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All HBS Web
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- Faculty Publications (43)
- 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 D. 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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Keywords:
Health Testing and Trials;
Business and Government Relations;
Governing Rules, Regulations, and Reforms;
Information Publishing;
Medical Devices and Supplies Industry;
United States
Kaplan, Aaron V., and Ariel D. Stern. "The Central and Unacknowledged Role of the U.S. Food and Drug Administration in the Design and Execution of Medical Device Pivotal Trials." JAMA Cardiology 3, no. 1 (January 2018): 5–6.
- 2020
- Working Paper
Trials and Terminations: Learning from Competitors' R&D Failures
I analyze project continuation decisions where firms may resolve uncertainty through news about competitors' research and development (R&D) failures, as well as through their own results. I examine the trade-offs and interactions between product-market competition and...
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Krieger, Joshua L. "Trials and Terminations: Learning from Competitors' R&D Failures." Harvard Business School Working Paper, No. 18-043, November 2017. (Revised June 2020. Forthcoming in Management Science.)
- September 2017 (Revised July 2023)
- 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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Keywords:
Clinical Trials;
Cancer;
Adaptive Platform Trials;
Platform Trials;
Adaptive Trials;
Glioblastoma;
Health;
Health Care and Treatment;
Health Testing and Trials;
Business Strategy;
Innovation Strategy;
Health Industry;
United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future?" Harvard Business School Case 618-025, September 2017. (Revised July 2023.)
- June 2016
- Teaching Plan
Terrapin Laboratory
By: Joseph B. Fuller and Andrew Otazo
This teaching plan accompanies the case "Terrapin Laboratory," HBS No. 315-098. That case describes the formation and rapid growth of a drug testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug...
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- 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...
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Keywords:
CV Ingenuity;
CVI;
Drug Eluting Balloon;
DEB;
Drug Eluting Stent;
Angioplasty Balloon;
FoxHollow;
Medical Device;
Medical Device Startup;
Premarket Approval;
PMA;
Lutonix;
Stellarex;
LEVANT;
ILLUMENATE;
Clinical Trials;
Peripheral Arterial Disease;
PAD;
Healthcare Startups;
Covidien;
Health Care and Treatment;
Health Testing and Trials;
Business Startups;
Commercialization;
Health Industry;
Medical Devices and Supplies Industry;
United States;
Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised January 2024.)
- 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...
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Keywords:
CV Ingenuity;
CVI;
Drug Eluting Balloon;
DEB;
Drug Eluting Stent;
Angioplasty Balloon;
FoxHollow;
Medical Device;
Medical Device Startup;
Premarket Approval;
PMA;
Lutonix;
Stellarex;
LEVANT;
ILLUMENATE;
Clinical Trials;
Peripheral Arterial Disease;
PAD;
Healthcare Startups;
Covidien;
Health Care and Treatment;
Health Testing and Trials;
Business Startups;
Commercialization;
Strategy;
Health Industry;
Medical Devices and Supplies Industry;
United States;
Europe
Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (B): Epilogue." Harvard Business School Supplement 315-087, March 2015. (Revised February 2022.)
- March 2015 (Revised September 2016)
- Case
Terrapin Laboratory
By: Richard G. Hamermesh and Joseph B. Fuller
Describes the formation and rapid growth of a drug testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug treatment center business. The associated teaching materials provide students the opportunity...
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Keywords:
Business Growth;
Entrepreneurial Management;
Entrepreneurship;
Growth Strategy;
Market Entry;
Venture Capital;
Growth Management;
Expansion;
Financing and Loans;
Health Care and Treatment;
Health Testing and Trials;
Business Startups;
Pharmaceutical Industry;
Health Industry
Hamermesh, Richard G., and Joseph B. Fuller. "Terrapin Laboratory." Harvard Business School Case 315-098, March 2015. (Revised September 2016.)
- January 2014 (Revised June 2014)
- Case
23andMe: Genetic Testing for Consumers (A)
By: John A. Quelch and Margaret L. Rodriguez
On November 22, 2013, the direct-to-consumer genetic testing provider, 23andMe, received a letter from the U.S. Food and Drug Administration (FDA) ordering the company to halt the sale and promotion of its genetic testing kit. The FDA stated that the product was...
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Keywords:
Public Health;
Genome Testing;
Health Care;
Ancestry;
23andMe;
Marketing;
Product Launch;
Health;
Health Care and Treatment;
Health Testing and Trials;
Genetics;
Strategy;
Health Industry;
United States
Quelch, John A., and Margaret L. Rodriguez. "23andMe: Genetic Testing for Consumers (A)." Harvard Business School Case 514-086, January 2014. (Revised June 2014.)
- 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
Keywords:
Health Care;
Health Care Industry;
Health Care Policy;
Health Services;
Healthcare;
Healthcare Reform;
Healthcare Ventures;
Nonprofit;
Non-profit Management;
Not-for-profit;
Incubator;
Accelerator;
Venture Philanthropy;
Medical Services;
Medical Solutions;
Medical Research;
Medical Treatment;
Clinical Trials;
Drug Reimbursement;
Early Stage;
Early Stage Research Funding;
Early Stage Funding;
Milken Institute;
Michael Milken;
David Baltimore;
Partnering For Cures;
National Institutes Of Health;
Cancer Care In The U.S.;
Cancer Care Services;
Policy-making;
Health Care and Treatment;
Health;
Health Testing and Trials;
Entrepreneurship;
Social Entrepreneurship;
Nonprofit Organizations;
Policy;
Health Industry;
United States;
District of Columbia
Hamermesh, Richard G., and James Weber. "FasterCures: Removing Barriers to Treatments." Harvard Business School Case 814-003, October 2013.
- November 2009
- Case
The Explosion of Genetic Testing: Opportunities and Challenges
By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon
This case study invites the reader to consider genetic testing in several different lights. First, can the business of genetic testing be considered a disruptive innovation to the current drug therapy model as defined by Harvard Business School Professor Clay...
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- 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...
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Keywords:
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Marketing Strategy;
Product Positioning;
Genetics;
Biotechnology Industry;
Europe;
United States
Hamermesh, Richard G., Raju Kucherlapati, and Rachel Gordon. "Managing Drugs on the Forefront of Personalized Medicine: The Erbitux and Vectibix Story." Harvard Business School Case 810-066, November 2009. (Revised March 2010.)
- April 2009 (Revised May 2010)
- Case
Partners In Health: HIV Care in Rwanda
By: Michael E. Porter, Scott S. Lee, Joseph Rhatigan and Jim Yong Kim
In 2005, Partners in Health (PIH) was invited by the Rwandan Ministry of Health to assume responsibility for the management of public health care in two rural districts in Eastern Rwanda and create an HIV treatment program at these sites. PIH successfully implemented a...
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Keywords:
Developing Countries and Economies;
Health Care and Treatment;
Health Testing and Trials;
Medical Specialties;
Service Delivery;
Nonprofit Organizations;
Expansion;
Health Industry;
Rwanda
Porter, Michael E., Scott S. Lee, Joseph Rhatigan, and Jim Yong Kim. "Partners In Health: HIV Care in Rwanda." Harvard Business School Case 709-474, April 2009. (Revised May 2010.)
- 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...
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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
Margolis, Joshua D., Thomas J. DeLong, and Terence Heymann. "Antegren: A Beacon of Hope." Harvard Business School Case 408-025, November 2007.
- October 2006 (Revised August 2007)
- Case
Calloway Laboratory: Pee for Profit
By: Richard G. Hamermesh and David Kiron
Describes the formation and rapid growth of a drug-testing company. The company needs to decide whether to enter the painkiller testing market, in addition to growing its drug treatment center business.
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Keywords:
For-Profit Firms;
Health Care and Treatment;
Health Testing and Trials;
Growth and Development Strategy;
Market Entry and Exit;
Health Industry
Hamermesh, Richard G., and David Kiron. "Calloway Laboratory: Pee for Profit." Harvard Business School Case 807-040, October 2006. (Revised August 2007.)
- 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,...
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Keywords:
Risk and Uncertainty;
Health Pandemics;
Health Testing and Trials;
Developing Countries and Economies;
Pharmaceutical Industry;
Nigeria
Spar, Debora L., and Adam Day. "Drug Testing in Nigeria (A)." Harvard Business School Case 706-033, January 2006. (Revised July 2006.)
- 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...
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Keywords:
Health Testing and Trials;
Internet and the Web;
Information Technology;
Adoption;
Business Processes;
Industry Structures;
Technological Innovation;
Service Operations;
Pharmaceutical Industry;
United States
Huckman, Robert S., and Mark J. Cotteleer. "Procter & Gamble: Electronic Data Capture and Clinical Trial Management." Harvard Business School Case 606-033, August 2005. (Revised December 2006.)
- February 2005 (Revised April 2006)
- Case
Rx Depot: Importing Drugs from Canada
By: Debora L. Spar
In 2002, a handful of entrepreneurs began to ship drugs from Canada into the United States, taking advantage of regulatory and price differentials across the neighboring countries. Using the Internet and a low-cost network of Canadian pharmacies, firms like Rx Depot...
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Keywords:
Courts and Trials;
Entrepreneurship;
Intellectual Property;
Laws and Statutes;
Pharmaceutical Industry;
Canada;
United States
Spar, Debora L., and Adam Day. "Rx Depot: Importing Drugs from Canada." Harvard Business School Case 705-010, February 2005. (Revised April 2006.)
- August 2003 (Revised July 2023)
- Case
Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment
By: Regina E. Herzlinger and John McDonough
What can Dr. Dean Ornish learn from the successes and failures of his competitors in ameliorating morbid obesity to create a business model that will “do good” by combatting obesity and associated chronic diseases and “do well” by growing a widely adopted business?...
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Keywords:
Three Pillars;
Industry Analysis;
Health Disorders;
Health Care and Treatment;
Innovation and Invention;
Business Model;
Analysis;
Innovation and Management;
Medical Specialties;
Mission and Purpose;
Health Industry
Herzlinger, Regina E., and John McDonough. "Fighting the Battle of the Bulge—Evaluating Do Good/Do Well Innovations in Morbid Obesity Treatment." Harvard Business School Case 304-009, August 2003. (Revised July 2023.)
- 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...
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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
Sucher, Sandra J., and Stacy McManus. "Novartis: The Challenge of Success (A)." Harvard Business School Case 603-043, April 2003. (Revised October 2004.)