Mr. Sailstad Brings Over 35 Years of Experience Developing, Validating, and Applying Regulatory-Compliant Methods for Biological and Immunological-Based Testing
JANUARY 30, 2017–Durham, NC—BioAgilytix, a leading provider of contract bioanalytical testing services with specialization in large molecule bioanalysis, has announced the addition of Jeff Sailstad to its leadership team as USA Chief Scientific Officer. Mr. Sailstad brings with him an extensive background working with pharmaceutical and biotechnology organizations to develop, validate, and apply regulatory-compliant methods for biological and immunochemistry assays. He is a world-renowned thought leader in the development and application of bioanalytical methods used in regulatory submissions, and is specifically skilled in mentoring scientific teams on how to meet increased regulatory requirements as they move projects from research to full development.
While Mr. Sailstad will be working closely with many departments in his role at BioAgilytix, a primary focus will be supporting operations for assay development, qualification, and validation, as well as providing strategic oversight of study and experimental designs. He will be offering BioAgilytix’s clients solutions that enable them to get their products to market quickly while ensuring safety. “BioAgilytix deals with a number of exciting, complex large molecule studies, and I’m looking forward to contributing my expertise to support these challenging projects,” said Sailstad. “As a team we will help ensure that our customers’ studies uphold the demands of regulatory agencies and enable a smooth, streamlined submission process as those studies progress.”
“Jeff is recognized by regulatory agencies as a leader in the application of statistically sound practices for bioanalytical method development, and his deep regulatory expertise will be of great benefit to our organization,” said Jim Datin, Chief Executive Officer of BioAgilytix. “Jeff’s veteran expertise perfectly complements that of the other expert scientists on our leadership team, and his addition further strengthens our differentiation as one of the most expert teams in large molecule bioanalysis in the world.”
BioAgilytix is a leading bioanalytical testing laboratory specializing in large molecule bioanalysis. With laboratory locations in North Carolina’s Research Triangle area and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of biologics across a number of industries and disease states. BioAgilytix offers assay development, validation, and sample analysis under non-GLP, spirit-of-GLP, GLP, and GCP, as well as product release testing under GMP.
BioAgilytix’s team of highly experienced scientific and QA professionals ensures high quality science, data integrity, and regulatory compliance through all phases of clinical development, and is a trusted partner to 23 of the top 25 global pharmaceutical and biotech companies. For more information, visit www.bioagilytix.com.