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- Faculty Publications (106)
- 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.
- 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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Keywords:
Prescription Drugs;
Medication Adherence;
Personal Health Costs;
Health;
Behavior;
Motivation and Incentives;
Communication Strategy
Jachimowicz, Jon M., Joe J. Gladstone, Dan Berry, Charlotte L. Kirkdale, Tracey Thornley, and Adam D. Galinsky. "Making Medications Stick: Improving Medication Adherence by Highlighting the Personal Health Costs of Non-compliance." Behavioural Public Policy 5, no. 3 (July 2021): 396–416.
- Article
Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users
By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling...
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Keywords:
Pharmaceuticals;
Drug Spending;
Drug Pricing;
Health Care and Treatment;
Spending;
Price;
Markets;
Cost Management;
United States
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.
- 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.
- May 2021
- Case
The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease
By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory...
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Keywords:
Innovation and Invention;
Strategy;
Business or Company Management;
Society;
Health;
Public Administration Industry;
Health Industry;
United States
Chandra, Amitabh, Spencer Lee-Rey, and Caroline Marra. "The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease." Harvard Business School Case 621-112, May 2021.
- 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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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).
- 2021
- Working Paper
The Health Costs of Cost-Sharing
By: Amitabh Chandra, Evan Flack and Ziad Obermeyer
We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in...
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Chandra, Amitabh, Evan Flack, and Ziad Obermeyer. "The Health Costs of Cost-Sharing." NBER Working Paper Series, No. 28439, February 2021.
- January 2021
- Case
Value-Based Insurance Design at Onex
By: Joshua Schwartzstein, Amitabh Chandra and Amram Migdal
The operating executives of Health and Benefits for Onex Partners, Megan Jackson Frye and Sam Camens, faced a challenge: Healthcare costs for employees of Onex’s portfolio companies were continuing to rise above the consumer price index, reflecting broader trends...
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Keywords:
Decision Making;
Cost vs Benefits;
Decision Choices and Conditions;
Decisions;
Finance;
Behavioral Finance;
Insurance;
Health;
Health Care and Treatment;
Human Resources;
Compensation and Benefits;
Markets;
Demand and Consumers;
Consumer Behavior;
Social Psychology;
Behavior;
Interests;
Motivation and Incentives;
Perception;
Health Industry;
Insurance Industry;
North America;
United States
Schwartzstein, Joshua, Amitabh Chandra, and Amram Migdal. "Value-Based Insurance Design at Onex." Harvard Business School Case 921-023, January 2021.
- January 2021 (Revised June 2021)
- Case
Hester Pharmaceuticals (A): A Pricing Dilemma
By: Dante Roscini and John Masko
In August 2019, the leadership of Hester Pharmaceuticals (Hester) had a problem. Italy promised to be a key market for their new breakthrough oncology drug Akrozumab, but for almost two years, its single-payer healthcare system had been unable to agree with Hester on a...
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Keywords:
Macroeconomics;
Trade;
Price;
Global Range;
Global Strategy;
Globalized Markets and Industries;
Health Care and Treatment;
Patents;
Monopoly;
Negotiation;
Business and Government Relations;
Risk and Uncertainty;
Human Needs;
Business Strategy;
Commercialization;
Pharmaceutical Industry;
Italy
Roscini, Dante, and John Masko. "Hester Pharmaceuticals (A): A Pricing Dilemma." Harvard Business School Case 721-001, January 2021. (Revised June 2021.)
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded...
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Keywords:
Medical Devices;
FDA;
Health Care and Treatment;
Government Administration;
Information;
Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- 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...
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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
Bussgang, Jeffrey J., and Olivia Hull. "COVID-19 Testing at Everlywell." Harvard Business School Case 821-001, October 2020. (Revised November 2023.)
- 2021
- Working Paper
Development of CAR-T Therapies: Case Histories of Significant Medical Advances
By: Amar Bhidé and Srikant M. Datar
In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works; 2) the foundational advances and discoveries; 3)...
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Keywords:
Immunotherapy;
Health Care and Treatment;
Innovation and Invention;
Research and Development;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, and Srikant M. Datar. "Development of CAR-T Therapies: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-035, August 2020. (Revised May 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...
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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).
- 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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Keywords:
Health Economics;
Medication Adherence;
Physician Payment Incentives;
Primary Care;
Quality Improvement;
Health Care and Treatment;
Motivation and Incentives;
Behavior
Kong, Edward, John Beshears, David Laibson, Brigitte Madrian, Kevin Volpp, George Loewenstein, Jonathan Kolstad, and James J. Choi. "Do Physician Incentives Increase Patient Medication Adherence?" Health Services Research 55, no. 4 (August 2020): 503–511.
- 2020
- Working Paper
What Can Economics Say About Alzheimer's Disease?
By: Amitabh Chandra, Courtney Coile and Corina Mommaerts
Alzheimer’s Disease (AD) affects one in ten people aged 65 or older and is the most expensive disease in the United States. We describe the central economic questions raised by AD. While there is overlap with the economics of aging, the defining features of the...
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Chandra, Amitabh, Courtney Coile, and Corina Mommaerts. "What Can Economics Say About Alzheimer's Disease?" NBER Working Paper Series, No. 27760, August 2020.
- Article
Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study
By: Noy Alon, Ariel Dora Stern and John Torous
BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...
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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
- July 2020
- Article
Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany
By: Victoria D. Lauenroth, Aaron S. Kesselheim, Ameet Sarpatwari and Ariel Dora Stern
Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the U.S., it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been...
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Keywords:
Pharmaceuticals;
Prescription Drug Costs;
Drug Pricing;
Access To Care;
Cost Reduction;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Cost Management;
Germany
Lauenroth, Victoria D., Aaron S. Kesselheim, Ameet Sarpatwari, and Ariel Dora Stern. "Lessons from the Impact of Price Regulation on the Pricing of Anticancer Drugs in Germany." Health Affairs 39, no. 7 (July 2020): 1185–1193.
- 2021
- Working Paper
Cephalosporins: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
Our case history describes the development of three generations of cephalosporins—antibiotics that have significantly reduced hospital infections. After providing an overview of antibiotic development and its challenges we describe how: 1) Early (pre-cephalosporin)...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Cephalosporins: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised May 2021.)
- 2021
- Working Paper
SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
Our case history describes the development of Prozac, a blockbuster drug that transformed the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we chronicle the: 1) prior treatments for depression and the research that...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant M. Datar, and Katherine Stebbins. "SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-135, July 2020. (Revised June 2021.)
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.