Short Course Description

Automation for In Vitro Diagnostics

Course Description

In vitro diagnostics (IVD) entails the diagnosis, screening, and monitoring of human diseases based on identification and quantification of small molecules, proteins, nucleic acids, or cells obtained from patient specimens. Automation has fundamentally changed the IVD industry, and continues to play an important role in the move towards disseminated testing and personalized medicine.

Who Should Attend

Anyone interested in a general overview of the in vitro diagnostics industry with a focus on automation approaches and emerging trends.

How You'll Benefit from This Course

  • Become aware of the main in vitro diagnostics market segments
  • Understand the automation needs for clinical diagnostics versus drug discovery
  • Discuss case examples that illustrate automation approaches for a centralized clinical laboratory, and for point of care testing
  • Discuss how biomarkers can bring together diagnostics and therapeutics under the umbrella of personalized medicine
  • Learn about the path to market for new IVD products

Course Topics

  • Overview of the In Vitro Diagnostic Industry
  • Automation in the Clinical Laboratory
    • Impact and Requirements
    • Case Examples*: Clinical Chemistry & Immunoassays; Histology & Cytology; Hematology & Coagulation
  • Automation for Point of Care Diagnostics
    • Impact and Requirements
    • Case Examples: Diabetes monitoring; Hospital POC testing; Telemedicine
  • Emerging Trends: Biomarkers and Personalized Medicine
  • Product Development and Regulatory Requirements for Medical Diagnostics

* Note: this course does not cover automation for molecular diagnostics (i.e. nucleic acid testing), which is the topic of another SLAS short course


Course Fee:
US $500/$600*
Course Format:
Lecture
Class Limit:
40


Instructors:

Angelika Niemz Angelika Niemz, Ph.D.

Keck Graduate Institute
Claremount, CA
USA

Dr. Niemz, a native of Germany, received her undergraduate degree in chemistry in 1992 at the University of Konstanz (Germany), and her PhD in chemistry in 1999 at the University of Massachusetts (Amherst). After working as a Postdoctoral Fellow in Chemical Engineering at the California Institute of Technology, she joined Keck Graduate Institute in 2002, first as Assistant and since 2008 as Associate Professor. Since 2009 she serves as Director of Research. At Keck Graduate Institute, she teaches courses on medical diagnostics, high throughput technologies, and instrumentation development. Her current research focuses on development of assays and devices for isothermal nucleic acid amplification and associated sample preparation and detection methods for molecular diagnostics applications. In 2009, she worked during a 6-month sabbatical for Roche Molecular Diagnostics in Switzerland. Her research interests also include nanoscale self-assembly and molecular recognition in biological and man-made systems.


Jim Osborne Jim Osborne, PhD.

Industry professor
Director of the Center for Biomarker research
Keck Graduate Institute
Claremont, California
USA

Jim Osborne earned his Bachelor of Arts and Master of Science degrees in Chemistry from the University of Maryland in Baltimore County, and his doctorate in Biochemistry from the University of Maryland Medical School in Baltimore. From 1974 to 1985 he was a staff researcher at the National Heart, Lung and Blood Institute at NIH in Bethesda, Maryland.

At NIH, Jim studied cholesterol transport and lipoprotein metabolism and investigated the hydrodynamic and enzymatic properties of apolipoproteins, choleragen, hepatic lipase, calmodulin and various other proteins and lipids. His research was aimed at understanding reversible homogenous and heterogeneous interactions between proteins and involved analytical ultracentrifuge and circular dichroic studies. For the past 25 years Jim has worked at Beckman Coulter, Inc. where he directed research, and was involved in the development and commercialization of a new analytical ultracentrifuge, applications and attachments for robotic workstations, capillary electrophoresis instruments, DNA synthesis and sequencing systems, DNA and Immunoassay multiplex arrays, as well as numerous reagent kits for diagnostic testing.

Jim is currently Director of the Center for Biomarker Research at the Keck Graduate Institute and is investigating better diagnostic biomarkers for rare diseases.


* higher fee applies to those who are not SLAS members



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