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Skip to Main Content Cold Call A podcast featuring faculty discussing cases they've written and the lessons they impart. Subscribe on iTunes 29 Sep...
Above: illustration by Matthew Roharik/Getty Images In November 2019, a team from the National Institute of Allergy and Infectious Diseases, part of...
- October 2020
- Teaching Plan
Merck: COVID-19 Vaccines
By: Willy C. Shih
COVID-19 infections were still climbing across the U.S. and many other parts of the world in September 2020, and it seemed that every time Ken Frazier, the CEO of Merck & Co. consented to an interview in recent months he always seemed to hear the same question,...
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- October 2020
- Case
COVID-19 Testing at Everlywell
By: Jeffrey J. Bussgang and Olivia Hull
In March 2020, as COVID-19 spreads rapidly across the U.S., Everlywell founder Julia Cheek considers how to respond as a small start-up specializing in at-home lab testing. After making dramatic budget cuts, she decides to pivot the organization to address the...
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Keywords:
Entrepreneurship;
Business Strategy;
Venture Capital;
health Care And Treatment;
health Disorders;
Leading Change;
Technology Adoption;
Technology Platform;
Competitive Strategy;
Science;
Adaptation;
Corporate Social Responsibility And Impact;
Crisis Management;
Social Entrepreneurship;
Ethics;
Government Legislation;
health;
health testing And trials;
health Pandemics;
Consumer Products Industry;
health Industry;
Technology Industry;
Texas;
United States
- September 2020
- Case
Merck: COVID-19 Vaccines
By: Willy C. Shih
COVID-19 infections were still climbing across the U.S. and many other parts of the world in September 2020, and it seemed that every time Ken Frazier, the CEO of Merck & Co. consented to an interview in recent months he always seemed to hear the same question,...
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- 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...
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- 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...
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- Article
Quantifying the Use of Connected Digital Products in Clinical Research
By: Caroline Marra, Jacqueline L. Chen, Andrea Coravos and Ariel D. Stern
Over recent years, the adoption of connected technologies has grown dramatically, with potential for improving health care delivery, research, and patient experience. Yet, little has been documented about the prevalence and use of connected digital products (e.g.,...
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- March 30, 2020
- Article
Why Is the U.S. Behind on Coronavirus Testing?
By: Stefan Thomke
Coronavirus testing is needed to address the uncertainty in making decisions about patient treatment, resource allocation, policy, and so much more. Answers to questions such as “When should we relax social distancing measures—and for whom?” or “How many ventilators...
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- February 2020
- Teaching Note
Theranos: Who Has Blood on Their Hands? (A) and (B)
By: Nien-he Hsieh and Christina R. Wing
Teaching Note for HBS Nos. 619-039 and 320-091.
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- February 2020
- Case
Theranos: Who Has Blood on Their Hands? (B)
By: Nien-he Hsieh, Christina R. Wing and John Masko
This supplemental case tracks the results of the Colman and Taubman-Dye class action suit against Theranos as well as Theranos’ other legal challenges and chronicles the final demise of the company in 2019.
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- 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...
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- October 2019 (Revised April 2020)
- Background Note
Note on Funding Deep Tech Startups
This Background Note provides essential information on funding deep technologies—those technologies that were inherently capital intensive, time consuming, risky, and potentially disruptive. Both dilutive and non-dilutive sources of investment are highlighted, along...
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Keywords:
Entrepreneurship;
Energy;
Venture Capital;
Corporate Finance;
Initial Public Offering;
Investment;
health testing And trials;
Innovation And Invention;
Technological Innovation;
Intellectual Property;
Product Design;
Product Development;
Technology;
Research And Development;
Risk And Uncertainty;
Technology Industry;
Biotechnology Industry;
United States;
North America;
Europe;
Asia
- October 2019
- Article
Adaptive Platform Trials: Definition, Design, Conduct and Reporting Considerations
By: Derek C. Angus, Brian M. Alexander, Scott Berry, Meredith Buxton, Roger Lewis, Melissa Paoloni, Steven A. R. Webb, Steven Arnold, Anna Barker, Donald A. Berry, Marc J. M. Bonten, Mary Brophy, Christopher Butler, Timothy F. Cloughesy, Lennie P. G. Derde, Laura J. Esserman, Ryan Ferguson, Louis Fiore, Sarah C. Gaffey, J. Michael Gaziano, Kathy Giusti, Herman Goossens, Stephane Heritier, Bradley Hyman, Michael Krams, Kay Larholt, Lisa M. LaVange, Philip Lavori, Andrew W. Lo, Alexander J. London, Victoria Manax, Colin McArthur, Genevieve O’Neill, Giovanni Parmigiani, Jane Perlmutter, Elizabeth A. Petzold, Craig Ritchie, Kathryn M. Rowan, Christopher W. Seymour, Nathan I. Shapiro, Diane M. Simeone, Bradley Smith, Bradley Spellberg, Ariel Dora Stern, Lorenzo Trippa, Mark Trusheim, Kert Viele, Patrick Y. Wen and Janet Woodcock
Researchers, clinicians, policymakers, and patients are increasingly interested in questions about therapeutic interventions that are difficult or costly to answer with traditional, free-standing, parallel-group randomized controlled trials (RCTs). Examples include...
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- September 2019
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (B)
By: Ariel D. Stern and Sarah Mehta
This case provides an update to the (A) case, which introduces students to adaptive platform trials, an ambitious, more efficient type of clinical trial that increases access to therapies. The (A) case centers on Dr. Brian Alexander’s efforts to launch an adaptive...
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- February 2019 (Revised February 2020)
- Case
Theranos: Who Has Blood on Their Hands? (A)
By: Nien-hê Hsieh, Christina R. Wing, Emilie Fournier and Anna Resman
This case covers the rise and fall of Theranos, the company founded by Elizabeth Holmes in 2004 to revolutionize the blood testing industry by creating a device that could provide from a small finger prick the same results and accuracy as intravenous blood draws. As...
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- 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...
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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
- March 2018
- Teaching Note
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
This teaching note provides guidance and recommendations for teaching HBS Case No. 618-025, entitled “Adaptive Platform Trials: The Clinical Trial of the Future?”
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- January 2018
- Article
The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials
By: Aaron V. Kaplan and Ariel Dora Stern
The introduction of new medical devices has transformed cardiovascular care in recent decades. Devices, such as heart valves, pacemakers, stents, ventricular assist devices, and implantable defibrillators, have prolonged and improved the quality of life for millions of...
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- September 2017 (Revised January 2018)
- Case
Adaptive Platform Trials: The Clinical Trial of the Future?
By: Ariel D. Stern and Sarah Mehta
In July 2017, Dr. Brian M. Alexander, president and CEO of the AGILE Research Foundation, was preparing to launch a new type of clinical trial—an adaptive platform trial—to study potential therapies for glioblastoma (GBM), an aggressive form of brain cancer....
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- September 2017 (Revised February 2018)
- Case
Becton Dickinson: Global Health Strategy
By: Mark R. Kramer and Sarah Mehta
Becton, Dickinson and Company (BD) was a medical technology firm headquartered in Franklin Lakes, New Jersey, with 43,000 employees and 2016 revenues of $12.5 billion. For several years, the company had pursued developing products that created shared value, defined as...
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Keywords:
Shared Value;
Creating Shared Value;
Odon Device;
Medical Technology;
Value Creation;
Values And Beliefs;
Philanthropy And Charitable Giving;
health;
health Care And Treatment;
health testing And trials;
Emerging Markets;
Social Issues;
Competitive Strategy;
Medical Devices And Supplies Industry;
Africa;
Asia;
Middle East
- January 2017
- Supplement
Terrapin Laboratory: Exercise
By: Joseph B. Fuller and Christopher Payton
In this exercise, we examine the capital requirements of Terrapin Laboratory as they contemplate entering into a new market segment. The company is faced with two potential financing options which have different effects on the ownership structure of the company....
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