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 organization towards making a meaningful impact on pediatric health, medicine, research, and innovation. If you are interested in becoming a member of iCAN’s Scientific Advisory Board, please contact Meghan Gwara, iCAN coordinator at [email protected]
Meet the Scientific Advisory Board
Stephen P. Spielberg, M.D., PhD
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.
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, M.D., M.P.H., FAAP is Vice President of Child Health Innovation and Leadership Department (CHILD), at Johnson & Johnson (J&J). He joined J&J in February 2000. Dr. Maldonado graduated with an MD degree from the National University of Honduras. He completed his pediatric residency at Henry Ford Hospital in Detroit, MI and a fellowship in Pediatric Infectious Diseases at Children’s National Medical Center in Washington, D.C. and his Masters in Public Health at George Washington University in Washington, D.C. 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 across therapeutic areas. He also represents Regulated Industry at the FDA Pediatric Advisory Committee and at the International Conference of Harmonization (ICH). In the last three years, he has worked in bringing together a diverse group of 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’s experience in public policy and operational issues related to drug development expands over 26 years, of which 8 he served as Medical Officer at the FDA and the last 18 in 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 completed a Ph.D. in electronics and electrical engineering at the University of Southampton in England and received an M.Phil. from Cambridge University in speech and language processing after undergraduate studies in engineering. He was a Marie Curie Research Fellow at the Institut de la Communication Parlée in Grenoble, France for two years, and also worked at the University of Waterloo, Canada and the Université Libre de Bruxelles, Belgium. He has held visiting positions at the University of Western Sydney, Australia and Addis Ababa University, 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, most recently 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, based on developmentally appropriate mechanisms of social contingency that promote vocal interaction, 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 as well as participants 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 encompassing all pediatric age ranges. Additionally she has provided expertise for clinical trials in the adult and pediatric infectious diseases arena. Dr. Jackson has a broad understanding of regulatory requirements for pediatric clinical trials and also special expertise in global pediatric clinical trial strategy and clinical development planning. Dr. Jackson graduated from Des Moines University College of Osteopathic Medicine in Des Moines, Iowa. She completed a rotating internship followed by a residency in Pediatrics at Western Reserve Care System/Tod Children’s Hospital in Ohio. Dr. Jackson completed a fellowship in Pediatric Infectious Diseases at Duke University Medical Center in Durham, NC and a fellowship in the Department of Virology, HIV Pathogenesis Lab at Glaxo Wellcome, Inc. She has been a faculty member at the Duke University School of Medicine and the University of Illinois Chicago, College of Medicine at Peoria. 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. 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 under an Isaac B. Singer full tuition scholarship, 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. When his hospital and many others nationwide could not purchase equipment vital to the care of the neonates he treats. Dr. Goldstein rallied. He wrote senators and congressman. He testified in front of a United States Senate Sub-Committee of the Judiciary regarding the practices of the Group Purchasing Organizations and the potential for restriction of access to vital medical devices. The story of Dr. Goldstein’s vigilance, success in helping modify these practices, and improve patient care made the front page of the New York Times. Dr. Goldstein has also been a vocal advocate for RSV prophylaxis and “right” sizing technology for the needs of neonates. He is a past president of the Perinatal Advisory Council, Legislation, Advocacy and Consultation (PACLAC – the Regional Perinatal Program for the Inland Empire) as well as a past president of the National Perinatal Association (NPA). Dr. Goldstein is the twice recipient of the annual Jack Haven Emerson Award presented to the physician with the most promising study involving innovative pulmonary research and the 2013 recipient of the National Perinatal Association Stanley Graven lifetime achievement award presented for his ongoing commitment to the advancement of neonatal and perinatal health issues. PACLAC’s annual dedication to community award is named for Dr. Goldstein. Dr. Goldstein is the editor of PACLAC’s Neonatal Guidelines of Care as well as the Principal author of both the National Perinatal Association’s 2011 Best Practice Checklist – Oxygen Management for Preterm Infants and Respiratory Syncytial Virus (RSV) Prophylaxis 2015 Guidelines. Dr. Goldstein chaired the NPA National Conferences in 2004, 2008 (which was actually held at Loma Linda University Children’s Hospital) and 2011 and continues to be active in conference planning as the CME Continuing Medical Education (CME) chair for PACLAC. Dr. Goldstein serves on the editorial board of the Journal of Perinatology as well as Neonatology Today, has represented the NPA to the American Academy of Pediatrics (AAP) perinatal section, and is a moderator of NICU-NET, a neonatal listserv. Dr. Goldstein is the Medical Director of the National Coalition for Infant Health, a coalition of National Organizations involved in perinatal health including the American Academy of Pediatrics, NANN, and AHWONN. In this role, he has continued to press for access to important medical therapies for babies including an exclusive breastmilk diet, RSV prophylaxis, and appropriate prenatal care, especially in those babies who have been impacted by disparity. He frequently travels to Sacramento and Washington to speak on their behalf. 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. Dr. Goldstein’s recent publications have included “Critical Complex Congenital Heart Disease (CCHD)” which was dual published in Neonatology Today and Congenital Cardiology Today, the “Late Preterm Guidelines of Care” published in the Journal of Perinatology, and “Safety and Quality: Are they compatible?” published in Neonatology Today.
Raymond Koteras is a healthcare management executive who completed graduate studies in health services administration from the George Washington University School of Government and Business Administration in Washington DC. He completed residency training in hospital administration at the Foster G McGaw Hospital of Loyola University in Maywood, Illinois, and laboratory internships in clinical chemistry, microbiology, hematology, and blood banking as part of his undergraduate training in medical technology from the State University of New York (SUNY) at Buffalo School of Allied Health Professions. Currently, Ray is Director, Technical and Medical Services, Department of Subspecialty Pediatrics, for the American Academy of Pediatrics (AAP), a 66,000 member not-for-profit medical specialty society dedicated to the optimal physical, mental, and social health and well-being of infants, children, adolescents, and young adults. Throughout his 25+ year career at the AAP, Ray has provided strategic direction and leadership for a diverse portfolio of mission-driven programs and services that include clinical policy, advocacy, professional education, and member engagement. He has provided management support for an extensive number of national committees and subspecialty sections that work in concert with internal and external partners to establish national policies that serve to guide clinical practice, inform the unique health needs of children, and foster access to essential primary and subspecialty care. Ray’s scope of endeavor spans all core operations and includes point-of-care publications such as the Report of the Committee on Infectious Diseases (aka Red Book), and Pediatric Nutrition Handbook; ongoing advocacy to support the rational use of medications in children including the Best Pharmaceutical for Children’s Act (BPCA); assorted federal grants and contracts; continuing medical education courses; and member value programs. He was a member of the Planning Committee for the 2014 Global Pediatric Clinical Trials Symposium, helped facilitate the first national harmonized medical/dental guidelines for sedation monitoring in children undergoing diagnostic and therapeutic procedures and serves as the primary 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.