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- 2024
- Working Paper
Dusting Off the Old Ones: Drug Licensing to Startups, Innovation Success and Efficiency
By: Mosab Hammoudeh, Joshua Lev Krieger and Jiajie Xu
This paper investigates whether moving R&D from incumbents to startups can increase innovation. Using comprehensive drug development data, we examine the outcomes of drug projects licensed from large firms to startups. We find that these projects licensed to startups...
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Keywords:
Product Development;
Innovation and Invention;
Business Startups;
Research and Development;
Performance Efficiency;
Pharmaceutical Industry
Hammoudeh, Mosab, Joshua Lev Krieger, and Jiajie Xu. "Dusting Off the Old Ones: Drug Licensing to Startups, Innovation Success and Efficiency." Harvard Business School Working Paper, No. 24-067, March 2024.
- April 2024 (Revised July 2024)
- Case
Market Dynamics and Moral Dilemmas: Novo Nordisk’s Weight-Loss Drugs
By: Joseph L. Badaracco, Tom Quinn and John Schultz
Danish pharmaceutical company Novo Nordisk was owned by a charitable foundation, and since its founding in the 1920s had focused on producing insulin to treat diabetes. In 2017, however, it released Ozempic, a diabetes treatment with the revolutionary side effect of...
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Keywords:
Cost vs Benefits;
Decisions;
Judgments;
Values and Beliefs;
Global Strategy;
Health Care and Treatment;
Patents;
Growth and Development Strategy;
Growth Management;
Product Positioning;
Supply and Industry;
Supply Chain;
Corporate Social Responsibility and Impact;
Mission and Purpose;
Philanthropy and Charitable Giving;
Opportunities;
Social Issues;
Equality and Inequality;
Pharmaceutical Industry;
Health Industry;
Denmark;
United States;
Europe;
China;
India;
Middle East;
North Africa
Badaracco, Joseph L., Tom Quinn, and John Schultz. "Market Dynamics and Moral Dilemmas: Novo Nordisk’s Weight-Loss Drugs." Harvard Business School Case 324-114, April 2024. (Revised July 2024.)
- March 2024
- Article
Medicare Price Negotiation and Pharmaceutical Innovation Following the Inflation Reduction Act
By: Matthew Vogel, Pragya Kakani, Amitabh Chandra and Rena M. Conti
The Inflation Reduction Act (IRA) requires Medicare to negotiate lower prices for some medicines with high Medicare spending. Using historical data from public and proprietary sources to apply the IRA's negotiation criteria retrospectively, we identify all drugs that...
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Keywords:
Policy;
Government Legislation;
Health Care and Treatment;
Negotiation;
Price;
Pharmaceutical Industry
Vogel, Matthew, Pragya Kakani, Amitabh Chandra, and Rena M. Conti. "Medicare Price Negotiation and Pharmaceutical Innovation Following the Inflation Reduction Act." Nature Biotechnology 42, no. 3 (March 2024): 406–412.
- February 2024
- Case
Compass Pathways: Pioneering Psychedelic Treatment
By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no...
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Keywords:
Commercialization;
Corporate Strategy;
Competitive Strategy;
Product Launch;
Health Testing and Trials;
Research and Development;
Laws and Statutes;
Pharmaceutical Industry;
Europe;
United States;
United Kingdom
Zuzul, Tiona, Kisha Lashley, and Gamze Yucaoglu. "Compass Pathways: Pioneering Psychedelic Treatment." Harvard Business School Case 724-412, February 2024.
- February 2024
- Article
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...
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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." Quarterly Journal of Economics 139, no. 1 (February 2024): 575–635.
- January 2024
- Article
Cost of Exempting Sole Orphan Drugs from Medicare Negotiation
By: Matthew Vogel, Olivia Zhao, William B. Feldman, Amitabh Chandra, Aaron S. Kesselheim and Benjamin N. Rome
Importance: The Inflation Reduction Act (IRA) requires Medicare to negotiate prices for some high-spending drugs but exempts drugs approved solely for the treatment of a single rare disease.
Objective: To estimate Medicare spending and global... View Details
Objective: To estimate Medicare spending and global... View Details
Vogel, Matthew, Olivia Zhao, William B. Feldman, Amitabh Chandra, Aaron S. Kesselheim, and Benjamin N. Rome. "Cost of Exempting Sole Orphan Drugs from Medicare Negotiation." JAMA Internal Medicine 184, no. 1 (January 2024): 63–69.
- October 2023
- Case
Vida Health: Transforming Chronic Disease Treatment
By: William Sahlman and Nicole Tempest Keller
San Francisco based Vida Health, founded by Stephanie Tilenius, former vice president of Commerce and Payments at Google, was a B2B digital health startup focused on the treatment of cardiometabolic conditions, such as diabetes and obesity. Its innovative digital...
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Keywords:
Corporate Strategy;
Growth and Development Strategy;
Demand and Consumers;
Health Care and Treatment;
Product Marketing;
Risk and Uncertainty;
Technological Innovation;
Health Industry;
Technology Industry;
United States;
California;
San Francisco
Sahlman, William, and Nicole Tempest Keller. "Vida Health: Transforming Chronic Disease Treatment." Harvard Business School Case 824-001, October 2023.
- September 2023 (Revised April 2024)
- Case
Atomwise: Strategic Opportunities in AI for Pharma
By: Satish Tadikonda
Abraham Heifets and his co-founder, Izhar Wallach, had founded Atomwise to develop i) an AI engine to transform drug discovery by creating better medicines faster, and ii) a machine learning-based discovery engine that combined the power of convolutional neural...
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Keywords:
Business Model;
Business Startups;
AI and Machine Learning;
Science-Based Business;
Technological Innovation;
Biotechnology Industry;
Pharmaceutical Industry
Tadikonda, Satish. "Atomwise: Strategic Opportunities in AI for Pharma." Harvard Business School Case 824-043, September 2023. (Revised April 2024.)
- August 2023 (Revised May 2024)
- Case
Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations
By: Satish Tadikonda and Amanda McEwen
The success or failure of Dicerna Pharmaceuticals (Dicerna) as an emerging pharmaceutical company would likely hinge on its lead drug candidate Nedosiran and the company’s ability to see it successfully through clinical development. Ralf Rosskamp, Chief Medical...
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Keywords:
Business Strategy;
Health Testing and Trials;
Product Development;
Governing Rules, Regulations, and Reforms;
Pharmaceutical Industry
Tadikonda, Satish, and Amanda McEwen. "Dicerna Pharmaceuticals: Decision Making in Clinical Trial Design and Operations." Harvard Business School Case 824-018, August 2023. (Revised May 2024.)
- June 2023 (Revised July 2024)
- Case
Biogen and the Aduhelm Melee
By: Amitabh Chandra and Lauren Gunasti
Alzheimer's Disease is a devastating condition affecting millions of Americans. At this time, there is no cure. In 2021, Biogen's Aduhelm (aducanumab) received FDA approval under the accelerated approval pathway after a controversial approval process.
This... View Details
This... View Details
Keywords:
Health Testing and Trials;
Governing Rules, Regulations, and Reforms;
Valuation;
Product Development;
Pharmaceutical Industry
Chandra, Amitabh, and Lauren Gunasti. "Biogen and the Aduhelm Melee." Harvard Business School Case 623-046, June 2023. (Revised July 2024.)
- 2023
- Working Paper
Evaluation and Learning in R&D Investment
By: Alexander P. Frankel, Joshua L. Krieger, Danielle Li and Dimitris Papanikolaou
We examine the role of spillover learning in shaping the value of exploratory versus incremental
R&D. Using data from drug development, we show that novel drug candidates generate more
knowledge spillovers than incremental ones. Despite being less likely to reach...
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Frankel, Alexander P., Joshua L. Krieger, Danielle Li, and Dimitris Papanikolaou. "Evaluation and Learning in R&D Investment." Harvard Business School Working Paper, No. 23-074, May 2023. (NBER Working Paper Series, No. 31290, May 2023.)
- May 2023 (Revised June 2023)
- Case
Novartis (A): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Care and Treatment;
Business Model;
Leadership;
Pharmaceutical Industry;
Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (A): Reimagining Medicine." Harvard Business School Case 723-443, May 2023. (Revised June 2023.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (B): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Care and Treatment;
Business Model;
Production;
Business Strategy;
Pharmaceutical Industry
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (B): Reimagining Medicine." Harvard Business School Supplement 723-444, May 2023. (Revised June 2023.)
- May 2023 (Revised June 2023)
- Supplement
Novartis (C): Reimagining Medicine
By: Ramon Casadesus-Masanell, Claudio Feser, Karolin Frankenberger and David Redaschi
This case unfolds around the first-ever approved personalized cancer treatment, how Novartis wrapped it into a new business model design, and how Novartis scaled it. Novartis — one of the largest pharmaceutical companies in the world — is, among other ventures,...
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Keywords:
Health Testing and Trials;
Health Care and Treatment;
Business Model;
Problems and Challenges;
Pharmaceutical Industry;
Switzerland
Casadesus-Masanell, Ramon, Claudio Feser, Karolin Frankenberger, and David Redaschi. "Novartis (C): Reimagining Medicine." Harvard Business School Supplement 723-445, May 2023. (Revised June 2023.)
- January 2023
- Case
Cleave Therapeutics: Taking a Risk on Oncology Drug Discovery
By: Regina Herzlinger and Brian Walker
What should a successful executive (HBS Baker Scholar) assess as her next move as the CEO of a firm with a promising and yet uncertain new drug? Amy Burroughs’ mandate to successfully commercialize Cleave Therapeutics’ drug for a cancer with no current successful...
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Keywords:
Product Development;
Leadership;
Health Testing and Trials;
Research and Development;
Risk and Uncertainty;
Financial Condition;
Partners and Partnerships;
Pharmaceutical Industry
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...
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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, 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...
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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
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.
- 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...
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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.
- 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...
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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.]....
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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 (A)." Harvard Business School Case 822-104, February 2022. (Revised September 2022.)