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- November 2024
- Supplement
AlphaGo (C): Birth of a New Intelligence
By: Shikhar Ghosh and Shweta Bagai
This case, the final of a three-part series, explores DeepMind's pivotal transition from mastering games to solving real-world scientific challenges. In December 2020, DeepMind's AI system AlphaFold 2 achieved a breakthrough by solving protein folding—a 50-year-old... View Details
Keywords: AI; Artificial Intelligence; Machine Learning; Research; Autonomy; Deep Learning; Drug Discovery; Healthcare Innovation; Neural Networks; Information Technology; Research And Development; Scientific Research; Technology Startup; AI and Machine Learning; Technological Innovation; United States
- August 2024
- Article
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... View Details
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?" American Economic Journal: Economic Policy 16, no. 3 (August 2024): 314–346.
- June 2024
- Article
Valuing the Societal Impact of Medicines and Other Health Technologies: A User Guide to Current Best Practices
By: Jason Shafrin, Jaehong Kim, Joshua T. Cohen, Louis P. Garrison, Dana A. Goldman, Jalpa A. Doshi, Joshua Krieger, Darius N. Lakdawalla, Peter J. Neumann, Charles E. Phelps, Melanie D. Whittington and Richard Willke
This study argues that value assessment conducted from a societal perspective should rely on the Generalized Cost-Effectiveness Analysis (GCEA) framework proposed herein. Recently developed value assessment inventories—such as the Second Panel on Cost-Effectiveness’s... View Details
Shafrin, Jason, Jaehong Kim, Joshua T. Cohen, Louis P. Garrison, Dana A. Goldman, Jalpa A. Doshi, Joshua Krieger, Darius N. Lakdawalla, Peter J. Neumann, Charles E. Phelps, Melanie D. Whittington, and Richard Willke. "Valuing the Societal Impact of Medicines and Other Health Technologies: A User Guide to Current Best Practices." Forum of Health Economics and Policy 27, no. 1 (June 2024): 29–116.
- February 2024
- Case
Civica Rx: A Not-for-Profit Founded to Address Market Failures in the Generic Drug Industry
By: Leemore S. Dafny
Dafny, Leemore S. "Civica Rx: A Not-for-Profit Founded to Address Market Failures in the Generic Drug Industry." Harvard Business School Case 324-057, February 2024.
- February 2024
- Article
Representation and Extrapolation: Evidence from Clinical Trials
By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
This article examines the consequences and causes of low enrollment of Black patients in clinical
trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is
more relevant for decision-making by physicians and patients when it... View Details
Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." Quarterly Journal of Economics 139, no. 1 (February 2024): 575–635.
- 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... View Details
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.)
- 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... View Details
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... View Details
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.
- 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... View Details
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.
- 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... View Details
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.
- 2024
- Working Paper
Cephalosporins—Fighting Hospital Infections: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
This case history describes the development of three generations of cephalosporins – antibiotics that have significantly reduced hospital infections. Specifically, we chronicle how: 1) Early (pre-cephalosporin) antibiotics were developed in the first half of the 20th... View Details
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—Fighting Hospital Infections: Case Histories of Transformational Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised May 2024.)
- 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,... View Details
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... View Details
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... View Details
- 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
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.)
- 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
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... View Details
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... View Details
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.)