ÃÛÌÒ´«Ã½¡¯s Centre for Paediatric Clinical Development invites you to celebrate World Children¡¯s Day virtually with us on November 13, 2023. World Children¡¯s Day is recognised as an international coming together to advocate for, promote, and celebrate the rights and welfare of children and create dialogue and action plans to build a better world for children. First established in 1954, it also commemorates the day when the UN General Assembly adopted the Declaration of the Rights of the Child in 1959 and when the UN General Assembly adopted the Convention on the Rights of the Child in 1989.
ÃÛÌÒ´«Ã½ proudly commemorates World Children's Day annually, uniting the clinical research community to reflect on the pivotal role it plays in enhancing the well-being of children. Our focus is on advancing clinical development to benefit not only these young patients but also their families.
In this year's event, expect to gain insights into ongoing regulatory initiatives that aim to promote diversity and inclusion within paediatric therapeutics development. Our distinguished speakers will also delve into the crucial realm of paediatric formulation development, ensuring that children across all age groups get access to safe and accurately dosed medicines, easing the burden on caregivers. Additionally, our expert speakers will address the challenges faced and offer strategies to expedite progress in this critical field of paediatric research.
Join us for this webinar and learn more about:
- Ongoing regulatory efforts to increase accessibility in paediatric therapeutics development
- Increasing awareness of the needs and effort behind providing access to safe and accurate dosage forms of medicines for every child
- How we can expedite drug development for children and their families to provide access to adapted medicines and innovative medicines.
Audience summary
- Research and development
- Clinical research
- Medical affairs
- Scientific affairs
- Regulatory affairs
- Clinical affairs
- Project management
- Clinical operations
- Risk management
- Executives
- Healthcare professionals
- Patient advocacy groups and their members
- Anyone who has an interest in the future of Paediatrics research
Speakers:
Mark Sorrentino, MD
Dr. Sorrentino has 20 years of experience in the pharmaceutical and biotech industries and currently leads ÃÛÌÒ´«Ã½¡¯s global Centre for Paediatric Clinical Development. Prior to joining ÃÛÌÒ´«Ã½, Dr Sorrentino was the global chair and founder of the paediatric practice area at a leading CRO, overseeing all aspects of strategy and paediatric clinical development, as well as the global therapeutic head of critical care and the interim head of infectious diseases. He has also held several roles in the biopharmaceutical industry having served as the global chief medical officer at a biotechnology company where he oversaw all clinical development operations, and as director of medical science at a pharmaceutical company, 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.
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 and has an interest in disaster management and special operations/tactical medicine. He holds active medical licenses in California and Maryland.
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, He holds an appointment as an assistant clinical professor at the George Washington University School of Medicine. He is an active medical team member of Team Rubicon, and the California Medical Reserve Corps. He has deployed to disasters in the US and has also volunteered on several international medical missions. In addition, he is on the board of directors for the non-profit life sciences education company, the CMR Institute, the Industry Advisory Board of CureSearch for Children¡¯s Cancer, and two Enpr-EMA Working Groups.
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 paediatric leadership. Prior to joining ÃÛÌÒ´«Ã½, 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 organisations ¨C 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).
In 2015, Dr. Dehlinger-Kremer was named one of PharmaVOICE¡¯s 100 Most Inspiring People in Life Sciences.
Dr. Dehlinger-Kremer earned a Doctorate in Sciences from the J. W. Goethe University in Francfort on the Main, Germany; a Diploma of Advanced Study in Neurophysiology from the University Louis-Pasteur, Strasbourg, France; and a Master of Sciences degree from University Moulin de la Housse in Reims, France.
Lynne Yao, MD
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
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.
He is Author/co-author of more than 250 publications in peer-reviewed and has been invited as speaker at more than 300 conferences and international workshops across the world.
Eric Zuckerman, DO
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.
Through the Foundation¡¯s web site and social media channels, Dr. Zuckerman regularly communicates with parents of children with IBD from all over the world. He frequently provides guidance to parents with educational information and resources, understanding from his own experience the challenges faced by families living with IBD.