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- October 2019
- Supplement
Impax Laboratories: Executing Accretive Transactions (A)
By: Benjamin C. Esty and Daniel Fisher
Impax Laboratories was a technology-based pharmaceutical company that used a “dual platform” strategy to sell both generic and branded treatments. While Impax had grown organically for most of its history, it was beginning to use major acquisitions for growth. In the... View Details
- September 2019 (Revised October 2019)
- Case
Aura Biosciences: Bringing a Breakthrough Drug to Market
By: Robert J. Dolan and Navid Mojir
- 2019
- Article
Pay-for-Monopoly?: An Assessment of Reverse Payment Deals by Pharmaceutical Companies
By: Sana Rafiq and Max Bazerman
Abstract
Over the past eighteen years, pharmaceutical firms have developed a blueprint to impede competition in order
to maintain their monopoly profits. This scheme, termed pay-for-delay, involves direct or indirect payment of
money from a branded-drug manufacturer... View Details
- 2024
- Working Paper
Magnetic Resonance Imaging—High Quality and Radiation Free: Case Histories of Transformational Advances
By: Srikant M. Datar, Amar Bhidé and Katherine Stebbins
This case history describes how Magnetic Resource Imaging (MRI) came to complement – and partially replace -- computed tomography (CT) imaging of soft tissue. Specifically, we chronicle 1) the development of foundational techniques and prototypes (through the 1970s);... View Details
- 2019
- Chapter
Characterizing the Drug Development Pipeline for Precision Medicines
By: Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
BOOK ABSTRACT: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement... View Details
- February 2019 (Revised September 2019)
- Case
Theranos: The Unicorn That Wasn't
By: Joseph B. Fuller and John Masko
In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains... View Details
Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry
- Article
Health as a Way of Doing Business
By: Howard Koh, Sara J. Singer and Amy C. Edmondson
For too long, the worlds of business and health have been mired in a checkered, sometimes contentious, history. Millions of deaths worldwide can be attributed to risk factors including tobacco use, alcohol and drug misuse, and suboptimal dietary intake linked to... View Details
- December 19, 2018
- Article
It's Time to Reform the Orphan Drug Act
By: Nicholas Bagley, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
- November 2018
- Case
David Hysong and SHEPHERD Therapeutics
By: Ananth Raman, John Masko and Aldo Sesia
In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his... View Details
- November 2018
- Case
Aura Biosciences: Bringing a Breakthrough Drug to Market
By: Robert J. Dolan and Navid Mojir
- 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
- August 2018 (Revised February 2019)
- Case
Alvogen: Scaling Entrepreneurship
By: Daniel Isenberg, William R. Kerr and Alexis Brownell
- June 2018
- Teaching Note
Sandra Brown Goes Digital
By: Rosabeth Moss Kanter and Jonathan Cohen
As a middle manager at a biotechnology company, Sandra Brown harnessed digital tools and social media to engage others and build campaigns for change in the company. This Teaching Note presents strategies for teaching the Sandra Brown case series, which follows Brown's... View Details
- March 2018
- Case
Sandra Brown Goes Digital (A): The Promise and Perils of Social Movements in a Healthcare Company
By: Rosabeth Moss Kanter and Jonathan Cohen
As a middle manager at a biotechnology company, Sandra Brown harnessed digital tools and social media to engage others and build campaigns for change in the company. This case follows her career at the company and describes the challenges she faced as a change agent,... View Details
Keywords: Digital; Engagement; Stakeholder Engagement; Grassroots Movement; Organization Change And Adaptation; Quality; Health Care; Health Care Industry; Career Path; Leading Change; Management; Innovation and Management; Personal Development and Career; Organizational Change and Adaptation; Biotechnology Industry; Health Industry
- January 2018
- Supplement
BeiGene Supplemental PowerPoint
By: Willy C. Shih and Jimmy Zhang
BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window... View Details
- January 2018
- Teaching Note
BeiGene
By: Willy Shih and Jimmy Zhang
Teaching Note for HBS No. 618-033. View Details
- 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
- November 2017
- Case
BeiGene
By: Willy Shih and Jimmy Zhang
BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window... View Details
- November 2017
- Case
The 'Wonder Drug' That Killed Babies
By: Joshua Lev Krieger, Tom Nicholas and Matthew Preble
In the early 1960s, a popular drug taken by patients worldwide for a range of maladies was found to cause severe birth defects and other health problems in babies born to mothers who had taken it during a certain stage of fetal development. As many as 10,000 children... View Details
Keywords: Regulation; Business and Government Relations; Business and Community Relations; Business and Stakeholder Relations; Product Marketing; Corporate Social Responsibility and Impact; Business History; Health; Government Legislation; Corporate Accountability; Ethics; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry; Public Administration Industry; United States; United Kingdom; Australia; Germany; Europe
- 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