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Expression Analysis
BT 3125 / 4 q.h.
Boston
The explosion in microarray technologies allows scientists to measure the expression level of thousands of genes simultaneously from a single biological sample on one “gene chip.” This course will survey available expression measurement techniques with a discussion of their relative strengths and weaknesses. The course provides hands-on practice searching databases for sequence similarities. Students will discuss data visualization, and clustering and analysis, including applications to toxicology, drug target, and diagnostic marker discovery.
(formerly BIO 3120, Expression Analysis)
Clinical Trial Design Optimization and Problem Solving
BT 3213 / 4 q.h.
Quantitative data analysis in the creation of dynamic drug-disease models, strategic market models, trial simulation models, and integrated financial models enable the analysis of key variables in development of clinical trials in real time. This integrated approach allows all decisions in the design to optimize value against both scientific and business criteria simultaneously and continuously. Students will learn to take a complete view of the development process at the outset -- across time, across the portfolio, and at all levels in the organization. This allows for greater insight into a drug's potential early in the development process and leads to a more focused development program for promising compounds, including an optimized clinical trial design. It also allows for earlier cessation of unpromising clinical trials, saving development time and funds.
The Business of Medicine and Biotechnology
BT 3500 / 4 q.h.
Developing new drugs, biologics, and medical devices involves much more than simply showing a clinical benefit. Understanding how integrating cost, reimbursement, intellectual property, product liability, and FDA issues into an overall product development strategy is vital in bringing a new medical product to the American market. And in light of high-profile product failures such as VIOXX and others, reimportation of drugs, reuse of single-use medical devices, and the impact of generic biologics, keeping your medical product on the market can be as much of a challenge as getting it there. In this course, students use group discussions and debates to consider current case studies in order to understand how and why certain medical products succeed while others do not. The course concludes with a group debate where students recreate an FDA panel meeting to try and understand the FDA approval process. |
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