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New Horizons in Pediatric Drug Development Symposium

New Horizons in Pediatric Drug Development Symposium
Presentations

Introduction & Welcome

Patrick Smith, PharmD

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SVP, Commercial Strategy & Innovation, IDD – Certara

Keynote – Accelerating Global Pediatric Drug Development – Challenges and Opportunities

Lynne Yao, MD

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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

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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

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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

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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)