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- All HBS Web (171)
- Faculty Publications (65)
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- All HBS Web (171)
- Faculty Publications (65)
- August 2001
- Case
Scios, Inc.
Scios, filled with distinguished scientists and experienced managers, nevertheless fails to clear the FDA Phase III process for an important biotechnology drug. This case asks the students to analyze the social costs and benefits of the regulatory process.
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- 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...
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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.)
- January 2007 (Revised January 2007)
- Background Note
Note on the U.S. Food and Drug Administration
By: Robert F. Higgins, Richard G. Hamermesh and Virginia Fuller
Describes the U.S. FDA with particular emphasis on its role in the development of new drugs, biologic products, and medical devices today. Provides context for the drug approval process by describing the FDA's history and organizational structure.
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Keywords:
Health;
Governance Compliance;
Policy;
Product Development;
Government and Politics;
Pharmaceutical Industry;
Medical Devices and Supplies Industry;
Biotechnology Industry;
Public Administration Industry;
United States
Higgins, Robert F., Richard G. Hamermesh, and Virginia Fuller. "Note on the U.S. Food and Drug Administration." Harvard Business School Background Note 807-050, January 2007. (Revised January 2007.)
- November 2009 (Revised December 2009)
- Case
GTC Biotherapeutics: Developing Medicines in the Milk of Goats
By: Ray A. Goldberg and Sarah Morton
GTC is the first company in the animal world to receive FDA approval of a transgenic pharmaceutical. What are the implications for other firms in plants and animals and their opportunities to produce new medicines in an economical and safe fashion?
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Keywords:
Health Care and Treatment;
Animal-Based Agribusiness;
Plant-Based Agribusiness;
Science-Based Business;
Medical Specialties;
Product;
Technological Innovation;
Health Industry;
Pharmaceutical Industry;
United States
Goldberg, Ray A., and Sarah Morton. "GTC Biotherapeutics: Developing Medicines in the Milk of Goats." Harvard Business School Case 910-403, November 2009. (Revised December 2009.)
- 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.
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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.
- 24 Sep 2007
- Research & Ideas
The FDA: What Will the Next 100 Years Bring?
(coauthored with Joanna Radin), Perspectives on Risk and Regulation: The FDA at 100, has just been released. The book collects views on the work and challenges of the agency from FDA officials past and...
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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.)
- 2021
- Working Paper
Regulatory Approval and Expanded Market Size
By: Benjamin Berger, Amitabh Chandra and Craig Garthwaite
Regulatory review of new medicines is often viewed as a hindrance to innovation by increasing the hurdle to bring products to market. However, a more complete accounting of regulation must also account for its potential market expanding effects through quality...
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Keywords:
New Medicines;
Regulatory Approval;
Health Care and Treatment;
Research and Development;
Governing Rules, Regulations, and Reforms;
Markets;
Expansion;
Pharmaceutical Industry
Berger, Benjamin, Amitabh Chandra, and Craig Garthwaite. "Regulatory Approval and Expanded Market Size." NBER Working Paper Series, No. 28889, June 2021.
- 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.)
- 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.)
- 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.
- 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.
- 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.
- 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.
- 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;
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.
- 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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- 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 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.)