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- All HBS Web (175)
- Faculty Publications (64)
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- December 2006 (Revised January 2008)
- Case
ViaGen: Revolutionizing the Livestock Industry
By: David E. Bell, Reed Martin and Mary L. Shelman
ViaGen has invested heavily to develop cloning technology for the livestock industry. Cloning has the potential to significantly improve the genetics of livestock, leading to higher quality meat, healthier animals, and more efficient production. Since 2003, the firm...
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Keywords:
Animal-Based Agribusiness;
Business Plan;
Governing Rules, Regulations, and Reforms;
Marketing Communications;
Industry Structures;
Business and Government Relations;
Genetics;
Commercialization;
Agriculture and Agribusiness Industry;
Biotechnology Industry
Bell, David E., Reed Martin, and Mary L. Shelman. "ViaGen: Revolutionizing the Livestock Industry." Harvard Business School Case 507-021, December 2006. (Revised January 2008.)
- October 2002
- Case
A Father's Love: Novazyme Pharmaceuticals, Inc.
By: Richard M.J. Bohmer and Bradley Campbell
John Crowley, CEO of Novazyme Pharmaceuticals, a start-up biotechnology firm developing an orphan drug to treat a rare lysosomal storage disorder from which his children suffer, must choose between a partnership and a buyout to have sufficient funds and support to get...
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Keywords:
Technological Innovation;
Business Startups;
Partners and Partnerships;
Financing and Loans;
Governing Rules, Regulations, and Reforms;
Sales;
Price;
Product Development;
Motivation and Incentives;
Decision Choices and Conditions;
Biotechnology Industry;
Pharmaceutical Industry
Bohmer, Richard M.J., and Bradley Campbell. "A Father's Love: Novazyme Pharmaceuticals, Inc." Harvard Business School Case 603-048, October 2002.
- 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.)
- 2021
- Working Paper
Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances
By: Amar Bhide and Srikant M. Datar
By 2013, after many decades of very slow development and adoption, Fecal Microbiota Transplantation procedures were attracting widespread attention. This case history chronicles the: 1) pioneering fecal transplants performed in the 20th century; 2) development of the...
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Keywords:
Health Care and Treatment;
Innovation and Invention;
Governing Rules, Regulations, and Reforms
Bhide, Amar, and Srikant M. Datar. "Fecal Microbiota Transplants (FMT): Case Histories of Significant Medical Advances." Harvard Business School Working Paper, No. 21-132, June 2021.
- September 2009 (Revised August 2012)
- Case
Novasys Medical
By: Richard G. Hamermesh and Lauren Barley
Novasys has developed a new medical device and procedure for the treatment of female stress urinary incontinence that is cheaper and can be performed in doctors' offices. In spite of FDA approval, the American Medical Association has been unwilling to approve the...
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Keywords:
Entrepreneurship;
Governing Rules, Regulations, and Reforms;
Policy;
Health Care and Treatment;
Health Disorders;
Product Development;
Business and Government Relations;
Medical Devices and Supplies Industry;
United States
Hamermesh, Richard G., and Lauren Barley. "Novasys Medical." Harvard Business School Case 810-027, September 2009. (Revised August 2012.)
- June 2019
- Teaching Note
Zebra Medical Vision
By: Shane Greenstein and Sarah Gulick
Teaching note is meant to accompany Zebra Medical Vision case, which offers a look at a company’s decisions as a small startup competing with other startups and major technology companies. It also demonstrates the challenges faced by a machine learning company working...
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- April 2010
- Case
Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug
By: John A. Quelch and Heather Beckham
Metabical is a new weight loss drug from Cambridge Sciences Pharmaceuticals intended for moderately overweight individuals. In anticipation of final FDA approval, the senior director of marketing, Barbara Printup, prepares for the product launch and must make several...
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Keywords:
Return On Investment;
Forecasting;
Pricing Policies;
Demand Planning;
Marketing Strategy;
Price;
Consumer Behavior;
Investment Return;
Forecasting and Prediction;
Product Launch;
Planning;
Brands and Branding;
Pharmaceutical Industry
Quelch, John A., and Heather Beckham. "Metabical: Pricing, Packaging, and Demand Forecasting Recommendations for a New Weight Loss Drug." Harvard Business School Brief Case 104-183, April 2010.
- June 2016
- Case
Aggressive Growth Plans For Zimmer Spine
By: Kevin Schulman and Miranda Shaw
Steve Healy, the President of Zimmer Spine, has to transform his organization into a market leader. Zimmer is a major medical device firm, but the Spine division has underperformed, and its core technology did not get the expanded FDA label that had been expected. The...
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Keywords:
Medical Device;
Organizational Innovation;
Organizational Growth;
Organizations;
Growth and Development Strategy;
Medical Devices and Supplies Industry
Schulman, Kevin, and Miranda Shaw. "Aggressive Growth Plans For Zimmer Spine." Harvard Business School Case 316-106, June 2016.
- July 2010
- Case
Metabical: Positioning and Communications Strategy for a New Weight Loss Drug
By: John A. Quelch and Heather Beckham
Cambridge Sciences Pharmaceuticals (CSP) expects final approval for its revolutionary weight loss drug, Metabical. Metabical will be the only weight loss drug with FDA approval that is also clinically proven to be effective for moderately overweight people. Barbara...
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Keywords:
Product Positioning;
Marketing Communications;
Product Launch;
Consumer Behavior;
Pharmaceutical Industry;
United States
Quelch, John A., and Heather Beckham. "Metabical: Positioning and Communications Strategy for a New Weight Loss Drug." Harvard Business School Brief Case 104-240, July 2010.
- February 2024
- Case
Compass Pathways: Pioneering Psychedelic Treatment
By: Tiona Zuzul, Kisha Lashley and Gamze Yucaoglu
This case follows Compass Pathways, a pioneering company developing treatment for depression based on psilocybin, the compound found in ‘magic mushrooms.’ Psilocybin was a federally illegal substance in the U.S., and a “Schedule I” drug, defined as a drug “with no...
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Keywords:
Commercialization;
Corporate Strategy;
Competitive Strategy;
Product Launch;
Health Testing and Trials;
Research and Development;
Laws and Statutes;
Pharmaceutical Industry;
Europe;
United States;
United Kingdom
Zuzul, Tiona, Kisha Lashley, and Gamze Yucaoglu. "Compass Pathways: Pioneering Psychedelic Treatment." Harvard Business School Case 724-412, February 2024.
- February 1992 (Revised September 2003)
- Case
Beech-Nut Nutrition Corporation (A-1)
By: Lynn S. Paine
The CEO of Beech-Nut Nutrition Corp. must decide what to do when he receives information that the company's supply of apple juice concentrate may be adulterated. The concentrate is used in many of the company's juice products. It appears that others in the company may...
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Keywords:
Quality;
Law;
Ethics;
Nutrition;
Management Teams;
Decisions;
Business or Company Management;
Communication;
Governance Compliance;
Information Management;
Corporate Finance;
Food and Beverage Industry;
United States
Paine, Lynn S. "Beech-Nut Nutrition Corporation (A-1)." Harvard Business School Case 392-084, February 1992. (Revised September 2003.)
- December 2022 (Revised June 2023)
- Case
Sword Health
By: Regina E. Herzlinger and Annelena Lobb
Virgilio “V” Bento, CEO of Sword Health—a startup that provided virtual physical therapy to patients in self-insured firms via AI and sensor technology with supervision by a physical therapist with a doctorate—considered how to increase its U.S. market share. To do so,...
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Keywords:
Business Growth and Maturation;
Competitive Strategy;
Health Industry;
Technology Industry
Herzlinger, Regina E., and Annelena Lobb. "Sword Health." Harvard Business School Case 323-022, December 2022. (Revised June 2023.)
- July 2001 (Revised August 2005)
- Case
Medicines Company, The
It is early 2001 and the Medicines Co. just received FDA approval to market Angiomax, a blood thinner to be used during angioplasties and heart procedures. It is intended to be a better alternative to Heparin, an 80-year-old drug that costs less then $10 per dose. The...
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Keywords:
Business Model;
Change Management;
Decision Choices and Conditions;
Cost Management;
Price;
Product Marketing;
Product Launch;
Product Development;
Risk and Uncertainty;
Health Industry;
Pharmaceutical Industry
Gourville, John T. "Medicines Company, The." Harvard Business School Case 502-006, July 2001. (Revised August 2005.)
- April 1998
- Case
Cephalon, Inc.
By: Peter Tufano
In early 1997, Cephalon, awaited an FDA panel's decision on whether its drug, Myotrophin, would be approved. If the drug was approved, the firm might need substantial additional funds to commercialize as well as to buy back rights to it (which had been sold earlier to...
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Keywords:
Risk Management;
Financing and Loans;
Health Care and Treatment;
Pharmaceutical Industry;
United States
Tufano, Peter, Geoffrey Verter, and Markus Mullarkey. "Cephalon, Inc." Harvard Business School Case 298-116, April 1998.
- May 2021 (Revised May 2022)
- Case
Headspace vs. Calm: A Mindful Competition
By: Ayelet Israeli and Anne Wilson
By 2021, the mindfulness app wars reached their apex. Over 2,000 meditation apps were available to consumers, but two apps, Headspace and Calm, dominated the space, jointly holding about 70% of the total market. Headspace had established itself as the approachable...
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Keywords:
Marketing Communication;
Integrated Strategy;
Brand;
Brand & Product Management;
Brand Communication;
Brand Differentiation;
Brand Building;
Brand Management;
E-Commerce Strategy;
Ecommerce;
App;
App Development;
Applications;
COVID;
COVID-19;
Pandemic;
Pricing;
Pricing Strategy;
Subscription Model;
Subscription;
Partnerships;
Strategic Partnerships;
B2B Vs. B2C;
B2B;
Health & Wellness;
Wellbeing;
Digitization;
Commoditization;
Mobile App;
Mobile App Industry;
Mobile Healthcare;
Mobile Marketing;
Digital Brand;
Digital Health;
Consumer Health;
Apps;
Online Business;
Online Competition;
Online Community;
Online Entertainment;
Entertainment And Leisure;
Meditation;
Marketing;
Marketing Communications;
Brands and Branding;
Price;
Strategy;
Competition;
Competitive Strategy;
Competitive Advantage;
Partners and Partnerships;
Health;
Well-being;
Mobile and Wireless Technology;
Communication;
Communication Strategy;
Disruption;
Consumer Behavior;
Digital Marketing;
E-commerce;
Applications and Software;
Health Industry;
Technology Industry;
Communications Industry;
United States;
North America;
United Kingdom
Israeli, Ayelet, and Anne Wilson. "Headspace vs. Calm: A Mindful Competition." Harvard Business School Case 521-102, May 2021. (Revised May 2022.)
- December 2014 (Revised August 2015)
- Case
Improving Melanoma Screening: MELA Sciences
By: Regina E. Herzlinger, Kevin Schulman and Frédéric Dijols
MELA is a start-up medical device company looking to develop a novel technology to help physicians diagnose a deadly skin cancer, melanoma. The case reviews the FDA medical device development process, the development path pursued by MELA, and the regulatory and...
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- 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.
- 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.)
- April 2020
- Article
Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning
By: Ariel Dora Stern and W. Nicholson Price, II
In recent years, the applications of Machine Learning (ML) in the health care delivery setting have grown to become both abundant and compelling. Regulators have taken notice of these developments and the U.S. Food and Drug Administration (FDA) has been engaging...
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Keywords:
Machine Learning;
Causal Inference;
Health Care and Treatment;
Safety;
Governing Rules, Regulations, and Reforms
Stern, Ariel Dora, and W. Nicholson Price, II. "Regulatory Oversight, Causal Inference, and Safe and Effective Health Care Machine Learning." Biostatistics 21, no. 2 (April 2020): 363–367.