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November 2009 (Revised August 2010)
Case

NovoCure Ltd.

By: William A. Sahlman and Sarah Flaherty

Venture capitalist William Doyle must raise $35 million for a portfolio company with a promising, novel cancer therapy, just as global capital markets are imploding in the fall of 2008. NovoCure, Ltd., has developed an electrical-field-based therapy, called Tumor... View Details

Keywords: Financial Crisis; Entrepreneurship; Venture Capital; Investment; Health Care and Treatment; Health Testing and Trials; Technological Innovation; Financial Services Industry

March 2025
Case

Niramai: An AI Solution to Save Lives

By: Rembrand Koning, Maria P. Roche and Kairavi Dey

Founded in 2017, Niramai developed Thermalytix, a breast cancer screening tool. Thermalytix used a high-resolution thermal sensing device and machine learning algorithms to analyze thermal images and detect tumors. Its patented solution leveraged big data analytics,... View Details

Keywords: Entrepreneurship; AI and Machine Learning; Technology Adoption; Health Care and Treatment; Technology Industry; Health Industry; Asia; India; South Asia

November 2018
Case

David Hysong and SHEPHERD Therapeutics

By: Ananth Raman, John Masko and Aldo Sesia

In 2016, David Hysong, at age 27, found out he had a rare, incurable cancer. Rather than wait around to die, Hysong, a recent graduate of Harvard Divinity School, decided to launch a biotechnology company called Shepherd Therapeutics to development treatments for his... View Details

Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges

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

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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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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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

January 2006 (Revised July 2006)
Case

Drug Testing in Nigeria (A)

By: Debora L. Spar

In 1996, a meningitis epidemic swept across Nigeria. Thousands of children were struck and, lacking appropriate medicine, were liable to die from the disease. Doctors at Pfizer had an antibiotic that could probably save most of these children's lives. The drug was new,... View Details

Keywords: Risk and Uncertainty; Health Pandemics; Health Testing and Trials; Developing Countries and Economies; Pharmaceutical Industry; Nigeria

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

December 2019
Technical Note

Technical Note on Bayesian Statistics and Frequentist Power Calculations

By: Amitabh Chandra and Ariel Dora Stern

This Technical Note provides an introduction to Bayes’ Rule and the statistical intuition that stems from it. In this note, we review the concepts that underlie Bayesian statistics, and we offer several simple mathematical examples to illustrate applications of Bayes’... View Details

Keywords: Bayesian Statistics; Mathematical Methods

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

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

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

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 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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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

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

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

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

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