ICON’s World Children’s Day: Special Panel Discussion

Lynne Yao, MD, Director, Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research, FDA

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 Pediatrics and Pediatric Nephrology. Prior to joining FDA, Dr. Yao was the Director of Dialysis and Associate Pediatric Residency Program Director at the Inova Fairfax Hospital for Children in Fairfax, VA.  She has been with the FDA since 2008. The Division of Pediatric and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric 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.

Christina Bucci-Rechtweg, MD, Global Head, Pediatric & Maternal Health Policy, Drug Regulatory Affairs, Novartis Pharmaceuticals Corporation

Dr. Bucci-Rechtweg graduated with an 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 @ Buffalo. She has over 20 years of pharmaceutical industry experience with roles in Clinical Development & Medical Affairs as well as Regulatory and Development Policy where she was responsible for 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 in Phase II and III, including those with pediatric regulatory obligations in the EU and US, and is widely regarded for her negotiating skills in adult and pediatric drug development, as well as health policy and international regulatory consensus building.

Christina is actively involved in numerous external organizations advancing the regulatory and development environment for pediatric and maternal health globally, including the U.S. National Advisory Council for Child Health and Human Development, ICH Pediatric Standing Advisory Cmte, ICH E11A Pediatric Extrapolation Expert Working Group, Critical Path Institute’s International Neonatal Consortium, EFGCP Children’s Medicines Working Party, the IQ Consortia’s Pediatric Clinical Pharmacology Leadership Group, HHS Task Force on Research in Pregnant Women & Lactating Women, as well as numerous professional societies and the trades. Christina is currently the Global Head for Pediatric and Maternal Health Policy at Novartis Pharmaceuticals Corporation.

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

Dr. Sorrentino has over 20 years of experience in the pharmaceutical and biotech industries and currently leads ICON’s global pediatric center of excellence. 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. Prior to joining the industry, Dr. Sorrentino was an attending physician in the CNMC pediatric intensive care unit for 8 years and participated in numerous industry-sponsored critical care trials. He holds active medical licenses in California and Maryland.

John Ssentami, Director of the Good Shepherd Primary School and Founder of the Busubi Learning Centre

John Ssentamu is a teacher by profession and lives in Kisekka Sub-county, Lwengo District in Uganda.  He founded the Busubi Empowered Communities Learning Centre and currently serves as the Director of the Good Shepherd Primary school in Katwadde Cell, Nyendo-Mukungwe Division in Masaka City – Uganda and is President of the Rural Teachers Association.  He is passionate about improving health care for children through education in his remote location of Kaziru Village on shores of L. Victoria and has a vision to build a children’s hospital there. The closest medical facility is Masaka Referral Hospital approximately 40km away and only has a small ward for children.  He aims to develop a free standing children’s hospital in his community.

Gianna “Gigi” McMillan, DBe, Acting Graduate Director for the Bioethics Institute, Loyola Marymount University

Dr. McMillan develops academic curriculum and teaches Research Ethics at Loyola Marymount University in Los Angeles. She received her master’s degree from LMU and her doctorate from Loyola Chicago. Dr. McMillan has been an adviser to the Children’s Brain Tumor Foundation, the National Brain Tumor Society, and the Pediatric Brain Tumor Consortium. She has extensive experience as a Subject/Patient Advocate on local and national IRBs, was a member of the Subpart A Subcommittee for the Secretary’s Advisory Committee on Human Research Protection and is a member of the FDA’s Pediatric Advisory Committee. Dr. McMillan has served on the board of the American Society for Bioethics and Humanities and is currently on the Board of PRIM&R (Public Responsibility in Medicine & Research.) She is the Director of Community Engagement for the academic journal, Narrative Inquiry in Bioethics. Her primary interests are consent issues in clinical research and the use of narrative as an educational tool in bioethics.

Children’s Panel, European Young Person’s Advisory Group Network (eYPAGnet)

The European Young Persons Advisory Group Network (eYPAGnet) is a consortium of Young People’s Advisory Groups (YPAGs) across Europe. It was founded by the following groups:  GenerationR (Liverpool, England). Kids Barcelona, Kids France, and ScotCRN (Scotland). eYPAGnet provides a platform for children and young people to have a voice across Europe, share their opinions, and apply their experience to a variety of issues in clinical trials, such as relevant endpoints, protocol design, formulations, age-appropriate information, and patient tools.

(Moderator) Pamela Dicks, PhD, Manager, National Health Services Children Research Network, Scotland; Member of ICON’s Paediatric Research Partners

Dr. Dicks works with industry, governance, and research nurses to facilitate the efficient set up and timely delivery of paediatric clinical research across all Scottish sites. There are more than 100 trials in the paediatric portfolio. She is main point of contact with industry for the network and the lead for the Paediatric Research Partners site relationship with ICON, formerly PRA Health Sciences. She is a member of the EnprEMA coordinating group, national representative on NIHR Children’s Specialty Group and Conect4children National Hub. She has experience in clinical trials design, recruitment and retention strategies, and her most recent publication looked at the impact of changes to the clinical pathway to mitigate the transmission of COVID-19 on the recruitment to paediatric research. She has more than 12 years’ experience coordinating the ScotCRN YPAG, is a founder of eYPAGnet and was the host of the International Children’s Advocacy Network Summit in Edinburgh 2018.

Dr. Martine Dehlinger-Kremer, PhD, Vice President, Scientific Affairs, Pediatric Subject Matter Expert, Center for Pediatric Clinical Development, ICON

Dr. Dehlinger-Kremer has more than 30 years of experience in the research industry, including regulatory, medical affairs, and pediatric leadership expertise. Prior to joining ICON, she served in several executive leadership roles at global CROs and coordinated global drug development in more than 40 countries. She has contributed to 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 President of the European CRO Federation (EUCROF), chair and board member of the European Forum for Good Clinical Practice (EFGCP) Children Medicines Working Party and is active in the International Children’s Advisory Network (iCAN).

In 2015 Dr. Dehlinger-Kremer was named one of PharmaVOICE 100’s Most Inspiring People in Life Sciences. Dr. Dehlinger-Kremer earned a doctorate in sciences from the Goethe University in Frankfurt am Main, Germany; a degree of advanced study in neurophysiology from the University Louis Pasteur in Strasbourg, France; and Master of Sciences from Moulin de la Housse, the University of Reims Champagne-Ardenne in Reims, France.

Kirsten Sherman Cervati, BA, CCRP, Senior Director, Global Head, ICON’s Paediatric Research Partners, Center for Pediatric Clinical Development, ICON

Ms. Sherman Cervati has 20+ years of experience in the industry, having held operations and leadership positions at Duke Clinical Research Institute, Neeman Medical International, and PPD. Prior to joining ICON in November 2017 to develop and lead the Pediatric Research Partners, Ms. Sherman Cervati led global teams in the conduct of protocol and site feasibility, strategic site partnerships, and clinical trial management system administration. She is a fierce advocate for children’s healthcare and rights in both her professional and personal life, as she has been actively involved in the International Children’s Advisory Network (iCAN) since inception, currently leading one of the youth chapters. Ms. Sherman Cervati was recently selected to serve on the Executive Advisory Board for the American Academy of Pediatrics Section on the Advancement of Therapeutics and Technology.

Heather Peterson, RN, BSN, Pediatric Strategy Liaison, Center for Pediatric Clinical Development, ICON

Ms. Peterson has a diverse background in clinical research, both as a registered nurse and in clinical operations. She is a passionate advocate for the needs of children and families and considers the patient journey as she applies her expertise to pediatric clinical trial development. Most recently, she served as the lead clinical research coordinator at Renown Regional Medical Center, a non-profit hospital in Reno, Nevada, where she coordinated and managed clinical trials. She worked across several therapeutic specialties to streamline scientific review committees and IRB submission processes and centralize the hospital’s research departments under the office of research and education. She brings a perspective that is valuable in developmental aspects of patient recruitment, enrollment, and retention. Ms. Peterson also serves as a member on the IRB at the University of Nevada, Reno, and volunteers for the Medical Reserve Corps of Washoe County.