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Show Results For
- All HBS Web
(234)
- People (2)
- News (74)
- Research (151)
- Multimedia (1)
- Faculty Publications (60)
- 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... View Details
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.
- 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
Jachimowicz, Jon M., Joe J. Gladstone, Dan Berry, Charlotte L. Kirkdale, Tracey Thornley, and Adam D. Galinsky. "Making Medications Stick: Improving Medication Adherence by Highlighting the Personal Health Costs of Non-compliance." Behavioural Public Policy 5, no. 3 (July 2021): 396–416.
- 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
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.)
- 01 Mar 2007
- News
Daniel Vasella
the test as he methodically refashioned the two old-line chemical companies with disparate corporate cultures into a single entity focused on health care and powered by an innovative approach to R&D. Today, Novartis is one of the world’s... View Details
- 10 Aug 2015
- Research & Ideas
New Medical Devices Get To Patients Too Slowly
Delicate Balance For nearly 80 years, the FDA has performed a delicate balancing act between getting life-saving drugs to market, and ensuring that those drugs will be safe when taken by patients. In order... View Details
- 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... View Details
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.)
- 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... View Details
- 19 Dec 2016
- News
Dr. Lauren Cohen Breaks All Time Squat Record
- February 2024
- Article
Representation and Extrapolation: Evidence from Clinical Trials
By: Marcella Alsan, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein and Heidi L. Williams
This article examines the consequences and causes of low enrollment of Black patients in clinical
trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is
more relevant for decision-making by physicians and patients when it... View Details
Keywords: Representation; Racial Disparity; Health Testing and Trials; Race; Equality and Inequality; Innovation and Invention; Pharmaceutical Industry
Alsan, Marcella, Maya Durvasula, Harsh Gupta, Joshua Schwartzstein, and Heidi L. Williams. "Representation and Extrapolation: Evidence from Clinical Trials." Quarterly Journal of Economics 139, no. 1 (February 2024): 575–635.
- 01 Dec 2003
- Research & Ideas
Sometimes Success Begins at Failure
In the late 1980s, scientists for New York City-based drug-maker Pfizer began testing what was then known as compound UK-92,480 for the treatment of angina. Although UK-92,480 seemed promising in the lab and in animal tests, the compound... View Details
- 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. View Details
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.)
- 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
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.)
- 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... View Details
- August 1995 (Revised June 1997)
- Case
Hillcrest Research Associates, Inc.
Hillcrest designs and administers testing procedures for drugs to determine whether they pass FDA specifications. As the company grows, it encounters problems with information technology and with the clinical research associates, who feel pressured to report more... View Details
Keywords: Growth Management; Information Technology; Health Testing and Trials; Pharmaceutical Industry
Barnes, Louis B. "Hillcrest Research Associates, Inc." Harvard Business School Case 496-021, August 1995. (Revised June 1997.)
- August 2020
- Article
Do Physician Incentives Increase Patient Medication Adherence?
By: Edward Kong, John Beshears, David Laibson, Brigitte Madrian, Kevin Volpp, George Loewenstein, Jonathan Kolstad and James J. Choi
We conducted a randomized experiment (911 primary care practices and 8,935 nonadherent patients) to test the effect of paying physicians for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. We measured... View Details
Keywords: Health Economics; Medication Adherence; Physician Payment Incentives; Primary Care; Quality Improvement; Health Care and Treatment; Motivation and Incentives; Behavior
Kong, Edward, John Beshears, David Laibson, Brigitte Madrian, Kevin Volpp, George Loewenstein, Jonathan Kolstad, and James J. Choi. "Do Physician Incentives Increase Patient Medication Adherence?" Health Services Research 55, no. 4 (August 2020): 503–511.
- January 2020
- Article
Assessing the Safety of Electronic Health Records: A National Longitudinal Study of Medication-related Decision Support
By: A Jay Holmgren, Zoe Co, Lisa Newmark, Melissa Danforth, David Classen and David Bates
Background Electronic health records (EHR) can improve safety via computerised physician order entry with clinical decision support, designed in part to alert providers and prevent potential adverse drug events at entry and before they reach the patient.... View Details
Keywords: Hospital; Electronic Health Records; Health Care and Treatment; Information Technology; Safety; Performance; Quality; Performance Improvement
Holmgren, A Jay, Zoe Co, Lisa Newmark, Melissa Danforth, David Classen, and David Bates. "Assessing the Safety of Electronic Health Records: A National Longitudinal Study of Medication-related Decision Support." BMJ Quality & Safety 29, no. 1 (January 2020): 52–59.
- 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.... View Details
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.)
- September 2020
- Case
Minerva 2004: Discovery
By: John R. Wells and Benjamin Weinstock
After nearly five years in operation, Doctor Cynthia Bamdad, founder and CEO of Minerva Biotechnologies Corporation (Minerva), was reflecting on the company’s next steps. In a few short years, she and her small team had managed to develop a nanoparticle process for... View Details
Keywords: Entrepreneurship; Financing and Loans; Strategy; Decision Choices and Conditions; Biotechnology Industry
Wells, John R., and Benjamin Weinstock. "Minerva 2004: Discovery." Harvard Business School Case 721-389, September 2020.
- November 2008 (Revised July 2009)
- Background Note
A Managerial Perspective on Clinical Trials
By: Arthur A. Daemmrich
This note describes the history and regulation of clinical trials, managerial challenges related to pharmaceutical product testing, and current debates regarding prescription drug safety. Since clinical testing takes between five and seven years, and consumes up to 70... View Details
Keywords: Governing Rules, Regulations, and Reforms; Health Testing and Trials; Product Development; Safety; Biotechnology Industry; Pharmaceutical Industry
Daemmrich, Arthur A. "A Managerial Perspective on Clinical Trials." Harvard Business School Background Note 709-033, November 2008. (Revised July 2009.)