The APDC Clinical Core provides collaborative and consultative support on human factors, clinical significance, and works closely with the ADPC Biostatistics Core on study design consultation for device validation studies. The core also grants comprehensive clinical expertise and guidance for APDC innovators in identifying and ensuring timely access to additional critical resources such as specialized clinical end users who can provide specific feedback necessary for targeted innovations.
The core offers input by clinical advisors from a number of different subspecialties who have extensive patient care background combined with clinical research experience. These advisors assist APDC innovators starting from very early preconcept phase in addressing the specific needs of children suffering from disease or disabilities, and understanding the clinical environment in which their novel devices will be used to help improve pediatric clinical care. These core advisors provide expert consultation in clinical merit and gaps, warn of possible clinical challenges, and offer insights into clinical effectiveness of the medical devices specifically designed for children. Collectively, this group serves as reviewers, evaluators, mentors, and advisors who can be called upon as needed to fill identified gaps on projects and can tailor their assistance per project.
Inci Yildirim, M.D., Ph.D., M.Sc. Inci Yildirim serves as the Director for the APDC Clinical Core and is an Assistant Professor of Pediatric Infectious Diseases and Epidemiology at Emory University Schools of Medicine and Public Health. Her research investigates the comparative- and cost-effectiveness of interventions to identify and treat vaccine preventable diseases, employing methods of clinical epidemiology, and clinical economics. Yildirim provides essential input and expertise as our device projects enter the clinical testing phase of development. Yildirim has over 50 peer-reviewed publications and serves on several committees focused on optimizing health outcomes in children.
Nikhil Chanani, M.D. Nikhil Chanani is a Cardiac Intensive Care Unit Attending at Children’s Healthcare of Atlanta and an Assistant Professor of Pediatrics at Emory University School of Medicine. His clinical responsibilities include quality and process improvement within the cardiac service line. His research interests include clinical studies focused on improving patient care for children with congenital heart disease, including device and information systems.
Henry J. Rozycki, M.D. Henry Rozycki is currently Vice-Chair for Research in the Department of Pediatrics at the Children’s Hospital of Richmond at VCU and a Professor at Virginia Commonwealth University. He is also an active member of the Division of Neonatal Medicine. Over the last thirty years his research has focused on neonatal care and newborn lung injury and development, focusing on the development of innate inflammation and the role of alveolar Type I cells in lung development and injury. Among his over 40 publications are studies on devices to deliver aerosols to intubated infants. He is currently investigating potential devices to enhance chest wall rigidity in extremely premature infants.
Stephanie Meisner, RN, BSN, CCRP Stephanie Meisner is the Director of Clinical Research at Children’s Healthcare of Atlanta and the Pediatric Nursing Director for the Georgia Clinical & Translational Science Alliance (GaCTSA). She started as a Pediatric Intensive Care nurse then migrated into clinical research. She has a proven track record recruiting, enrolling, and managing numerous clinical trials for federal, industry, and investigator-initiated projects, Phases I-IV. In her current role, she supervises the execution of over 115 clinical trials for 15 pediatric subspecialties with over 35 Principal Investigators & their teams. For the Atlanta Clinical Translational Science Institute funded by the NIH, she is a member of the Pediatric Program Committee and the Scientific Advisory Board. She is a past recipient of the DAISY Award for Extraordinary Nurses and was the 2013 March of Dimes Georgia Nurse of the Year in Pediatrics. In 2014, she collaborated with the American Academy of Pediatrics (AAP) and the International Children’s Advisory Network (iCAN) to co-find KIDS Georgia; an advisory group of children, adolescents, and families focused on understanding, communicating, and improving the process of medical innovation for children.