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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

10 Aug 2015
Research & Ideas

New Medical Devices Get To Patients Too Slowly

Delicate Balance For nearly 80 years, the FDA has performed a delicate balancing act between getting life-saving drugs to market, and ensuring that those drugs will be safe when taken by patients. In order... View Details

Keywords: by Michael Blanding; Health; Technology

March 2015 (Revised September 2016)
Case

Terrapin Laboratory

By: Richard G. Hamermesh and Joseph B. Fuller

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 treatment center business. The associated teaching materials provide students the opportunity... View Details

Keywords: Business Growth; Entrepreneurial Management; Entrepreneurship; Growth Strategy; Market Entry; Venture Capital; Growth Management; Expansion; Financing and Loans; Health Care and Treatment; Health Testing and Trials; Business Startups; Pharmaceutical Industry; Health Industry

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... View Details

Keywords: Business Growth; Entrepreneurial Management; Growth Strategy; Market Entry; Venture Capital; Market Entry and Exit; Entrepreneurship; Health Testing and Trials; Growth and Development Strategy; Pharmaceutical Industry

February 2024
Article

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... View Details

Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry

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01 Dec 2003
Research & Ideas

Sometimes Success Begins at Failure

In the late 1980s, scientists for New York City-based drug-maker Pfizer began testing what was then known as compound UK-92,480 for the treatment of angina. Although UK-92,480 seemed promising in the lab and in animal tests, the compound... View Details

Keywords: by Henry Chesbrough; Health; Pharmaceutical

March 2015 (Revised January 2024)
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... View Details

October 2006 (Revised August 2007)
Case

Calloway Laboratory: Pee for Profit

By: Richard G. Hamermesh and David Kiron

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 treatment center business. View Details

Keywords: For-Profit Firms; Health Care and Treatment; Health Testing and Trials; Growth and Development Strategy; Market Entry and Exit; Health Industry

November 2009
Case

The Explosion of Genetic Testing: Opportunities and Challenges

By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon

This case study invites the reader to consider genetic testing in several different lights. First, can the business of genetic testing be considered a disruptive innovation to the current drug therapy model as defined by Harvard Business School Professor Clay... View Details

Keywords: Genetics; Health Care and Treatment; Health Testing and Trials; Disruptive Innovation; Business Model; Biotechnology Industry; Health Industry

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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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... View Details

Keywords: Health Economics; Medication Adherence; Physician Payment Incentives; Primary Care; Quality Improvement; Health Care and Treatment; Motivation and Incentives; Behavior

January 2020
Article

Assessing the Safety of Electronic Health Records: A National Longitudinal Study of Medication-related Decision Support

By: A Jay Holmgren, Zoe Co, Lisa Newmark, Melissa Danforth, David Classen and David Bates

Background Electronic health records (EHR) can improve safety via computerised physician order entry with clinical decision support, designed in part to alert providers and prevent potential adverse drug events at entry and before they reach the patient.... View Details

Keywords: Hospital; Electronic Health Records; Health Care and Treatment; Information Technology; Safety; Performance; Quality; Performance Improvement

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September 2017 (Revised July 2023)
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.... View Details

Keywords: Clinical Trials; Cancer; Adaptive Platform Trials; Platform Trials; Adaptive Trials; Glioblastoma; Health; Health Care and Treatment; Health Testing and Trials; Business Strategy; Innovation Strategy; Health Industry; United States

September 2020
Case

Minerva 2004: Discovery

By: John R. Wells and Benjamin Weinstock

After nearly five years in operation, Doctor Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), was reflecting on the company’s next steps. In a few short years, she and her small team had managed to develop a nanoparticle process for... View Details

Keywords: Entrepreneurship; Financing and Loans; Strategy; Decision Choices and Conditions; Biotechnology Industry

November 2008 (Revised July 2009)
Background Note

A Managerial Perspective on Clinical Trials

By: Arthur A. Daemmrich

This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70... View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Safety; Biotechnology Industry; Pharmaceutical Industry

January 2009 (Revised July 2009)
Case

Targanta Therapeutics: Hitting a Moving Target

By: Arthur A. Daemmrich

This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful... View Details

Keywords: Decision Choices and Conditions; Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Business and Government Relations; Business Strategy; Biotechnology Industry; Pharmaceutical Industry

2023
Working Paper

Market Exclusivity and Innovation: Evidence From Antibiotics

By: Edward Kong and Olivia Zhao

The US incentivizes drug innovation via patents as well as market exclusivity periods awarded by the US Food and Drug Administration. We estimate the causal effects of extending market exclusivity for an important drug class: antibiotics. Using a... View Details

Keywords: Health Testing and Trials; Innovation and Invention; Motivation and Incentives; Government Administration; Government Legislation; Pharmaceutical Industry; United States

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... View Details

Keywords: Health Care and Treatment; Product Launch; Product Positioning; Marketing Strategy; Adoption; Pharmaceutical Industry

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... View Details

Keywords: COVID-19; Health Pandemics; Strategy; Leadership

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September 2017
Case

Dr. William Carson— Intrapreneurial Innovation in the Pharmaceutical Industry

By: Steven Rogers and Alyssa Haywoode

Dr. William Carson, an African-American alum of Harvard University became the President and CEO of a multi billion dollar division of Otsuka, a Japan based pharmaceutical company. His ascension to this leadership position followed a thriving career in academic medicine... View Details

Keywords: Dr. Williams Carson; Otsuka America Pharmaceutical; Harvard; Abilify; Aripiprazole; Health Testing and Trials; Globalized Firms and Management; Globalized Markets and Industries; Cross-Cultural and Cross-Border Issues; Decision Choices and Conditions; Pharmaceutical Industry; Japan

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