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January 2018
Article

The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials

By: Aaron V. Kaplan and Ariel D. Stern

The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of... View Details

Keywords: Health Testing and Trials; Business and Government Relations; Governing Rules, Regulations, and Reforms; Information Publishing; Medical Devices and Supplies Industry; United States

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January 2018
Teaching Note

BeiGene

By: Willy Shih and Jimmy Zhang

Teaching Note for HBS No. 618-033. View Details

Keywords: Biotechnology; Drug Development; Corporate Strategy; Business Startups; Technological Innovation; Situation or Environment; Biotechnology Industry; Pharmaceutical Industry; China

September 2014
Case

Pfizer's Centers for Therapeutic Innovation (CTI)

By: Gary Pisano, James Weber and Kait Szydlowski

In 2010, Pfizer established four small research units in New York, Boston, San Francisco, and San Diego located close to several premier Academic Medical Centers (AMCs), or hospitals with adjoining medical schools. The goal of these units was to redesign collaboration... View Details

Keywords: Drug Development; Academic Collaboration; Research And Development; Innovation; Translational Research; Management; Operations; Problems and Challenges; Research; Science; Information Technology; Strategy; Biotechnology Industry; Pharmaceutical Industry; North and Central America; Europe; Asia

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

2004
Article

Do Firms Change Capabilities by Hiring New People? A Study of the Adoption of Science-based Drug Discovery

By: Rebecca M. Henderson, Nicola Lacetera and Iain Cockburn

Keywords: Selection and Staffing; Change; Science; Health; Information

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August 1997
Article

Preventable Adverse Drug Events in Hospitalized Patients: A Comparative Study of Intensive Care and General Care Units

By: D. J. Cullen, J. Sweitzer, D. W. Bates, E. Burdick, A. Edmondson and L. L. Leape

Keywords: Health; Information

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09 Apr 2019
News

Expect a fiery hearing on Capitol Hill today over the role of pharmacy middle man drug pricing

February 2016 (Revised February 2017)
Case

Alvogen

By: Daniel Isenberg and William Kerr

Alvogen is a young Icelandic generic pharmaceutical company, whose CEO believes that his global strategy will give them an edge in this competitive industry.
Robert Wessman, Alvogen’s CEO, was also previously the CEO of Actavis, another Icelandic generics... View Details

Keywords: Pharmaceutical Companies; Generic Drugs; Entrepreneurship; Globalization; Risk and Uncertainty; Pharmaceutical Industry; Iceland

December 2020 (Revised May 2021)
Background Note

Tales of Life-changing Innovations: Living Drugs | Note on the Development of CAR-T Therapies (through 2019)

By: Amar Bhidé and Srikant M. Datar

April 2017
Case

Imprimis (A)

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

This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in... View Details

Keywords: Strategy; Healthcare; Drug Compounding; Pharmaceuticals; Compounding; Drug Development; Decision-making; Mark Baum; Imprimis; Small Business; Decisions; Cost vs Benefits; Business Strategy; Business Model; Decision Choices and Conditions; Pharmaceutical Industry; United States

August 2018 (Revised February 2019)
Case

Alvogen: Scaling Entrepreneurship

By: Daniel Isenberg, William R. Kerr and Alexis Brownell

Keywords: Pharmaceutical Companies; Scaling; Generic Drugs; Entrepreneurship; Leadership; Pharmaceutical Industry; Asia; Europe; United States; Iceland

September 2022
Article

Find and Replace: R&D Investment Following the Erosion of Existing Products

By: Joshua L. Krieger, Xuelin Li and Richard T. Thakor

How do innovative firms react when existing products experience negative shocks? We explore this question with detailed project-level data from drug development firms. Using FDA Public Health Advisories as idiosyncratic negative shocks to approved drugs, we first... View Details

Keywords: R＆D Investments; Drug Development; Product Shocks; M＆A; Biopharmaceutical Industry; FDA; System Shocks; Research and Development; Investment; Decision Making; Pharmaceutical Industry

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December 2008 (Revised October 2013)
Case

Amylin Pharmaceuticals: Diabetes and Beyond (A)

By: Richard G. Hamermesh and Rachel Gordon

Ginger Graham, CEO of Amylin Pharmaceuticals, joined the company with the expectation of taking the company's signature drug, Symlin, to market. However, unforeseen regulatory challenges have put the approval process in jeopardy. At the same time, the company has a... View Details

Keywords: Regulations; Drug Regulations; Symlin; Negotiation; Governing Rules, Regulations, and Reforms; Resource Allocation; Negotiation Deal; Product Development; Research and Development; Commercialization; Pharmaceutical Industry; United States

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

29 Jun 2020
News

After saving his own life with a repurposed drug, a professor reviews every drug being tried against Covid-19. Here's what he's found

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

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

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

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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

July 2016
Case

Product Portfolio Management at Genentech

By: Kevin Schulman and Jamie Gresh

Genentech, long the darling of the biotechnology industry, was acquired by Swiss pharmaceutical company Roche in 2009. The combined company retains the name Genentech in the US, but must now move to achieve the promises made at the time of this merger—to build from... View Details

Keywords: Portfolio Management; Drug Development; Postmerger Integration; Marketing Strategy; Mergers and Acquisitions; Integration; Biotechnology Industry; Pharmaceutical Industry; United States

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