Clinical Trials - Publications - Faculty & Research - Harvard Business School

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November 1994 (Revised December 1995)
Case

Scripps Research Institute, The: November 1993 (Abridged)

By: Josh Lerner

In November 1993, Dr. Richard Lerner, president of the Scripps Research Institute, faces the challenge of maintaining his organization's financial and scientific vitality. A proposed cooperative venture with Sandoz has attracted considerable criticism. Meanwhile, a new... View Details

Keywords: Joint Ventures; Financing and Loans; Policy; Management; Organizational Change and Adaptation; Problems and Challenges; Research; Nonprofit Organizations

27 Oct 2008
News

Disruption, One Step at a Time

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

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

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Incentives for Bad Science

Randomized controlled trials (RCTs) inform medical practice, health care delivery, follow-on research, regulation, and health policy. Yet, many RCTs are inadequately randomized, blinded, and reported. To analyze scientists' and firms' incentives to meet clinical trial... View Details

July 2011 (Revised September 2012)
Case

Intraoperative Radiotherapy for Breast Cancer (A)

"This trial is going to take longer." Those were words that Michael Kaschke, CEO of Carl Zeiss AG, was not surprised to hear as he nurtured the intraoperative radiotherapy business inside his company's microsurgery unit. But he also didn't expect it to take 13 years to... View Details

Keywords: Finance; Business History; Disruptive Innovation; Emerging Markets; Organizational Change and Adaptation; Research and Development; Safety

Trends and Predictors of Biomedical Research Quality, 1990-2015

This work leverages the strengths of expert human assessments of randomized controlled trials (RCTs) included in Cochrane reviews with data science techniques to build a comprehensive database on biomedical research quality. The data links the full-text and... View Details

26 Apr 2019
HBS Seminar

Maryaline Catillon, Harvard University

December 2016 (Revised January 2017)
Case

Nutrition Science Initiative: Are All Calories Created Equal?

By: Kevin Schulman and Matan Dabora

In 2012, Gary Taubes lunched the Nutrition Science Initiative (NuSI), a not-for-profit organization aiming to question the mainstream scientific paradigm regarding obesity and dietary recommendations. This case provides a brief scientific background on obesity and its... View Details

Keywords: Nonprofit Organizations; Nutrition

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

04 Jun 2019
News

Finding The Sweet Spot: Why Industry, Nonprofits Should (Or Can) Collaborate On Master Protocols

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

March 2018
Teaching Note

Twine Health

By: Robert S. Huckman and Ariel D. Stern

In late 2014, Dr. John Moore (CEO), Frank Moss (chairman), and Scott Gilroy (CTO) of Twine Health (Twine) had to resolve several challenges that threatened to restrict the widespread dissemination of its sole product, Twine. Twine was a cloud-based platform that... View Details

Keywords: Health Care; Chronic Disease; Digital Health; Health Acceleration Challenge; Strategy; Disease Management; Health; Health Care and Treatment; Information Technology; Mobile and Wireless Technology; Technology Adoption; Health Industry; United States; Massachusetts

March 2015
Case

Twine Health

By: Robert S. Huckman, Ariel D. Stern and Matthew G. Preble

In late 2014, Dr. John Moore (CEO), Frank Moss (chairman), and Scott Gilroy (CTO) of Twine Health (Twine) had to resolve several challenges that threatened to restrict the widespread dissemination of its sole product, Twine. Twine was a cloud-based platform that... View Details

Keywords: Health Care; Chronic Disease; Technology Adoption; Digital Health; Health Acceleration Challenge; Strategy; Disease Management; Health; Health Care and Treatment; Information Technology; Mobile and Wireless Technology; Health Industry; United States; Massachusetts

June 2021
Article

From Predictions to Prescriptions: A Data-driven Response to COVID-19

By: Dimitris Bertsimas, Léonard Boussioux, Ryan Cory-Wright, Arthur Delarue, Vassilis Digalakis Jr, Alexander Jacquillat, Driss Lahlou Kitane, Galit Lukin, Michael Lingzhi Li, Luca Mingardi, Omid Nohadani, Agni Orfanoudaki, Theodore Papalexopoulos, Ivan Paskov, Jean Pauphilet, Omar Skali Lami, Bartolomeo Stellato, Hamza Tazi Bouardi, Kimberly Villalobos Carballo, Holly Wiberg and Cynthia Zeng

The COVID-19 pandemic has created unprecedented challenges worldwide. Strained healthcare providers make difficult decisions on patient triage, treatment and care management on a daily basis. Policy makers have imposed social distancing measures to slow the disease, at... View Details

Keywords: COVID-19; Health Pandemics; AI and Machine Learning; Forecasting and Prediction; Analytics and Data Science

February 15, 2022
Article

How Managers Can Build a Culture of Experimentation

By: Frank V. Cespedes and Neil Hoyne

Testing in business presents qualitatively different challenges than those in clinical trials and most scientific research. There are very few opportunities for randomized control experiments in a changing, competitive market. Yet, change and competition make testing a... View Details

Keywords: Experimentation; Management; Decision Making

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April 2017
Case

Luminopia: Improving Treatment for Visual Disorders

By: Doug J. Chung and Sarah Mehta

Luminopia—a start-up founded in January 2016 by three Harvard College freshmen—uses virtual reality technology to treat amblyopia (more commonly called “lazy eye”), the single biggest cause of visual disorders among children. By February 2017, the three founders had... View Details

Keywords: Pricing; Virtual Reality; Startup; Marketing; Marketing Channels; Product Marketing; Product Launch; Product Positioning; Business Startups; Price; Medical Devices and Supplies Industry; Cambridge; Massachusetts; United States

November 1991 (Revised April 1994)
Case

Nucleon, Inc.

By: Gary P. Pisano

Nucleon is a small biotechnology company whose first potential product is about to enter clinical testing. Before Nucleon can begin clinical trials, however, its management must decide how and where to manufacture the product. Three options are being contemplated: 1)... View Details

Keywords: Factories, Labs, and Plants; Entrepreneurship; Health Testing and Trials; Rights; Product Development; Production; Partners and Partnerships; Research and Development; Biotechnology Industry

Article

Ushering in Safe, Effective, Secure, and Ethical Medicine in the Digital Era

By: William J. Gordon, Andrea Coravos and Ariel Dora Stern

From clinical trials to care delivery, advanced, digitally enabled technologies and analytics offer new approaches to how we think about medicine, health, and biology. The COVID-19 pandemic has accelerated this conversation, and forced a roadmap, once measured in years... View Details

Keywords: Digital Medicine; Health Care and Treatment; Technological Innovation; Safety; Ethics

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

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