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- All HBS Web (351)
- Faculty Publications (142)
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- September 2022
- Article
Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities
By: Leemore Dafny, Christopher Ody and Teresa Rokos
The federal Anti-Kickback Statute prohibits biopharmaceutical manufacturers from directly covering Medicare enrollees’ out-of-pocket spending for the drugs they manufacture, but manufacturers may donate to independent patient assistance charities and earmark donations... View Details
Keywords: Cost Sharing; Prescription Drugs; Drug Spending; Medicare; Dual Eligibility; Cost; Health Care and Treatment; Philanthropy and Charitable Giving; Pharmaceutical Industry
Dafny, Leemore, Christopher Ody, and Teresa Rokos. "Giving a Buck or Making a Buck? Donations by Pharmaceutical Manufacturers to Independent Patient Assistance Charities." Health Affairs 41, no. 9 (September 2022).
- January 2009
- Teaching Note
Biocon: Launching a New Cancer Drug in India (TN)
By: Sunil Gupta and Das Narayandas
Teaching Note for [508026]. View Details
- 2008
- Case
Eli Lilly: Recreating Drug Discovery for the 21st Century
By: Rebecca Henderson and C. Reavis
- 2018
- Chapter
The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century
By: Nicholas Bagley, Benjamin Berger, Amitabh Chandra, Craig Garthwaite and Ariel Dora Stern
On the 35th anniversary of the adoption of the Orphan Drug Act (ODA), we describe the enormous changes in the markets for therapies for rare diseases that have emerged over recent decades. The most prominent example is the fact that the profit-maximizing price of new... View Details
Keywords: Health Care and Treatment; Laws and Statutes; Research and Development; Investment; Markets; Monopoly
Bagley, Nicholas, Benjamin Berger, Amitabh Chandra, Craig Garthwaite, and Ariel Dora Stern. "The Orphan Drug Act at 35: Observations and an Outlook for the Twenty-First Century." Chap. 4 in Innovation Policy and the Economy, Volume 19, edited by Josh Lerner and Scott Stern, 97–137. University of Chicago Press, 2018.
- 22 Feb 2021
- Working Paper Summaries
Private and Social Returns to R&D: Drug Development and Demographics
- November 2019
- Case
The Genesis Lab at Novartis
By: Amy C. Edmondson, Ranjay Gulati, Patrick J. Healy and Kerry Herman
Novartis' Genesis Labs program, launched in 2016 as part of Novartis Institutes for Biomedical Research (NIBR), hosted pitch competitions where teams of NIBR scientists proposed ideas to explore that aimed to revolutionize drug discovery. The goal was to break down... View Details
Keywords: Drug Discovery; Health Care and Treatment; Research and Development; Innovation and Invention; Programs; Management
Edmondson, Amy C., Ranjay Gulati, Patrick J. Healy, and Kerry Herman. "The Genesis Lab at Novartis." Harvard Business School Case 620-007, November 2019.
- January–February 2021
- Article
Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses
By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded... View Details
Keywords: Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards
Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
- April 2017
- Supplement
Imprimis (B)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case is a supplement to Imprimis (A). It describes the company’s decision to enter into the pharmaceutical compounding business in 2013–2014. Imprimis purchased a compounded ophthalmological medication called Dropless Therapy, which was injected into patients’... View Details
Keywords: Healthcare; Drug Compounding; Drug Development; Pharmaceuticals; Small Business; Decision-making, Business Model; Mark Baum; Imprimis; Decision Making; Strategy; Health Care and Treatment; Policy; Pharmaceutical Industry; United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (B)." Harvard Business School Supplement 717-496, April 2017.
- October 2023
- Article
Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record
By: Anna D Sinaiko, Caroline E Sloan, Mark J Soto, Olivia Zhao, Chen-Tan Lin and Foster R Goss
Keywords: Prescription Drugs; Electronic Health Records; Physicians; Prescription Drug Costs; Health Care and Treatment; Price; Health Industry
Sinaiko, Anna D., Caroline E Sloan, Mark J Soto, Olivia Zhao, Chen-Tan Lin, and Foster R Goss. "Clinician Response to Patient Medication Prices Displayed in the Electronic Health Record." JAMA Internal Medicine 183, no. 10 (October 2023): 1172–1175.
- Article
Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry
By: Leemore S. Dafny, Christopher Ody and Matt Schmitt
The analogy between value-based purchasing in pharmaceuticals and the new frontier of alternative payment models for health care providers is relatively straightforward. Insurers are increasingly demanding steep discounts from providers in exchange for inclusion in... View Details
Keywords: Drug Copayment Coupons; Prescription Drug Policy; Health Care and Treatment; Insurance; Cost; Policy; Pharmaceutical Industry
Dafny, Leemore S., Christopher Ody, and Matt Schmitt. "Undermining Value-Based Purchasing — Lessons from the Pharmaceutical Industry." New England Journal of Medicine 375, no. 21 (November 24, 2016): 2013–2015.
- Article
Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study
By: Maryaline Catillon
Keywords: Biomedical Research; R&D; Innovation; Technology; Drug Trials; RCT; Health; Healthcare; Health Care And Treatment; Health Care Policy; Innovation and Invention; Innovation Strategy; Research and Development; Technological Innovation; Health Industry; Pharmaceutical Industry
Catillon, Maryaline. "Trends and Predictors of Biomedical Research Quality, 1990–2015: A Meta-Research Study." BMJ Open 9, no. 9 (September 2019).
- January 2018 (Revised January 2019)
- Case
ZappRx
By: Jeffrey J. Bussgang and Olivia Hull
In October 2015, ZappRx founder Zoe Barry is deciding between two business models for her health technology start-up. Her product, a software application that aims to expedite the prescription fulfillment process for patients with rare diseases, has attracted interest... View Details
- 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.
- 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... View Details
Keywords: Clinical Trials; Drug Trials; Drug Testing; Cancer Trials; Glioblastoma; Platform Trials; Adaptive Trials; Adaptive Platform Trials; Health Testing and Trials; Health Care and Treatment; Financing and Loans; Business Strategy; Health Industry; United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (B)." Harvard Business School Supplement 620-001, September 2019.
- 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?” View Details
- 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.)
- July 2021
- Supplement
Adaptive Platform Trials: The Clinical Trial of the Future? (C)
By: Ariel D. Stern and Sarah Mehta
This (C) case provides an update on the work of the Global Coalition for Adaptive Research (GCAR) and also illustrates how adaptive platform trials can nimbly respond to a global pandemic. View Details
Keywords: Clinical Trials; Drug Trials; Drug Testing; Cancer Trials; Glioblastoma; Platform Trials; Adaptive Trials; Adaptive Platform Trials; Health Testing and Trials; Health Care and Treatment; Business Strategy; Health Industry; United States
Stern, Ariel D., and Sarah Mehta. "Adaptive Platform Trials: The Clinical Trial of the Future? (C)." Harvard Business School Supplement 622-012, July 2021.
- March 2008
- Case
The Multiple Sclerosis Center of Atlanta
By: Regina E. Herzlinger and Alfred Martin
The Multiple Sclerosis Center of Atlanta wishes to expand beyond Georgia. The factors influencing this decision are discussed, including drug treatments currently available, and the impact of future drugs in the FDA pipeline as well as financing issues. View Details
Keywords: Decision Choices and Conditions; Financing and Loans; Health Care and Treatment; Health Disorders; Medical Specialties; Expansion; Health Industry; Atlanta
Herzlinger, Regina E., and Alfred Martin. "The Multiple Sclerosis Center of Atlanta." Harvard Business School Case 308-085, March 2008.
- September 1991 (Revised February 1993)
- Case
Burroughs Wellcome and AZT (A)
Burroughs Wellcome Co., developer of AZT, the first drug approved by the U.S. Food and Drug Administration for the treatment of Acquired Immune Deficiency Syndrome (AIDS), finds itself under siege in September 1989 by AIDS activists and various segments of the U.S.... View Details
Keywords: Governing Rules, Regulations, and Reforms; Ethics; Business and Government Relations; Communication Strategy; Health Care and Treatment; Monopoly; Intellectual Property; Research and Development; Price; Pharmaceutical Industry; London
Emmons, Willis M., III. "Burroughs Wellcome and AZT (A)." Harvard Business School Case 792-004, September 1991. (Revised February 1993.)
- September 1998 (Revised July 1999)
- Case
Discovery Health (B)
By: Samuel S. Chun and Shaun Matisonn
A South African health insurance company grapples with designing a financially viable coverage solution for a new prescription drug treatment for male impotence. View Details
Keywords: Motivation and Incentives; Service Delivery; Insurance; Health Care and Treatment; Insurance Industry; South Africa
Chun, Samuel S., and Shaun Matisonn. "Discovery Health (B)." Harvard Business School Case 599-047, September 1998. (Revised July 1999.)