Translating Academic Assays for GLP Use

Why Should You Attend:

Laboratory Developed Tests have long been popular tests to perform in clinical diagnostics. These tests can offer unique insights not available using standard diagnostic kits and can offer patients opportunities to improve their health. Historically, the US FDA has used regulatory discretion to not regulate the use of these tests so long as they were performed by qualified personnel. However, changes in both technology and the business of laboratory developed tests have changed the FDA’s perspective with these tests and the regulatory approach therein.

With this webinar, you will learn what the FDA is asking for with regard to these new regulations, and how they can be integrated into your laboratory’s regulatory validation. While compliance can be simple for a wide variety of LDTs, others will require a variety of changes. This webinar seeks to help you navigate these changes in order to roll out and maintain laboratory developed tests. Laboratories need to transition technologies all of the time. From new ways to perform assays, to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another.

You will be able to fully understand how your assay is currently running and make note of what the new technology should be able to do. Then you will learn how to slowly get the new technology up and running, validating the quality system, equipment and the assay itself. You will learn what you need to understand in the process of transitioning old samples onto the new system and deal with any potential issues. Finally, you will develop a final validation plan that will allow you to embrace the new technology fearlessly. On a regular basis, there are assays that get developed that have a clear utility in the clinic. However, what may be practical within a research context may not be practical within a clinical context. In addition, these assays have to be able to handle clinically relevant samples, which often differ from the samples used in research studies. Unless an assay can give clinically actionable results in a clinical laboratory, whatever utility the assay may have will be useless to clinical practioners, who have different demands than research laboratories. By the time you are finished with this seminar, you will be able to learn what needs to be done to an assay to make sure it is ready for the clinic and how to validate such changes. In addition, you will learn how to select a clinically relevant population for a given assay, validate the assay within such a population and how to select Gold Standards for comparison. Finally, you will be able to develop clinical quality monitoring standards to make sure the assay remains relevant in a clinical context Every day, there are a number of novel and interesting discoveries that are published in the academic literature. Many of them, if proven to be true, will lead to improved industrial research and potentially improved human health. However, there is a dramatic difference in documentation standards between the academic world and the industrial world, and learning how to bridge that gap successfully will require strong investigational skills to find out what truly happened during the performance of the assay and the conditions therein needed to perform it.

After this seminar, you will be able to fill in the gaps with confidence and learn what you need to find out to shepherd key discoveries between worlds to ultimately further the goal of the biotechnology and pharmaceutical industries of improving human life.

Learning Objectives:

1. What are the key differences between a research assay and a clinical assay?
2. How to make sure an assay can regularly be performed by a medical technologist, and how to validate those changes?
3. How do you find clinical relevant samples to test your assay against?
4. How to find a Gold Standard assay and develop a validation plan against it?
5. How to validate an assay for clinical use?
6. How to develop a clinical quality plan to make sure the assay remains valid?

Areas Covered in the Webinar:

1. What to look for in lab books and other notes to see what was performed
2. How to ask academic scientific staff for other key information they may not realize is important
3. How to determine whether a test is feasible for industrial usage, regardless of the technical validity of the test
4. How to track down controls, reagents and test appartus and test them using existing methods for suitability and quality
5. How to develop the necessary reagents needed to perform the assay in an industrial context
6. What kinds of repetition and repeatability studies are typically needed

Who Will Benefit:

• Senior management
• Quality Assurance
• Research and Development
• Medical Technologists

Todd Graham
Managing Partner, Delevan Street Biosciences

Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

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