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- All HBS Web (175)
- Faculty Publications (64)
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- January 2014
- Supplement
Fred Khosravi and AccessClosure (C)
By: Richard Hamermesh and Lauren Barley
On September 11, 2013, the three-judge panel of the U.S. Court of Appeals for the Federal Circuit denied St. Jude's request to rehear an appeal on the "double patenting" ruling for the '439 patent. Further, it removed the injunction threat that was hanging over the...
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Keywords:
Medical Devices;
Vascular Closure Device;
Patent Litigation;
Patenting;
Biomedical Research;
Biotechnology;
Biotech;
Technological Innovation;
Patents;
Health Care and Treatment;
Biotechnology Industry;
United States
Hamermesh, Richard, and Lauren Barley. "Fred Khosravi and AccessClosure (C)." Harvard Business School Supplement 814-074, January 2014.
- August 2008 (Revised September 2008)
- Case
The Flaxil Label (A)
This case focuses on the 2001 negotiation between Mytex Pharmaceuticals and the U.S. Food and Drug Administration (FDA). The outcome of the negotiation would determine the new label for Mytex's blockbuster drug for arthritis, Flaxil. The negotiation is quite...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Disorders;
Product Launch;
Negotiation Process;
Business and Government Relations;
Safety;
Pharmaceutical Industry
Barron, Greg M. "The Flaxil Label (A)." Harvard Business School Case 909-001, August 2008. (Revised September 2008.)
- August 2012 (Revised December 2023)
- Background Note
Note on Health Insurance Coverage, Coding, and Payment
By: Regina E. Herzlinger and Jo Ellen Slurzberg
This note explains how health care technology and service innovators receive payment from government insurers, in the U.S. and abroad, and from private insurers. It describes each of the three steps needed to obtain reimbursement: coverage, coding, and payment. It also...
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- January 2018
- Case
Spark Therapeutics: Pioneering Gene Therapy
By: Robert F. Higgins and Tina Liu
Spark Therapeutics is a pioneering gene therapy startup. It was spun out of The Children’s Hospital of Philadelphia (CHOP). The company had taken with it much of the intellectual property and talent that CHOP had developed. The company is considering an initial public...
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Keywords:
Health Care and Treatment;
Innovation and Invention;
Business Startups;
Opportunities;
Problems and Challenges;
Strategy
Higgins, Robert F., and Tina Liu. "Spark Therapeutics: Pioneering Gene Therapy." Harvard Business School Case 818-059, January 2018.
- 2024
- Article
Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway
By: Mateo Aboy, Cristina Crespo and Ariel Stern
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between...
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Keywords:
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Technology Adoption;
Technological Innovation;
Safety;
Medical Devices and Supplies Industry;
United States
Aboy, Mateo, Cristina Crespo, and Ariel Stern. "Beyond the 510(k): The Regulation of Novel Moderate-Risk Medical Devices, Intellectual Property Considerations, and Innovation Incentives in the FDA’s De Novo Pathway." Art. 29. npj Digital Medicine 7 (2024).
- 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...
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- 2022
- Article
Missing Novelty in Drug Development
By: Joshua Krieger, Danielle Li and Dimitris Papanikolaou
We provide evidence that risk aversion leads pharmaceutical firms to underinvest in radical innovation. We introduce a new measure of drug novelty based on chemical similarity and show that firms face a risk-reward trade-off: novel drug candidates are less likely to...
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Keywords:
Drug Development;
Risk Aversion;
Research and Development;
Innovation and Invention;
Investment;
Pharmaceutical Industry
Krieger, Joshua, Danielle Li, and Dimitris Papanikolaou. "Missing Novelty in Drug Development." Review of Financial Studies 35, no. 2 (February 2022): 636–679.
- January 2020
- Case
Celata Bioinnovations
By: John R. Wells and Benjamin Weinstock
In December 2019, Jon Hu (HBS ‘19) and Dr. Samantha Dale Strasser, co-founders of Celata Bioinnovations, were raising $1 million to launch their company. They had founded Celata less than six months earlier with the aim of redefining the drug discovery process....
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Keywords:
Drug Development;
Drug Discovery;
Drug Trials;
Pharmaceutical Companies;
Pharmaceutical Company;
Pharmaceuticals;
Therapeutics;
Biologics;
Biotech;
Biotechnology;
Biopharmacy Company;
Biochemistry;
Technology Commercialization;
Technology Companies;
Drug Testing;
Startup;
Start-up;
Startups;
Start-ups;
Startup Financing;
Strategic Decision Making;
Strategic Decisions;
Strategic Evolution;
FDA;
Food And Drug Administration;
Clinical Trials;
Disease Management;
Market Attractiveness;
Market Entry;
Market Opportunities;
Health Disorders;
Technological Innovation;
Information Technology;
Commercialization;
Business Startups;
Finance;
Decision Making;
Strategy;
Market Entry and Exit;
Opportunities;
Pharmaceutical Industry;
Biotechnology Industry
Wells, John R., and Benjamin Weinstock. "Celata Bioinnovations." Harvard Business School Case 720-427, January 2020.
- 2023
- Article
Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance
By: Alexander O. Everhart, Soumya Sen, Ariel D. Stern, Yi Zhu and Pinar Karaca-Mandic
Importance: Most regulated medical devices enter the U.S. market via the 510(k) regulatory submission pathway, wherein manufacturers demonstrate that applicant devices are “substantially equivalent” to 1 or more “predicate” devices (legally marketed medical devices...
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Everhart, Alexander O., Soumya Sen, Ariel D. Stern, Yi Zhu, and Pinar Karaca-Mandic. "Association Between Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance." JAMA, the Journal of the American Medical Association 329, no. 2 (2023): 144–156.
- November 2012 (Revised January 2013)
- Case
Companion Diagnostics: Uncertainties for Approval and Reimbursement
By: Richard G. Hamermesh, Norman C. Selby and Phillip Andrews
The FDA approvals of novel therapeutics were seen as signs in the personalized medicine community of real progress in the growth of personalized medicine. The FDA's approval of such drugs, along with companion diagnostics, suggested a shift in thinking and regulatory...
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Keywords:
Models Of Reimbursement;
Personalized Medicine;
Regulation;
Healthcare Reform;
Health Care and Treatment;
Health Industry;
United States
Hamermesh, Richard G., Norman C. Selby, and Phillip Andrews. "Companion Diagnostics: Uncertainties for Approval and Reimbursement." Harvard Business School Case 813-037, November 2012. (Revised January 2013.)
- May 2016
- Case
AbbVie
By: Kevin Schulman, Laura Little, Samyukta Mullangi and Stephen Schleicher
This case focuses on the impact of a novel regulatory pathway, the biosimilars pathway, on the strategy of a major pharmaceutical firm that finds its largest product (60% of revenue) at risk. The case reviews the rationale for the pathway, the emerging biosimilars...
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- June 2010 (Revised August 2010)
- Case
Dr. Cameron Powell and AirStrip Technologies: After the Apple Worldwide Developers Conference
Dr. Cameron Powell and his partner, Trey Moore, co-founders of the innovative company, AirStrip Technologies, have developed a series of apps for the iPhone and other smartphones that can help doctors monitor the vital signs of their patients anytime, anywhere. They...
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Keywords:
Information Technology;
Entrepreneurship;
Applications and Software;
Health Care and Treatment;
Mobile and Wireless Technology;
Product Development;
Information Technology Industry;
Health Industry;
United States
Chakravorti, Bhaskar, and N. Venkatraman. "Dr. Cameron Powell and AirStrip Technologies: After the Apple Worldwide Developers Conference." Harvard Business School Case 810-143, June 2010. (Revised August 2010.)
- January 2001 (Revised July 2003)
- Case
Pharmacyclics: Financing Research & Development
By: Malcolm P. Baker, Richard S. Ruback and Aldo Sesia
Pharmacyclics (NASDAQ: PCYC), a pharmaceutical company that manufactures products that will improve existing therapeutic treatments for cancer, arteriosclerosis, and retinal disease, was considering a $60 million private placement in February 2000. The company had more...
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Keywords:
Valuation;
Cash Flow;
Financing and Loans;
Business Startups;
Financial Strategy;
Medical Devices and Supplies Industry;
Pharmaceutical Industry;
Health Industry
Baker, Malcolm P., Richard S. Ruback, and Aldo Sesia. "Pharmacyclics: Financing Research & Development." Harvard Business School Case 201-056, January 2001. (Revised July 2003.)
- October 2022 (Revised May 2023)
- Case
Podimetrics: Next Steps for Diabetes Cases
By: Regina E. Herzlinger and Ben Creo
Podimetrics, a virtual care management company treating adults with acute diabetes, sat at the intersection of medical device technology, digital health, and health services. Its SmartMat had demonstrated that it could help prevent amputations and that people with...
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Keywords:
Health Care;
Health Care Delivery;
Health Care Entrepreneurship;
Health Care Outcomes;
Diabetes;
Chronic Disease;
Chronic Illness;
Health Care and Treatment;
Health Disorders;
Medical Specialties;
Technological Innovation;
Innovation Strategy;
Product Development;
Business Model;
Customer Focus and Relationships;
Medical Devices and Supplies Industry;
Health Industry
- January 2009 (Revised July 2009)
- Case
Targanta Therapeutics: Hitting a Moving Target
By: Arthur A. Daemmrich
This case explores regulatory, product testing, and business strategy at Targanta Therapeutics, a biotech company preparing its first new drug application to the FDA. In October 2007, Mark Leuchtenberger, president and CEO of Targanta—which has just held a successful...
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Keywords:
Decision Choices and Conditions;
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Health Testing and Trials;
Product Development;
Business and Government Relations;
Business Strategy;
Biotechnology Industry;
Pharmaceutical Industry
Daemmrich, Arthur A. "Targanta Therapeutics: Hitting a Moving Target." Harvard Business School Case 709-002, January 2009. (Revised July 2009.)
- May 2016 (Revised March 2020)
- Teaching Note
Cyberdyne: A Leap to the Future
By: Doug J. Chung and Mayuka Yamazaki
Cyberdyne Inc. was a Japanese technology venture founded in 2004 by scientist Yoshiyuki Sankai to commercialize a hybrid assistive limb (HAL). HAL was a robotic exoskeleton system for people who had difficulty walking due to nervous system disabilities resulting from...
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- December 2006 (Revised August 2008)
- Case
Pervasis Therapeutics, Inc.
By: Robert F. Higgins and Virginia Fuller
In May 2005, Steve Bollinger was about to become president and chief operating officer of Pervasis Therapeutics, a small cell therapy start-up in Cambridge, Mass. If proven successful, Pervasis' product, Vascugel, could change the way vascular disease is treated and...
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Keywords:
Business Startups;
Venture Capital;
Financial Strategy;
Governing Rules, Regulations, and Reforms;
Health Care and Treatment;
Health Testing and Trials;
Health Industry;
Cambridge
Higgins, Robert F., and Virginia Fuller. "Pervasis Therapeutics, Inc." Harvard Business School Case 807-026, December 2006. (Revised August 2008.)
- April 2017
- Case
Imprimis (A)
By: Ramon Casadesus-Masanell, Karen Elterman and Marc Appel
This case examines the strategic choices and evolving business model of Imprimis Pharmaceuticals from the perspective of CEO Mark Baum. The (A) case provides a brief history of the company and of the compounding business, outlining the challenges faced by Imprimis in...
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Keywords:
Strategy;
Healthcare;
Drug Compounding;
Pharmaceuticals;
Compounding;
Drug Development;
Decision-making;
Mark Baum;
Imprimis;
Small Business;
Decisions;
Cost vs Benefits;
Business Strategy;
Business Model;
Decision Choices and Conditions;
Pharmaceutical Industry;
United States
Casadesus-Masanell, Ramon, Karen Elterman, and Marc Appel. "Imprimis (A)." Harvard Business School Case 717-426, April 2017.
- October 2010 (Revised November 2010)
- Background Note
Plavix: Drugs in the Age of Personalized Medicine
By: Richard G. Hamermesh, Mara G. Aspinall and Rachel Gordon
PIavix, one of the world's best selling drugs in 2010, appears to have a limited future. Its patent was due to expire soon, and recently new data had been discovered that indicated that a small subset of the population would be at risk for stroke, heart attack, or even...
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Keywords:
Health Care and Treatment;
Product Positioning;
Business and Government Relations;
Genetics;
Competitive Strategy;
Pharmaceutical Industry
Hamermesh, Richard G., Mara G. Aspinall, and Rachel Gordon. "Plavix: Drugs in the Age of Personalized Medicine." Harvard Business School Background Note 811-001, October 2010. (Revised November 2010.)
- 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...
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Keywords:
Financial Crisis;
Entrepreneurship;
Venture Capital;
Investment;
Health Care and Treatment;
Health Testing and Trials;
Technological Innovation;
Financial Services Industry
Sahlman, William A., and Sarah Flaherty. "NovoCure Ltd." Harvard Business School Case 810-045, November 2009. (Revised August 2010.)