Joe Kaeller is a Managing Partner with Gila Bioscience.  Prior to starting Gila Bioscience, Joe Kaeller was a Director of Manufacturing, Site Manager and Program Manager at DCN Diagnostics. Joe has over 25 years of experience in assay development, design transfer, manufacturing, quality, regulatory and consulting relative to immunoassay and molecular diagnostics.  With a graduate degree from the University of Texas system, Joe continued with work at the UT Health Science Center focusing on the proteasome to provide insight into differences between function and structure between normal and aging tissues, as well as studies into the vestibular system.  This was followed by 23 years’ experience in the diagnostic field; specifically in the development, transfer, production and submission of lateral flow devices and molecular based assays that span human, animal, biodefense and food testing fields.  Some of those devices included some of first FDA cleared Adenovirus, StrepA and Respiratory Syncytial Virus (RSV) lateral flow devices.  In addition to the development of clinical assays, Joe was integral in securing multiple government contracts for various assays to detect biological warfare agents in various environmental matrices.  Along with assay development, Joe also has 5 years’ experience in the Quality Assurance and Regulatory field: helping build an ISO approved Quality System to procure a government contract, obtaining AOAC approval for a novel food test and writing submissions for various regulatory bodies.  Joe has also played a leadership role in due diligence for acquisitions as well as Site Management for product and services in the dry chemistry field.

Prior to founding Gila Bioscience LLC in 2024, Bret Sheffield served as a Program Manager at DCN Diagnostics, where he successfully led numerous diverse projects from feasibility through validation and transfer. His expertise included providing strategic guidance on experimental design, risk analysis, and analytical studies, all while ensuring programs adhered to strict timeline and budget goals. Bret earned his degree in Molecular Biology from San Diego State University and brings over 23 years of experience in the in-vitro diagnostics (IVD) field. His extensive background encompasses assay development, design transfer, scale-up, manufacturing, quality assurance, regulatory compliance, and process improvement across the human, veterinary, and food safety diagnostic markets. Throughout his career, Bret has been instrumental in developing diagnostic assays that achieved FDA clearance, including lateral flow, ELISA, and DFA (direct fluorescent antibody) tests for detecting specific gastrointestinal parasites in humans. He also led teams that obtained USDA licensing for lateral flow and ELISA diagnostic assays for companion animals. His expertise extends beyond development to include drafting essential documentation for scale-up and design transfer, analytical verification and validation protocols, manufacturing processes, risk assessments, pre-submission requests, and outlines of production. Bret has consistently worked under GMP conditions in FDA- and USDA-certified laboratories, ensuring the highest standards of compliance and quality.