Events

Join us for the demonstration of the prototype of an automated software tool for determining cut point using Random Effects Model. Additionally, Dr. Stephanie Pasas-Farmer will be presenting at Bioassay Summit as well as co-presenting with Dr. Cheikh Kane from KCAS at Immunogenicity Summit.

In April 2022, we discussed the role of molecular testing platforms, such as qPCR, ddPCR and NGS in enabling discovery and development of cell and gene therapy products. These technologies were recently introduced to bioanalysis of cell and gene therapy products, resulting in many unanswered questions on the appropriate use of these technologies in the field of bioanalysis, especially due to the lack of prescriptive guidance. We will use a redacted and anonymized qPCR case study to answer some of the questions that frequently come up.

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.

LAWRENCE, KS, March 8, 2021 ̶ On February 25, 2021, the Lawrence Chamber of Commerce officially welcomed Ariadne Software®, LLC to Lawrence, Kansas. Ariadne, a pharmaceutical software developer, employs advanced computational techniques and artificial intelligence to review and audit scientific data generated during drug discovery and development. The company, which moved from Philadelphia to Lawrence, has been growing and has added a job and an internship in the past four months in the Lawrence area. To add more resources, Ariadne leveraged the resources provided by the city and the Lawrence Chamber of Commerce to get a small business loan awarded from the Kansas Community Investment Fund through NetWork Kansas and Great Plains Development, Inc. on March 5, 2021.

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.