James T. Ryaby, PhD Vice President, Biologics

Dr. Ryaby manages and directs the biologics and pharmaceutical development program for MCRA and its clients. Dr. Ryaby has 30+ years experience in Biotech, Pharmaceutical, and Medical Device technology development. Dr. Ryaby specializes in designing and directing preclinical and clinical programs in support of IND/NDA-BLA and IDE/PMA Technologies and Therapeutics and works closely with the MCRA regulatory team on these programs. 

In recent years, Dr. Ryaby has served from March 2008 to December 2010 as the part-time Vice President of Research and Clinical Affairs at Mesoblast Ltd, of Melbourne, Australia, where he co-designed and co-directed all clinical and pre-clinical research in support of IND/BLA submissions. He currently serves as a Board Member for two medical device and pharmaceutical companies, Carticept Medical, an Atlanta, GA-based company, and Pharmapros Corporation, a Cambridge, MA-based company.

Prior to his time at Mesoblast, Dr. Ryaby served as the Chief Scientific Officer and SVP of Research and Clinical Affairs at OrthoLogic Corp, a biotechnology company in Phoenix, AZ. Dr. Ryaby led the program on Chrysalin, a novel peptide-based therapeutic, through the IND process into Phase 3 clinical development. This clinical program included the largest clinical trials to date on acceleration of fresh fracture healing as well as early stage programs in spine fusion and cartilage repair.

Dr. Ryaby is a member of six professional societies in the musculoskeletal area including the American Academy of Orthopedic Surgeons and the Osteoarthritis Research Society. To date, He has led and/or participated in over 15 FDA meetings with CDRH, CBER, and CDER; as well as meetings with regulatory authorities in Canada, Europe, and Australia.  

Dr. Ryaby has held various academic appointments over the course of his career, and serves as an Ad Hoc journal reviewer for many journals in the musculoskeletal field. He has been an invited speaker at a number of national and international conferences on current orthopedic and biological innovations, as well as serving on over 25 Grant Review Committees over the past 18 years. He has extensive experience designing post-marketing studies to support sales and marketing efforts. He has co-authored over 60 articles on various topics published in various medical and orthopedic journals, including the Journal of Orthopedic Research, Journal of Bone and Joint Surgery, Wound Repair and Regeneration, and Spine.

Dr. Ryaby received his B.A. in Chemistry from Hiram College, OH, and his Ph.D. in Cell Biology from the Mt. Sinai School of Medicine, NY.