Da Yu Protein Sciences – Management
The Da Yu Protein Sciences team is led by Donald O’Keefe, Ph.D., who has served as Managing Director since the Company’s inception. Dr. O’Keefe has more than 25 years experience in the biopharmaceutical industry supporting preclinical and clinical Biologics development. He has broad experience with Biologics process development including peptides, recombinant proteins, monoclonal antibodies and numerous types of vaccines such as subunit, conjugate, and viral vector-based vaccines. Dr. O’Keefe has provided CMC support to more than 40 Biologics in clinical development and has contributed to more than a dozen INDs and several BLAs/NDAs. He has expertise in biophysical and analytical technologies applied to the preformulation, formulation, testing and characterization of Biologics. Dr. O’Keefe is experienced in analytical assay development, qualification and validation consistent with current regulatory requirements. He has direct experience with cGMP environments having had responsibility for clinical release testing, stability testing and assay transfer to commercial Quality Control laboratories. During his career he has held senior leadership positions in Biologics CMC development at Wyeth Vaccines (now Pfizer), Centocor R&D (now Janssen) and Shire HGT. He is a doctoral graduate of the Department of Molecular and Cell Biology at the University of Texas at Dallas and was a National Research Service Award recipient while serving as a Research Fellow at Harvard Medical School. Dr. O'Keefe has authored or co-authored more than 20 peer-reviewed manuscripts and is listed as an inventor on 9 issued patents.