Publications

April 2003 (Revised October 2004)
Case

Novartis: The Challenge of Success (A)

By: Sandra J. Sucher and Stacy McManus

Preliminary results from Phase 1 clinical trials of a newly developed compound, STI571, showed that 31 out of 31 patients with chronic myelogenous leukemia (CML) had their blood counts return to normal. In the world of oncology, this was unheard of. This was the... View Details

Keywords: Decision Making; Health Testing and Trials; Innovation and Invention; Markets; Distribution; Product Development; Production; Problems and Challenges; Research; Research and Development; Complexity; Biotechnology Industry; Pharmaceutical Industry

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... View Details

Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry

April 2017
Supplement

Imprimis (D)

By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel

This case is a supplement to Imprimis (A, B, & C). It describes Imprimis’s 2015 decision to develop a $1 per pill compounded alternative to Daraprim, the branded drug that had recently undergone an extreme price hike, raising its price to $750 per pill. Imprimis also... View Details

Keywords: Decision Choices and Conditions; Growth and Development Strategy; Pharmaceutical Industry; United States

January 2018
Supplement

BeiGene Supplemental PowerPoint

By: Willy C. Shih and Jimmy Zhang

BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window... View Details

Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; Biotechnology Industry; China

18 Dec 2018
First Look

New Research and Ideas, December 18, 2018

R&D-intensive firms react to negative shocks to their existing products? We explore this question using detailed project-level data from drug development firms. Using FDA Public Health Advisories as an... View Details

Keywords: Dina Gerdeman

March 2008 (Revised June 2008)
Case

Sirtris Pharmaceuticals: Living Healthier, Longer

Describes a set of key strategic decisions facing the scientific founder and CEO of a promising, early stage bio-pharmaceuticals company. Should the company establish a proposed alliance with a pharmaceutical firm? Should it create a nutraceuticals business in parallel... View Details

Keywords: Business Startups; Decision Choices and Conditions; Entrepreneurship; Growth and Development Strategy; Risk Management; Brands and Branding; Pharmaceutical Industry

23 Jun 2015
Video

Innovations Wanted: Beating Brain Disease

September 1993
Case

Manufacturing at ALZA: The Right Prescription? (A)

By: Dorothy A. Leonard

ALZA, a company specializing in drug delivery systems such as transdermal patches, considers manufacturing its own products. Until now, the company has conducted research and development on its patented system but has then licensed the technology to client-partner... View Details

Keywords: Business or Company Management; Technological Innovation; Innovation and Management; Growth and Development Strategy; Problems and Challenges; Production; Research and Development; Organizational Change and Adaptation; Pharmaceutical Industry; Medical Devices and Supplies Industry

Find at Harvard

14 Jul 2023
Video

BiGS Idea: Rethinking Health Equity

November 2017
Case

BeiGene

By: Willy Shih and Jimmy Zhang

BeiGene was a biopharmaceutical company founded on exploiting a temporal regulatory policy discontinuity. Because of regulatory challenges in China, most innovative new drugs launched there four to six years after their initial U.S. launches. This gave BeiGene a window... View Details

Keywords: Biotechnology; Pharmaceutical Company; Pharmaceuticals; China; Regulatory Environment; Business Strategy; Business Startups; Innovation Strategy; Situation or Environment; Pharmaceutical Industry; China

September 2017
Case

Dr. William Carson— Intrapreneurial Innovation in the Pharmaceutical Industry

By: Steven Rogers and Alyssa Haywoode

Dr. William Carson, an African-American alum of Harvard University became the President and CEO of a multi billion dollar division of Otsuka, a Japan based pharmaceutical company. His ascension to this leadership position followed a thriving career in academic medicine... View Details

Keywords: Dr. Williams Carson; Otsuka America Pharmaceutical; Harvard; Abilify; Aripiprazole; Health Testing and Trials; Globalized Firms and Management; Globalized Markets and Industries; Cross-Cultural and Cross-Border Issues; Decision Choices and Conditions; Pharmaceutical Industry; Japan

12 Nov 2019
Video

Kiran Mazumdar Shaw

Kiran Mazumdar-Shaw, Chairperson and Managing Director of Biocon, India’s largest biopharmaceutical company, explains how her firm developed over four years a new technology for making insulin, an essential... View Details

October 2012
Case

Sirtris Pharmaceuticals: Living Healthier, Longer (Abridged)

By: Toby Stuart and James Weber

Describes a set of key strategic decisions facing the scientific founder and CEO of a promising, early stage bio-pharmaceuticals company. Should the company establish a proposed alliance with a pharmaceutical firm? Should it create a nutraceuticals business in parallel... View Details

Keywords: Business Startups; Decision Choices and Conditions; Entrepreneurship; Growth and Development Strategy; Risk Management; Brands and Branding; Pharmaceutical Industry

Profile

Avi Kremer

millions of dollars into research, and removed critical barriers to the development of treatments. “Our focus was to get drug companies to invest money in ALS,” says Kremer, who was diagnosed in 2004, just... View Details

Keywords: Health Care; Entrepreneurship

2024
Working Paper

Chimeric Antigen Receptor T-Cell Therapy—Living Drugs: Case Histories of Transformational 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) the... View Details

Keywords: Immunotherapy; Health Care and Treatment; Innovation and Invention; Research and Development; Governing Rules, Regulations, and Reforms

SSRN

Read Now

10 Aug 2015
Research & Ideas

New Medical Devices Get To Patients Too Slowly

While the US Food and Drug Administration has chiseled away pharmaceutical review times over the years to speed innovative drugs to market, the opposite seems to have occurred in the agency's approval of... View Details

Keywords: by Michael Blanding; Health; Technology

2024
Working Paper

Prozac—Controversial Blockbuster: Case Histories of Transformational Advances

By: Amar Bhidé, Srikant M. Datar and Katherine Stebbins

This case history describes the development of Prozac, a blockbuster drug that transformed the treatment of depression – and became a cultural phenomenon in the United States. Specifically, we chronicle the: 1) prior treatments for depression and the research that... View Details

Keywords: Health Care and Treatment; Technological Innovation; Innovation Strategy; Technology Adoption; Collaborative Innovation and Invention; Innovation and Invention; Governing Rules, Regulations, and Reforms