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- March 2025
- Case
Niramai: An AI Solution to Save Lives
By: Rembrand Koning, Maria P. Roche and Kairavi Dey
Founded in 2017, Niramai developed Thermalytix, a breast cancer screening tool. Thermalytix used a high-resolution thermal sensing device and machine learning algorithms to analyze thermal images and detect tumors. Its patented solution leveraged big data analytics,... View Details
- February 2025
- Case
Abiomed: Clinical Trials and Tribulations
By: Satish Tadikonda, Faith Robertson and William Marks
- September 2024
- Case
Myeloma Investment Fund
By: Kyle Myers and Scott Sawaya
This case explores a critical decision facing the Myeloma Investment Fund (MIF) as it evaluates two investment opportunities aimed at accelerating a cure for multiple myeloma.
The MIF, a venture philanthropy fund, must choose between two distinct paths. One... View Details
The MIF, a venture philanthropy fund, must choose between two distinct paths. One... View Details
- 2024
- Working Paper
The Cram Method for Efficient Simultaneous Learning and Evaluation
By: Zeyang Jia, Kosuke Imai and Michael Lingzhi Li
We introduce the "cram" method, a general and efficient approach to simultaneous learning and evaluation using a generic machine learning (ML) algorithm. In a single pass of batched data, the proposed method repeatedly trains an ML algorithm and tests its empirical... View Details
Keywords: AI and Machine Learning
- 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
- 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... View Details
- December 2023 (Revised March 2024)
- Case
Manufacturing Moderna's Future
By: Satish Tadikonda and William Marks
In 2019, Moderna faced long odds of survival having failed to develop a successful clinical program out of the vast platform technology they had built around mRNA. Nearly overnight, the company skyrocketed to success with a vaccine for COVID-19, leading to an extremely... View Details
- September 2023
- Case
THREAD Research: Decentralized Clinical Trials and Beyond
By: Satish Tadikonda, Amanda McEwen and William Marks
- 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
- 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,... 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
- 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.... View Details
- 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... View Details
- 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
- 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... View Details
- 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... View Details
- 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... View Details
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... View Details
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
- 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... View Details
- 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... View Details