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- 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;
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.
- January 2024
- Supplement
Accounting Red Flags or Red Herrings at Catalent? (B)
By: Joseph Pacelli, ZeSean Ali and Tom Quinn
GlassHouse Research identified accounting red flags at Catalent. Fiat Lux Partners countered most of GlassHouse’s claims. Who was right? This update explores the aftermath of the short seller duel.
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Keywords:
Accounting Audits;
Acquisition;
Budgets and Budgeting;
Business Earnings;
Earnings Management;
Cost Accounting;
Fair Value Accounting;
Financial Reporting;
Revenue Recognition;
Integrated Corporate Reporting;
Fairness;
Moral Sensibility;
Values and Beliefs;
Government Legislation;
Conflict of Interests;
Announcements;
Blogs;
Debates;
Lawsuits and Litigation;
Stocks;
Performance Productivity;
Pharmaceutical Industry;
Pharmaceutical Industry;
United States
Pacelli, Joseph, ZeSean Ali, and Tom Quinn. "Accounting Red Flags or Red Herrings at Catalent? (B)." Harvard Business School Supplement 124-055, January 2024.
- November 2023 (Revised April 2024)
- Case
BiomX: Bringing Phage Back to the Stage
By: Paul A. Gompers, Elie Ofek, Orna Dan and Emilie Billaud
In the spring of 2023, and following the favorable results of a trial involving its phage cocktail for treating lung infections among cystic fibrosis (CF) patients, the leadership of BiomX had several critical issues to wrestle with. First, given its precarious...
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Keywords:
Working Capital;
Financing and Loans;
Health Testing and Trials;
Product Development;
Research and Development;
Science-Based Business;
Commercialization;
Pharmaceutical Industry;
Pharmaceutical Industry
Gompers, Paul A., Elie Ofek, Orna Dan, and Emilie Billaud. "BiomX: Bringing Phage Back to the Stage." Harvard Business School Case 524-051, November 2023. (Revised April 2024.)
- October 2023 (Revised April 2024)
- Case
Accounting Red Flags or Red Herrings at Catalent? (A)
By: Joseph Pacelli, ZeSean Ali and Tom Quinn
Fund manager Janet Curie asked for a recommendation about the pharmaceutical company Catalent. The company seemed like a solid investment. However, a pair of research reports issued over the previous two months complicated this narrative. GlassHouse Research, a short...
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Keywords:
Accounting Audits;
Budgets and Budgeting;
Business Earnings;
Earnings Management;
Cost Accounting;
Fair Value Accounting;
Financial Reporting;
Revenue Recognition;
Integrated Corporate Reporting;
Fairness;
Moral Sensibility;
Values and Beliefs;
Government Legislation;
Conflict of Interests;
Forms of Communication;
Announcements;
Blogs;
Debates;
Pharmaceutical Industry;
Pharmaceutical Industry;
United States
Pacelli, Joseph, ZeSean Ali, and Tom Quinn. "Accounting Red Flags or Red Herrings at Catalent? (A)." Harvard Business School Case 124-024, October 2023. (Revised April 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.)
- April 2023
- Case
Elliott Management: Capital Allocation in Biopharma
By: Amitabh Chandra, Paul Clancy and Lauren Gunasti
The case explores the intersection of capital allocation and shareholder activism in the biopharmaceutical industry. As many biopharma companies face looming patent expirations for key medicines, the case asks the question of whether investing in R&D and M&A is an...
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Keywords:
Finance;
Strategy;
Capital Allocation;
Biopharmaceutical Industry;
Shareholder Activism;
Investment Activism;
Resource Allocation;
Research and Development;
Business and Shareholder Relations;
Corporate Strategy;
Pharmaceutical Industry
Chandra, Amitabh, Paul Clancy, and Lauren Gunasti. "Elliott Management: Capital Allocation in Biopharma." Harvard Business School Case 623-045, April 2023.
- March 2023
- Case
Moderna
By: Marco Iansiti, Karim R. Lakhani, Hannah Mayer, Kerry Herman, Allison J. Wigen and Dave Habeeb
This multimedia case follows the story of Moderna and its entry into vaccine development in the wake of the COVID-19 pandemic. In summer 2020, Stephane Bancel, CEO of biotech firm Moderna, faces several challenges as his company races to develop a vaccine for COVID-19....
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- 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.
- December 2022
- Article
The Contribution of Price Growth to Pharmaceutical Revenue Growth in the United States: Evidence from Medicines Sold in Retail Pharmacies
By: Pragya Kakani, Michael Chernew and Amitabh Chandra
Context: To what extent does pharmaceutical revenue growth depend on new medicines versus increasing prices for existing medicines? Moreover, does using list prices, as is commonly done, instead of prices net of confidential rebates offered by manufacturers, which are...
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Kakani, Pragya, Michael Chernew, and Amitabh Chandra. "The Contribution of Price Growth to Pharmaceutical Revenue Growth in the United States: Evidence from Medicines Sold in Retail Pharmacies." Journal of Health Politics, Policy and Law 47, no. 6 (December 2022): 629–648.
- 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.
- 2023
- Working Paper
Scoring and Funding Breakthrough Ideas: Evidence from a Global Pharmaceutical Company
By: Joshua Krieger, Ramana Nanda, Ian Hunt, Aimee Reynolds and Peter Tarsa
We study resource allocation to early-stage ideas at an internal startup program of
one the largest pharmaceutical firms in the world. Our research design enables us to
elicit every evaluator’s scores across five different attributes, before seeing how they
would...
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Keywords:
Project Selection;
Pharmaceuticals;
Financing Innovation;
Resource Allocation;
Innovation and Invention;
Research and Development
Krieger, Joshua, Ramana Nanda, Ian Hunt, Aimee Reynolds, and Peter Tarsa. "Scoring and Funding Breakthrough Ideas: Evidence from a Global Pharmaceutical Company." Harvard Business School Working Paper, No. 23-014, August 2022. (Revised November 2023.)
- 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.
- Summer 2021
- Article
The Cost and Evolution of Quality at Cipla Ltd, 1935–2016
By: Muhammad H. Zaman and Tarun Khanna
This article examines the evolution of Indian pharmaceutical manufacturer Cipla towards producing drugs that met the quality standards of European and U.S. regulators. It employs new research in Cipla’s corporate archives, the Creating Emerging Markets database, and...
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Keywords:
Cipla;
Pharmaceuticals;
Drug Quality;
Generics;
Quality;
Standards;
Information Technology;
Cost;
Organizational Culture;
Business History;
Pharmaceutical Industry;
India
Zaman, Muhammad H., and Tarun Khanna. "The Cost and Evolution of Quality at Cipla Ltd, 1935–2016." Business History Review 95, no. 2 (Summer 2021): 249–274.
- 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.