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New Horizons in Pediatric Drug Development Symposium

New Horizons in Pediatric Drug Development Symposium
Presentations
Introduction & Welcome
Patrick Smith, PharmD | SVP, Commercial Strategy & Innovation, IDD - Certara
Keynote – Accelerating Global Pediatric Drug Development – Challenges and Opportunities
Lynne Yao, MD | Director, Division of Pediatrics and Maternal Health, Center for Drug Evaluation and Research (CDER)
Session 1 – Innovative Techniques Toward Extrapolation and Efficient Drug Development
Hannah Batchelor, PhD - Robert “Skip” Nelson, PhD | Lily Mulugeta, PharmD (moderator)
Evidence to support pediatric approval through extrapolation (20 min), Pediatric formulations, considerations for BA/BE studies (20 min), Panel discussion (25 min)
Session 2 – Researching Agreement with Regulators on Global Approach to Pediatric Drug Development
Gregory Reaman, MD | Lynne Georgopoulos, RN, MSHS, RAC (moderator)
Changing Regulatory Landscape and Pediatric Oncology Development (20 minutes), European Perspective/ICH Pediatric Guidelines (adolescents in adults studies) (20 minutes), FAIR Trials, Panel discussion (25 mins)
Session 3 – Neonatal Research Insights
John van den Anker, MD, PhD - Karen Rowland Yeo, PhD - John van den Anker, MD, PhD |
Challenges in planning and conducting successful trials in infants/neonates (20 min), PBPK – Applications of modeling and simulation – infants and neonates (20 min), Challenges in planning and conducting successful trials in infants/neonates (20 min)
Session 4 – Novel Clinical Trial Design
Alex Bliu, PhD - Jeff Barrett, PhD | Amy Cheung, PhD (moderator)
Adaptive Clinical Trial Designs and Bayesian Approaches (20 min), Use of Real-World Data to Support Clinical Trial Designs or Development Programs (20 minutes), Panel discussion (25 min)
Session 5 – Multifaceted Approach to Patient Engagement in Pediatric Clinical Research
Mark Turner, PhD - Elin Haf Davies, PhD |
Research Networks (20 min), Enhancing Family/Patient Engagement Through Technology (20 min), Panel discussion (25 min)
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