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All HBS Web
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- Faculty Publications (278)
Drug →
- November 2019 (Revised April 2020)
- Technical Note
The Life Sciences Revolution: A Technical Primer
By: Gary P. Pisano, William J. Anderson, Amitabh Chandra, Clarissa Ceruti and Stephanie Oestreich
For more than two decades, scientific advances have been driving profound changes in drug discovery and the drug industry itself. This case provides an overview and description of these technical and scientific advances. Written for the nonscientific reader, it may be...
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Keywords:
Science;
Technological Innovation;
Technology;
Pharmaceutical Industry;
Biotechnology Industry
Pisano, Gary P., William J. Anderson, Amitabh Chandra, Clarissa Ceruti, and Stephanie Oestreich. "The Life Sciences Revolution: A Technical Primer." Harvard Business School Technical Note 620-054, November 2019. (Revised April 2020.)
- October 2019
- Case
Impax Laboratories: Executing Accretive Acquisitions (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...
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Keywords:
Financial Reporting;
Financial Statements;
Mergers and Acquisitions;
Capital Structure;
Competition;
Competitive Advantage;
Corporate Strategy;
Pharmaceutical Industry;
United States
Esty, Benjamin C., and Daniel Fisher. "Impax Laboratories: Executing Accretive Acquisitions (A)." Harvard Business School Case 220-030, October 2019.
- 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...
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- 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...
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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
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Supplement 620-001, September 2019.
- September 2019 (Revised October 2019)
- Case
Aura Biosciences: Bringing a Breakthrough Drug to Market
By: Robert J. Dolan and Navid Mojir
Dolan, Robert J., and Navid Mojir. "Aura Biosciences: Bringing a Breakthrough Drug to Market." Harvard Business School Case 520-032, September 2019. (Revised October 2019.)
- 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...
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Rafiq, Sana, and Max Bazerman. "Pay-for-Monopoly? An Assessment of Reverse Payment Deals by Pharmaceutical Companies." Journal of Behavioral Economics for Policy 3, no. 1 (2019): 37–43.
- July 2019
- Article
The Impact of Price Regulation on the Availability of New Drugs in Germany
By: Ariel Dora Stern, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim and Ameet Sarpatwari
The 2011 German Pharmaceutical Market Restructuring Act (“AMNOG”) subjected branded, non-rare disease drugs to price regulation based on an assessment of their clinical benefit. Assessment outcomes range from “major added benefit” to “less benefit than the appropriate...
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Keywords:
Regulation;
Pharmaceuticals;
Healthcare;
Health Care and Treatment;
Price;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry;
Germany
Stern, Ariel Dora, Felicitas Pietrulla, Annika Herr, Aaron S. Kesselheim, and Ameet Sarpatwari. "The Impact of Price Regulation on the Availability of New Drugs in Germany." Health Affairs 38, no. 7 (July 2019): 1182–1187.
- Article
Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries
By: Ariel Dora Stern, William J. Gordon, Adam B. Landman and Daniel B. Kramer
Objectives:
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
To more clearly define the landscape of digital medical devices subject to U.S. Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and... View Details
Keywords:
Digital;
Medicine;
FDA;
Health Care and Treatment;
Applications and Software;
Safety;
Cybersecurity;
Medical Devices and Supplies Industry
Stern, Ariel Dora, William J. Gordon, Adam B. Landman, and Daniel B. Kramer. "Cybersecurity Features of Digital Medical Devices: An Analysis of FDA Product Summaries." BMJ Open 9, no. 6 (June 2019).
- 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...
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Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern. "Characterizing the Drug Development Pipeline for Precision Medicines." Chap. 5 in Economic Dimensions of Personalized and Precision Medicine, edited by Ernest R. Berndt, Dana P. Goldman, and John W. Rowe, 115–158. University of Chicago Press, 2019.
- February 14, 2019
- Other Article
We Should Treat Algorithms like Prescription Drugs
By: Andy Coravos, Irene Chen, Ankit Gordhandas and Ariel Dora Stern
Coravos, Andy, Irene Chen, Ankit Gordhandas, and Ariel Dora Stern. "We Should Treat Algorithms like Prescription Drugs." Quartz (February 14, 2019).
- 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...
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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
Fuller, Joseph B., and John Masko. "Theranos: The Unicorn That Wasn't." Harvard Business School Case 319-068, February 2019. (Revised September 2019.)
- 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...
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Koh, Howard, Sara J. Singer, and Amy C. Edmondson. "Health as a Way of Doing Business." JAMA, the Journal of the American Medical Association 321, no. 1 (January 1, 2019): 33–34.
- December 19, 2018
- Article
It's Time to Reform the Orphan Drug Act
By: Nicholas Bagley, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "It's Time to Reform the Orphan Drug Act." NEJM Catalyst (December 19, 2018).
- 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...
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- 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...
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Keywords:
Health Care and Treatment;
Laws and Statutes;
Research and Development;
Investment;
Markets;
Monopoly
Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
- 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
Isenberg, Daniel, William R. Kerr, and Alexis Brownell. "Alvogen: Scaling Entrepreneurship." Harvard Business School Case 819-038, August 2018. (Revised February 2019.)
- August 2018
- Article
The Impact of the Entry of Biosimilars: Evidence from Europe
By: Fiona M. Scott Morton, Ariel Dora Stern and Scott Stern
Biologics represent a substantial and growing share of the U.S. drug market. Traditional “small molecule” generics quickly erode the price and share of the branded product upon entry; however, only a few biosimilars have been approved in the U.S. since 2015, thereby...
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Keywords:
Health Care;
Biosimilars;
Biologics;
Pharmaceutical Competition;
Healthcare Spending;
Innovation;
Health Care and Treatment;
Spending;
Market Entry and Exit;
Competition;
Innovation and Invention;
Pharmaceutical Industry;
United States;
Europe
Scott Morton, Fiona M., Ariel Dora Stern, and Scott Stern. "The Impact of the Entry of Biosimilars: Evidence from Europe." Review of Industrial Organization 53, no. 1 (August 2018): 173–210.
- 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...
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- 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,...
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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
Kanter, Rosabeth Moss, and Jonathan Cohen. "Sandra Brown Goes Digital (A): The Promise and Perils of Social Movements in a Healthcare Company." Harvard Business School Case 318-082, March 2018.