Events

Stephanie Pasas-Farmer had a problem. Drawing upon the field of artificial intelligence, she had created a software tool to make her own job as a pharmaceutical researcher less tedious while improving the quality of her data. But once she formed a company to sell that tool to others, she encountered unexpected resistance. Potential users feared the software might replace their jobs. Or that the emphasis on quality implied there was something wrong with their work.

Balance design and its requirement in the successful establishment of an Anti-Drug Antibody (ADA) cut point is a hot button topic currently. Although it is stated directly in the FDA 2019 guidance that “balance study designs should be used for cut-point determination”, this requirement is not strictly followed within the industry. Many reasons are reported for this lack of adherence to this recommendation the most prevalent one being that this approach is more of a “nice to have” rather than a “must have” for appropriate setting of a cut point during validation. The goal for this e-Chalk Talk is to walk through a general overview of what a balance design is and why it is truly needed to successfully set a cut point for ADA determination.

Join us via Facebook Live for a virtual ribbon cutting to celebrate with Ariadne Software, LLC on February 25 at 4:00pm!

October 30, 2020

October 29, 2020