Fundamentals for Clinical Trials of Tissue-engineered Medical Products:
A Webinar Series from the University of Connecticut Convergence Institute for Translation in Regenerative Engineering
This series will inform ARMI members how to conduct clinical trials for tissue-engineered medical products. The series will cover the following
(1) IRB process, and FDA and Federal Regulations on Informed Consent
(2) Quantitative Histology in Clinical Trials
(3) Design and Statistical Rigor in Clinical Trials for Regenerative Medicine
(4) Personalized and Precision Medicine Approaches in Regenerative Clinical Trials.
FORMAT: Webinar (or Zoom) presentation for 1 hr., with 15 additional minutes for Q&A via chat. Hosted by Dr. Gualberto Ruaño at UConn.
DATE and TIME: Tuesday, November 24, at 12 noon Eastern
TITLE: Personalized and Precision Medicine Approaches in Regenerative Clinical Trials
Description of content: Precision medicine entails the introduction of biomarkers in the research, diagnosis and treatment of disease. Examples of precision medicine designs for clinical research and trials will be presented. Approaches of the concept to development of tissue engineered medical products will then be discussed.
Gualberto Ruaño, M.D., Ph.D.
Assistant Directotr, Special Projects
Connecticut Convergence Institute for Translation in Regenerative Engineering
University of Connecticut School of Medicine
Dr. Ruaño has been an innovator in the biotechnology industry for 25 years, and is a pioneering expert in the science and clinical deployment of personalized medicine. His continued record of scholarship and innovation in translational genomics and clinical decision support. He has pioneered physiogenomics (U.S. Patent 7,747,392) based on multi-gene DNA markers and bioinformatics for the diagnosis of disease and prediction of human physiological responses to a wide array of clinical treatments (neuro-psychiatric and cardio-metabolic drugs, exercise, diet, surgery, hospitalization). Dr. Ruaño invented the Coupled Amplification and Sequencing System (U.S. Patent 5,427,911) for the rapid determination of sequence variation which enabled the first FDA-approved pharmacogenomic diagnostic system. Dr. Ruaño was a founding Director of the Personalized Medicine Coalition in Washington, D.C. and senior editor of the journal Personalized Medicine (London). He has served on steering committees working with the FDA on pharmacogenomic guidelines and as a member at the Manhattan Institute’s 21st Century FDA Task Force. He obtained his B.A. degree from Johns Hopkins University, where he was elected to Phi Betta Kappa. He obtained M.D. and Ph.D. degrees from Yale University, where he was a Fellow of the NIH Medical Scientist Training Program and the Ford Foundation. He is one of the 28 alumni in the University’s history honored in the Yale Innovation Timeline.