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      • Faculty Publications  (109)

      Drug Development Remove Drug Development →

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      • 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.
      • 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.
      • 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
      • 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.
      • September 2021
      • Article

      Trials and Terminations: Learning from Competitors' R&D Failures

      By: Joshua L. Krieger
      I analyze project continuation decisions where firms may resolve uncertainty through news about competitors' research and development (R&D) failures, as well as through their own results. I examine the trade-offs and interactions between product-market competition and...  View Details
      Keywords: Research and Development; Projects; Failure; Decision Making; Learning
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      Krieger, Joshua L. "Trials and Terminations: Learning from Competitors' R&D Failures." Management Science 67, no. 9 (September 2021).
      • 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
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      Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
      • May 2021
      • Case

      The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease

      By: Amitabh Chandra, Spencer Lee-Rey and Caroline Marra
      This case explores incentives for rare disease drug development by chronicling the role of the Spinal Muscular Atrophy (SMA) Foundation in forming strategic partnerships with the scientific research community and pharmaceutical developers to transform the trajectory...  View Details
      Keywords: Innovation and Invention; Strategy; Business or Company Management; Society; Health; Public Administration Industry; Health Industry; United States
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      Chandra, Amitabh, Spencer Lee-Rey, and Caroline Marra. "The SMA Foundation: Steering Therapeutic Research and Development in a Rare Disease." Harvard Business School Case 621-112, May 2021.
      • May 2021
      • Article

      Private and Social Returns to R&D: Drug Development and Demographics

      By: Efraim Benmelech, Janice Eberly, Dimitris Papanikolaou and Joshua Krieger
      Investment in intangible capital such as R&D has increased dramatically since the 1990s. However, productivity growth remains sluggish in recent years. One potential reason is that a significant share of the increase in intangible investment is geared toward consumer...  View Details
      Keywords: Drug Development; Research and Development; Investment Return; Demographics; Pharmaceutical Industry
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      Benmelech, Efraim, Janice Eberly, Dimitris Papanikolaou, and Joshua Krieger. "Private and Social Returns to R&D: Drug Development and Demographics." AEA Papers and Proceedings 111 (May 2021): 336–340.
      • Article

      A Feasibility Study Using Time-driven Activity-based Costing as a Management Tool for Provider Cost Estimation: Lessons from the National TB Control Program in Zimbabwe in 2018

      By: J. Chirenda, B. Nhlema Simwaka, C. Sandy, K. Bodnar, S. Corbin, P. Desai, T. Mapako, S. Shamu, C. Timire, E. Antonio, A. Makone, A. Birikorang, T. Mapuranga, M. Ngwenya, T. Masunda, M. Dube, E. Wandwalo, L. Morrison and R. S. Kaplan
      Background: This study used process maps and time-driven activity-based costing to document TB service delivery processes. The analysis identified the resources required to sustain TB services in Zimbabwe, as well as several opportunities for more effective and...  View Details
      Keywords: Time-Driven Activity-Based Costing; Provider Cost; Health Care and Treatment; Cost Management; Activity Based Costing and Management; Zimbabwe
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      Chirenda, J., B. Nhlema Simwaka, C. Sandy, K. Bodnar, S. Corbin, P. Desai, T. Mapako, S. Shamu, C. Timire, E. Antonio, A. Makone, A. Birikorang, T. Mapuranga, M. Ngwenya, T. Masunda, M. Dube, E. Wandwalo, L. Morrison, and R. S. Kaplan. "A Feasibility Study Using Time-driven Activity-based Costing as a Management Tool for Provider Cost Estimation: Lessons from the National TB Control Program in Zimbabwe in 2018." BMC Health Services Research 21, no. 242 (2021).
      • December 2020 (Revised May 2021)
      • Background Note

      Tales of Life-changing Innovations: Living Drugs | Note on the Development of CAR-T Therapies (through 2019)

      By: Amar Bhidé and Srikant M. Datar
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      Bhidé, Amar, and Srikant M. Datar. "Tales of Life-changing Innovations: Living Drugs | Note on the Development of CAR-T Therapies (through 2019)." Harvard Business School Background Note 321-063, December 2020. (Revised May 2021.)
      • 2021
      • Working Paper

      Development of CAR-T Therapies: Case Histories of Significant Medical Advances

      By: Amar Bhidé and Srikant M. Datar
      In 2017, the US Food and Drug Administration (FDA) approved an immunotherapeutic treatment, called CAR-T therapy, for two kinds of blood cancers—acute leukemia (ALL) and a lymphoma. We describe 1) how CAR-T works; 2) the foundational advances and discoveries; 3)...  View Details
      Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms
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      Bhidé, Amar, and Srikant M. Datar. "Development of CAR-T Therapies: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-035, August 2020. (Revised May 2021.)
      • Article

      Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study

      By: Noy Alon, Ariel Dora Stern and John Torous
      BACKGROUND: As the development of mobile health apps continues to accelerate, the need to implement a framework that can standardize categorizing these apps to allow for efficient, yet robust regulation grows. However, regulators and researchers are faced with numerous...  View Details
      Keywords: Mobile Health; Smartphone; Food And Drug Administration; Risk-based Framework; Health Care and Treatment; Mobile and Wireless Technology; Applications and Software; Framework
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      Alon, Noy, Ariel Dora Stern, and John Torous. "Assessing the Food and Drug Administration's Risk-Based Framework for Software Precertification with Top Health Apps in the United States: Quality Improvement Study." JMIR mHealth and uHealth 8, no. 10 (October 2020).
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