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- All HBS Web
(168)
- News (56)
- Research (97)
- Events (1)
- Multimedia (1)
- Faculty Publications (61)
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- 2021
- Working Paper
The Health Costs of Cost-Sharing
By: Amitabh Chandra, Evan Flack and Ziad Obermeyer
We use the design of Medicare’s prescription drug benefit program to demonstrate three facts about the health consequences of cost-sharing. First, we show that an as-if-random increase of 33.6% in out-of-pocket price (11.0 percentage points (p.p.) change in... View Details
Chandra, Amitabh, Evan Flack, and Ziad Obermeyer. "The Health Costs of Cost-Sharing." NBER Working Paper Series, No. 28439, February 2021.
- February 2000 (Revised October 2000)
- Case
Kendle International Inc.
By: Dwight B. Crane, Paul W. Marshall and Indra Reinbergs
Candace Kendle and Christopher Bergen, the CEO and COO of Kendle International, Inc., are reviewing ways to finance the growth of their privately-owned company. Kendle is a contract research organization that conducts clinical drug trials for pharmaceutical and... View Details
Keywords: Acquisition; Financing and Loans; Venture Capital; Stock Options; Banks and Banking; Debt Securities; International Finance; Financial Strategy; Management Skills; Private Ownership; Initial Public Offering; Biotechnology Industry; Pharmaceutical Industry
Crane, Dwight B., Paul W. Marshall, and Indra Reinbergs. "Kendle International Inc." Harvard Business School Case 200-033, February 2000. (Revised October 2000.)
- September 2020
- Case
Minerva 2004: Discovery
By: John R. Wells and Benjamin Weinstock
After nearly five years in operation, Doctor Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), was reflecting on the company’s next steps. In a few short years, she and her small team had managed to develop a nanoparticle process for... View Details
Keywords: Entrepreneurship; Financing and Loans; Strategy; Decision Choices and Conditions; Biotechnology Industry
Wells, John R., and Benjamin Weinstock. "Minerva 2004: Discovery." Harvard Business School Case 721-389, September 2020.
- 10 Aug 2015
- Research & Ideas
New Medical Devices Get To Patients Too Slowly
companies are just the ones that are more likely to take on the task of bringing a novel high-risk product to market." The big question: why? Device Testing Is Different It's certainly true that clinical trials for medical devices are not... 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.
- 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.
- 2023
- Working Paper
Market Exclusivity and Innovation: Evidence From Antibiotics
By: Edward Kong and Olivia Zhao
The US incentivizes drug innovation via patents as well as market exclusivity periods awarded by the US Food and Drug Administration. We estimate the causal effects of extending market exclusivity for an important drug class: antibiotics. Using a... View Details
Keywords: Health Testing and Trials; Innovation and Invention; Motivation and Incentives; Government Administration; Government Legislation; Pharmaceutical Industry; United States
Kong, Edward, and Olivia Zhao. "Market Exclusivity and Innovation: Evidence From Antibiotics." Working Paper, December 2023.
- September 1991 (Revised August 1994)
- Background Note
Note on Pharmaceutical Industry Regulation
Traces the evolution of U.S. regulatory policy towards the pharmaceutical industry over the course of the twentieth century. A major theme is the steady shift away from a policy of 'let the buyer beware' to the creation of a complex and time-consuming review process,... View Details
Keywords: Safety; Industry Growth; Marketing; Research and Development; Health Testing and Trials; Economics; Pharmaceutical Industry; United States
Emmons, Willis M., III. "Note on Pharmaceutical Industry Regulation." Harvard Business School Background Note 792-002, September 1991. (Revised August 1994.)
- September 2024
- Case
Myeloma Investment Fund
By: Kyle Myers and Scott Sawaya
This case explores a critical decision facing the Myeloma Investment Fund (MIF) as it evaluates two investment opportunities aimed at accelerating a cure for multiple myeloma.
The MIF, a venture philanthropy fund, must choose between two distinct paths. One... View Details
The MIF, a venture philanthropy fund, must choose between two distinct paths. One... View Details
Keywords: Venture Philanthropy; Biomedical Research; Investing For Impact; Innovation ＆ Entrepreneurship; Venture Capital; Science-Based Business; Philanthropy and Charitable Giving; Decision Making; Health Care and Treatment; Biotechnology Industry; Pharmaceutical Industry
Myers, Kyle, and Scott Sawaya. "Myeloma Investment Fund." Harvard Business School Case 625-047, September 2024.
- 2008
- Chapter
Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation
By: Arthur A. Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details
Keywords: Geographic Location; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Demand and Consumers; Pharmaceutical Industry; European Union; Germany; United States
Daemmrich, Arthur A. "Where is the Pharmacy to the World? Pharmaceutical Industry Location and International Regulatory Variation." Chap. 16 in Ways of Regulating: Therapeutic Agents between Plants, Shops, and Consulting Rooms. Vol. 363, edited by Jean Paul Gaudillière and Volker Hess, 271–290. Berlin, Germany: Max-Planck-Institut für Wissenschaftsgeschichte, 2008.
- March 2015 (Revised September 2016)
- Case
Terrapin Laboratory
By: Richard G. Hamermesh and Joseph B. Fuller
Describes the formation and rapid growth of a drug testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug treatment center business. The associated teaching materials provide students the opportunity... View Details
Keywords: Business Growth; Entrepreneurial Management; Entrepreneurship; Growth Strategy; Market Entry; Venture Capital; Growth Management; Expansion; Financing and Loans; Health Care and Treatment; Health Testing and Trials; Business Startups; Pharmaceutical Industry; Health Industry
Hamermesh, Richard G., and Joseph B. Fuller. "Terrapin Laboratory." Harvard Business School Case 315-098, March 2015. (Revised September 2016.)
- 2009
- Working Paper
Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location
By: Arthur Daemmrich
A consumer-oriented model for drug development and use has attracted attention in recent years as an alternative to the much-maligned approach of mass-marketing blockbuster drugs. In a parallel development, patients and disease-based organizations have assumed greater... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Disorders; Health Testing and Trials; Power and Influence; Competitive Strategy; Pharmaceutical Industry; European Union; Germany; United States
Daemmrich, Arthur. "Where Is the Pharmacy to the World? International Regulatory Variation and Pharmaceutical Industry Location." Harvard Business School Working Paper, No. 09-118, April 2009.
- 14 Dec 2020
- Research & Ideas
What Does December's Drug-Approval Dash Mean for COVID-19 Vaccines?
aspects of the drug trial and approval process, including allowing time for potential issues to materialize. When you see an FDA emergency approval for a COVID-19 vaccine, don't interpret this as a normal... View Details
- June 2016
- Teaching Plan
Terrapin Laboratory
By: Joseph B. Fuller and Andrew Otazo
This teaching plan accompanies the case "Terrapin Laboratory," HBS No. 315-098. That case describes the formation and rapid growth of a drug testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug... View Details
- 2010
- Chapter
From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance
By: Arthur A. Daemmrich
Adverse drug reactions pose distinct but potentially catastrophic risks to patients, physicians, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were built to collect, standardize, and respond to individual reports of... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Business and Government Relations; Risk and Uncertainty; Safety; Pharmaceutical Industry; United States
Daemmrich, Arthur A. "From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance." Chap. 13 in The Fragmentation of U.S. Health Care: Causes and Solutions, edited by Einer Elhauge, 301–322. Oxford: Oxford University Press, 2010.
- 01 Dec 2003
- Research & Ideas
Sometimes Success Begins at Failure
In the late 1980s, scientists for New York City-based drug-maker Pfizer began testing what was then known as compound UK-92,480 for the treatment of angina. Although UK-92,480 seemed promising in the lab and in animal tests, the compound showed little benefit in... View Details
- 18 Dec 2018
- First Look
New Research and Ideas, December 18, 2018
firms face little competition, even after the end of formal periods of patent protection and market exclusivity. Additionally, the evolving technologies of drug development—in particular, the increasingly common use of auxiliary endpoints... View Details
Keywords: Dina Gerdeman
- October 2006 (Revised August 2007)
- Case
Calloway Laboratory: Pee for Profit
By: Richard G. Hamermesh and David Kiron
Describes the formation and rapid growth of a drug-testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug treatment center business. View Details
Keywords: For-Profit Firms; Health Care and Treatment; Health Testing and Trials; Growth and Development Strategy; Market Entry and Exit; Health Industry
Hamermesh, Richard G., and David Kiron. "Calloway Laboratory: Pee for Profit." Harvard Business School Case 807-040, October 2006. (Revised August 2007.)
- August 1995 (Revised June 1997)
- Case
Hillcrest Research Associates, Inc.
Hillcrest designs and administers testing procedures for drugs to determine whether they pass FDA specifications. As the company grows, it encounters problems with information technology and with the clinical research associates, who feel pressured to report more... View Details
Keywords: Growth Management; Information Technology; Health Testing and Trials; Pharmaceutical Industry
Barnes, Louis B. "Hillcrest Research Associates, Inc." Harvard Business School Case 496-021, August 1995. (Revised June 1997.)
- 05 Dec 2017
- First Look
First Look at New Research and Ideas, December 5, 2017
the stigma of financial misconduct could reach alumni employees and need not be confined to executives and directors that oversaw the organization during the misconduct. Download working paper: https://www.hbs.edu/faculty/Pages/item.aspx?num=53547 View Details
Keywords: Sean Silverthorne