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- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
How can a successful executive assess her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to find a therapeutic window for Cleave Therapeutics oncology drug was on track but faced an uncertain future. Overseeing the...
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- Working Paper
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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- 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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- 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...
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- 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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- 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...
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- October 2020 (Revised June 2021)
- 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...
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Keywords:
Entrepreneurship;
Business Strategy;
Venture Capital;
Health Care and Treatment;
Health Disorders;
Leading Change;
Technology Adoption;
Digital Platforms;
Competitive Strategy;
Science;
Adaptation;
Corporate Social Responsibility and Impact;
Crisis Management;
Social Entrepreneurship;
Ethics;
Government Legislation;
Health;
Health Testing and Trials;
Health Pandemics;
Consumer Products Industry;
Health Industry;
Technology Industry;
Texas;
United States
- 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...
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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...
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- 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...
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- January 2020
- Article
The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System
By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...
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- September 2019
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (B)
By: Ariel D. Stern and Sarah Mehta
This case provides an update to the (A) case, which introduces students to adaptive platform trials, an ambitious, more efficient type of clinical trial that increases access to therapies. The (A) case centers on Dr. Brian Alexander’s efforts to launch an adaptive...
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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...
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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
- March 2018
- Teaching Note
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
This teaching note provides guidance and recommendations for teaching HBS Case No. 618-025, entitled “Adaptive Platform Trials: The Clinical Trial of the Future?”
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- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel D. Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...
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- September 2017 (Revised January 2018)
- Case
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
In July 2017, Dr. Brian M. Alexander, president and CEO of the AGILE Research Foundation, was preparing to launch a new type of clinical trial—an adaptive platform trial—to study potential therapies for glioblastoma (GBM), an aggressive form of brain cancer....
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- 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...
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- 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...
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- March 2015 (Revised February 2022)
- 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...
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Keywords:
CV Ingenuity;
CVI;
Drug Eluting Balloon;
DEB;
Drug Eluting Stent;
Angioplasty Balloon;
FoxHollow;
Medical Device;
Medical Device Startup;
Premarket Approval;
PMA;
Lutonix;
Stellarex;
LEVANT;
ILLUMENATE;
Clinical Trials;
Peripheral Arterial Disease;
PAD;
Healthcare Startups;
Covidien;
Health Care and Treatment;
Health Testing and Trials;
Business Startups;
Commercialization;
Health Industry;
Medical Devices and Supplies Industry;
United States;
Europe
- 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...
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Keywords:
CV Ingenuity;
CVI;
Drug Eluting Balloon;
DEB;
Drug Eluting Stent;
Angioplasty Balloon;
FoxHollow;
Medical Device;
Medical Device Startup;
Premarket Approval;
PMA;
Lutonix;
Stellarex;
LEVANT;
ILLUMENATE;
Clinical Trials;
Peripheral Arterial Disease;
PAD;
Healthcare Startups;
Covidien;
Health Care and Treatment;
Health Testing and Trials;
Business Startups;
Commercialization;
Strategy;
Health Industry;
Medical Devices and Supplies Industry;
United States;
Europe