Publications
Publications
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- All HBS Web
(579)
- Faculty Publications (122)
- January–February 2023
- Article
Data-Driven COVID-19 Vaccine Development for Janssen
By: Dimitris Bertsimas, Michael Lingzhi Li, Xinggang Liu, Jennings Xu and Najat Khan
The COVID-19 pandemic has spurred extensive vaccine research worldwide. One crucial part of vaccine development is the phase III clinical trial that assesses the vaccine for safety and efficacy in the prevention of COVID-19. In this work, we enumerate the first... View Details
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- September 2021
- Article
Trials and Terminations: Learning from Competitors' R&D Failures
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
- 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
- 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
- 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
- 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
- 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
- 2024
- Working Paper
Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational 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) the... 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
- 2024
- Working Paper
Prozac—Controversial Blockbuster: Case Histories of Transformational Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
This case history describes the development of Prozac, a blockbuster drug that transformed
the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we
chronicle the: 1) prior treatments for depression and the research that... View Details
- June 2020
- Case
Breakthroughs at Blueprint Medicines
By: Richard G. Hamermesh, Kathy Giusti and Susie L. Ma
Precision medicine company Blueprint Medicines was building a successful track record for bringing drug therapies to market 40% faster than average. The company had spent $40 million dollars and two years building a compound library that became its drug development... View Details
- May 6, 2020
- Article
We Shouldn't Wait for a Breakthrough in the COVID-19 Pandemic
By: Gary P. Pisano
The ultimate solutions to the COVID-19 crisis may be big breakthroughs in building massive test and trace capacity and developing vaccines and drug remedies. But in the meantime, we should not ignore the potential cumulative impact of the many small things we already... View Details
- November 2019
- Case
The Genesis Lab at Novartis
By: Amy C. Edmondson, Ranjay Gulati, Patrick J. Healy and Kerry Herman
Novartis' Genesis Labs program, launched in 2016 as part of Novartis Institutes for Biomedical Research (NIBR), hosted pitch competitions where teams of NIBR scientists proposed ideas to explore that aimed to revolutionize drug discovery. The goal was to break down... View Details