How To Translate Academic and Discovery Assays Into GLP Compliant Assays

Why Should You Attend:

Every day, there are a number of novel and interesting discoveries that are published in 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.

This webinar will help attendees to fill in the gaps with confidence and learn what one needs to find out to shepherd key discoveries between worlds to ultimately further the goal of the biotechnology and pharmaceutical industries of improving human life.

Areas Covered in the Webinar:

This webinar will help attendees identify the key steps needed to be taken while transitioning a new assay from the academic world to the industrial world. The webinar will include the following critical information:

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

Who will Benefit:

This topic applies to personnel / companies in the biotechnology and pharmaceutical industries. The employees who will benefit most include:

• Senior management
• Quality Assurance
• Research and Development
• Project management

Instructor Profile:

Todd Graham, is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. Mr. Graham has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries. He has a broad level of expertise in assay development for quality control, pharmaceutical development and clinical diagnostics. His particular levels of expertise are molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He is also in the process of establishing a consultancy that assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.

Topic Background:

While academic research needs only to be novel, interesting and scientifically sound to be published, there may be gaps in the known information about the assay to allow it to go into production use, either for internal industrial research laboratory efforts, clinical trial usage or even for use as a diagnostic assay.

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