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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... 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

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

Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry

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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

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

Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry

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

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

Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry

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

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July 2021
Article

Making Medications Stick: Improving Medication Adherence by Highlighting the Personal Health Costs of Non-compliance

By: Jon M. Jachimowicz, Joe J. Gladstone, Dan Berry, Charlotte L. Kirkdale, Tracey Thornley and Adam D. Galinsky

Poor compliance of prescription medication is an ongoing public health crisis. Nearly half of patients do not take their medication as prescribed, harming their own health while also increasing public health care costs. Despite these detrimental consequences, prior... View Details

Keywords: Prescription Drugs; Medication Adherence; Personal Health Costs; Health; Behavior; Motivation and Incentives; Communication Strategy

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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

October 2020 (Revised November 2023)
Case

COVID-19 Testing at Everlywell

By: Jeffrey J. Bussgang and Olivia Hull

In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the... View Details

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

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August 2020
Article

Do Physician Incentives Increase Patient Medication Adherence?

By: Edward Kong, John Beshears, David Laibson, Brigitte Madrian, Kevin Volpp, George Loewenstein, Jonathan Kolstad and James J. Choi

We conducted a randomized experiment (911 primary care practices and 8,935 nonadherent patients) to test the effect of paying physicians for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. We measured... View Details

Keywords: Health Economics; Medication Adherence; Physician Payment Incentives; Primary Care; Quality Improvement; Health Care and Treatment; Motivation and Incentives; Behavior

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

Keywords: COVID-19; Health Pandemics; Strategy; Leadership

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February 2019 (Revised September 2019)
Case

Theranos: The Unicorn That Wasn't

By: Joseph B. Fuller and John Masko

In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains... View Details

Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry

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

June 2016
Teaching Plan

Terrapin Laboratory

By: Joseph B. Fuller and Andrew Otazo

This teaching plan accompanies the case "Terrapin Laboratory," HBS No. 315-098. That case describes the formation and rapid growth of a drug testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug... View Details

Keywords: Business Growth; Entrepreneurial Management; Growth Strategy; Market Entry; Venture Capital; Market Entry and Exit; Entrepreneurship; Health Testing and Trials; Growth and Development Strategy; Pharmaceutical Industry

March 2015 (Revised January 2024)
Case

CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies

By: Regina E. Herzlinger and Andrew Otazo

Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details

March 2015 (Revised February 2022)
Supplement

CV Ingenuity (B): Epilogue

By: Regina E. Herzlinger and Andrew Otazo

Duke Rohlen used a lea-nfunding, iconoclastic strategy for his start up for a drug eluding balloon for peripheral artery disease. His giant competitors were first movers. Did Duke obtain the funding he sought? How did his DEB fare versus that of his competitors? The... View Details

March 2015 (Revised September 2016)
Case

Terrapin Laboratory

By: Richard G. Hamermesh and Joseph B. Fuller

Describes the formation and rapid growth of a drug testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug treatment center business. The associated teaching materials provide students the opportunity... View Details

Keywords: Business Growth; Entrepreneurial Management; Entrepreneurship; Growth Strategy; Market Entry; Venture Capital; Growth Management; Expansion; Financing and Loans; Health Care and Treatment; Health Testing and Trials; Business Startups; Pharmaceutical Industry; Health Industry

January 2015 (Revised July 2019)
Case

CVS Health: Promoting Drug Adherence

By: Leslie John, John Quelch and Robert Huckman

Email mking@hbs.edu for a courtesy copy.

The case describes a program that CVS Health recently implemented to improve medication adherence, an important problem from a societal, public policy, and firm... View Details

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