ICON’s World Children’s Day

Mark Sorrentino, MD, Vice President, Center for Pediatric Clinical Development, ICON

Mark Sorrentino, MD, Vice President, Center for Pediatric Clinical Development, has 20 years of experience in the pharmaceutical and biotech industries and currently leads Icon’s global pediatric center of excellence. In addition, he founded and oversaw the Center for Vaccines and Emerging Infectious Diseases before the PRA/Icon merger. Prior to joining ICON, Dr Sorrentino spent 5 years as the global chair and founder of the pediatric practice area at a leading CRO, overseeing all aspects of strategy and pediatric clinical development, as well as the global therapeutic head of critical care and the interim head of infectious diseases. In addition to working at CROs, Dr Sorrentino has served as the global chief medical officer at ADMA Biologics, where he oversaw all clinical development operations, and as director of medical science at MedImmune, where he was responsible for development and oversight of numerous Phase 4/post-marketing studies across several therapeutic areas, including infectious diseases, respiratory diseases, and transplant medicine. As a former consultant to biotechnology firms, Dr Sorrentino has also overseen implementation of medical information systems. Having earned his medical degree and master’s degree in clinical nutrition from the Chicago Medical School, Dr Sorrentino completed both a residency in pediatrics and a fellowship in pediatric critical care at Children’s National Medical Center (CNMC) in Washington, DC. Currently, Dr Sorrentino holds an appointment as an assistant clinical professor at the George Washington University School of Medicine.

Dr. Martine Dehlinger-Kremer, PhD, MS, Vice President of Scientific Affairs, Pediatric Subject Matter Expert, Drug Development Solutions, ICON

Dr. Dehlinger-Kremer’s expertise spans more than 30 years in the research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior to joining ICON, she served in several executive leadership roles at global CROs, and has experience in global drug development in more than 40 countries. She has contributed to the global development of numerous products, including medicines for children, drugs for orphan diseases and biosimilars.  Her vision and leadership extend to service with a number of professional organizations – she is an observer member of the Coordinating Group of the European Network of Pediatric Research (Enpr-EMA) at the European Medicines Agency, chair of the Pediatric Working Group and also President of the European CRO Federation (EUCROF), serves as chair of the European Forum for Good Clinical Practice (EFGCP) Children’s Medicines Working Party and Board Member of the association, and is active in the International Children’s Advisory Network (iCAN).

Lynne Yao, MD, Director, Division of Paediatrics and Maternal Health (DPMH) in the Office of New Drugs, Center for Drug Evaluation and Research, FDA (Food and Drug Administration)

Lynne Yao, MD is the Director, Division of Paediatrics and Maternal Health (DPMH) in the Office of New Drugs, Center for Drug Evaluation and Research. Dr. Yao received a B.S. degree in Biology from Yale University, and an M.D. degree from the George Washington University School of Medicine. She is board certified in both Paediatrics and Paediatrics Nephrology. Prior to joining the FDA, Dr. Yaowas was the Director of Dialysis and Associate Paediatrics Residency Program Director at the Inova Fairfax Hospital for Children in Fairfax, VA. She has been with the FDA since 2008.

Since 2017, Dr. Yao has served as the Rapporteur for the International Conference on Harmonization (ICH) E11A Paediatrics Extrapolation Guideline Expert Working Group. As DPMH Director, Dr. Yao oversees quality initiatives which promote and necessitate the study of drug and biological products in the Paediatrics population; and improve collection of data to support the safe use of drugs and biological products in pregnant and lactating individuals. She collaborates with numerous stakeholders both inside and outside of FDA to advance development of safe and effective therapies for children, and pregnant and lactating women.

Carlo Giaquinto, MD, President of Penta Foundation and Full Professor of Paediatrics at the University of Padua, Penta - Child Health Research

Carlo Giaquinto, MD is a Professor of Paediatrics at the University of Padova, he is Head of the Paediatric AIDS and ID Unit at the Department of Women and Child Health of Padova. Chair of PENTA-ID Network and President of the PENTA Foundation. Honorary Senior Lecturer in the Centre for Paediatric Epidemiology and Biostatistics, Institute of Child Health, London till 2010.

He spent more than 30 years on HIV research in both developed and developing countries with specific interest in clinical trials and observational research. Other areas of interest include antibiotics, paediatric medicine, and vaccinology. Since 1992 he has coordinated several large EU funded research projects (TEDDY, PENTA/ECS, ACTIVATE, PENTA/LABNET, NEOMERO, GRIP, NeoVanc) and is participating representing paediatric network and expertise in many others.

Eric Zuckerman, DO, Board Chairman and founding board member, Paediatrics IBD Foundation

Eric Zuckerman, DO, has been the Board Chairman of the Paediatrics IBD Foundation since its inception in 2008. Dr. Zuckerman is a Michigan based ophthalmologist whose daughter was diagnosed with Crohn’s Disease in 2003.

Dr. Zuckerman was selected to become an FDA patient representative in Paediatrics IBD in 2012. Under his leadership, the Foundation served as the lead co-sponsor for FDA’s GREAT 2 and GREAT 3 meetings. These groundbreaking meetings saw regulators, industry, and researchers at the same table in collaborative discussions about safety monitoring and streamlining drug approvals for children with inflammatory bowel disease. At GREAT 3, Dr. Zuckerman presented a model for a drug agnostic data sharing IBD registry to monitor drug safety and meet post marketing (phase 4) requirements called the Children’s REgistry for the Advancement of ThErapeutics, (CREATE). Continuing his work as an advocate for children with IBD, Dr. Zuckerman submitted testimony to Congress in support of a National Drug Safety registry for IBD.