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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...  View Details
      Keywords: Recalls; Governing Rules, Regulations, and Reforms; Medical Devices and Supplies Industry
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      Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
      • 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...  View Details
      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
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      Srinivasan, Suraj, and Li-Kuan Ni. "The Opioid Settlement and Executive Pay at AmerisourceBergen." Harvard Business School Teaching Note 123-067, January 2023.
      • 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...  View Details
      Keywords: Product Development; Leadership; Health Testing and Trials; Research and Development; Risk and Uncertainty; Financial Condition; Partners and Partnerships; Pharmaceutical Industry
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      Herzlinger, Regina, and Brian Walker. "Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery." Harvard Business School Case 323-045, January 2023.
      • 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...  View Details
      Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development
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      Chandra, Amitabh, Jennifer Kao, Kathleen Miller, and Ariel D. Stern. "Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation." NBER Working Paper Series, No. 30712, December 2022.
      • 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...  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
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      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.
      • 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...  View Details
      Keywords: Pharmaceutical Companies; Technological And Scientific Innovation; Organ Donation; Health Care and Treatment; Health Disorders; Innovation and Invention; Pharmaceutical Industry; Medical Devices and Supplies Industry; United States; District of Columbia
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      Spar, Debora L., and Julia M. Comeau. "Martine Rothblatt and United Therapeutics: A Series of Implausible Dreams." Harvard Business School Case 323-039, November 2022. (Revised 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....  View Details
      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
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      MacKay, Alexander, and James Barnett. "Cost Plus Drugs." Harvard Business School Case 723-362, October 2022.
      • 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...  View Details
      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
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      Herzlinger, Regina E., and Ben Creo. "mPharma: Scaling Access to Affordable Primary Care in Africa." Harvard Business School Case 323-033, October 2022.
      • 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...  View Details
      Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
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      Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." NBER Working Paper Series, No. 30575, October 2022. (Revise and resubmit, Quarterly Journal of Economics.)
      • 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...  View Details
      Keywords: R&D Investments; Drug Development; Product Shocks; M&A; Biopharmaceutical Industry; FDA; System Shocks; Research and Development; Investment; Decision Making; Pharmaceutical Industry
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      Krieger, Joshua L., Xuelin Li, and Richard T. Thakor. "Find and Replace: R&D Investment Following the Erosion of Existing Products." Management Science 68, no. 9 (September 2022): 6552–6571.
      • 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...  View Details
      Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
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      Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
      • 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...  View Details
      Keywords: Healthcare; Utilization; Financial Assistance; Health Care and Treatment; Social Issues; Poverty; Health Industry
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      Adams, Alyce S., Raymond Kluender, Neale Mahoney, Jinglin Wang, Francis Wong, and Wesley Yin. "The Impact of Financial Assistance Programs on Health Care Utilization: Evidence from Kaiser Permanente." American Economic Review: Insights 4, no. 3 (September 2022): 389–407.
      • 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...  View Details
      Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina
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      Calonico, Sebastian, Rafael Di Tella, and Juan Cruz Lopez Del Valle. "Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina." NBER Working Paper Series, No. 30084, May 2022.
      • 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...  View Details
      Keywords: Health Care; Digital Health; Technology; Innovation; Health Care and Treatment; Technological Innovation; Digital Transformation; Health Industry; United States
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      Grimpe, Christoph, Timo Minssen, W. Nicholson Price, II, and Ariel Dora Stern. "Will mRNA Technology Companies Spawn Innovation Ecosystems?" Harvard Business Review (website) (April 18, 2022).
      • 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...  View Details
      Keywords: Teams; Psychological Safety; Groups and Teams; Diversity; Interpersonal Communication; Performance
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      Bresman, Henrik, and Amy C. Edmondson. "Exploring the Relationship between Team Diversity, Psychological Safety and Team Performance: Evidence from Pharmaceutical Drug Development." Harvard Business School Working Paper, No. 22-055, February 2022.
      • 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.]....  View Details
      Keywords: AI; Artificial Intelligence; Entrepreneurship; Operations; Business Subsidiaries; Brands and Branding; Innovation and Invention; Growth and Development Strategy; AI and Machine Learning; Technology Industry; Africa
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      Ghosh, Shikhar, and Esel Çekin. "InstaDeep: AI Innovation Born in Africa (A)." Harvard Business School Case 822-104, February 2022. (Revised September 2022.)
      • 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.]....  View Details
      Keywords: AI; Artificial Intelligence; Entrepreneurship; Operations; Business Subsidiaries; Brands and Branding; Innovation and Invention; Growth and Development Strategy; AI and Machine Learning; Technology Industry; Africa
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      Ghosh, Shikhar, and Esel Çekin. "InstaDeep: AI Innovation Born in Africa (B)." Harvard Business School Supplement 822-105, February 2022. (Revised July 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...  View Details
      Keywords: Prescription Drugs; Coupons; Impact; Health Care and Treatment; Markets; Price; Spending; Pharmaceutical Industry; United States
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      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.
      • 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...  View Details
      Keywords: Drug Development; Risk Aversion; Research and Development; Innovation and Invention; Investment; Pharmaceutical Industry
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      Krieger, Joshua, Danielle Li, and Dimitris Papanikolaou. "Missing Novelty in Drug Development." Review of Financial Studies 35, no. 2 (February 2022): 636–679.
      • 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...  View Details
      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
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      Srinivasan, Suraj, and Li-Kuan Ni. "The Opioid Settlement and Controversy Over CEO Pay at AmerisourceBergen." Harvard Business School Case 122-014, October 2021. (Revised October 2022.)
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