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2008
Chapter

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

By: Arthur A. 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: Geographic Location; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Demand and Consumers; Pharmaceutical Industry; European Union; Germany; United States

September 2024
Case

Myeloma Investment Fund

By: Kyle Myers and Scott Sawaya

This case explores a critical decision facing the Myeloma Investment Fund (MIF) as it evaluates two investment opportunities aimed at accelerating a cure for multiple myeloma.

The MIF, a venture philanthropy fund, must choose between two distinct paths. One... View Details

Keywords: Venture Philanthropy; Biomedical Research; Investing For Impact; Innovation ＆ Entrepreneurship; Venture Capital; Science-Based Business; Philanthropy and Charitable Giving; Decision Making; Health Care and Treatment; Biotechnology Industry; Pharmaceutical Industry

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

2022
Working Paper

Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina

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

Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its... View Details

Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina

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Satish K. Tadikonda

Satish Tadikonda is a Senior Lecturer in the Entrepreneurial Management Unit at Harvard Business School. In the MBA program, Satish teaches The Entrepreneurial Manager, a required first-year MBA course, and Entrepreneurship in Life Sciences, an elective course for... View Details

September 2012 (Revised November 2014)
Case

Cialis Lifecycle Management: Lilly's BPH Dilemma

By: Elie Ofek and Natalie Kindred

How should Eli Lilly further develop and market a new indication of its highly successful erectile-dysfunction (ED) drug, Cialis, without confusing Cialis's hard-won brand equity with physicians and patients? With the final stages of clinical trials for the new... View Details

Keywords: Product Positioning; Attitudes; Brands and Branding; Pharmaceutical Industry; United States

August 2003 (Revised August 2024)
Case

Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment

By: Regina E. Herzlinger and John McDonough

Many health care innovations appear successful; but fail. This is the first case in the Innovating Health Care course that investigates how to create successful health care innovations. It is part of the first module in the course. This module focuses on how to... View Details

Keywords: Three Pillars; Industry Analysis; Health Care and Treatment; Innovation and Invention; Innovation and Management; Medical Specialties; Health Industry

March 2020 (Revised June 2023)
Case

EyeControl: Inspiring Communication

By: Paul A. Gompers and Danielle Golan

Eye-controlled communication device startup EyeControl was founded in Tel Aviv, Israel in 2016 by cofounders with a shared personal connection to locked-in syndrome—a neurological disorder that left sufferers cognitively sound, yet paralyzed, with the exception of eye... View Details

Keywords: Health Disorders; Communication Technology; Business Startups; Expansion; Finance; Decision Making; Social Enterprise; Medical Devices and Supplies Industry

November 2003 (Revised September 2008)
Case

Circle Gastroenterology Products (A)

By: Regina E. Herzlinger and James Weber

A new, minimally invasive medical device has achieved only one-third of its budget. Was the problem one of marketing strategy, sales, reimbursement, and/or clinical trials? View Details

Keywords: Health Testing and Trials; Marketing Strategy; Product Marketing; Sales; Medical Devices and Supplies Industry

July 31, 2017
Article

A Commitment Contract to Achieve Virologic Suppression in Poorly Adherent Patients with HIV/AIDS

By: Marcella Alsan, John Beshears, Wendy S. Armstrong, James J. Choi, Brigitte C. Madrian, Minh Ly T. Nguyen, Carlos Del Rio, David Laibson and Vincent C. Marconi

Objective: Assess whether a commitment contract informed by behavioral economics leads to persistent virologic suppression among HIV-positive patients with poor antiretroviral therapy (ART) adherence. Design: Single-center pilot randomized clinical trial and a... View Details

Keywords: Adherence; Antiretroviral Therapy; Behavioral Economics; Commitment Contract; Financial Incentives; HIV-1 Virologic Suppression; Health Disorders; Motivation and Incentives

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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

February 2022
Case

Leading The UK Vaccine Task Force

By: Amy C. Edmondson and Claudia Pienica

This case describes the first six months of the UK Vaccine Taskforce, under the leadership of Kate Bingham. With a career spent in the private sector as a biotech investor, Bingham’s appointment within the government was considered unusual. The overarching brief given... View Details

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

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August 1995 (Revised June 1997)
Case

Hillcrest Research Associates, Inc.

Hillcrest designs and administers testing procedures for drugs to determine whether they pass FDA specifications. As the company grows, it encounters problems with information technology and with the clinical research associates, who feel pressured to report more... View Details

Keywords: Growth Management; Information Technology; Health Testing and Trials; Pharmaceutical Industry

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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

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December 2023 (Revised March 2024)
Case

Manufacturing Moderna's Future

By: Satish Tadikonda and William Marks

In 2019, Moderna faced long odds of survival having failed to develop a successful clinical program out of the vast platform technology they had built around mRNA. Nearly overnight, the company skyrocketed to success with a vaccine for COVID-19, leading to an extremely... View Details

Keywords: Health Pandemics; Health Testing and Trials; Technological Innovation; Product Development; Production; Science-Based Business; Biotechnology Industry

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... View Details

Keywords: Cost-sharing; Impact; Health Care and Treatment; Insurance; Health; Consumer Behavior

2024
Working Paper

The Cram Method for Efficient Simultaneous Learning and Evaluation

By: Zeyang Jia, Kosuke Imai and Michael Lingzhi Li

We introduce the "cram" method, a general and efficient approach to simultaneous learning and evaluation using a generic machine learning (ML) algorithm. In a single pass of batched data, the proposed method repeatedly trains an ML algorithm and tests its empirical... View Details

Keywords: AI and Machine Learning

June 2004 (Revised November 2004)
Case

Acorda Therapeutics: Rebuilding the Spinal Cord

Acorda is an early-stage life science start-up with a promising product that is close to reaching the market (Phase III clinical trials). The company is grappling with how to expand its portfolio of molecules to make the business more sustainable. It faces classic... View Details

Keywords: Decision Making; Science-Based Business; Health Testing and Trials; Business Startups; Product Development; Biotechnology Industry

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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

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