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- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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- January 2023
- Teaching Note
The Opioid Settlement and Executive Pay at AmerisourceBergen
By: Suraj Srinivasan and Li-Kuan Ni
Teaching Note for HBS Case No 122-014. In 2020, AmerisourceBergen Corporation, a Fortune 50 company in the drug distribution industry, agreed to settle thousands of lawsuits filed nationwide against the company for its opioid distribution practices that critics alleged...
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Keywords:
Opioids;
Shareholder Activism;
Investment Activism;
Corporate Accountability;
Corporate Governance;
Governance Compliance;
Governance Controls;
Executive Compensation;
Risk Management;
Corporate Social Responsibility and Impact;
Business and Shareholder Relations;
Business and Stakeholder Relations;
Distribution Industry;
Health Industry;
Pharmaceutical Industry;
United States;
West Virginia;
Tennessee;
Ohio;
Pennsylvania
- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
How can a successful executive assess her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to find a therapeutic window for Cleave Therapeutics oncology drug was on track but faced an uncertain future. Overseeing the...
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- 2022
- Working Paper
Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation
By: Amitabh Chandra, Jennifer Kao, Kathleen Miller and Ariel D. Stern
Regulators of new products confront a tradeoff between speeding a new product to market and collecting additional product quality information. The FDA’s Breakthrough Therapy Designation (BTD) provides an opportunity to understand if a regulator can use new policy to...
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- 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 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 technological innovation...
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- November 2022 (Revised November 2022)
- Case
Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams
By: Debora L. Spar and Julia M. Comeau
In 1990, satellite expert and Sirius XM founder Martine Rothblatt was determined to save the life of her seven-year-old daughter, Jenesis, who was diagnosed with a terminal illness called Pulmonary Arterial Hypertension (PAH). At the time, there was little medication...
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- 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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- October 2022
- Case
mPharma: Scaling Access to Affordable Primary Care in Africa
By: Regina E. Herzlinger and Ben Creo
mPharma CEO Greg Rockson is attempting to create the largest pan-African primary healthcare company. He must evaluate a three-year strategy potentially involving three key components: a rapid and extensive expansion of the company's network of 600 retail pharmacies in...
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Keywords:
Africa;
Pharmaceutical Companies;
Pharmacy Benefit Manager;
Health Care;
Health Care And Treatment;
Health Care Costs;
Health Care Delivery;
Health Care Entrepreneurship;
Telehealth;
Health Equity;
Corporate Strategy;
Social Entrepreneurship;
Equity;
Growth and Development Strategy;
Expansion;
Product Launch;
Customer Value and Value Chain;
Social Enterprise;
Multinational Firms and Management;
Pharmaceutical Industry;
Health Industry;
Africa
- Working Paper
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...
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- September 2022
- Article
Find and Replace: R&D Investment Following the Erosion of Existing Products
By: Joshua L. Krieger, Xuelin Li and Richard T. Thakor
How do innovative firms react when existing products experience negative shocks? We explore this question with detailed project-level data from drug development firms. Using FDA Public Health Advisories as idiosyncratic negative shocks to approved drugs, we first...
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- September 2022
- Article
Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities
By: Leemore Dafny, Christopher Ody and Teresa Rokos
The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations...
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- September 2022
- Article
The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente
By: Alyce S. Adams, Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong and Wesley Yin
Most hospitals have financial assistance programs for low-income patients. We use administrative data from Kaiser Permanente to study the effects of financial assistance on health care utilization. Using a regression discontinuity design based on an income threshold...
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- 2022
- Working Paper
Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina
By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle
Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its...
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- April 18, 2022
- Article
Will mRNA Technology Companies Spawn Innovation Ecosystems?
By: Christoph Grimpe, Timo Minssen, W. Nicholson Price, II and Ariel Dora Stern
The mRNA technologies that helped rapidly create effective COVID-19 vaccines could become technology platform businesses, which has tremendous implications for players in the world of drug development. These platforms could attract other companies interested in...
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- 2022
- Working Paper
Exploring the Relationship between Team Diversity, Psychological Safety and Team Performance: Evidence from Pharmaceutical Drug Development
By: Henrik Bresman and Amy C. Edmondson
Breakthrough performance in teams requires pooling diverse perspectives and expertise. To realize the potential of diversity, communicating and translating across differences is essential. However, left to their own devices, diverse teams tend to underperform, in part...
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- February 2022 (Revised September 2022)
- Case
InstaDeep: AI Innovation Born in Africa (A)
By: Shikhar Ghosh and Esel Çekin
Karim Beguir and Zohra Slim were the co-founders of InstaDeep, a deep tech startup focusing on artificial intelligence (AI) solutions. Instadeep was one of the few companies globally that were partnering with DeepMind, an AI subsidiary of Google [Alphabet Inc.]....
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- February 2022 (Revised July 2022)
- Supplement
InstaDeep: AI Innovation Born in Africa (B)
By: Shikhar Ghosh and Esel Çekin
Karim Beguir and Zohra Slim were the co-founders of InstaDeep, a deep tech startup focusing on artificial intelligence (AI) solutions. Instadeep was one of the few companies globally that were partnering with DeepMind, an AI subsidiary of Google [Alphabet Inc.]....
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- 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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- 2022
- Article
Missing Novelty in Drug Development
By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou
We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to...
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- October 2021 (Revised October 2022)
- Case
The Opioid Settlement and Controversy Over CEO Pay at AmerisourceBergen
By: Suraj Srinivasan and Li-Kuan Ni
In 2020, AmerisourceBergen Corporation, a Fortune 50 company in the drug distribution industry, agreed to settle thousands of lawsuits filed nationwide against the company for its opioid distribution practices that critics alleged had contributed to the nationwide...
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Keywords:
Opioids;
Drug;
Investors;
Shareholder Activism;
Investment Activism;
Executive Compensation;
Corporate Accountability;
Corporate Governance;
Governance Compliance;
Governance Controls;
Risk Management;
Corporate Social Responsibility and Impact;
Business and Shareholder Relations;
Business and Stakeholder Relations;
Legal Liability;
Distribution Industry;
Health Industry;
Pharmaceutical Industry;
United States;
West Virginia;
Tennessee;
Ohio;
Pennsylvania