Scientific Advisors

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Dr. Cicalese was born in Rome, Italy and earned his MD and did his General Surgery Residency at the University of Rome, “La Sapienza”, Rome, Italy,and his Clinical Fellowship in Transplant Surgery at the T.E. Starzl Transplantation Institute, at the University of Pittsburgh.

Dr. Cicalese is a surgeon with over 25 years of clinical experience in transplantation, general and hepatobiliary surgery in academic institutions in the US. He has been Director of the Intestinal and Pediatric Liver Transplant Program at the University of Illinois at Chicago. In 2002, Dr. Cicalese became the Section Chief of the Liver and Intestinal Transplantation Program at the University of Massachusetts. While there, he successfully performed the first living-related small bowel transplant in New England. In 2007 Dr. Cicalese came to work at the University of Texas Medical Branch (UTMB) where he has been Director of the Transplant Center and later Hepatobiliary Surgery in the Department of Surgery. He also developed an international PhD program in collaboration with the University of Palermo, Italy.

Dr. Cicalese's research interests are in transplantation, cancer, organ regeneration and role of immunosuppressive drugs on Neurodegenerative diseases. He is the author and co-author of over 100 peer-reviewed publications, has been the P.I. (Primary Investigator) or Co-P.I. on over 30 grants and trials, is the author or co-author on 8 book chapters. 

Dr. Shaun Snyders is the founder of Outeniqua Regulatory Consulting, LLC, where he helps biotechnology and pharmaceutical companies turn complex regulatory challenges into clear, actionable approval strategies. With more than 25 years of global CMC and product regulatory leadership across cell and gene therapies, mRNA platforms, biologics, and small molecules (siRNA), Shaun brings deep firsthand experience leading high-stakes submissions, health authority engagement, manufacturing comparability strategies, and lifecycle management for innovative therapies. 

Prior to his work at Outeniqua Regulatory Consulting, Shaun held positions of increasing responsibility at pharmaceutical and biotech companies including Bristol Myers Squibb, Merck, Incyte and Adaptimmune. He has written over 150 filings with resulting in successful interactions with FDA, EMA, PMDA, Health Canada, and other global agencies. Shaun holds a PhD from Wesleyan University and BSc and Honors from University of the Western Cape.

Dr. Cristiana Rastellini is a professor of neurobiology at The University of Texas Medical Branch in Galveston (UTMB). She earned her medical degree summa cum laude from the University of Rome "La Sapienza" in 1992. Over the past three decades, she has made significant contributions to medical education, research, and academic leadership.

Beyond her teaching accolades, Dr. Rastellini is an accomplished researcher specializing in transplantation immunology and pancreatic islet transplantation. She has secured numerous grants and contributed to over 300 presentations, abstracts, and lectures. Her research has advanced the understanding of transplantation science with a meaningful impact on patient care.

  Lynn Fallon has over 35 years of clinical, academic and industry experience focusing on transplantation, cell and gene therapy and rare disease. She was the President, Vice-Chair & Co-Founder of CTI Clinical Trial & Consulting for 25 years, leading the growth and development of the organization with a focus on Business Development, Acquisitions, Clinical Trials, Innovative technology, Global Regulatory & Scientific Affairs, Medical Affairs, Real World Evidence and Training. Lynn is currently Vice-Chair of the CTI Board, and on the Executive Board of the Gift of Life.  Prior to CTI, Lynn held development and commercial positions at both Wyeth Pharmaceuticals and Fujisawa Healthcare (Astellas Pharmaceuticals), and she held clinical positions at Albert Einstein Medical Center and Thomas Jefferson University in Philadelphia. Lynn received her Bachelor of Science in Nursing from Penn State University & the University of the State of New York.