Publications

2008
Case

Eli Lilly: Recreating Drug Discovery for the 21st Century

By: Rebecca Henderson and C. Reavis

Keywords: Innovation and Invention; Health Care and Treatment; Pharmaceutical Industry

September 2022
Article

Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities

By: Leemore Dafny, Christopher Ody and Teresa Rokos

The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations... View Details

Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry

Register to Read

2018
Chapter

The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century

By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern

On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new... View Details

Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly

Register to Read

22 Feb 2021
Working Paper Summaries

Private and Social Returns to R&D: Drug Development and Demographics

Keywords: by Efraim Benmelech, Janice Eberly, Dimitris Papanikolaou, and Joshua Krieger; Pharmaceutical

November 2019
Case

The Genesis Lab at Novartis

By: Amy C. Edmondson, Ranjay Gulati, Patrick J. Healy and Kerry Herman

Novartis' Genesis Labs program, launched in 2016 as part of Novartis Institutes for Biomedical Research (NIBR), hosted pitch competitions where teams of NIBR scientists proposed ideas to explore that aimed to revolutionize drug discovery. The goal was to break down... View Details

Keywords: Drug Discovery; Health Care and Treatment; Research and Development; Innovation and Invention; Programs; Management

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... View Details

Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards

Read Now

April 2017
Supplement

Imprimis (B)

By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel

This case is a supplement to Imprimis (A). It describes the company’s decision to enter into the pharmaceutical compounding business in 2013–2014. Imprimis purchased a compounded ophthalmological medication called Dropless Therapy, which was injected into patients’... View Details

Keywords: Healthcare; Drug Compounding; Drug Development; Pharmaceuticals; Small Business; Decision-making, Business Model; Mark Baum; Imprimis; Decision Making; Strategy; Health Care and Treatment; Policy; Pharmaceutical Industry; United States

October 2023
Article

Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record

By: Anna D Sinaiko, Caroline E Sloan, Mark J Soto, Olivia Zhao, Chen-Tan Lin and Foster R Goss

Keywords: Prescription Drugs; Electronic Health Records; Physicians; Prescription Drug Costs; Health Care and Treatment; Price; Health Industry

Article

Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry

By: Leemore S. Dafny, Christopher Ody and Matt Schmitt

The analogy between value-based purchasing in pharmaceuticals and the new frontier of alternative payment models for health care providers is relatively straightforward. Insurers are increasingly demanding steep discounts from providers in exchange for inclusion in... View Details

Keywords: Drug Copayment Coupons; Prescription Drug Policy; Health Care and Treatment; Insurance; Cost; Policy; Pharmaceutical Industry

Read Now

January 2018 (Revised January 2019)
Case

ZappRx

By: Jeffrey J. Bussgang and Olivia Hull

In October 2015, ZappRx founder Zoe Barry is deciding between two business models for her health technology start-up. Her product, a software application that aims to expedite the prescription fulfillment process for patients with rare diseases, has attracted interest... View Details

Keywords: Speciality Drugs; Hub Services; Pivot; Speciality Prescriptions; Health Care and Treatment; Customization and Personalization; Internet and the Web; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; Massachusetts

Article

Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study

By: Maryaline Catillon

Keywords: Biomedical Research; R＆D; Innovation; Technology; Drug Trials; RCT; Health; Healthcare; Health Care And Treatment; Health Care Policy; Innovation and Invention; Innovation Strategy; Research and Development; Technological Innovation; Health Industry; Pharmaceutical Industry

Read Now

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

Register to Read

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... View Details

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; Financing and Loans; Business Strategy; Health Industry; United States

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?” View Details

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

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

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. View Details

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

March 2008
Case

The Multiple Sclerosis Center of Atlanta

By: Regina E. Herzlinger and Alfred Martin

The Multiple Sclerosis Center of Atlanta wishes to expand beyond Georgia. The factors influencing this decision are discussed, including drug treatments currently available, and the impact of future drugs in the FDA pipeline as well as financing issues. View Details

Keywords: Decision Choices and Conditions; Financing and Loans; Health Care and Treatment; Health Disorders; Medical Specialties; Expansion; Health Industry; Atlanta

September 1991 (Revised February 1993)
Case

Burroughs Wellcome and AZT (A)

By: Willis M. Emmons III

Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S.... View Details

Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London

September 1998 (Revised July 1999)
Case

Discovery Health (B)

By: Samuel S. Chun and Shaun Matisonn

A South African health insurance company grapples with designing a financially viable coverage solution for a new prescription drug treatment for male impotence. View Details

Keywords: Motivation and Incentives; Service Delivery; Insurance; Health Care and Treatment; Insurance Industry; South Africa