Publications

January–February 2023
Article

Data-Driven COVID-19 Vaccine Development for Janssen

By: Dimitris Bertsimas, Michael Lingzhi Li, Xinggang Liu, Jennings Xu and Najat Khan

The COVID-19 pandemic has spurred extensive vaccine research worldwide. One crucial part of vaccine development is the phase III clinical trial that assesses the vaccine for safety and efficacy in the prevention of COVID-19. In this work, we enumerate the first... View Details

Keywords: COVID-19; Health Testing and Trials; Forecasting and Prediction; AI and Machine Learning; Research; Pharmaceutical Industry

Forthcoming
Article

Regulatory Incentives for Innovation: The FDA's Breakthrough Therapy Designation

By: Amitabh Chandra, Jennifer Kao, Kathleen L. Miller and Ariel Dora Stern

Regulators of new products confront a tradeoff between speeding a product to market and collecting additional product quality information. The FDA's Breakthrough Therapy Designation (BTD) provides an opportunity to understand if regulators can use new policy to... View Details

Keywords: Innovation and Invention; Governing Rules, Regulations, and Reforms; Government Administration; Research and Development; Pharmaceutical Industry

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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

Keywords: Cost-sharing; Impact; Health Care and Treatment; Insurance; Health; Consumer Behavior

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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

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

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

Keywords: by Michael Blanding; Health; Technology

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

Keywords: Research and Development; Governing Rules, Regulations, and Reforms; Product Development

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

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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

SSRN

September 1991 (Revised August 1994)
Background Note

Note on Pharmaceutical Industry Regulation

By: Willis M. Emmons III

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

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

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

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

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

Keywords: by Danielle Kost; Pharmaceutical; Health

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

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