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Biotechnology

Courselist

  • BIOT E-200 Graduate Research Methods and Scholarly Writing in Biotechnology (Fall, Spring)
  • BIOT E-205 Drug Discovery, Project Design, and Management (Spring)
  • BIOT E-210 Biotechnology in Drug Development: Tools for Business (Fall)
  • BIOT E-215 Elements of Clinical Investigation (Spring)
  • BIOT E-220 Introduction to Regulatory Affairs for Biotechnology Professionals (Fall)
BIOT E-200 Graduate Research Methods and Scholarly Writing in Biotechnology
Fall term, Section 1 (13645)
Kristy Townsend, PhD, Postdoctoral Research Fellow, Joslin Diabetes Center, Harvard Medical School.
Wednesdays beginning Aug. 31, 7:35-9:35 pm.
Course tuition: graduate credit $1,900.
Graduate proseminar. Limited enrollment.
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Fall term, Section 2 (13855)
*** BIOT E-200 Fall term, section 2 (13855) has been CANCELED. ***
Spring term (23457)
Mary Ellen Wiltrout, PhD, Preceptor in Molecular and Cellular Biology, Harvard University.
Wednesdays beginning Jan. 25, 5:30-7:30 pm.
Course tuition: graduate credit $1,900.
Graduate proseminar. Limited enrollment.
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In this proseminar, we focus on science writing, data interpretation, and collaborative and independent experimental design. Students who successfully complete the course will be those who demonstrate an ability to assess information from the primary scientific literature, a command of oral and written communication skills, and the ability to generate a logical progression of experiments to help validate or nullify their hypothesis. Reading materials include publications on scientific writing and experimental design. The fall section covers the biology of obesity and body weight regulation and the spring section focuses on DNA repair and mutagenesis. Prerequisites: instructors assume that students already have undergraduate degrees in an area of life, physical, or computer science, as well as professional scientific training. Scientists coming from a physical or computer science background should successfully complete BIOS E-1a and BIOS E-1b as well as BIOS E-12 before attempting to take BIOT E-200. Students must earn a satisfactory score on the mandatory test of critical reading and writing skills. (4 credits)
BIOT E-205 Drug Discovery, Project Design, and Management
Spring term (23604)
Donald R. Kirsch, PhD, Chief Scientific Officer, Cambria Pharmaceuticals.
Thursdays beginning Jan. 26, 5:30-7:30 pm.
Course tuition: noncredit $650, graduate credit $1,900.
Website Printable version
The course outlines the basic principles underlying the design of drug discovery campaigns and the management of such programs without formal authority (matrix management). The course acquaints the student with current drug discovery practices in the biotechnology and pharmaceutical industries. The steps in the process are presented and strategic considerations are discussed through case studies. The course helps prepare students who already have a background in the scientific disciplines underlying drug discovery (cell biology, biochemistry, molecular biology, genetics, pharmacology, organic chemistry, and medicinal chemistry) to take on the design and management of research programs aimed at the discovery of new or improved pharmacological agents. The course is not specific to one therapeutic area but rather provides information common to drug discovery in all therepeutic areas. Prerequisites: the course assumes a solid understanding of science. BIOS E-10, BIOS E-12, and BIOS E-16 or the equivalent. (4 credits)
BIOT E-210 Biotechnology in Drug Development: Tools for Business
Fall term (13752)
Lynn C. Klotz, PhD, Consultant in Biotechnology and Biobusiness.
Thursdays beginning Sept. 1, 7:35-9:35 pm.
Course tuition: noncredit $650, graduate credit $1,900.
Syllabus Printable version
This course is an overview of biotechnology in modern drug discovery and development, with an emphasis on business aspects for student with undergraduate degrees in life sciences or business. This course provides science students with the tools and knowledge to embark on biotechnology career paths such as employment in investment, consulting, and legal firms, and non-research roles in biotechnology companies. (4 credits)
BIOT E-215 Elements of Clinical Investigation
Spring term (23639)
Katherine Arbour, ALM, Director of Clinical Data Management, ARIAD Pharmaceuticals.
Tuesdays beginning Jan. 24, 7:35-9:35 pm.
Course tuition: noncredit $1,025, graduate credit $1,950.
Online option available. Lecture 1 video.
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This course provides an introduction to clinical and translational research. Such research is characterized by a spectrum of activities where critical insights are passed between research modalities so that biomedical discoveries can lead to tangible improvement in human health. Students are introduced to the T1-T4 translational research spectrum and become familiar with the essential components necessary to conduct clinical investigation along this translational research pathway. Topics include biostatistics and research design, ethics and regulatory considerations, social science research and health policy, research tools (biomedical informatics, imaging and biomarkers, genetics), and the communication of scientific information. Prerequisite: STAT E-50, or the equivalent. (4 credits)
BIOT E-220 Introduction to Regulatory Affairs for Biotechnology Professionals
Fall term (13742)
Virginia Garcia, MPP, Regulatory Affairs Associate, Advanced Technologies and Regenerative Medicine, LLC.
Mondays beginning Aug. 29, 7:35-9:35 pm.
Course tuition: noncredit $650, graduate credit $1,900.
Website Printable version
The regulatory affairs (RA) environment encompasses the regulations and standards governing product development through post-approval marketing. In today's regulatory environment, biotechnology products may be classified as drugs, biologics, medical devices, or combination products. In almost every country in the world, each type of product is regulated by a different entity and often has its own distinct regulations. Focusing on the United States and the European Union framework, this course provides an overview of RA and how the regulatory environment can shape product development. Course topics include the history of RA, regulatory agencies, accessing regulatory information, drug submissions, biologics submissions, medical device submissions, and FDA inspections. Regulations of other regions such as Canada and Japan are also introduced. (4 credits)

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