iCAN continually seeks to improve the quality of our services and optimize our efforts to support the most pressing research needs. To better serve the medical, scientific and patient communities, we utilize our Scientific Advisory Board to identify possible avenues of collaboration, review network-wide projects, and offer advice to maximize our efforts globally.
The Scientific Advisory Board meets once quarterly via teleconference and helps steer our organisation towards making a meaningful impact on paediatric health, medicine, research, and innovation. If you are interested in becoming a member of iCAN’s Scientific Advisory Board, please contact us.
Eric W. Ng, M.D., FAAP
Eric W. Ng, MD, FAAP is a Medical Director at Amgen and is serving as Co-Chair for the iCAN Scientific Advisory Board. Dr. Ng is currently working in the Maternal and Pediatrics Team where he helps oversee regulatory and clinical development teams regarding pediatric drug development. In addition, he serves as an advocate across the company to ensure kids are always considered when new therapies are being developed. He is also active with the American Academy of Pediatrics, serving on the Executive Committee for the Section on Advances in Therapeutics and Technology. Dr. Ng joined Amgen in 2010 as part of the Maternal and Pediatric Safety Team and later working in Global Patient Safety. Prior to working in the biotechnology industry, Dr. Ng was attending as an Emergency Transport Physician at Children’s Hospital Los Angeles as well as a Pediatric Hospitalist at a community hospital in the San Fernando Valley. He did his undergraduate studies the University of California, Berkeley and received his medical degree at Rush Medical College. He did is internship and residency at Children’s Hospital Los Angeles. Dr. Ng enjoys snowboarding and spending time at the beach with his wife and three kids.
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.
Hidefumi Nakamura, M.D., PhD
Hidefumi Nakamura, MD, PhD is the Director for Clinical R&D, Center for Clinical Research and Development, NCCHD, Tokyo. He is a pediatrician, a pediatric pharmacologist and a clinical trialist trained at the National Medical Center, Tokyo, Hospital for Sick Children, Canada and the Rainbow Babies and Children’s Hospital, USA. He also has experience as a senior reviewer at the Japanese regulatory agency, PMDEC. He has been involved in 70+ industry-sponsored and 25+ investigator-initiated multi-center clinical trials in Japanese children. He is currently involved in several national and international activities including: the advisory board for the PMDA, the Pediatric WG for the Task Force for Off-label and Unlicensed Drugs, the Committee on Pharmaceutical Affairs of Japan Pediatric Society, the Steering Committee for the Japan Society of Developmental Pharmacology and Therapeutics, the Coordinating Committee of the International Neonatal Consortium, the EU FP7 Global Research in Paediatrics project, the executive committee of the Pediatric Clinical Pharmacology Section of IUPHAR. One of his current focus is on setting up a pilot pediatric advisory group in collaboration with patient/parent representatives, child life specialists and pharmacists in Japan.
Edress Darsey graduated with her Doctorate of Pharmacy Degree from Mercer University in Atlanta Georgia. She completed a Clinical Pharmacy Practice Residency at the University of Alabama in Birmingham followed by a Specialty Residency in Clinical Pharmacokinetics at Mercer University, Atlanta, Georgia. Following her training, Edress spent eight years developing and leading clinical pharmacy services and a pediatric pharmacy residency program at Children’s Healthcare of Atlanta. During this time, she researched and published studies around pediatric pharmacokinetics, pain management and other areas of need. Edress also served on the Board of Directors for the Pediatric Pharmacy Advocacy Group, an international organization dedicated to improving clinical pharmacy services to children. In 2000, Edress joined the Clinical Education Consultants team at Pfizer Pharmaceuticals. She moved to the US Field Based Medical Affairs group for Urology and Women’s Health in 2006 and in January 2014 became a Pediatric Global Medical Director to help build Pfizer’s Pediatric Center of Excellence. This group is dedicated to improving the health of children across the world. Edress lives in Atlanta, Georgia with her husband and two children.
Christina Bucci-Rechtweg, M.D.
Dr. Christina Bucci-Rechtweg graduated with a MD from the University of Rochester School of Medicine & Dentistry and was Residency trained in Pediatrics and Fellowship trained in Pediatric Critical Care Medicine at the State University of New York at Buffalo. She has 15 years of pharmaceutical industry experience with roles in Clinical Development & Medical Affairs as well as Drug Regulatory Affairs, including the oversight and registration of global clinical development programs. In her career she has developed and implemented clinical programs as a Global Medical Director for pediatric and women’s health drug development programs in phase II and III, including those with pediatric regulatory obligations in the EU and US. Christina is actively involved in numerous external organizations advancing the regulatory and development environment for pediatric and maternal health globally, including the ICH E11 Expert Working Group, Coordinating Committee of the C-Path Institute’s International Neonatal Consortium, EFGCP Children’s Medicines Working Party, as well as contributing to the trades and their affiliated projects. Christina is currently the Global Head for Pediatric and Maternal Health Policy at Novartis Pharmaceuticals.
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, 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 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.
Collin A. Hovinga, Pharm.D., M.S.
FCCP Director of Research Support Services Ascension Texas Hospitals, Clinical Associate Professor University of Texas Austin
Doctor Hovinga completed his Bachelor of Science Degree in Biology and Doctor of Pharmacy degrees from Creighton University in Omaha, Nebraska. After which he pursued a Residency and Fellowship in Pediatric Pharmacotherapy with emphasis in Pediatric Neuroscience at the University of Tennessee, Memphis, LeBonheur Children’s Medical Center. He completed a second a Fellowship at the Food and Drug Administration Office of Clinical Pharmacology and a Masters of Epidemiology from the University of Tennessee Health Science Center. Dr. Hovinga recognized as an expert in
neuropharmacology and has held appointments with the FDA’s PNS/CNS Advisory Committee, FDA Clinical Pharmacology Advisory Committee and Editorial Board for Lexicomp and other Pharmacology journals. Dr. Hovinga has had leadership roles in neuroprotective drug pharmacology NIH projects and most recently Chair of ACCPs Practice Based Research Advisory Committee. He has been active as a leader in practice based guidelines and evidence-based medicine. He is a recognized consultant in the conduct of pediatric clinical trials and patient reported outcomes. Dr. Hovinga’s understanding of developmental pharmacology and pediatric neurological conditions has made him unique in the pharmacology arena and has led to him being a journal reviewer and an invited speaker at many national organizational meetings. He is also involved with ethics of research in children and adolescents. He is active as a board member and advocate in many pediatric neurological conditions successful in passing patient right legislation.
Senior Director of The Center for Pediatric Clinical Development at PRA Health Sciences
Kirsten has over 20 years of experience in industry and recently accepted the role of Senior Director of The Center for Pediatric Clinical Development at PRA Health Sciences with specific remit to develop, recruit for and lead the PRA Pediatric Site Network. Kirsten is particularly passionate to advance treatment options for the pediatric population not only as a professional in this field but as a parent of a child with a chronic disease.
Prior to joining PRA, Kirsten spent 15 years at PPD in positions of increasing responsibility having led global teams focused on site intelligence, clinical study feasibility, investigator payments and site relations. In her most recent role as Director of Strategic Site Collaborations, Kirsten was responsible for the implementation of a formalized site partnership program for the company. In this capacity she oversaw the development of both multi-therapeutic site alliances as well as a network specific to pediatric centers of excellence on a global scale.
Before joining PPD, Kirsten held operations management roles at Neeman Medical International, Duke Clinical Research Institute and served in the public sector as a social worker in the state of Maine.
Stephen P. Spielberg, M.D., PhD
Immediate Past Co-Chair
Stephen P. Spielberg, MD, PhD is a pediatric clinical pharmacologist who is serving as Chair for iCAN’s Scientific Advisory Board. He has worked in research, teaching, and clinical care in children’s hospitals in the US and Canada (also serving as a medical school dean), headed pediatric drug development at a large pharmaceutical company, and served as Deputy Commissioner of the US Food and Drug Administration. He has helped write and implement pediatric drug legislation (The Best Pharmaceuticals for Children Act in the US), and international pediatric trial agreements (“ICH-E-11”). His research areas have been focused on adverse drug reaction mechanisms, and on genetic variability in the population that alters how well a drug works and what kinds of side effects it can cause in different people. Now, “semi-retired”, he edits a medical journal focused on drug development and evaluation, sits on the boards of several non-profit organizations (including the US Pharmacopeia that focuses on the quality of medicines), and advises on how best to evaluate medicines in children.
Elizabeth Sheeren is a senior at Grosse Pointe South High School in Grosse Pointe, MI. Her ongoing battle with six autoimmune diseases has inspired her to advocate for young people living with illnesses of all kinds. Within iCAN, Elizabeth serves as a Scientific Advisory Board Youth Representative, Youth Council Co-Chair, and member of the Summit Planning, Conference, and Education Committees. Elizabeth is also the Co-Chair of the Teen Advisory Council (KIDS Michigan) at the CS Mott Children’s Hospital in Ann Arbor, MI. She has been a Ranger for two years at Flying Horse Farms (a Paul Newman camp) in Mt. Gilead, OH, and is a youth leader at her church in Detroit. Elizabeth is also an experienced public speaker, having been featured at a number of fundraisers and blood drives. She contributed to an article published in the medical journal Clinical Therapeutics, and is currently working with students at the University of Michigan to develop a unique app for teenagers and young adults to track medications and daily health. In her spare time, Elizabeth enjoys art, music, and her Portuguese Water Dog.