Yvette M. Blanco-Jivanjee, MS, is a Clinical Research Professional with 17 years of experience within the Academic and Biomedical Industries.
Yvette has led clinical and quality teams to achieve site compliance by providing training and education on SOPs, GCP, documentation practices, ICF process, AE/SAE reporting & CAPA implementation & effectiveness, while maintaining a professional relationship with the Sponsor, PI and research study teams. Yvette has formerly held Quality Assurance/Regulatory Affairs Manager positions within the biomedical industry at BioTissue, Inc. and TissueTech, Inc. and is currently a Senior Clinical Research Monitor at the University of Miami School of Medicine. Therapeutic Areas: Oncology, Stem Cell Research, Medical Device, Regenerative Biologic Therapy, Kidney & Pancreatic Islet Cell Transplantation, Ophthalmology, Dermatology & Cutaneous Surgery, Spinal Cord Injury and Hepatology. Manufacturing Experience: Development of 510 (k) Class II Medical Device, Cosmetics & Human Cell Tissue Products.
Marisol Castro-Paiz, PhD
Marisol Castro-Paiz, PhD, is an accomplished and highly skilled scientist dedicated to the research and development of pharmaceuticals and medical products from early discovery through regulatory and clinical development. S
he has extensive experience managing pre-clinical and clinical research and development projects in biological sciences, immunology, ophthalmology, study design, assay development, biomarker analysis, and scientific writing. In multidisciplinary product development and research project teams, utilizes scientific knowledge and technical expertise to design experiments, address complex questions, and interpret results in the broader context of the project. She demonstrates attention to detail and strong written and verbal communication skills in effectively managing collaborations and relationships with clinical investigators and CROs, developing and writing study protocols, and preparing high quality reports and publications.
Rafael Gonzalez, Ph.D
Dr. Gonzalez serves as Vice President of Research & Development at DaVinci Biosciences and is responsible for the development of clinical stem cell applications for several disease/trauma states.
Dr. Gonzalez has been Member of Advisory Board at BioStem Technologies, Inc. since October 2014. Dr. Gonzalez has expertise in degenerative disorders involving the spinal cord and has extensive experience in stem cell culture and biology from human embryonic, pre-natal and adult sources. Prior to joining DaVinci Biosciences, Dr. Gonzalez served as a Research Scientist at PrimeGen Biotech where he was responsible for the design and execution of experiments involving adult (bone marrow, menstrual blood, adipose) and pre-natal stem cells (neural, bone marrow, liver, gonadal) for potential clinical application. Dr. Gonzalez was also responsible for developing PrimeGen's pre-clinical stem cell/spinal cord injury model. Dr. Gonzalez developed his thesis at the Reeve-Irvine Research Center, University of California, Irvine, under the advisory of Dr. Hans Keirstead, entitled: "The Role of the Chemokine CXCL10 in Secondary Degeneration Following Spinal Cord Injury". Pre-clinical studies conducted during this time lead by Dr. Gonzalez were aimed at reducing secondary degenerative effects. The studies conducted by Dr. Gonzalez and Dr. Keirstead precipitated the start-up of Ability Biomedical, a company that developed anti-IP10 antibody, an antibody which can be used to treat several degenerative disorders such as multiple sclerosis, rheumatoid arthritis, and SCI. Ability Biomedical was purchased by Medarex in 2007 which was purchased by Bristol-Myers Squibb that sponsors a phase II clinical trial using anti-IP10 antibody (MDX-1100). He also was involved with preclinical studies in the development of the use of human embryonic stem cells into spinal cord injury. Dr. Gonzalez has several scientific publications in the field of stem cells, spinal cord injury and the immune system. Dr. Gonzalez received his BS in Biological Science and his Ph.D. in Anatomy and Neurobiology from the University of California, Irvine, CA.
Tan Ince, MD, PhD
Dr. Ince received his PhD in Pharmacology from Cornell and completed clinical training at Massachusetts General Hospital, Brigham and Women's Hospital, and Harvard Medical School.
Dr. Ince was a visiting clinical scientist at Massachusetts Institute of Technology, 2000-2007, where he developed a new cell culture nutrient medium that is now widely used to grow human breast and ovary cells. In 2010, he was recruited to the Braman Family Breast Cancer Institute at the University of Miami Miller School of Medicine. Dr. Ince's research focuses on the role of normal cell-of-origin in determining tumor phenotype and development of culture systems for in vitro culture of primary human tissues and tumors. The use of normal cell types as a reference to classify tumors, however, has not been widely emulated in solid tumors, partly due to a more limited understanding of epithelial cell differentiation. Dr. Ince used a new and innovative multiplexed immunofluorescence technology to monitor multiple markers simultaneously in the very same cells. Based on the study, Dr. Ince and colleagues described eleven new normal breast subtypes and showed that each human tumor is similar to one of these normal cell types. These results led to new normal cell type-based classification of breast cancers that has important implications for understanding breast cancer prognostics and how breast cancer is treated. In brief, the results of this study indicate that breast tumors arising from different normal cells have significantly different clinical outcomes and drug response, and should be classified and treated differently.
Shalesh Kaushal, MD, PhD
Dr. Shalesh Kaushal obtained his BS degree at Yale University in Molecular Biophysics and Biochemistry. Subsequently, he completed his MD at Johns Hopkins and PhD at MIT with the Nobel Laureate Dr. Har Gobind Khorana.
He then completed his residency at the Doheny Eye Institute/USC Department of Ophthalmology and his surgical retina fellowship at the Washington University St. Louis/Barnes Retina Institute. He then spent an additional year at Moorfields Eye Institute and at the Institute of Ophthalmology in London. While at the University of Florida, he was the Richardson II Chair and head of the retina division. Dr. Kaushal established the clinical and surgical retina division, recruited physicians, trained residents, surgical fellows as well as mentored undergraduates, medical students, graduate students, post-docs in his research lab. Further, he organized an annual retina symposium and that attracted many key leaders both in the US and internationally. During that time, he established and became the Director of the Charlie Mack Overstreet Laboratory for Retinal Therapies. He was recruited to the University of Massachusetts in 2009 as the chairman built a brand new Eye Center and the first new academic department of ophthalmology in the United States in over 25 years. Besides these academic pursuits, he is the founder of three biotech companies and has been a consultant for most of the leading ophthalmic pharmaceutical companies. He returned back to Florida two years ago. The thrust of Dr. Kaushal's basic research is to understand the cellular, molecular and biochemical events that cause retinal and macular degeneration. Collectively, the major research projects in his lab couple biochemical, small molecule and genetic approaches to understanding these important retinal diseases. Some of this work has lead to novel, physician initiated clinical trials. More recently, his research has led to the identification of certain nutraceuticals to mitigate common retinal diseases like macular degeneration and diabetic retinopathy. This has led him to further understand the direct role of nutritional biochemistry in controlling the structure and function of the retina. Dr. Kaushal is a member of the Association of Research in Vision and Ophthalmology (ARVO), American Academy of Ophthalmology (AAO), the Macula Society, American Ophthalmological Society (AOS), Retina Society, the American Society of Retina Specialists (ASRS), and Fellow of the American College of Nutrition (ACN). He is board certified by the American Board of Ophthalmology and the American Board of Integrative and Holistic Medicine (ABIHM). He has been invited as a speaker throughout the US and internationally.
Anasua Kusari, PhD
Dr. Anasua Kusari is a scientist and Molecular Biology Core Manager at DaVinci Biosciences. She has decades of expertise in cell signaling and protein-protein interactions in mammalian cells. For last several years she has been working with stem cells. Currently, Dr. Kusari is working on developing a better understanding of the differentiation of cartilage from bone marrow stromal cells at the molecular level. She has many publications of her work in peer reviewed journals.
Kevin MacDonald has more than 25 years of experience and a successful track record with achieving regulatory market clearances/approvals in the United States and abroad. His main area of expertise is as a regulatory, clinical, and quality consultant working with small medical device startup companies. He has held Vice President positions at NeoTract, Concentric Medical and RA/CA/QA positions with Fox Hollow Technologies, Heartport, Cordis, Boston Scientific Corporation, and CR Bard.
Sharon McQuillan, MD
Sharon McQuillan, MD is a board-certified physician specializing in integrative, regenerative, and aesthetic medicine. She graduated from The Ohio State University School of Medicine and is a member of Alpha Omega Alpha Medical Honors Society.
As a board-certified family practitioner, she focused on preventive medicine, diet and exercise, bio-identical hormone replacement, and the mind-body connection long before integrative medicine was mainstream. As a practicing physician, she quickly realized that a healthy self-image is a critical component of optimal health and was one of the first physicians to offer the full spectrum of health, wellness, and cosmetic procedures in her practice. After over twenty years of success in Central Ohio, Dr. McQuillan relocated her practice to Florida, where she further intensified her commitment to individualized medicine by incorporating the healing power of a patient's own stem cells to treat various degenerative conditions. In conjunction with an international team of experts, she has authored over twenty clinical studies utilizing autologous stem cells to treat many common ailments. Dr. McQuillan's passion for teaching, standardization, and superior patient outcomes led her to the formation of Ageless Health, a hands-on training company for medical professionals. Dr. McQuillan has educated thousands of her colleagues in the art and science of integrative, regenerative, and aesthetic medicine. Some of Dr. McQuillan's prestigious titles include Medical Director of both the Aesthetic and Stem Cell and Regenerative Medicine Fellowships for the American Academy of Anti-Aging Medicine. Dr. McQuillan speaks internationally on the subjects of integrative, regenerative, and aesthetic medicine for many organizations and has been featured in numerous national and trade publications. She has appeared on Telemundo and Good Morning America and has made numerous local television appearances. Her commitment to wellness beauty, and successful aging has expanded to other organizations as well. She currently serves as Medical Director for Great HealthWorks, a consumer-directed health and wellness product manufacturer and distributor. As Co-Executive Editor of New You Magazine and Chairman of the New You Medical Advisory Board, she educates the public responsibly in the best practices for successful aging.
Gabriel Nistor, MD
Broad, multidisciplinary knowledge and skills in all science areas with main expertise in biology and medicine. Following residency program, MD practice and postdoctoral studies at University California Irvine, Gabriel Nistor serves as vice president for Research at Caladrius Biotechnology, recognizing 15 years of research leadership in regenerative medicine and cancer immunotherapy.
Nelson Piludu, MT
Nelson Piludu, MT is a Medical Technologist by training and has over 10 years experience in the Clinical Research industry.
He studied Medicine in Universidad Nacional Autónoma de Nicaragua, León and obtained a degree from Miami Dade in Medical Technology. He has worked and specialized in the field of Flow Cytometry for such institutions as University of Miami School of Medicine, Transplant, the Johns Hopkins School of Public Health and the Johns Hopkins Hospital performing Flow Cytometry analysis, validation, cell sorting in the pediatric and adult myelodysplasias arenas. Since 2006 he has been a Clinical Research Associate working in the development and conduct of Clinical Trials, phases I to IV for pharmaceutical companies such as Pfizer, Takeda, MGI and others. His experience in therapeutics areas include oncology, neurology, regenerative medicine, endocrine and metabolic, biological and device studies. Currently Mr. Piludu holds a position as a Senior Clinical Research Monitor for the University of Miami School of Medicine.
Marcela Salgado, MD
Marcela Salgado MD, a Medical Research administrator with extensive and proven expertise in Clinical & Translational Research and Pathology.
Received her Medical Doctor degree from the El Bosque University at Bogota, Colombia following her internship with focus in Dermatology and Pathology. Her post doctoral training initiated working as a Post Doctoral fellow at the Department of Dermatology of El Bosque University and lately with the interest of clinical research and pathology developed since her first approach with Tropical Diseases and retrospective studies from her country working with a group of expert researchers to facilitate case managing and surveillance of terrible diseases like Hemorrhagic Dengue. Dr Salgado developed great interest in teaching and education during her years working as an Assistant Professor at South Colombian University. Her development in Clinical Research continues at the University of Miami- Miller School of Medicine working initially a a Clinical Research fellow as her first approach to Stem Cell Therapies and subsequently as an Assistant Scientist and Sr Clinical Research Coordinator at the Interdisciplinary Stem Cell Institute and the department of Dermatology and Cutaneous Surgery conducting several research studies Preclinical (Translational) and FDA approved Phase I/II Clinical Research Trials with Stem Cell therapies and Regenerative Medicine awarded by the National Institutes of Health (NIH) and The Department of Defense (DOD) for the past 6 years. Her evolution in Translational as well as Clinical research contributed to multiple scientific papers, abstracts, and Two University of Miami research patents involving Human Mesenchymal Stem Cells and multiple grants submissions. She is an active member of the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP) since 2009 to develop her continuous research education following the most current FDA Clinical Trials requirements, regulations and compliance, promoting Good Clinical Practice policies.
H. Thomas Temple, MD
H. Thomas Temple, MD, has a medical career that spans nearly three decades. He joins Nova Southeastern University from the University of Miami- Miller School Of Medicine, where he served most recently as chief of the Orthopaedic Oncology Division, director of the University of Miami Tissue Bank, professor of Orthopaedics and pathology and vice-chairman of the Department of Orthopaedics.
Dr. Temple’s clinical interests are novel treatment of benign and malignant bone and soft tissue tumors in children and adults, tissue transplantation and complex limb reconstruction. His research interests are stem cell applications in bone and cartilage regeneration, tissue banking and developing targeted therapies for sarcomas. Dr. Temple earned his Bachelor of Arts degree from Harvard University in Cambridge, Mass., and his Doctor of Medicine from Jefferson Medical College in Philadelphia. He completed his residency in Orthopaedic Surgery at Walter Reed Army Medical Center in Washington, D.C., and his musculoskeletal oncology fellowship at Harvard University/Massachusetts General Hospital/Boston Children’s Hospital in Boston. Dr. Temple is board certified by the American Board of Orthopaedic Surgery.
Roberto Vazquez-Padron, PhD
Dr. Roberto I. Vazquez-Padron received his Ph.D. in Biology from the University of Havana in 1999, after receiving multiple National Awards from the Cuban Academy of Sciences and being selected as one of the Latin-American Talent Young Investigators by the Biochemistry and Molecular Biology Brazilian Society.
In year 2000, he decided to continue his education in the United States toward a more clinically related experience and interdisciplinary training. He was highly motivated by the challenge of finding cures and better treatments for cardiovascular diseases, the number one killer in America. He joined the Cardiothoracic Research Laboratory in the Department of Surgery and the Vascular Biology Institute at the University of Miami, Miller School of Medicine. He engaged in basic science projects to study the molecular mechanism of aged-related vascular diseases. He demonstrated the hyper-proliferative response of aging vascular smooth muscle cells to post injury growth factors. Following four years of postdoctoral training, Dr. Alan Livingstone, Chairman of Surgery, promoted him to Research Assistant Professor. In 2005, using the resources from an American Heart Association Scientific Development Award, he put together his own multidisciplinary laboratory equipped with microsurgery and molecular and cell biology facilities. Currently, he is an NIH-award winning scientist, mentor and professor, focused on understanding the cellular and molecular mechanisms underlying vascular obstructive diseases like atherosclerosis, in-stent restenosis, transplant vasculopathy, and arteriovenous fistula failure. A full-time scientist, post-doctoral fellows and graduate students currently form his lab. His laboratory is currently supported by three major NIH grants. He has published +60 peer-reviewed scientific articles and book chapters and presented his work in multiple national and international meetings. He is currently a member of the NHLBI Mentored Clinical and Basic Science Review Committee and the NIH Cardiovascular and Respiratory Sciences (CVRS) Integrated Fellowship Review Group. He was a member of the American Heart Association's Vascular Wall Angiogenesis, Atherosclerosis, General and Inflammation Peer Review Committee (2010-2015). He serves as reviewer of multiple indexed journals. Apart from his work in academia, he is a founder of the Miami Cardiovascular Innovations Corp.