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All HBS Web
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- Faculty Publications (106)
- Working Paper
Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S.
By: Pragya Kakani, Michael Chernew and Amitabh Chandra
Rising list prices are often used to illustrate the burden of prescription drug spending, but payers routinely negotiate rebates from manufacturers that generate differences between list and net prices. List prices are easily available and affect patient cost-sharing,...
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Keywords:
Pharmaceuticals;
Rebates;
Health Care and Treatment;
Markets;
Price;
Analysis;
Pharmaceutical Industry
Kakani, Pragya, Michael Chernew, and Amitabh Chandra. "Rebates in the Pharmaceutical Industry: Evidence from Medicines Sold in Retail Pharmacies in the U.S." NBER Working Paper Series, No. 26846, March 2020.
- January 2020
- Article
The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System
By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz
Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has...
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Monteleone, Peter P., Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry, and Mark J. Pirwitz. "The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System." Journal of Invasive Cardiology 32, no. 1 (January 2020).
- November 2019
- Case
The Genesis Lab at Novartis
By: Amy C. Edmondson, Ranjay Gulati, Patrick J. Healy and Kerry Herman
Novartis' Genesis Labs program, launched in 2016 as part of Novartis Institutes for Biomedical Research (NIBR), hosted pitch competitions where teams of NIBR scientists proposed ideas to explore that aimed to revolutionize drug discovery. The goal was to break down...
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Keywords:
Drug Discovery;
Health Care and Treatment;
Research and Development;
Innovation and Invention;
Programs;
Management
Edmondson, Amy C., Ranjay Gulati, Patrick J. Healy, and Kerry Herman. "The Genesis Lab at Novartis." Harvard Business School Case 620-007, November 2019.
- 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.
- 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.
- 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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- 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
- 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.
- 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?”
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- 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...
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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....
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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
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future?" Harvard Business School Case 618-025, September 2017. (Revised July 2023.)
- 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...
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Keywords:
Health Care and Treatment;
Product Launch;
Product Positioning;
Marketing Strategy;
Adoption;
Pharmaceutical Industry
Ofek, Elie, and Amanda Dai. "MannKind Corporation: Take a Deep Breath, This Time Afrezza Will Work." Harvard Business School Case 518-031, August 2017. (Revised July 2018.)
- 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’...
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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
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (B)." Harvard Business School Supplement 717-496, April 2017.
- April 2017
- Supplement
Imprimis (C)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case is a supplement to Imprimis (A & B). Set in 2015, it first describes Imprimis’s decision to introduce its own line of compounded eye drop medication called LessDrops. The case then examines the moral dilemma faced by CEO Mark Baum, who was struck by the...
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Keywords:
Health Care and Treatment;
Cost;
Moral Sensibility;
Competitive Strategy;
Decision Choices and Conditions;
Pharmaceutical Industry;
United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (C)." Harvard Business School Supplement 717-497, April 2017.
- Article
Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry
By: Leemore S. Dafny, Christopher Ody and Matt Schmitt
The analogy between value-based purchasing in pharmaceuticals and the new frontier of alternative payment models for health care providers is relatively straightforward. Insurers are increasingly demanding steep discounts from providers in exchange for inclusion in...
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Keywords:
Drug Copayment Coupons;
Prescription Drug Policy;
Health Care and Treatment;
Insurance;
Cost;
Policy;
Pharmaceutical Industry
Dafny, Leemore S., Christopher Ody, and Matt Schmitt. "Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry." New England Journal of Medicine 375, no. 21 (November 24, 2016): 2013–2015.
- 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...
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- March 2016 (Revised March 2022)
- Teaching Note
Express Scripts: Promoting Prescription Drug Home Delivery (A) and (B)
By: John Beshears
The pharmacy benefit manager (PBM) sector processes prescription drug claims on behalf of companies that offer a prescription drug benefit to their employees. The case associated with this teaching note follows Bob Nease, chief scientist at Express Scripts, as he...
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Keywords:
Pharmaceuticals;
Prescription Drugs;
Pharmacy Benefit Manager;
PBM;
Healthcare;
Behavioral Economics;
Choice Architecture;
Active Choice;
Service Delivery;
Decision Choices and Conditions;
Consumer Behavior;
Distribution Channels;
Health Care and Treatment;
Service Industry;
Pharmaceutical Industry
- February 2016
- Case
Express Scripts: Promoting Prescription Drug Home Delivery (A)
By: John Beshears, Patrick Rooney and Jenny Sanford
The pharmacy benefit manager (PBM) sector processes prescription drug claims on behalf of companies that offer a prescription drug benefit to their employees. This case follows Bob Nease, Chief Scientist at Express Scripts, as he considers methods to promote home...
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Keywords:
Pharmaceuticals;
Prescription Drugs;
Pharmacy Benefit Manager;
PBM;
Healthcare;
Behavioral Economics;
Choice Architecture;
Active Choice;
Service Delivery;
Decision Choices and Conditions;
Health Care and Treatment;
Order Taking and Fulfillment;
Compensation and Benefits;
Pharmaceutical Industry
Beshears, John, Patrick Rooney, and Jenny Sanford. "Express Scripts: Promoting Prescription Drug Home Delivery (A)." Harvard Business School Case 916-026, February 2016.