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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

November 2009 (Revised March 2010)
Case

Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story

By: Richard G. Hamermesh, Raju Kucherlapati and Rachel Gordon

In May 2007, Amgen Inc. (Amgen) received disappointing news from the European Medicines Agency (EMEA) that its drug Vectibix, developed to fight metastatic colorectal cancer, had been rejected. This was especially surprising news given that a similar rival drug had... View Details

Keywords: Entrepreneurship; Governing Rules, Regulations, and Reforms; Health Testing and Trials; Marketing Strategy; Product Positioning; Genetics; Biotechnology Industry; Europe; United States

28 Mar 2023
Research & Ideas

The FDA’s Speedy Drug Approvals Are Safe: A Win-Win for Patients and Pharma Innovation

spent $83 billion on research and development (R&D) in 2019, according to a 2021 report from the nonpartisan Congressional Budget Office (CBO). The median cost to develop one drug was $900 million, with half of that amount going... View Details

Keywords: by Kasandra Brabaw; Pharmaceutical

2018
Chapter

The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century

By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern

On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new... View Details

Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly

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1996
Chapter

The Determinants of Research Productivity in Ethical Drug Discovery

By: Rebecca M. Henderson and Ian Cockburn

Keywords: Ethics; Health Testing and Trials; Research and Development; Performance Productivity; Pharmaceutical Industry

January 2020
Case

Celata Bioinnovations

By: John R. Wells and Benjamin Weinstock

In December 2019, Jon Hu (HBS ‘19) and Dr. Samantha Dale Strasser, co-founders of Celata Bioinnovations, were raising $1 million to launch their company. They had founded Celata less than six months earlier with the aim of redefining the drug discovery process.... View Details

2022
Working Paper

Causal Inference During A Pandemic: Evidence on the Effectiveness of Nebulized Ibuprofen as an Unproven Treatment for COVID-19 in Argentina

By: Sebastian Calonico, Rafael Di Tella and Juan Cruz Lopez Del Valle

Many medical decisions during the pandemic were made without the support of causal evidence obtained in clinical trials. We study the case of nebulized ibuprofen (NaIHS), a drug that was extensively used on COVID-19 patients in Argentina amidst wild claims about its... View Details

Keywords: COVID-19; Drug Treatment; Health Pandemics; Health Care and Treatment; Decision Making; Outcome or Result; Argentina

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March 2015 (Revised February 2022)
Supplement

CV Ingenuity (B): Epilogue

By: Regina E. Herzlinger and Andrew Otazo

Duke Rohlen used a lea-nfunding, iconoclastic strategy for his start up for a drug eluding balloon for peripheral artery disease. His giant competitors were first movers. Did Duke obtain the funding he sought? How did his DEB fare versus that of his competitors? The... View Details

March 2015 (Revised January 2024)
Case

CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies

By: Regina E. Herzlinger and Andrew Otazo

Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire... View Details

Article

Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study

By: Maryaline Catillon

Keywords: Biomedical Research; R＆D; Innovation; Technology; Drug Trials; RCT; Health; Healthcare; Health Care And Treatment; Health Care Policy; Innovation and Invention; Innovation Strategy; Research and Development; Technological Innovation; Health Industry; Pharmaceutical Industry

July 2021
Article

Making Medications Stick: Improving Medication Adherence by Highlighting the Personal Health Costs of Non-compliance

By: Jon M. Jachimowicz, Joe J. Gladstone, Dan Berry, Charlotte L. Kirkdale, Tracey Thornley and Adam D. Galinsky

Poor compliance of prescription medication is an ongoing public health crisis. Nearly half of patients do not take their medication as prescribed, harming their own health while also increasing public health care costs. Despite these detrimental consequences, prior... View Details

Keywords: Prescription Drugs; Medication Adherence; Personal Health Costs; Health; Behavior; Motivation and Incentives; Communication Strategy

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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

October 2002
Case

A Father's Love: Novazyme Pharmaceuticals, Inc.

By: Richard M.J. Bohmer and Bradley Campbell

John Crowley, CEO of Novazyme Pharmaceuticals, a start-up biotechnology firm developing an orphan drug to treat a rare lysosomal storage disorder from which his children suffer, must choose between a partnership and a buyout to have sufficient funds and support to get... View Details

Keywords: Technological Innovation; Business Startups; Partners and Partnerships; Financing and Loans; Governing Rules, Regulations, and Reforms; Sales; Price; Product Development; Motivation and Incentives; Decision Choices and Conditions; Biotechnology Industry; Pharmaceutical Industry

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

February 2019 (Revised September 2019)
Case

Theranos: The Unicorn That Wasn't

By: Joseph B. Fuller and John Masko

In 2003, 19-year-old Elizabeth Holmes founded a startup dedicated to making blood testing easier and more affordable. By 2015, her company, Theranos, was worth $9 billion. It boasted a star-studded board and contracts with national pharmacy and supermarket chains... View Details

Keywords: Theranos; Blood; Lab Testing; Fraud; Holmes; Balwani; Shultz; Carreyrou; Securities And Exchange Commission; Food And Drug Administration; FDA; SEC; Health Testing and Trials; Corporate Accountability; Organizational Culture; Misleading and Fraudulent Advertising; Crime and Corruption; Entrepreneurship; Medical Devices and Supplies Industry

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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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
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

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

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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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