertsimas, Michael Lingzhi Li, Xinggang Liu, Jennings Xu and Najat Khan
The COVID-19 pandemic has spurred extensive vaccine research worldwide. One crucial part of vaccine development is the phase III clinical trial that assesses the vaccine for safety and efficacy in the prevention of COVID-19. In this work, we enumerate the first... View Details
Keywords: COVID-19; Health Testing and Trials; Forecasting and Prediction; AI and Machine Learning; Research; Pharmaceutical Industry
Bertsimas, Dimitris, Michael Lingzhi Li, Xinggang Liu, Jennings Xu, and Najat Khan. "Data-Driven COVID-19 Vaccine Development for Janssen." INFORMS Journal on Applied Analytics 53, no. 1 (January–February 2023): 70–84.