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- 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...
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Keywords:
Commercialization;
Corporate Strategy;
Competitive Strategy;
Product Launch;
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.
- February 2024
- Article
Representation and Extrapolation: Evidence from Clinical Trials
By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
This article examines the consequences and causes of low enrollment of Black patients in clinical
trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is
more relevant for decision-making by physicians and patients when it...
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Keywords:
Representation;
Racial Disparity;
Health Testing and Trials;
Race;
Equality and Inequality;
Innovation and Invention;
Pharmaceutical Industry
Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." Quarterly Journal of Economics 139, no. 1 (February 2024): 575–635.
- September 2023
- Case
THREAD Research: Decentralized Clinical Trials and Beyond
By: Satish Tadikonda, Amanda McEwen and William Marks
- August 2023 (Revised September 2023)
- Case
Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations
By: Satish Tadikonda and Amanda McEwen
- August 2023
- Supplement
Parexel (B): The Future of the CRO Industry
By: Regina E. Herzlinger and Ben Creo
How should Parexel respond to the rapidly changing environment in clinical research, now that it is owned by a private equity firm and its founder is no longer with the firm?
Parexel, a major clinical research organization, has experienced substantial... View Details
Parexel, a major clinical research organization, has experienced substantial... View Details
- 2023
- Article
Evidence from the First Shared Medical Appointments (SMAs) Randomised Controlled Trial in India: SMAs Increase the Satisfaction, Knowledge, and Medication Compliance of Patients with Glaucoma
By: Nazlı Sönmez, Kavitha Srinivasan, Rengaraj Venkatesh, Ryan W. Buell and Kamalini Ramdas
In Shared Medical Appointments (SMAs), patients with similar conditions meet the physician together and each receives one-on-one attention. SMAs can improve outcomes and physician productivity. Yet privacy concerns have stymied adoption. In physician-deprived nations,...
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Sönmez, Nazlı, Kavitha Srinivasan, Rengaraj Venkatesh, Ryan W. Buell, and Kamalini Ramdas. "Evidence from the First Shared Medical Appointments (SMAs) Randomised Controlled Trial in India: SMAs Increase the Satisfaction, Knowledge, and Medication Compliance of Patients with Glaucoma." e0001648. PLoS Global Public Health 3, no. 7 (2023).
- June 2023
- 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
- March 2023
- Case
Moderna
By: Marco Iansiti, Karim R. Lakhani, Hannah Mayer, Kerry Herman, Allison J. Wigen and Dave Habeeb
This multimedia case follows the story of Moderna and its entry into vaccine development in the wake of the COVID-19 pandemic. In summer 2020, Stephane Bancel, CEO of biotech firm Moderna, faces several challenges as his company races to develop a vaccine for COVID-19....
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- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful...
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Keywords:
Product Development;
Leadership;
Health Testing and Trials;
Research and Development;
Risk and Uncertainty;
Financial Condition;
Partners and Partnerships;
Pharmaceutical Industry
Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
- 2022
- Working Paper
Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina
By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its...
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Keywords:
COVID-19;
Drug Treatment;
Health Pandemics;
Health Care and Treatment;
Decision Making;
Outcome or Result;
Argentina
Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
- April 2022
- Teaching Note
CVS Health: Prescription for Transformation
By: Rosabeth Moss Kanter and Catarina Martinez
In 2021, new CEO Karen Lynch (named the most powerful woman in business) considered the next transformation phase for CVS Health (a Fortune 5 corporate giant). The 2018 acquisition of Aetna insurance brought her to the company as part of its long evolution from a...
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Keywords:
Health;
COVID-19 Pandemic;
Primary Care;
Leadership;
Change Management;
Women Executives;
Retail;
Pharmacy;
Pharmacy Benefit Manager;
Clinical Trials;
Vaccination;
Acquisition;
Innovation and Invention;
Transformation;
Retail Industry;
Pharmaceutical Industry;
Health Industry;
United States
- February 2022
- Case
Leading The UK Vaccine Task Force
By: Amy C. Edmondson and Claudia Pienica
This case describes the first six months of the UK Vaccine Taskforce, under the leadership of Kate Bingham. With a career spent in the private sector as a biotech investor, Bingham’s appointment within the government was considered unusual. The overarching brief given...
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Keywords:
COVID-19;
Vaccine;
Government;
Health Pandemics;
Health Care and Treatment;
Science;
Innovation and Invention;
Groups and Teams;
Leadership;
Decision Making;
Government and Politics;
Health;
Innovation and Management;
Governance;
Change;
Government Administration;
Health Industry;
Financial Services Industry;
Public Administration Industry;
Europe;
United Kingdom
Edmondson, Amy C., and Claudia Pienica. "Leading The UK Vaccine Task Force." Harvard Business School Case 622-079, February 2022.
- February 15, 2022
- Article
How Managers Can Build a Culture of Experimentation
By: Frank V. Cespedes and Neil Hoyne
Testing in business presents qualitatively different challenges than those in clinical trials and most scientific research. There are very few opportunities for randomized control experiments in a changing, competitive market. Yet, change and competition make testing a...
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Cespedes, Frank V., and Neil Hoyne. "How Managers Can Build a Culture of Experimentation." Harvard Business Review Digital Articles (February 15, 2022).
- January 17, 2022
- Article
Reducing Racial Disparities in Cancer Outcomes
By: Kathy Giusti and Richard G. Hamermesh
A disproportionate number of Black patients die from cancer in the United States. A key to addressing this problem is enrolling more Black patients in clinical trials. A strategy consisting of these three parts can help accomplish this goal: 1) centralize information...
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Giusti, Kathy, and Richard G. Hamermesh. "Reducing Racial Disparities in Cancer Outcomes." Harvard Business Review (website) (January 17, 2022).
- October 2021 (Revised January 2022)
- Supplement
Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)
By: Linda A. Hill and Emily Tedards
This case is the third installment in a series about the 10-year cultural and digital transformation of Pfizer’s Global Clinical Supply organization. In 2011, Michael Ku became Pfizer’s Vice President of Global Clinical Supply (GCS) after the company had undergone...
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Keywords:
Clinical Supply Chain;
COVID-19;
Vaccine;
Agile;
Innovation and Invention;
Change Management;
Organizational Culture;
Transformation;
Leadership;
Corporate Strategy;
Health Pandemics;
Crisis Management;
Mission and Purpose;
Health Care and Treatment;
Supply Chain Management;
Digital Transformation
Hill, Linda A., and Emily Tedards. "Michael Ku and Global Clinical Supply at Pfizer Inc.: Bringing Hope to Patients (C)." Harvard Business School Supplement 422-041, October 2021. (Revised January 2022.)
- July 2021
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (C)
By: Ariel D. Stern and Sarah Mehta
This (C) case provides an update on the work of the Global Coalition for Adaptive Research (GCAR) and also illustrates how adaptive platform trials can nimbly respond to a global pandemic.
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Keywords:
Clinical Trials;
Drug Trials;
Drug Testing;
Cancer Trials;
Glioblastoma;
Platform Trials;
Adaptive Trials;
Adaptive Platform Trials;
Health Testing and Trials;
Health Care and Treatment;
Business Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (C)." Harvard Business School Supplement 622-012, July 2021.
- June 11, 2021
- Article
Addressing Demographic Disparities in Clinical Trials
By: Kathy Giusti, Richard G. Hamermesh and Mark Krasnow
Disparities in health care are not just limited to the delivery of care. They also exist in the way that clinical trials are structured. Women, people of color, and the elderly often are not adequately represented. This article offers three strategies for addressing...
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Giusti, Kathy, Richard G. Hamermesh, and Mark Krasnow. "Addressing Demographic Disparities in Clinical Trials." Harvard Business Review Digital Articles (June 11, 2021).
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- Article
Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials
By: Caroline Marra, William J. Gordon and Ariel Dora Stern
Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of...
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Keywords:
Connected Digital Products;
Telehealth;
Remote Monitoring;
Health Testing and Trials;
Research;
Governing Rules, Regulations, and Reforms;
Information Technology
Marra, Caroline, William J. Gordon, and Ariel Dora Stern. "Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials." BMJ Open 11, no. 6 (2021).