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James Yates is Scientific Director at GSK and leads the nonclinical PKPD modelling team. He has a background in mathematics and engineering (University of Warwick, UK) and has 18 years’ experience in drug discovery and development, particularly in oncology. He has published over 80 papers on translational PKPD. He has a particular interest in the application of mathematical modelling for translation from nonclinical to patients and between patient populations....

Lynne Yao, M.D., is the Director, Division of Pediatric and Maternal Health (DPMH) in the Office of New Drugs at FDA. DPMH oversees initiatives for the study of medicines in the pediatric population; and improve collection of data to support the safe use of medicines in pregnant and lactating individuals....

I have worked in the NHS as a hospital pharmacist for a number of years and hold a PhD in clinical pharmacology, and MSc in Statistics. I am a member of the Royal Pharmaceutical Society, British Pharmacological Society, Fellow of the Royal Statistical Society, member of the European Society for Clinical Microbiology and Infectious Diseases and member of the International Society of Pharmacometrics. I have held two MRC academic fellowships (Methodology 2011-2015, Clinician Scientist 2015-2020) which have led to the development of my paediatric pharmacometrics research group at the UCL Great Ormond Street Institute of Child Health. This group is funded from research council and European agencies (MRC, EU-FP7, Swedish Research Council) and charities/non-profit (Wellcome, DNDi, GOSHCC). I lead and teach...

Robert “Skip” Nelson, M.D., Ph.D. is Senior Director, Pediatric Drug Development at Johnson & Johnson. Previously (2006-2017), Dr. Nelson was Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration. Before joining FDA full-time, Dr. Nelson was Professor of Anesthesiology, Critical Care and Pediatrics at The Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine. Dr. Nelson is a member of the Secretary’s Advisory Committee on Human Research Protections and serves as the Industry Representative to the FDA Pediatric Advisory Committee....

Flora Musuamba holds a Ph.D. in Pharmacy and biomedical sciences from Université Catholique de Louvain, in Belgium. She is currently the vice-chair of the European medicines agency modelling and simulation working Party), a member of the EMA scientific advice and methodology working parties and a Pharmacometrics and Pharmacovigilance expert at the Belgian federal medicines agency. She is also an associate professor of Clinical Pharmacology at University of Namur....

Professor Jian Li is a Fellow of the American Academy of Microbiology and President of the International Society of Anti-infective Pharmacology. He has an internationally recognised track record in antimicrobial pharmacology and drug discovery with 414 publications (25,557 citations, h-index 78). His research has led to the first scientifically-based dosing recommendations for polymyxins and improved clinical practice worldwide. His team has developed a novel antibiotic QPX9003 from concept to clinical trials. He is a Web of Science Highly Cited Researcher in Pharmacology & Toxicology (2015-2017) and has received numerous awards, including the Australian Academy of Science Jacques Miller Medal (2017)....

Rachel G. Greenberg, MD, MB, MHS is a neonatologist and Associate Professor of Pediatrics at Duke University Medical Center and Duke Clinical Research Institute. Dr. Greenberg’s research focuses on improving safety and efficacy of drugs in infants and children, particularly through her efforts as co-Investigator for the NICHD-funded Pediatric Trials Network. She is also co-Investigator for the NCATS-funded Duke-Vanderbilt Trial Innovation Center, where she provides consultation to investigators developing multicenter studies. In addition, she has been principal investigator of multiple trials funded by the U.S. Food and Drug Administration, Centers for Disease Control, and National Institutes of Health....

Lynne Georgopoulos, RN, MSHS, RAC, is Vice President, Regulatory Strategy, Integrated Drug Development, and Lead of the Pediatric Integrated Practice Area, at Certara. Lynne has over 30 years of diverse biopharmaceutical and CRO industry experience developing and providing strategic guidance and clinical development and regulatory advice at all stages of product development. Lynne has lead numerous successful regulatory filings and agency interactions in the US and Europe with extensive experience in developing and negotiating innovative strategies to accelerate pediatric drug development across multiple therapeutic areas including rare/orphan diseases. Additionally, Lynne has extensive experience in clinical operations and has coordinated large multinational adult and pediatric trials. Previously, Lynne was VP of Regulatory Affairs and Pediatric Strategic Development at Synteract, and Sr. VP Regulatory Affairs and Clinical Development at KinderPharm.  Lynne received a nursing degree from...

Solange Corriol-Rohou, a pulmonologist and an immuno-allergist by training, joined AZ R&D in 2004 and is currently Sr. Director of Regulatory Affairs & Policy for Europe. Over the past 20 years, moving from the French Medicines Agency/EMA and a specialist physician position at the Hospital of Versailles to the pharmaceutical industry, she has gained strategic experience in drug development for different therapy areas, such as respiratory, inflammation and oncology. She is currently leading the AZ Paediatric Work Group. Solange, in her role as the chair of the Clinical Development Expert Group at the EFPIA, organized jointly with the EMA several workshops. Dr. Corriol-Rohou has recently been involved in critical issues, such as Complex Clinical Trial Designs, the use of Digital tools...

S. Y. Amy Cheung, PhD is a Senior Director in Integrated Drug Development with responsibility of Quantitative Sciences lead for the UK. She is a core member of the Pediatric Integrated Practice Area at Certara. She has over a decade of Pharma experience (AstraZeneca).  She obtained her PhD from the University of Manchester. After receiving her PhD, she worked at the Centre for Applied Pharmacokinetic Research (CAPKR) at The University of Manchester. Followed by a postdoc on mechanistic modelling. She has expertise in pediatric drug development, oncology, infection, CNS, vaccine, mAb, MIDD, PBPK, and extrapolation. She is a member of the IQ CPLG pediatric working group and chair of the IQ TALG CPLG Pediatric PBPK group. She is an affiliated...