ALS408 - In Vitro Diagnostics

ALS408 - In Vitro Diagnostics


This course is taught by Jim Osborne. Jim has a PhD in biochemistry from the University of Maryland Medical School in Baltimore.  From 1974 to 1985, he was a staff member of the National Heart, Lung and Blood Institute at NIH in Bethesda, Maryland.  He joined Beckman Instruments in 1985 as manager of Applications and Centrifuge Research.  He was named Director of Research and Applications in 1987 and was appointed Vice President in 1992.  From 1992 to 1996, he served as Vice President and Director of Advanced Chemistry and DNA Analysis and had responsibility for the Beckman Center of Advanced Capillary Electrophoresis, in addition to various analytical and specific chemistries.  In 1998, he became Corporate Vice President of Advanced Technology.  In 2008, Dr. Osborne transitioned back into academia by joining the faculty of KGI founding the Center for Biomarker Research. (excerpts from http://www.kgi.edu/faculty-and-research/profiles/james-c-osborne.html)

This fall Jim will be teaching ALS408. He's also involved in ALS320.
ALS408 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. Students will acquire in depth knowledge of technical aspects as well as an overview of relevant FDA regulatory concerns and market barriers to the adoption of new technologies. The course consists of lectures supplemented by assigned readings and in class exercises. The last six lectures are dedicated to case studies on IVD applications to particular diseases with student presentations.

Prerequisites

First year MBS science/engineering curriculum, in particular ALS 320.

Topics Covered

Regulation of IVDs, Adoption of new diagnostic tests, Immunoassays, Particle-based assays, Liquid handling, Micro-fluidic technologies, Cytometry: applications, Cytometry: fluidics and optics, Cytometry: GLP guidelines, Histology, Cytology, Infectious diseases, Nucleic acid testing, Pharmaco-genomics
Multivariate index assays, Drug-diagnostic co-development, Point of care diagnostics, Global health: diagnostics in limited resource settings, IVD case studies

Learning Objectives

After completion of this course, students should:
1.)    Be familiar with recent technology developments in the established and emerging areas of the in vitro diagnostics industry.
2.)    Be able to evaluate the advantages and technical limitations of different IVD assay formats and devices.
3.)    Comprehend general approaches, standard parameters, and statistical methods used to characterize IVD assay and device performance.
4.)    Have in-depth knowledge acquired through independent investigation of one emerging, high growth or high impact area of the IVD industry, both from a technical and business perspective. Be able to present this knowledge in oral and written form.
5.)    Understand the regulatory framework governing the IVD industry, regulatory constrains and loop-holes that impact new product development, as well as recent changes in the regulation of novel assay formats.

Grading

Class participation and in-class exercises 20%
IVD Case Study - Written Report and Presentation 40% (identify unmet need and discuss how it can be filled; defend your position and present findings)
Current Topics in Clinical Chemistry - Written Report & Presentaion 40%

Source: http://www.kgi.edu/current-students/academic-affairs/course-catalog/courses/als-408.html