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August 2001
Case

Scios, Inc.

By: Regina E. Herzlinger

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. View Details

Keywords: Governing Rules, Regulations, and Reforms; Health Care and Treatment; Cost Management; Cost vs Benefits; Social Issues; Pharmaceutical Industry; United States

November 1991 (Revised April 1994)
Case

Nucleon, Inc.

By: Gary P. Pisano

Nucleon is a small biotechnology company whose first potential product is about to enter clinical testing. Before Nucleon can begin clinical trials, however, its management must decide how and where to manufacture the product. Three options are being contemplated: 1)... View Details

Keywords: Factories, Labs, and Plants; Entrepreneurship; Health Testing and Trials; Rights; Product Development; Production; Partners and Partnerships; Research and Development; Biotechnology Industry

June 2011 (Revised October 2013)
Case

Gene Patents (A)

By: Richard Hamermesh, David Kiron and Phillip Andrews

In March 2010, U.S. District Court Judge Robert Sweet overturned 30 years of legal precedent and ruled that unaltered human genes could not be patented. This case reviews patent law and how it relates to our increasing knowledge of the Human Genome. The case issues... View Details

Keywords: Courts and Trials; Patents; Genetics; Judgments; Science-Based Business; Biotechnology Industry; United States

Research Summary

Research Interests

Research interests are focused on issues of innovation and productivity as they relate to improved outcomes in biotechnology and pharmaceutical R and D. These span topics from decision-making, organizational structure and communication, to the development of novel... View Details

October 2001 (Revised April 2002)
Case

Calgene, Inc.

By: Ray A. Goldberg and John T. Gourville

In 1993, Calgene is on the verge of introducing the world's first genetically engineered plant product--a tomato will taste better and stay fresh longer. At the same time, it is using biotechnology to produce improved plant products for the cottonseed and the... View Details

Keywords: Information Technology; Marketing Strategy; Market Entry and Exit; Product Launch; Innovation Strategy; Social Issues; Production; Problems and Challenges; Biotechnology Industry; Biotechnology Industry

August 2009 (Revised April 2012)
Case

Genzyme's CSR Dilemma: How to Play its HAND

By: Christopher A. Bartlett, Tarun Khanna and Prithwiraj Choudhury

Genzyme, a global biotechnology company, launches a program to develop therapies for neglected diseases (e.g., malaria, TB), giving away the intellectual property. This case focuses on the decision of which diseases, which partnerships, and which markets should... View Details

Keywords: Global Strategy; Health Care and Treatment; Intellectual Property; Corporate Social Responsibility and Impact; Partners and Partnerships; Research and Development; Biotechnology Industry

December 2012
Teaching Note

Gene Patents (A) (TN)

By: Richard G. Hamermesh and Matthew Preble

This is the teaching note for case Gene Patents (A). In March 2010, U.S. District Court Judge Robert Sweet overturned 30 years of legal precedent and ruled that unaltered human genes could not be patented. This case reviews patent law and how it relates to our... View Details

Keywords: Biotech; Human Genome; Patents; Genetics; Biotechnology Industry; United States

October 2012 (Revised March 2022)
Case

Kleiner-Perkins and Genentech: When Venture Capital Met Science

By: Felda Hardymon and Tom Nicholas

Genentech is a rare success story in the biotechnology industry. Hundreds of billions of dollars of venture capital have been invested without the expected transformational effects. Established in 1976, Genentech was to develop the new science of recombinant DNA into... View Details

Keywords: Innovation ＆ Entrepreneurship; Venture Capital; Innovation and Invention; Entrepreneurship; Information Technology; Science; Biotechnology Industry; United States

December 2009 (Revised February 2012)
Case

Monsanto: Helping Farmers Feed the World

By: David E. Bell, Carin-Isabel Knoop and Mary Shelman

Monsanto has led the effort to bring biotechnology to bear on food production. Through some management missteps and consumer resistance the company had difficulties in its early years. But since Hugh Grant became CEO the picture has brightened with widespread adoption... View Details

Keywords: Food; Global Strategy; Leadership; Production; Agriculture and Agribusiness Industry; Biotechnology Industry; United States

June 2018
Teaching Note

Sandra Brown Goes Digital

By: Rosabeth Moss Kanter and Jonathan Cohen

As a middle manager at a biotechnology company, Sandra Brown harnessed digital tools and social media to engage others and build campaigns for change in the company. This Teaching Note presents strategies for teaching the Sandra Brown case series, which follows Brown's... View Details

Keywords: Change Leadership; Change Management; Digital; Engagement; Stakeholder Engagement; Grassroots Movement; Health Care Industry; Career Path; Innovation; Leading Change; Management; Innovation and Management; Personal Development and Career; Organizational Change and Adaptation; Quality

October 2016 (Revised September 2017)
Case

The CRISPR-Cas9 Quarrel

By: Richard G. Hamermesh and Matthew G. Preble

In mid-2016, the Broad Institute and the University of California, Berkeley were in the middle of a contentious patent dispute over which entity controlled a breakthrough gene editing technology called CRISPR-Cas9. With CRISPR-Cas9, scientists might soon be able to... View Details

Keywords: CRISPR; Broad Institute; University Of California Berkeley; Intellectual Property; Patents; Law; Lawsuits and Litigation; Science; Genetics; Entrepreneurship; Biotechnology Industry; United States

April 1993 (Revised May 1994)
Case

Genzyme Corporation: Strategic Challenges with Ceredase

Genzyme Corp., one of the largest biotechnology companies, has succeeded in developing, manufacturing, and commercializing its first therapeutic, a treatment for a rare genetic disease. Analysis of the case requires students to identify and understand how Genzyme has... View Details

Keywords: Risk Management; Risk and Uncertainty; Corporate Strategy; Technology; Health; Product Development; Biotechnology Industry; Biotechnology Industry; United States

January 1996
Case

Biogen, Inc.: rBeta Interferon Manufacturing Process Development

By: Steven C. Wheelwright

Biogen, Inc., a Cambridge, MA-based biotechnology company, is wrapping up a project to develop a new manufacturing process for a new drug product that will reposition the company from a purely research-oriented company to a fully integrated pharmaceutical manufacturing... View Details

Keywords: Learning; Technological Innovation; Management Analysis, Tools, and Techniques; Product Development; Organizational Change and Adaptation; Projects; Research and Development; Corporate Strategy; Biotechnology Industry

2006
Book

Science Business: The Promise, the Reality, and the Future of Biotech

By: Gary P. Pisano

Why has the biotechnology industry failed to perform up to expectations—despite all its promise? In Science Business, Gary P. Pisano answers this question by providing an incisive critique of the industry. Pisano not only reveals the underlying causes of... View Details

Keywords: Science; Business Ventures; Biotechnology Industry

Find at Harvard

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... View Details

Keywords: Cancer; Therapeutics; Drugs; Health Care and Treatment; Business Startups; Product Development; Financing and Loans; Growth and Development Strategy; Problems and Challenges

February 2000 (Revised October 2000)
Case

Kendle International Inc.

By: Dwight B. Crane, Paul W. Marshall and Indra Reinbergs

Candace Kendle and Christopher Bergen, the CEO and COO of Kendle International, Inc., are reviewing ways to finance the growth of their privately-owned company. Kendle is a contract research organization that conducts clinical drug trials for pharmaceutical and... View Details

Keywords: Acquisition; Financing and Loans; Venture Capital; Stock Options; Banks and Banking; Debt Securities; International Finance; Financial Strategy; Management Skills; Private Ownership; Initial Public Offering; Biotechnology Industry; Biotechnology Industry

Research Summary

Does the Adoption of Rolling Forecasts Improve Planning?

This field study investigates the consequences of adopting rolling forecasts on organizational planning. Using quarterly product-line forecasted and realized sales data from several business units of a multinational biotechnology supplier, I find that subsequent to the... View Details

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; Biotechnology Industry

April 1993 (Revised October 1995)
Case

ALZA and Bio-Electro Systems (A): Technological and Financial Innovation

By: Josh Lerner and Peter Tufano

To develop the next generation of risky products, ALZA, a mature and profitable biotechnology firm specializing in drug delivery systems, must raise $40 million. Organizational constraints and competitive concerns demand that the work be done inside the firm. However,... View Details

Keywords: Risk and Uncertainty; Technological Innovation; Business Subsidiaries; Decision Choices and Conditions; Corporate Finance; Biotechnology Industry; Biotechnology Industry

January 2011 (Revised January 2012)
Supplement

The Case of the Unidentified Healthcare Companies2010 (CW)

By: Richard M.J. Bohmer, Ethan S Bernstein, Margarita Krivitski and Srinidhi Reddy

This case presents financial statements and selected rations for 14 unidentified healthcare organizations and asks that each set of financial information be matched with one of the following healthcare companies: a biotechnology firm, a community nursing company, a... View Details

Keywords: Financial Statements; Financial Management; Health Care and Treatment; Biotechnology Industry; Biotechnology Industry

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