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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: Autonomy; Deep Learning; Drug Discovery; Healthcare Innovation; Neural Networks; Scientific Research; Technology Startup; AI and Machine Learning; Technological Innovation; Research and Development; Business Model; Business Strategy; Open Source Distribution; Technology Industry; 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- August 2018 (Revised February 2019)
- Case
Alvogen: Scaling Entrepreneurship
By: Daniel Isenberg, William R. Kerr and Alexis Brownell
- 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
- 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
- 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