Section 1: From past to current needs in pediatric drug research
1. Preface: overview of pediatric drug development and pharmacovigilance
Elke Gasthuys, Lien Dossche, Karel Allegaert, Mark A Turner
2. Historical perspective
Pauline De Bruyne, Shinya Ito, Facundo Garcia-Bournissen
3. Parents' and children's needs in the drug development process
Maria Cavaller-Bellaubi, Ariane Weinman, Eric Vermeulen, Dimitrios Athanasiou, Mariette Driessens, Anita Kienesberger, Maria Borrell-Pages
4. The needs from the regulatory authorities’ perspective – current status and worldwide initiatives
Agnes V Klein, Mark A Turner, Junko Sato
5. Optimal pediatric therapeutic development – the partnership between patients/families/industry and academia: the pharmaceutical industry’s perspective
Solange Corriol-Rohou, Katharine Cheng, Susan McCune
6. The needs, challenges and opportunities from the academic researchers’ perspective
Elke Gasthuys, Karel Allegaert, Eva Degraeuwe, Hidefumi Nakamura, Johan Vande Walle, Gregory Kearns
7. The needs from a health care provider’s perspective
Lien Dossche, Janko Samardzic, Bieke Tack, Facundo Garcia-Bournissen, John van den Anker, Lenneke Schrier
Section 2: Designing pediatric drug research: from bench to bedside and back
8. Application of in vitro models
Pieter Annaert, Sagnik Chatterjee, Bhagwat Prasad
9. Application of preclinical juvenile animal models
Eline Hermans, Jaan Toelen, Domenico Ventrella, Luc De Schaepdrijver, Katie Turner, Siska Croubels, Mathias Devreese
10. Application of pediatric adapted modelling and simulation approaches
Pieter-Jan De Sutter, Jonas Langeraert, Robin Michelet, An Vermeulen
11. The promise of omics approaches for pediatric drug development
Sigrid Verhelst, Tess Goessens, Roger Pero-Gascon, Marthe De Boevre, Francis Impens, Dieter Deforce, Maarten Dhaenens
12. Generation and interpretation of big data in pediatric drug development
Jeff Barrett, Amanda Borens, Solange Corriol-Rohou
13. Investigational Medicinal Product considerations in pediatric clinical drug trials
Mandy Wan, Samantha Carmichael, Ciara Duffy
14. Co-designing pediatric clinical trials with multi-stakeholders: a step by step approach
Jennifer Preston, Sally Dews, Sophie Evett, Adit Bassi, Daisy Barrick, Sammy Ainsworth
Section 3: Improving the performance of pediatric drug research: big changes start with small steps
15. Principles of performing pediatric clinical drug trials
Eva Degraeuwe, Johan Vande Walle, Kim Jennings, Pirkko Lepola
16. Regulatory considerations in the design and conduct of pediatric clinical trials
Melanie Bhatnagar, Gilbert Burckart, Donna Snyder, Ralph Bax, Lynne Yao, Dionna Green
17. Ethical considerations in the design and conduct of pediatric clinical trials
Pirkko Lepola, Robert Nelson, Kenji Matsui
18. Performing clinical drug trials in acute and critically ill neonates and children
Pieter A De Cock, Anne Smits, Mehdi Oualha, Gideon Stitt, Tuuli Metsvaht, Nori Smeets, Karel Allegaert, Mark A Turner, Angela Amigoni, Athena F Zuppa, Saskia N de Wildt
19. Performing clinical drug trials in children with a rare disease
Victoria Hedley, Rebecca Leary, Anando Sen, Anna Irvin, Emma Heslop, Volker Straub
20. Policy of pediatric oncology drug development
Lenneke Schrier, C. Michel Zwaan, Carmelo Rizzari, Brenda Weigel, Nicole Scobie, Gregory Reaman, Andy Pearson
21. Practice of pediatric oncology drug development
Lenneke Schrier, Andy Pearson, Carmelo Rizzari, Brenda Weigel, Alwin Huitema, Nicole Scobie, Gregory Reaman, C. Michel Zwaan
22. Pediatric drug formulations
Issraa Al-Obaidi, Tsutomu Harada, Takahiro Matsumoto, Hannah Batchelor
23. Worldwide network initiatives in improving pediatric drug research
Sabah Attar, Eva Degraeuwe, Johan Walle, Mark A Turner
24. The patients’/parents’ voice within pediatric drug research
Begoña Nafria Escalera, Sarah Bernays, Magda Conway, Kenneth Getz, Lungile Jafta, Simon R Stones
25. Pediatric drug development issues during public health emergencies
Mariana Kruger, Moji Adeyeye, Barbara E Bierer
Section 4: Future perspectives in pediatric drug research: the road to better drugs for children
26. Future of pediatric drug research from different stakeholder perspectives
Lien Dossche, Elke Gasthuys, Mark A Turner