Publications

23 Jul 2013
First Look

First Look: July 23

School Case 713-483 Yammer (B) Supplement to "Yammer (A)," HBS case 713-407 Purchase this case: http://hbr.org/search/713483-PDF-ENG Harvard Business School Case 712-466 Moving to Universal Coverage: Health Care View Details

Keywords: Anna Secino

April 2011 (Revised October 2011)
Teaching Note

U.S. Healthcare Reform: International Perspectives (TN)

By: Arthur A. Daemmrich and Elia Cameron

Teaching Note for #710-040 and 711-103. View Details

Keywords: Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States

2023
Working Paper

The Political Economy of a 'Miracle Cure': The Case of Nebulized Ibuprofen and Its Diffusion in Argentina

By: Sebastian Calónico, Rafael Di Tella and Juan Cruz Lopez Del Valle

We document the diffusion of nebulized ibuprofen in Argentina as a treatment for COVID-19. As the pandemic spread, this clinically unsupported drug reached thousands of patients, even some seriously ill, despite warnings by the regulator and medical societies. Detailed... View Details

Keywords: COVID-19; Health Care and Treatment; Health Pandemics; Adoption; Behavior; Governing Rules, Regulations, and Reforms; Learning

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October 2024
Article

Medicare Part D Protected-Class Policy Is Associated with Lower Drug Rebates

By: Pragya Kakani, Michael Anne Kyle, Amitabh Chandra and Luca Maini

Medicare Part D does not allow plans to exclude drugs in six protected classes from their formularies, which may limit plans’ ability to negotiate rebates and lead to higher spending. We estimated the association between protected-class status, US-level estimated... View Details

Keywords: Insurance; Health Care and Treatment; Governing Rules, Regulations, and Reforms; United States

June 9, 2023
Article

A Radical Treatment for Insulin Pricing

By: Leemore S. Dafny

In 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar for long-acting insulin, which many hoped would be substantially cheaper than the reference branded product. I explain why prices have barely changed, and argue that a... View Details

Keywords: Biosimilars; Rebates; Pharmaceuticals; Health Care and Treatment; Price; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; United States

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26 Jul 2016
Working Paper Summaries

The Impact of the Entry of Biosimilars: Evidence from Europe

Keywords: by Fiona Scott Morton, Ariel Dora Stern, and Scott Stern; Health; Health; Health

2024
Working Paper

Fecal Microbiota Transplants —Too Simple to be Safe? Case Histories of Transformational Advances

By: Amar Bhide and Srikant M. Datar

By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the... View Details

Keywords: Health Care and Treatment; Innovation and Invention; Governing Rules, Regulations, and Reforms

SSRN

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

Educators

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... View Details

Keywords: New Medicines; Regulatory Approval; Health Care and Treatment; Research and Development; Governing Rules, Regulations, and Reforms; Markets; Expansion; Pharmaceutical Industry

11 Sep 2007
First Look

First Look: September 11, 2007

and reveals how to recruit, nurture, and promote this special type of leader. With a healthy supply of qualified internal candidates, companies get the leadership they need—when they need it. Who Killed Health Care? America's $2 Trillion... View Details

Keywords: Martha Lagace

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... View Details

Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology

25 Sep 2017
Research & Ideas

Why Politics is Failing America, and What Business Can Do To Help

has been a major obstacle to moving the country forward on nearly every front that makes a healthy business environment, from tax reform and restoring economic growth to improving public education and health... View Details

Keywords: by Christina Pazzanese, Harvard Gazette

Article

Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-Five Years of Drug Lag Debate

By: Arthur A. Daemmrich

Keywords: Cost; Health; Governing Rules, Regulations, and Reforms; Communication

19 Jun 2012
First Look

First Look: June 19

understand and capitalize on the needs of health care businesses. With the recent passage of health care reform adding to the pressures already squeezing the View Details

Keywords: Sean Silverthorne

2009
Working Paper

Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location

By: Arthur Daemmrich

A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Health Testing and Trials; Power and Influence; Competitive Strategy; Pharmaceutical Industry; European Union; Germany; United States

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

Educators

26 Apr 2016
First Look

April 26

the infant private sector in urban China. We show that a reform that untied access to housing in urban areas from working for the state sector accounts for more than a quarter of the overall increase in labor supply to the private sector... View Details

Keywords: Sean Silverthorne

2024
Working Paper

Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational 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) the... View Details

Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms

SSRN