Publications

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

Educators

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

14 Nov 2017
First Look

New Research and Ideas: November 14, 2017

authors provide numerous examples of health care organizations that are taking these steps—and seeing impressive results. Publisher's link: https://www.hbs.edu/faculty/Pages/item.aspx?num=53460 forthcoming JAMA Cardiology The Central and Unacknowledged Role of the U.S.... View Details

Keywords: Carmen Nobel

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

Educators

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

Find at Harvard

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

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

Research Summary

Clinical Trials as a setting for Health Policy and Management Research

The clinical trial marketplace is in flux. A decade ago, pharmaceutical firms almost exclusively conducted the study of their novel drug compounds within major academic medical centers. But today, industry-sponsored clinical trials are increasingly using community... View Details

January 2020
Article

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System

By: Peter P. Monteleone, Subhash Banerjee, Priya Kothapalli, Ariel Dora Stern, Daniel Fehder, Ron Ginor, Dominic Vollmar, Edward T. A. Fry and Mark J. Pirwitz

Background. A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has... View Details

Keywords: Medical Devices; Health Testing and Trials; Analysis; Sales

September 2020
Case

Minerva 2020: Clinical Trials

By: John R. Wells and Benjamin Weinstock

In March 2020, Dr. Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Inc. (Minerva), was reviewing the first results of human clinical trials for the company’s novel CAR-T drug therapeutic, one of the first ever to target solid cancer tumors. The results... View Details

Keywords: Biotechnology; Strategic Decision Making; Entrepreneurship; Health Testing and Trials; Decision Choices and Conditions; Strategy

Educators

01 Dec 2023
News

Wide Horizon

IP rights for suramin, a century-old drug historically used to treat African sleeping sickness, a parasitic disease, and later tested as a treatment for metastatic cancer. N of One had supported a trial by... View Details

Keywords: Dan Morrell; Photos by Sarah Wilson

21 Feb 2018
Research & Ideas

When a Competitor Abandons the Market, Should You Advance or Retreat?

test results, changing market conditions, deteriorating financials of the host company, or escalating project costs. Krieger chose to focus on drug development, in part, because in the United States... View Details

Keywords: by Rachel Layne; Pharmaceutical; Health

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

Find at Harvard

02 Mar 2007
What Do You Think?

What Is the Government’s Role in US Health Care?

avoidance on the part of physicians, a litigious society, and inadequate protection from it for physicians (Rowland Freeman), "defensive" medicine leading to unnecessary tests and treatments, an insurance system that is costly and... View Details

Keywords: by Jim Heskett; Health

16 Dec 2014
First Look

First Look: December 16

share the same ethnic, educational, or career background are more likely to syndicate with each other. This homophily reduces the probability of investment success, and the detrimental effect is most prominent for early-stage investments. A variety of View Details

Keywords: Sean Silverthorne

Article

Use of Connected Digital Products in Clinical Research Following the COVID-19 Pandemic: A Comprehensive Analysis of Clinical Trials

By: Caroline Marra, William J. Gordon and Ariel Dora Stern

Objectives: In an effort to mitigate COVID-19 related challenges for clinical research, the U.S. Food and Drug Administration (FDA) issued new guidance for the conduct of ‘virtual’ clinical trials in late March 2020. This study documents trends in the use of... View Details

Keywords: Connected Digital Products; Telehealth; Remote Monitoring; Health Testing and Trials; Research; Governing Rules, Regulations, and Reforms; Information Technology