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Symposium Program

Engage with Pediatric Thought Leaders in a Virtual 2-Day Symposium

8:00 am ET:  Introduction & Welcome, Patrick Smith, PharmD

8:15 – 8:45 am: 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)

8:45- 9:05 am: COVID-19 and Pediatrics

  • Donna Boyce – Senior Vice President Global Regulatory Affairs at Pfizer

9:05 – 9:10 am: Q&A 

9:10 am – 10:15: Session 1 – Innovative Techniques Toward Extrapolation and Efficient Drug Development

  • Evidence to support pediatric approval through extrapolation (20 min) Robert “Skip” Nelson, MD, PhD
  • Pediatric formulations, considerations for BA/BE studies (20 min) Hannah Batchelor, PhD
  • Panel discussion (25 min) Lily Mulugeta, PharmD, and Solange Corriol-Rohou, MD (moderators)

Break (15 min)

10:30 – 11:55 am: Session 2 – Reaching Agreement with Regulators on Global Approach to Pediatric Drug Development

  • Presentation 1 (20 min) Changing Regulatory Landscape and Pediatric Oncology Development Greg Reaman (FDA)
  • Presentation 2 (20 min) European Perspective/Global Collaboration Dominik Karres (EMA)
  • Presentation 3: (30 min) Fostering Age Inclusive Research (FAIR)  Nathalie Gaspar (Gustave Roussy Cancer Campus) and Chris Copland (Unite2 Cure)
  • Panel discussion (25 min) Lynne Georgopoulos (Certara), moderator; Lynne Yao (FDA) and Max Williamson 

9:00 – 10:05 am ET: Session 3 – Neonatal Research Insights

  • Challenges in planning and conducting successful trials in infants/neonates (20 min) John van den Anker, PhD, MD
  • PBPK – Applications of modeling and simulation – infants and neonates (20 min) Karen Rowland Yeo, PhD
  • Panel Discussion (25 min) Barry Mangum, PharmD

10:15 – 11:20 am ET: Session 4 – Novel Clinical Trial Design

  • Adaptive Clinical Trial Designs and Bayesian Approaches (20 min) Alex Bliu, PhD
  • Use of Real-World Data to Support Clinical Trial Designs or Development Programs (20 minutes)
    Jeff Barrett, PhD
  • Panel discussion (25 min) Amy Cheung, PhD, Jing Liu, PhD, Mark Shapiro, MBA, MA (moderator)

Break (10 min)

11:30 am – 12:55 pm ET: Session 5 – Multifaceted Approach to Patient Engagement in Pediatric Clinical Research

  • Research Networks (15 min) Mark Turner, PhD
  • Enhancing Family/Patient Engagement Through Technology (15 min) Elin Haf Davies, PhD
  • International Children’s Advisory Network (iCAN) (15 min) Amy Ohmer
  • The Patient Experience (15 min) Max Williamson
  • Panel discussion (25 min) Theresa Shalaby (moderator)

12:55 – 1:00 pm ET: Closing Remarks

Reserve your seat today at this virtual 2-day symposium