Students will be exposed to the conceptual foundations of biotechnology and the role played by discoveries and applications of molecular biology principles in advancing biotechnology horizons. This is a case-based course in which students will read landmark original papers and patents that shaped biotechnology, and discuss these in the class.

This course examines the role of genes, proteins and RNA in causing or combating diseases, and emphasizes the current conceptual and analytical tools that are brought to bear, and their limitations, on our understanding.

The science, technology and regulatory issues surrounding biopharmaceuticals.

Healthcare Informatics is a novel academic discipline bridging Medicine and Information Sciences that may be defined as the science that deals with the structure, acquisition and use of medical information. With the global boom in healthcare and quantum advancements in IT, medical informatics is already transforming the way healthcare is delivered today. In the last few decades we have witnessed the rapid development of extremely efficient genome sequencing and other high-throughput molecular biology research techniques. With these techniques came the need to store, make available, and analyze huge amounts of biological data. Bioinformatics brings together computer sciences, information technology and biology, to efficiently store and mine these datasets. The proliferation of databases, access of data, and new analysis methodologies necessitates that those involved in life sciences be proficient in the utility of databases and the manipulation and analysis of large data sets.

This course provides an overview of the in vitro diagnostics industry and will enable students to acquire the basic knowledge and skills needed to understand and ultimately design diagnostic assays and devices. Students will become familiar with the fundamentals of biomolecular recognition, assay development, engineering design, device fabrication, optics, fluid mechanics, and laboratory automation.

This course presents an overview of medical devices through the years, from historic breakthroughs to more recently developed devices associated with areas of high job growth.

This course is designed to provide you with an understanding of how pharmaceutical and biotechnology companies discover new drugs. This course will focus on the discovery of small molecule drugs.

Graduates in molecular biology, bioengineering, and many other fields can potentially take advantage of many exciting and lucrative career opportunities in biotechnology development, manufacturing, commercial operations, business development, licensing, and investment fund management.

This course follows course ALS 330 and together these course are designed to provide an understanding of how pharmaceutical and biotechnology companies discover, develop, and bring drugs to market. This course will focus on the development of drugs.

This 15-week course, will cover a number of ethical and broader social issues related to bioindustry, with the goal of familiarizing students with up-to-date thinking on these issues.

The goal of the course is to gain an appreciation and understanding of the topics covered.

The goal of this course is to develop a basic understanding of financial decision making.

The focus of this course is on the scientific study of behavioral processes in organizations. It highlights critical management issues involved in planning, organizing, controlling, and leading an organization. This course aims to strengthen students’ managerial potential by providing general frameworks, or “foundations,” for analyzing, diagnosing, and responding to complex organizational situations.

This introductory course in strategy is designed to help you beat the odds by improving your ability to perceive and seize success formulas before others do.

The course will equip students with an understanding of conceptual frameworks in market strategy and market assessment with reference to bioscience industries.

This course is designed around four broad themes: effective writing, oral communication, teamwork and leadership. Classes will be a blend of interactive lectures from faculty and industry executives, and workshops. Oral and written exercises will be coordinated with individual and team projects in ALS 320 and ALS 359, and students will participate in faculty and peer reviews to help each other improve professional skills.

This course incorporates psychology with traditional premed professional development to offer students the most well-rounded preparation for medical school.

The Team Masters Project (TMP) is the capstone activity for second-year Master of Bioscience (MBS) students and for Postdoctoral Professional Masters (PPM) students. It is assigned 2-course credits each semester for a total of 4 course credits and a passing grade in both semesters is required for graduation with an MBS or PPM degree.

This course will provide students with a background of the scientific basis of some key aspects of biotechnology based drug, biologic and vaccine design, discovery and development process. Students will learn about therapeutic and vaccine targets, and how the drugs and vaccines are designed, tested and produced.

This hands-on lab course focuses on applications of laboratory automation and high throughput technologies in drug discovery, biomarker discovery & validation, and basic research.

This course surveys the technology currently available for whole genome sequencing, the technical advancements that must occur before “$1,000 a genome” becomes a reality, the source and range of variations in human genomes, current methods and theories that associate variants with disease susceptibilities/drug responsiveness, their respective weaknesses, and ethical, legal, and business implications of personal genomics.

This course covers emerging, high impact, and high growth rate areas of the in vitro diagnostics industry such as novel immunoassay formats, diagnostic applications of flow cytometry, molecular diagnostics and pharmaco-genomics, personalized medicine and drug diagnostic co-development, point of care diagnostics in developed countries and in global health / limited resource settings, as well as micro-fluidics and nano-technology in diagnostics.

This course focuses on the use of laboratory automation and high throughput technologies in small molecule drug discovery, biomarker discovery, and basic research.

The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance and control. Through a series of lectures and case studies this course will teach the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.

This half-unit laboratory course provides hands-on experience with many of the techniques and principles taught in the complimentary lecture course, ALS 429.

This course focuses on issues specific to operations in biotechnology, including high variability in process operations, the need for very high supply reliability (no patient goes without) as well as long cycle times for biotech manufacturing.

Operations Management is concerned with the production and delivery of goods and services to meet customers' demands. It is one of the central functions of every business, government agency, and non-profit organizations.

This course covers technical and managerial aspects involved in the development and manufacturing of instruments used in the devices and diagnostics industry, through a combination of lectures and case studies, delivered by the course instructors and invited industry experts.

This course presents an overview of the Design Control process for product development, which is mandated by the Good Manufacturing Practices of the Food and Drug Administration (FDA). To complement Design Control, market release and post-market surveillance topics are also highlighted.

The scientific, engineering, and practical industrial aspects will be presented in a series of lectures.

This course provides the opportunity for students to gain first hand experience in bioprocessing research as part of the bioprocessing community at KGI.

Graduates in molecular biology, bioengineering, or many other fields can potentially take advantage of many exciting and lucrative careers opportunities in biotechnology development, manufacturing, commercial operations, quality assurance, regulatory affairs, business development, licensing, and investment fund management.

This course should provide the student with a deeper understanding of how pharmaceutical and biotechnology companies discover new drugs, and how larger companies manage their drug discovery portfolios

This course will equip students with an understanding on how to write an orphan drug designation application. The course will begin with a FDA Workshop on September 13, 2010 on how to write an orphan drug designation application. This workshop will be held at KGI and conducted by Dr. Matthew Thomas from the FDA. Students will receive further information from Dr Phillips on how to write their own orphan drug applications.

This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products.

This half-course provides a basic primer in statistical methods commonly used in the design of clinical trials.

This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States.

The course attempts to provide a general framework on which to fit future specialized knowledge encountered during a career in the various biomedical fields. Some of the subjects addressed are: underlying principles of pharmacology and clinical biology, assessing and weighing benefits and risks, how physicians select therapies for a given disorder, how side effects are assessed and dealt with, and how issues of cost and compliance are handled.

The course provides overviews of disease categories, issues of cost, marketing, and the clinical trial process.

This course examines the sources of financing available to start-up companies as they progress thorough the different stages of a firm’s lifecycle. The course introduces methods of valuation used by venture capitalists and other investors when considering investing in early stage firms. The course also examines alternative exit strategies and the impact of each strategy on the entrepreneur and the investors.

This course will equip students with tools to effectively understand global marketplace issues within the life sciences. The course has three broad aims.

This course focuses on marketing and its role within organizations. It introduces the marketing concept, examines its relationship to other functions in the firm and looks at techniques and frameworks used to examine marketing environments, understand consumer and organizational buying behavior, segment markets and position products, develop new products, manage existing products and promote, price and place products.

This course examines the role of networks within industries and within firms in allowing some companies to outsmart and outperform others.

The course will be concerned with new venture (seed-stage) business formation and implementation issues that relate to conceptualizing, developing and managing successful new ventures. These issues include corporate governance, entrepreneurial financing, competition, negotiation of term sheets and special issues related to seed-stage firms concerning intellectual property and technology transfer.

The focus of this course is on the concepts and practice of creating a new business. The course has many components in our attempts to make it realistic and useful, and these can be collected into two major categories: identifying and evaluating business opportunities, and conceiving, writing, executing and defending a business plan.

The course will consist of tutoring, lectures, small group writing, editing, and reviewing by the faculty advisor, and between the student team participants. The course requires dedicated focus to the chosen topic and a series of deadlines that must be met.

This course should provide students with a deeper understanding of the important role of Phase I studies in early pharmaceutical development. Students expand their knowledge of the business and scientific aspects of initiating first-time-in-human (FTIH) Phase I studies.

This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing).

The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires professionals have a good working knowledge, background and understanding of FDA's most recent developments, trends and legislation affecting product development, licensing and manufacturing of current and future pharmaceutical products and devices. ALS 463 is a one-credit course that will provide students with a broad background and understanding of the most current regulatory developments, strengthening their capacity to discuss and address contemporary issues effecting the pharmaceutical and medical device industry. The student will become familiar with the challenges posed by recent legislation and enforcement and be better able to analyze, plan and navigate in the dynamic and complex medical products industry.

The successful management of technological innovation is essential to the success of many life science businesses, whether in human therapeutics, medical devices or biofuels. This course examines firm strategies for creating sustainable competitive advantage in technology-based industries.

Most valuation courses focus on the valuation of a firm; however, in this course students will learn to address the issues of valuation, which are created by the limited exclusivity periods (patent protection) typical for intellectual property.