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All HBS Web
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- Faculty Publications (118)
- 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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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
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...
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Keywords:
Drug Development;
Risk Aversion;
Research and Development;
Innovation and Invention;
Investment;
Pharmaceutical Industry
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
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...
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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...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
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...
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Keywords:
Innovation and Invention;
Strategy;
Business or Company Management;
Society;
Health;
Public Administration Industry;
Health Industry;
United States
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...
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Keywords:
Drug Development;
Research and Development;
Investment Return;
Demographics;
Pharmaceutical Industry
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...
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Keywords:
Time-Driven Activity-Based Costing;
Provider Cost;
Health Care and Treatment;
Cost Management;
Activity Based Costing and Management;
Zimbabwe
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
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)...
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Keywords:
Immunotherapy;
Health Care and Treatment;
Innovation and Invention;
Research and Development;
Governing Rules, Regulations, and Reforms
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...
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Keywords:
Mobile Health;
Smartphone;
Food And Drug Administration;
Risk-based Framework;
Health Care and Treatment;
Mobile and Wireless Technology;
Applications and Software;
Framework
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).
- 2021
- Working Paper
Cephalosporins: Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant Datar and Katherine Stebbins
Our case history describes the development of three generations of cephalosporins—antibiotics that have significantly reduced hospital infections. After providing an overview of antibiotic development and its challenges we describe how: 1) Early (pre-cephalosporin)...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant Datar, and Katherine Stebbins. "Cephalosporins: Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-133, July 2020. (Revised May 2021.)
- 2021
- Working Paper
SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances
By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins
Our 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...
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Keywords:
Health Care and Treatment;
Technological Innovation;
Innovation Strategy;
Technology Adoption;
Collaborative Innovation and Invention;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhidé, Amar, Srikant M. Datar, and Katherine Stebbins. "SSRIs and Non-SSRIs (through 1999): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 20-135, July 2020. (Revised June 2021.)
- 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...
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Keywords:
Precision Medicine;
Cancer;
Biotechnology;
Drug Development;
Strategy;
Expansion;
Science;
Genetics;
Information Technology;
Entrepreneurship;
Organizational Culture;
Management;
Growth and Development;
Pharmaceutical Industry;
United States;
Cambridge;
Massachusetts
Hamermesh, Richard G., Kathy Giusti, and Susie L. Ma. "Breakthroughs at Blueprint Medicines." Harvard Business School Case 820-001, June 2020.
- 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...
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Pisano, Gary P. "We Shouldn't Wait for a Breakthrough in the COVID-19 Pandemic." Harvard Business Review Digital Articles (May 6, 2020).
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.
- 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...
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Keywords:
Drug Discovery;
Health Care and Treatment;
Research and Development;
Innovation and Invention;
Programs;
Management
Edmondson, Amy C., Ranjay Gulati, Patrick J. Healy, and Kerry Herman. "The Genesis Lab at Novartis." Harvard Business School Case 620-007, November 2019.
- 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...
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Rafiq, Sana, and Max Bazerman. "Pay-for-Monopoly? An Assessment of Reverse Payment Deals by Pharmaceutical Companies." Journal of Behavioral Economics for Policy 3, no. 1 (2019): 37–43.
- 2019
- Chapter
Characterizing the Drug Development Pipeline for Precision Medicines
By: Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
BOOK ABSTRACT: Personalized and precision medicine (PPM)—the targeting of therapies according to an individual’s genetic, environmental, or lifestyle characteristics—is becoming an increasingly important approach in health care treatment and prevention. The advancement...
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Chandra, Amitabh, Craig Garthwaite, and Ariel Dora Stern. "Characterizing the Drug Development Pipeline for Precision Medicines." Chap. 5 in Economic Dimensions of Personalized and Precision Medicine, edited by Ernest R. Berndt, Dana P. Goldman, and John W. Rowe, 115–158. University of Chicago Press, 2019.
- November 2018
- Case
David Hysong and SHEPHERD Therapeutics
By: Ananth Raman, John Masko and Aldo Sesia
In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his...
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- 2018
- Chapter
The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century
By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new...
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Keywords:
Health Care and Treatment;
Laws and Statutes;
Research and Development;
Investment;
Markets;
Monopoly
Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.