Pediatric Meeting Agenda


November 2, 2021

9:00 AM -  Welcome & Opening Remarks
Andrew Lewis, Quotient Sciences
Session 1: 9:15 - 10:15 AM  

Challenges of Drug Administration to Pediatric Patients
Louise Bracken, Co-Director Paediatric Medicines Research Unit, Alder Hey Children’s NHS Foundation Trust

Co-administration of Pediatric Medicines with Food and Drinks
Nikoletta Fotaki, Reader in BiopharmaceuticsUniversity of Bath
BREAK: 10:15 - 11:00 AM  
Session 2: 11:00 AM - 12:30 PM  

Developing ZENEO® Needle-free Auto-injector for Pediatric Use
Olivier Giré, Chief Operating Officer Specialty Pharma, Crossject
Donald Zinn, Vice President US Business, Crossject USA Inc
Henri Bodeau, Crossject

        Gire        Zinn       Bodeau


Pediatric Pharmaceutics
Catherine Tuleu, Professor in Pediatric Pharmaceutics, University College London School of Pharmacy

A Matter of Taste: Development of Palatable Paediatric Dosage Forms
David Clapham, Independent Pharmaceutical Consultant

David Clapham
BREAK: 12:30 - 12:45 PM  
Session 3: 12:45 - 2:15 PM  
ABC's of Pediatric CMC - An Industry Perspective
Stuart Charlton, Associate Scientific Director, Bristol Myers Squibb
Minitablets: Manufacturing, Characterization and Future Opportunities
Ron Smith, Principal, Pharmawyze, LLC

The Phillips-Medisize Mini-tablet Dispenser
Bjørn Knud Andersen, Director Front-End Innovation, Phillips-Medisize


BREAK: 2:15 - 3:00 PM  
Session 4: 3:00 - 4:00 PM  
How can we estimate food effects in children? Simulated Pediatric Breakfast Media (SPBM)
Sandra Klein, Professor of Pharmaceutical Technology, University of Greifswald
Development of an oral infant friendly Amphothericin B formulation
Ragna Berthelsen, Associate Professor, University of Copenhagen

November 3, 2021

9:00 AM - Welcome & Opening Remarks
Cornell Stamoran, Catalent Pharma Solutions
Session 1: 9:15 - 10:15 AM  

Insights and Lessons from the Development of Alkindi
Helen Coope, European Medical Affairs Manager, Diurnal

Helen Coope

Moxidectin Pediatric Formulation Development
Nicky Konstantopoulos, Associate Director, CMC, Medicines Development for Global Health

BREAK: 10:15 - 11:00 AM  
Session 2: 11:00 AM - 12:30 PM  

MicroCoatTM – Production of versatile micropellets for pediatric applications
Fang Liu, Founder & Director, Fluid Pharma


Design and Delivery of Paediatric Early Phase Clinical Trials - Learning from 10 years of Alder Hey Clinical Research Facility
Dan Hawcutt, Senior Lecturer Paediatric Clinical Pharmacology, University of Liverpool


Development and Characterization of Pediatric Formulations
Kingsley Iyoha, Director, Development, Pharmaceutical Sciences, Quotient Sciences

BREAK: 12:30 - 12:45 PM  
Session 3: 12:45 - 2:15 PM  

Developing Gene Therapy for Lethal Paediatric Neurometabolic Diseases
Ahad Rahim, Professor of Translational Neuroscience, University College London

Excipient Selection for Pediatric Drug Products
Kevin Hughes, Regulatory Affairs and QA Manager, Colorcon Ltd.
Overview of EU and FDA Pediatric Regulations
Gloria Garcia Palacios, Global Regulatory Affairs - EU Head I&I, Sanofi
Gloria Garcia
BREAK: 2:15 - 3:00 PM  
Session 4: 3:00 - 4:00 PM  

Oral Multiparticulates as a Platform Approach for Pediatric Drug Development
Matthew Santangelo, Principal Scientist, Pfizer Inc.

Drug Delivery for Children with Aggressive Brain Cancer
Maria Kavallaris, Director Australian Centre for NanoMedicine UNSW Sydney and Head of Translational Cancer Nanomedicine, Children's Cancer Institute