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- 2023
- Working Paper
Evaluation and Learning in R&D Investment
By: Alexander P. Frankel, Joshua L. Krieger, Danielle Li and Dimitris Papanikolaou
We examine the role of spillover learning in shaping the value of exploratory versus incremental
R&D. Using data from drug development, we show that novel drug candidates generate more
knowledge spillovers than incremental ones. Despite being less likely to reach...
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Frankel, Alexander P., Joshua L. Krieger, Danielle Li, and Dimitris Papanikolaou. "Evaluation and Learning in R&D Investment." Harvard Business School Working Paper, No. 23-074, May 2023. (NBER Working Paper Series, No. 31290, May 2023.)
- April 2023
- Background Note
Note on Healthcare in Ghana
By: Regina E. Herzlinger and Ben Creo
This note accompanies case 323-033, “mPharma: Scaling Access to Affordable Primary Care in Africa” which discusses mPharma’s make-or-break strategic decisions. This note’s coverage of the Ghanaian healthcare system ranges from how care and drugs are delivered and...
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- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful...
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Keywords:
Product Development;
Leadership;
Health Testing and Trials;
Research and Development;
Risk and Uncertainty;
Financial Condition;
Partners and Partnerships;
Pharmaceutical Industry
Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
- November 2022
- Case
The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales
By: Regina E. Herzlinger and Tiffany Farrell
Can an online, direct-to-consumer pharmacy both improve the quality and speed of care for patients who need branded drugs and stabilize profits for pharmaceutical manufacturers? UpScript, after years spent achieving legal and regulatory compliance and simultaneous...
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Keywords:
DTC;
Internet and the Web;
Marketing Channels;
Customer Value and Value Chain;
Governing Rules, Regulations, and Reforms;
Competitive Strategy;
Service Delivery;
Growth and Development Strategy;
Pharmaceutical Industry;
Health Industry;
Retail Industry
Herzlinger, Regina E., and Tiffany Farrell. "The Battle Among Channels for Marketing Pharmaceuticals: UpScript, Pharmacy Benefit Managers, and Direct-to-Consumer Sales." Harvard Business School Case 323-031, November 2022.
- October 2022
- Case
Cost Plus Drugs
By: Alexander MacKay and James Barnett
In September 2022, Mark Cuban Cost Plus Drugs Company CEO Alex Oshmyansky considered the future of the company. Cost Plus Drugs was a retailer for more than 340 generic oral medications, selling their drugs at significantly lower prices than typical pharmacies....
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Keywords:
Business Ventures;
Decision Making;
Entrepreneurship;
Ethics;
Health;
Markets;
Social Enterprise;
Society;
Strategy;
Health Care and Treatment;
Business Divisions;
Factories, Labs, and Plants;
Health Industry;
Pharmaceutical Industry;
United States;
Texas
MacKay, Alexander, and James Barnett. "Cost Plus Drugs." Harvard Business School Case 723-362, October 2022.
- 2022
- Working Paper
How Do Copayment Coupons Affect Branded Drug Prices and Quantities Purchased?
By: Leemore S. Dafny, Kate Ho and Edward Kong
Drug copayment coupons to reduce patient cost-sharing have become nearly ubiquitous for high-priced brand-name prescription drugs. Medicare bans such coupons on the grounds that they are kickbacks that induce utilization, but they are commonly used by...
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Keywords:
Prescription Drugs;
Coupons;
Impact;
Health Care and Treatment;
Markets;
Price;
Spending;
Pharmaceutical Industry;
United States
Dafny, Leemore S., Kate Ho, and Edward Kong. "How Do Copayment Coupons Affect Branded Drug Prices and Quantities Purchased?" NBER Working Paper Series, No. 29735, February 2022.
- Summer 2021
- Article
The Cost and Evolution of Quality at Cipla Ltd, 1935–2016
By: Muhammad H. Zaman and Tarun Khanna
This article examines the evolution of Indian pharmaceutical manufacturer Cipla towards producing drugs that met the quality standards of European and U.S. regulators. It employs new research in Cipla’s corporate archives, the Creating Emerging Markets database, and...
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Keywords:
Cipla;
Pharmaceuticals;
Drug Quality;
Generics;
Quality;
Standards;
Information Technology;
Cost;
Organizational Culture;
Business History;
Pharmaceutical Industry;
India
Zaman, Muhammad H., and Tarun Khanna. "The Cost and Evolution of Quality at Cipla Ltd, 1935–2016." Business History Review 95, no. 2 (Summer 2021): 249–274.
- Article
Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users
By: Ariel Dora Stern, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup and Ernst R. Berndt
Biologic drugs account for a disproportionate share of the increase in pharmaceutical spending in the U.S. and worldwide. Against this backdrop, many look to the expanding market for biosimilars—follow-on products to biologic drugs—as a vehicle for controlling...
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Keywords:
Pharmaceuticals;
Drug Spending;
Drug Pricing;
Health Care and Treatment;
Spending;
Price;
Markets;
Cost Management;
United States
Stern, Ariel Dora, Jacqueline L. Chen, Melissa Ouellet, Mark R. Trusheim, Zeid El-Kilani, Amber Jessup, and Ernst R. Berndt. "Biosimilars and Follow-On Products in the United States: Adoption, Prices, and Users." Health Affairs 40, no. 6 (June 2021): 989–999.
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- 2021
- Working Paper
Cephalosporins: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
Our case history describes the development of three generations of cephalosporins—antibiotics that have significantly reduced hospital infections. After providing an overview of antibiotic development and its challenges we describe how: 1) Early (pre-cephalosporin)...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Cephalosporins: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised May 2021.)
- 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.
- 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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- 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.
- 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.
- 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...
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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
Krieger, Joshua Lev, Tom Nicholas, and Matthew Preble. "The 'Wonder Drug' That Killed Babies." Harvard Business School Case 818-044, November 2017.
- 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.)
- May 2017
- Article
When Discounts Raise Costs: The Effect of Copay Coupons on Generic Utilization
By: Leemore S. Dafny, Christopher Ody and Matt Schmitt
Branded pharmaceutical manufacturers frequently offer “copay coupons” that insulate consumers from cost sharing, thereby undermining insurers’ ability to influence drug utilization. We study the impact of copay coupons on branded drugs first facing generic entry...
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Dafny, Leemore S., Christopher Ody, and Matt Schmitt. "When Discounts Raise Costs: The Effect of Copay Coupons on Generic Utilization." American Economic Journal: Economic Policy 9, no. 2 (May 2017): 91–123.
- 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
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
Isenberg, Daniel, and William Kerr. "Alvogen." Harvard Business School Case 816-064, February 2016. (Revised February 2017.)