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Dennis L. Broyles, MSHS, RAC, CCRA, CCRP

Clinical Trial Manager

San Diego, California

844.534.6835 x210

dbroyles@l3healthcare.com

Mr. Broyles has over thirty years of experience in clinical research. An accomplished clinical trial manager,  he has a proven track record of successful clinical trial completion with regulatory approvals in the US (PMA, de novo 510(k), 510(k)) and OUS. His diverse skill set includes several aspects of clinical operations from strategic planning to protocol development to data management and interpretation, in multiple therapeutic areas including oncology and hematology with an emphasis in stem cell transplantation.

Prior to L3, he worked at Beckman Coulter from 1993 to 2017; beginning as a Research Associate, becoming Senior Development Scientist in 2000, and finally, serving as Senior Staff Clinical Research Scientist. While Senior Development Scientist at Beckman Coulter, he was responsible for feasibility, development, and clinical evaluation of flow based tetrameter assay for post-stem cell transplantation monitoring.  Later, as Senior Staff Clinical Research Scientist, he was the clinical lead responsible for a multi-site clinical pivotal trial for prostate cancer detection using the [-2]proPSA biomarker, and a significant contributor to the clinical section of the FDA PMA submission.

Mr. Broyles has co-authored publications on topics including reproductive health and prostate cancer for various journals such as Clinical Chemistry, British Journal of Urology International, Prostate Cancer and Prostatic Diseases, and Cancer, Epidemiology, Biomarkers and Prevention. He also contributed to the 3rd edition of Management of Prostate Cancer, published by Humana Press.

He has won various awards, including an Immunoassay & Molecular Diagnostics Business Outstanding Award from Beckman Coulter and a Distinguished Abstract Award from the National Academy of Clinical Biochemistry (AACC). He played a key part in the product launches of the Prostate-Specific Antigen (P850048-S012) and Ostase (k972666, k994278) assays. Mr. Broyles also helped acquire FDA PMA (P090026) approval for [-2]proPSA and the prostate health index, and FDA de novo 510(k) approval (k051122) for the first tetramer based flow cytometry assay.

He received his MSHS in Clinical Research Administration from the George Washington University; and holds a BA in Biology, Certificate in Clinical Trials Design and Management, and a Certificate in Regulatory Affairs for the Biomedical Industry from the University of California, San Diego.