Biotechnology Operations

Year 1: Spring semester, 4 credits

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Course Overview

This course is designed to provide students with an understanding of how a biotechnology company must operate to be successful and to develop a product for a targeted market.

Students will learn about the specialties of nonclinical and clinical development, regulatory affairs, quality assurance, manufacturing, quality control, and program management, as well as their interdependency in support of a specific marketing plan. Students will learn how each of these disciplines are coordinated and synchronized and will develop an appreciation of how the successful biotechnology firm becomes effective and efficient in operations. Students will participate in practical exercises, which include developing products to fill the corporate pipeline, adding value to their products, and generating revenue for their model firms.

Goals of the Course

Upon completing Biotechnology Operations, each student will understand managerial and technological methods used to develop a biotechnology product.

Biotechnology Operations will cover most technological areas considered under the broad heading of biotechnology. These will include agricultural-biotechnology, plant and animal health, research reagents, diagnostics, and biological products for human health care and therapeutics. Other related subject areas, such as medical devices or drugs, will be mentioned whenever the examples are applicable to the overall objectives of this course. However, the course will focus upon teaching students the overall principles and common practices of biotechnology operations and specific technical areas will provide examples or models.

At the end of Biotechnology Operations, each student will:

• Understand the multiple disciplines required to successfully develop a variety of biotechnology products for targeted markets.
   
  
• Appreciate the need and understand the procedures to plan, manage, coordinate and synchronize development activities within a biotechnology firm.
   
  
• Be able to build team participation so as to increase product value and reach the marketplace with a variety of biotechnology products.
   
  
• Understand common principles applied to the development of various classes or types of biotechnology products.
   
  
• Demonstrate the ability to design a development strategy, clearly communicate objectives, and provide leadership throughout implementation.