Publications

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October 2013
Case

FasterCures: Removing Barriers to Treatments

By: Richard G. Hamermesh and James Weber

In mid-2013, as FasterCures celebrated its 10th anniversary as a center of the Milken Institute, Executive Director Margaret Anderson thought about what the organization should do to ensure it had even more impact in its next 10 years. FasterCures was a non-profit... View Details

September 2020
Case

Minerva 2010: Turbulent Times

By: John R. Wells and Benjamin Weinstock

In 2010, amid a flurry of new discoveries, Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), raised $6.6 million to test her new cancer drugs in mice. It had been more than 6 years since she had announced that she and her small team at... View Details

Keywords: Biotechnology; Research; Product Development; Commercialization; Strategy

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

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

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April 2009 (Revised May 2010)
Case

Partners In Health: HIV Care in Rwanda

By: Michael E. Porter, Scott S. Lee, Joseph Rhatigan and Jim Yong Kim

In 2005, Partners in Health (PIH) was invited by the Rwandan Ministry of Health to assume responsibility for the management of public health care in two rural districts in Eastern Rwanda and create an HIV treatment program at these sites. PIH successfully implemented a... View Details

Keywords: Developing Countries and Economies; Health Care and Treatment; Health Testing and Trials; Medical Specialties; Service Delivery; Nonprofit Organizations; Expansion; Health Industry; Rwanda

04 Sep 2018
First Look

New Research and Ideas, September 4, 2018

individuals have the choice to enact a variety of communication styles. We test the differential impact of being “warm and friendly” versus “tough and firm” in a distributive negotiation, when first offers are held constant and concession... View Details

Keywords: Dina Gerdeman

Research Summary

Health-care Applications

Active postmarketing drug surveillance. There is substantial interest within the U.S. health community and among health policymakers in developing a surveillance system that scans public health databases in order to proactively detect potential drug safety... View Details

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... View Details

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

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

Keywords: Health Testing and Trials; Governing Rules, Regulations, and Reforms; Valuation; Product Development; Pharmaceutical Industry

18 Aug 2011
Lessons from the Classroom

Business Plan Contest: 15 Years of Building Better Entrepreneurs

in 2001 with Alec Machiels (MBA '01) at the helm, its plan hinged on a mechanism created by a team of Harvard and MIT scientists that used atomic force microscopy in drug research. "A number of the scientists decided that being part of a... View Details

Keywords: by Julia Hanna; Education

Article

A Feasibility Study Using Time-driven Activity-based Costing as a Management Tool for Provider Cost Estimation: Lessons from the National TB Control Program in Zimbabwe in 2018

By: J. Chirenda, B. Nhlema Simwaka, C. Sandy, K. Bodnar, S. Corbin, P. Desai, T. Mapako, S. Shamu, C. Timire, E. Antonio, A. Makone, A. Birikorang, T. Mapuranga, M. Ngwenya, T. Masunda, M. Dube, E. Wandwalo, L. Morrison and R. S. Kaplan

Background: This study used process maps and time-driven activity-based costing to document TB service delivery processes. The analysis identified the resources required to sustain TB services in Zimbabwe, as well as several opportunities for more effective and... View Details

Keywords: Time-Driven Activity-Based Costing; Provider Cost; Health Care and Treatment; Cost Management; Activity Based Costing and Management; Zimbabwe

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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... View Details

Keywords: Business Strategy; Health Testing and Trials; Product Development; Governing Rules, Regulations, and Reforms; Pharmaceutical Industry

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,... View Details

Keywords: Health Testing and Trials; Health Care and Treatment; Business Model; Problems and Challenges; Pharmaceutical Industry; Switzerland

August 2005 (Revised December 2006)
Case

Procter & Gamble: Electronic Data Capture and Clinical Trial Management

By: Robert S. Huckman and Mark J. Cotteleer

Considers whether the management of Procter & Gamble (P&G) Pharmaceuticals should adopt Web-based electronic data capture (EDC) as the default standard for the management of its clinical drug trials. Provides a detailed description of the existing paper-based process... View Details

Keywords: Health Testing and Trials; Internet and the Web; Information Technology; Adoption; Business Processes; Industry Structures; Technological Innovation; Service Operations; Pharmaceutical Industry; United States

15 Jan 2019
First Look

New Research and Ideas, January 15, 2019

December 19, 2018 NEJM Catalyst It's Time to Reform the Orphan Drug Act By: Bagley, Nicholas, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern Abstract—No abstract available. Publisher's link:... View Details

Keywords: Dina Gerdeman

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

September–October 2020
Article

The Past, Present, and (Near) Future of Gene Therapy and Gene Editing

By: Julia Pian, Amitabh Chandra and Ariel Dora Stern

Emerging gene therapy and gene-editing technologies will have a growing impact on patient lives and health-care delivery. We analyzed a decade of data on clinical trials and venture capital investments to understand the likely trajectory of genetically focused... View Details

Keywords: Gene Therapy; Gene Editing; Impact; Health Care and Treatment; Technological Innovation; Health Testing and Trials; Venture Capital; Change

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November 2007
Case

Antegren: A Beacon of Hope

By: Joshua D. Margolis, Thomas J. DeLong and Terence Heymann

The CEO of Biogen Idec faces a set of difficult decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series focuses on operational decisions triggered by the drive for early approval. Sparks discussion... View Details

Keywords: Demand and Consumers; Leadership; Ethics; Corporate Social Responsibility and Impact; Decision Choices and Conditions; Crisis Management; Health Testing and Trials; Biotechnology Industry; Pharmaceutical Industry