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2022 SYMPOSIUM Reserve your seat today at this virtual 2-day symposium REGISTER NOW

9:00 – 9:05: Welcome and Opening Remarks

  • Lynne Georgopoulos, RN, MSHS, Vice President, Regulatory Strategy, Certara

9:05 – 9:30: Keynote Session: Pediatric Challenges both Big and Small

  • Brian Aylward, MD, Chair European Medicines Agency Paediatric Committee

9:30 – 11:20:  Challenges and Opportunities in Conducting Pediatric Rare Disease Trials

  • Pediatric Clinical Trials – Ethical Considerations Robert Nelson, PhD, MD,  Senior Director, Pediatric Drug Development, Johnson & Johnson
  • Facilitating Pediatric Research Through Data Sharing – Patients and Sponsors Arthur L. Caplan, PhD, Drs. William F and Virginia Connolly Mitty Chair Director, Division of Medical Ethics, NYU Grossman School of Medicine
  • Expanding the Clinical Trials Toolbox to Support Rare Pediatric Disease Research – Decentralized Clinical Trials Isaac Rodriguez-Chavez, ICON, USA
  • Developing novel endpoints for paediatric clinical trials with digital health technology David Nobbs, PhD, International Regulatory Policy Lead for Digital Health and Data Policy, Roche
  • 5 Voices Initiative Maryna Kolochavina, PharmD, PhD, PMP, Director, Five Voices Consortium
  • Panel Discussion moderated by Jeff Barrett, Aridhia DRE

11:20 – 1:15: Advancing Pediatric Drug Development for Rare Diseases through modeling and simulation

  • Accelerating Rare disease Cures (ARC) Program, Kerry Jo Lee, MD, Associate Director for Rare Diseases, OND/CDER/FDA
  • ICH E11A Pediatric Extrapolation Framework, Lynne Yao, MD, Director, Division of Pediatric and Maternal Health Center for Drug Evaluation and Research, CDER
  • Impact of Project Optimus on Pediatric Oncology Drug Development, Julie Bullock, PharmD, Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine, Certara
  • Moving towards a Question-centric approach for regulatory decision-making in the context of drug assessment, Flora Musuamba, PhD, Professor, University of Namur and Belgian Federal Agency for Medicines and Health Products
  • Panel Discussion moderated by: Dave Mitchell, PhD, Senior Vice President, Strategic Engagement, Certara

Closing Remarks

  • Lynne Georgopoulos, RN, MSHS, Vice President, Regulatory Strategy, Certara

9:00 – 9:05: Welcome and Opening Remarks

  • Amy Cheung, PhD, Senior Director of Integrated Drug Development, Certara

9:05 – 9:30: Keynote Session: Important Areas such as Data, Informatics and AI for Future Consideration for Pediatric Drug Development

  • Neil Sebire, MB BS, BClinSci MD, FRCR, FRCOG, FRCPath, FFFCI, Professor and Chief Research Information Officer, Great Ormond Street Hospital, HDR UK Chief Clinical Data Officer

9:30 – 11:00:  Pediatric Treatment and Prophylactic Use in Infectious Disease

  • Pediatric HIV: now and what’s next? Lionel Tan, MBBS FRCP PhD, DTM&H, ViiV Healthcare, Research and Development
  • MIDD journey to use MBMA for RSV mAb development in infants and children Brian Maas, PharmD, Principal Scientist, Merck
  • Quantitative approach to support neonatal sepsis treatment development Joe Standing, PhD, Professor of Pharmacometrics, Great Ormond Street Hospital for Children/University College London
  • Panel Discussion moderated by: Amy Cheung, PhD, Senior Director of Integrated Drug Development, Certara

11:00 – 1:10: Rare Disease and Challenge of more Vulnerable Population

    • How to make treatments for rare diseases less rare? The EFPIA Moonshot initiative Solange Rohou, MD, Sr. Director of Regulatory Affairs & Policy for Europe, AstraZeneca
    • TEDDY European Network for Pediatric Research Annagrazia Altavilla, TEDDY Network
    • Overview the need of better clinical trial in pregnancy and neonate’s clinical trial Leila Sahin
    • Pediatric Trials Networks Rachel G. Greenberg, MD, MB, MHS, Duke Clinical Research Institute
    • Case Study – Corticosteroids in pregnancy Utilizing PBPK Alice Ke, Senior Director, PBPK, Certara
    • Panel Discussion moderated by: Solange Rohou, MD, Sr. Director of Regulatory Affairs & Policy for Europe, AstraZeneca

Closing Remarks

  • Amy Cheung, PhD, Senior Director of Integrated Drug Development, Certara