|Sam Maldonado, M.D., M.P.H., FAAP||Sam Maldonado is the Vice President of Child Health Innovation and Leadership Department, at Johnson & Johnson. Dr. Maldonado graduated with an MD degree from the National University of Honduras and completed his pediatric residency at Henry Ford Hospital in Detroit, a fellowship in Pediatric Infectious Diseases at Children’s National Medical Center, and his Masters in Public Health at George Washington University. Dr. Maldonado was a Medical Officer at the FDA from 1990 to 1998. He participated in the policy, scientific, and regulatory processes leading to the Pediatric Exclusivity law. Since leaving the FDA, Dr. Maldonado has participated in the clinical and regulatory planning and execution of multiple global pediatric programs. He also represents Regulated Industry at the FDA Pediatric Advisory Committee and at the International Conference of Harmonization. Recently, he has brought together child advocates to form the International Neonatal Consortium and the Global Pediatric Clinical Trials Network Pre-launch Consortium, both under the sponsorship of the Critical Path Institute. Dr. Maldonado has over 26 years of experience in public policy and operational issues related to drug development, eight of which he served as Medical Officer at the FDA before moving to industry.|
|Gordon Ramsay, PhD||Gordon Ramsay PhD, has a Ph.D in electronics and electrical engineering from the University of Southampton and an M.Phil in speech and language processing from Cambridge University. He has worked in many countries around the world, including Canada, France, Australia, and Ethiopia. Before joining Emory, he was an Associate Research Scientist in the autism program led by Ami Klin, Ph.D., at the Yale Child Study Center, a Fellow of Saybrook College at Yale University, and Senior Scientist at Haskins Laboratories. He is currently an Assistant Professor in the Department of Pediatrics at Emory University School of Medicine. At the Marcus Autism Center, he directs the Spoken Communication Laboratory, where his research focuses on developmental profiling of vocal behavior, spoken communication, and social interaction in infants at risk of autism as part of an NIH-funded Autism Center of Excellence. The goal of his research program is to develop evidence-based community-viable technologies for early detection and intervention in ASD, to ensure that every child at risk of autism learns to talk. He also works to develop new high-school outreach initiatives to ensure that children with ASD and their parents are included as partners in research.|
|Cynthia Jackson, D.O., FAAP||Cynthia Jackson, D.O., FAAP, is Vice President and Head of the Pediatric and Rare Diseases Centers of Excellence at Quintiles, Inc. For over 15 years, Dr. Jackson has provided medical expertise and clinical development guidance for dozens of pediatric and rare disease clinical trials in a variety of therapeutic areas and age ranges. Dr. Jackson has a broad understanding of regulatory requirements for pediatric clinical trials and expertise in global pediatric clinical trial strategy and clinical development planning. Dr. Jackson graduated from Des Moines University College of Osteopathic Medicine and completed a rotating internship and residency in Pediatrics at Western Reserve Care System/Tod Children’s Hospital. Dr. Jackson completed a fellowship in Pediatric Infectious Diseases at Duke University Medical Center and a fellowship in the Department of Virology, HIV Pathogenesis Lab at Glaxo Wellcome, Inc. Dr. Jackson was previously the Chief of Pediatric Infectious Diseases at UIC and the Children’s Hospital of Illinois. She is currently an Assistant Consulting Professor of Pediatrics at Duke University, and has previously been a faculty member at Duke and the University of Illinois. When not working, she enjoys hiking in the mountains of southwest Virginia, gardening, horseback riding and volunteering at a local therapeutic horseback riding center.|
|Mitchell Goldstein, M.D.||Mitchell Goldstein, MD was born in Hollywood, CA and has lived In Southern California for most of his life. He attended the University of Miami’s Honor Program in Medical Education, completed his pediatric residency training at the University of California, Los Angeles, and finished his Neonatal Perinatal Medicine training at the University of California, Irvine. Dr. Goldstein is board certified in both Pediatrics and Neonatal Perinatal Medicine. He is an Associate Professor of Pediatrics at Loma Linda University Children’s Hospital and emeritus medical director of the Neonatal Intensive Care Unit at Citrus Valley in West Covina, CA. Perhaps Dr. Goldstein’s most important trait is his tireless devotion to patient access issues, writing to governmental figures, testifying in court, and even the front page of the New York Times Dr. Goldstein is the editor of many publications and has chaired scientific conferences in his field of expertise. He is the Medical Director of the National Coalition for Infant Health, a coalition of National Organizations involved in perinatal health, and he is the National Chair Elect of the Section on Advances in Therapeutics & Technology (SOATT) of the American Academy of Pediatrics. His research interests include the development of non-invasive monitoring techniques, evaluation of signal propagation during high frequency ventilation, and data mining techniques for improving quality of care.|
|Raymond Koteras||Raymond Koteras, a healthcare management executive, completed his graduate studies in health services administration from George Washington University and undergraduate studies in medical technology from the State University of New York (SUNY). Ray did his residency training in hospital administration at Loyola University, and laboratory internships in clinical chemistry, microbiology, hematology, and blood banking at SUNY.|
Currently, Ray is Director, Technical and Medical Services, Department of Subspecialty Pediatrics, for the American Academy of Pediatrics (AAP). Throughout his 25+ years at AAP, Ray has lead and consulted programs and services that include clinical policy, advocacy, professional education, and member engagement, such as publications titled: “Report of the Committee on Infectious Diseases” and the “Pediatric Nutrition Handbook”. He advocates for the rational use of medications in children specifically the Best Pharmaceutical for Children’s Act. Ray helped plan the 2014 Global Pediatric Clinical Trials Symposium, facilitated the first national harmonized medical/dental guidelines for sedation monitoring in children undergoing diagnostic and therapeutic procedures and is the manager for the AAP Committee on Drugs and Section on Clinical Pharmacology and Therapeutics.
Ray is an avid outdoorsman, baseball coach, and community volunteer. He lives in suburban Chicago with his wife and two sons.
|Dr. Ryan Carvalho MD||Dr. Ryan Carvalho is the Vice-President of Medical, Scientific and Regulatory Affairs at Nestle Infant Nutrition in North America, in addition to his role as Adjunct Associate Professor of Paediatrics at The Ohio State University College of Medicine. Graduating from medical school in India, Ryan took up a paediatic residency at the Brooklyn Hospital Center in 2000, before specialising in paediatric gastroenterology and nutrition during a clinical fellowship at John Hopkins Children’s Center. Over the years, Ryan has been involved in various review panels and committees, including the Food and Drug Administration orphan product development review panel, the North American Society of Paediatric Gastroenterology Hepatology and Nutrition committee and the Nestle Nutrition advisory board. He has also been a medical advisory for the Crohn’s and Colitis Foundation of America. Ryan has been an invited speaker to over 20 international meetings, and has an extensive list of peer-reviewed publications and conference proceedings. Outside of medicine, Ryan has published two e-books with iUniverse: 10 minutes for Dad and Lessons you taught us.|
|Claudio Fracasso||Claudio Fracasso graduated as a Medical Doctor at the University of Bari, Apulia, Italy, where he also completed his specialization in infectious diseases. Since the 1990s, he has been involved in basic and clinical research, with particular focus for clinical management and therapy of human immunodeficiency virus (HIV). In 1997, he was appointed Senior Researcher at the Superior Institute of Health in Rome, Italy, for the setup of the preclinical evaluation of a new anti-HIV vaccine. In 1999, he joined Wyeth and was responsible for the oversight of clinical trials conducted in several Mediterranean countries. In 2010, Claudio joined Pfizer as Regional Clinical Development Director, taking responsibility for the scientific integrity and medical oversight of clinical trials. He collaborates with several external organisations, including the Children’s Working Party at the European Forum for Good Clinical Practice and the Children Research Industry Group in the UK. Claudio also lectures on the Masters of Clinical Research course at the Catholic University of Rome. He is based in Rome, where he lives with his wife and daughter.|