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.

ACCESS WEBINAR HERE

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

ruano@uchc.edu

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.

The Connecticut Convergence Institute is proud to announce the selection of five new outstanding Young Innovative Investigator Program (YIIP) Scholars. These new YIIP Scholars are recent college graduates who will complete intense graduate level coursework and conduct high caliber research in elite biomedical laboratories on the UConn Health campus. Each year, the search for the next generation of advanced YIIP Scholars is conducted via a rigorous application process, where future students are selected by the YIIP Advisory Committee.

YIIP, which began in 2013, aims to provide academic training to underrepresented minority students who are dedicated to pursuing careers as scientists and scholars in biological and biomedical science, with the intent of developing the next generation of innovative scientists.

“The program provides tools for the YIIP Scholars to conduct intensive research, excel in an academic environment, and develop the skills to become high level candidates for graduate or medical schools. Increasing the number of underrepresented minority students in the fields of science and medicine is one of our primary goals as an Institute.” said Dr. Cato T. Laurencin, CEO of the Connecticut Convergence Institute for Translation in Regenerative Engineering.

The new YIIP Scholars are:

Kai Clarke: Florida Institute of Technology, Biomedical Engineering

Tebyan Khalfalla: University of Connecticut, Physiology & Neurobiology

David Onwuka: University of Connecticut, Molecular & Cell Biology

Mylan Panteah: New Mexico State Univ., Univ. of North Dakota, Biology, Allopathic Medicine

Christina Valera: University of Connecticut, Physiology & Neurobiology

FARMINGTON, CT- The University of Texas MD Anderson Cancer Center has announced Dr. Cato T. Laurencin as the recipient of the 2020 Mike Hogg Award and Lecture, the institution’s most prestigious award that is granted to practicing scientists and physicians who have made and continue to make exceptional transformative contributions to the field of biomedical research. Since the inaugural lecture in 1959, it has been awarded to 40 Nobel laureates and 13 Lasker Award winners. Dr. Laurencin’s lecture, titled Regenerative Engineering: A Convergence Approach for Addressing Grand Challenges, will be delivered virtually.

Dr. Laurencin’s work in medicine, engineering, science, and technology has been recognized in a number of ways. In medicine, he is an elected member of the National Academy of Medicine and received the Walsh McDermott Medal. In engineering, he is an elected member of the National Academy of Engineering and received the Simon Ramo Founders Award. In science, Dr. Laurencin is a Fellow of the American Association for the Advancement of Science and received the Philip Hauge Abelson Prize “for signal contributions to the advancement of science in the United States.” In technology, Dr. Laurencin is a Fellow of the National Academy of Inventors and received the National Medal of Technology and Innovation, the highest honor bestowed in America for technological achievement, from President Barack Obama in ceremonies at the White House.

The founder of the field of Regenerative Engineering, Laurencin’s new work focuses on the convergence of advanced materials science including nanotechnology, biophysics, medicine, and developmental biology. At the University of Connecticut, he leads the Hartford Engineering a Limb (HEAL) project, aimed at regenerating a limb by 2030. The National Institutes of Health and the National Science Foundation currently fund his research work. He is the recipient of both the NIH Director’s Pioneer Grant Award and the NSF Emerging Frontiers in Research and Innovation Grant Award.

In materials science, Dr. Laurencin is a pioneer in polymeric materials science for musculoskeletal systems. He produced seminal research work and discoveries in patents and papers on polymeric nanofiber technology, ushering in the field of nanomaterials for tissue regeneration. His work in published papers and patents focusing on polymer-ceramic systems inspired the development of biocomposite materials including interference screws for which he was named “One of the 100 Engineers of the Modern Era” by the American Institute of Chemical Engineers at their centennial celebration. Fundamental research on polymeric fiber systems for soft tissue regeneration has led to a number of soft tissue regenerative systems including the Laurencin-Copper (LC) bioengineered anterior cruciate ligament, now in humans. His work on engineered materials for soft tissue regeneration was highlighted by National Geographic Magazine in its “100 Scientific Discoveries that Changed the World” edition. He has worked with industry on the development and understanding of systems combining polymeric materials and allograft human tissue, creating technologies helping patients throughout the world.

Dr. Laurencin is a designated University Professor at the University of Connecticut, one of only two currently at the school. He serves as the Chief Executive Officer of The Connecticut Convergence Institute for Translation in Regenerative Engineering. He is the Albert and Wilda Van Dusen Distinguished Endowed Professor of Orthopaedic Surgery, Professor of Chemical Engineering, Materials Sciences, and Biomedical Engineering. He is a core faculty member of the Africana Studies Institute at the University of Connecticut.

Dr. Laurencin received his B.S.E in chemical engineering from Princeton University, and his M.D., magna cum laude, from the Harvard Medical School, receiving the Robinson Award for Surgery from National Medical Fellowships. He received his Ph.D. in biochemical engineering/biotechnology from the Massachusetts Institute of Technology where he was named a Hugh Hampton Young Fellow.