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New Horizon / 

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October 5, 2022

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....

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October 2, 2022

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....

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October 2, 2022

Dr. John van den Anker is a Professor of Pediatrics, Pharmacology, Physiology, Genomics and Precision Medicine at the George Washington University School of Medicine and Health Sciences, Washington, DC and holds the Evan and Cindy Jones Endowed Chair in Pediatric Clinical Pharmacology. He also is the Eckenstein-Geigy Distinguished Professor of Pediatric Pharmacology at the University Children’s Hospital of Basel, University of Basel, Switzerland....

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October 2, 2022

Lionel Tan is physician-scientist who is currently the Medicine Development Lead for Paediatric HIV at ViiV Healthcare with oversight over the paediatric R&D portfolio. Lionel joined ViiV Healthcare in 2020 from Global Health at GSK where he had been the clinical lead on an anti-malarial drug and an early phase drug for visceral leishmaniasis. Prior to this, Lionel worked in Infectious Diseases at GSK where he was the project physician lead on both early phase and late phase antibacterial compounds. Whilst in GSK Infectious Diseases, Lionel undertook a part-time secondment in Clinical Pharmacology with a focus on paediatrics and developed a passion for paediatric drug development. He co-chairs the Medicine for Children Advisory Network within GSK and the...

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October 2, 2022

Dr Karen Rowland Yeo is Senior Vice-President, Client & Regulatory Strategy at Certara UK Limited’s Simcyp Division. Prior to this, she was the Head of PBPK Consultancy Services at Simcyp where she led a team of scientists engaged in Consultancy projects relating to the application of physiologically based pharmacokinetic (PBPK) modeling in the drug development process. This involved putting a framework in place for developing PBPK models used for both internal decision-making and regulatory submissions. Her work ranged across most therapeutic areas and included the development of models used for dosing of special populations and assessment of drug-drug interactions. Prior to joining Simcyp Ltd in 2002, Karen held a 5-year lectureship in the Department of Clinical Pharmacology & Therapeutics at...

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October 2, 2022

Dr. Isaac R. Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research, and post-marketing studies. Currently, he is a Senior Vice President, Scientific & Clinical Affairs, and Head of the Center for DCTs and Digital Medicine at ICON plc. Past positions include FDA, CDER Senior Official for Clinical Research, Regulatory Compliance, and Policy Development to modernize clinical research through Decentralized Clinical Trials, Digital Health Technologies, and Real-World Evidence. He published numerous articles and has been an invited speaker at 100+ global conferences. He holds leadership roles at DiME, IEEE-SA-DCT, DTRA,...

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October 2, 2022

Ashley Strougo is currently the Program Lead for the Childhood Cancer Flagship, a commitment from Corporate Social Responsibility at Sanofi. Previously, she was the Head of the Modeling and Simulation Group in Germany where she also fulfilled the roles of Translation Medicine Lead and Modeling and Simulation Lead for late phase programs. Ashley has a long-standing interest in pediatric drug development with more than 15 years of experience in drug development, including significant contributions to planning, development and/or submission of many investigational drugs for children. She is a member of Sanofi’s Pediatric Network and Sanofi’s representative and former chair of the Pediatric Working Group at IQ Consortium. Prior to joining Sanofi in 2015, she worked as a quantitative clinical pharmacologist with...

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October 2, 2022

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...

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October 2, 2022

Dr. Virna Schuck is the Head of Clinical Pharmacology at Ribon Therapeutics. With 18 years of experience, Dr. Schuck has worked across Research and Development supporting projects in various therapeutic areas including infection and oncology. Prior to joining Ribon Therapeutics, Dr. Schuck held positions of increasing responsibilities at Certara, Novartis, AstraZeneca, and Millennium Pharmaceuticals. Throughout her professional career, Dr. Schuck work focused on profiling the ADME properties of novel compounds and integrating PK/PD data to drive clinical pharmacology strategies and dose recommendations to adult and pediatric populations. Dr. Virna Schuck obtained her Bachelor degree in Pharmacy and Masters in Pharmaceutical Sciences from the Federal University of Rio Grande do Sul - UFRGS- Brazil; and her PhD in Pharmaceutical Sciences from the...

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October 2, 2022

Leyla Sahin, MD is an obstetrician-gynecologist who is the Deputy Director for Safety in the Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research at FDA. She oversees pregnancy and lactation safety activities and leads various maternal health related scientific and regulatory/policy initiatives....

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