Filter Results
:
(109)
Show Results For
-
All HBS Web
(519)
- Faculty Publications (109)
Show Results For
-
All HBS Web
(519)
- Faculty Publications (109)
Page 1 of
109
Results
→
- 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
- 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
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
- 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
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
- 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
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
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
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
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
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
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
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...
View Details
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
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
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
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
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)...
View Details
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...
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
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).