Pediatric Meeting Agenda



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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

LBracken
Co-administration of Pediatric Medicines with Food and Drinks

Nikoletta Fotaki, Reader in BiopharmaceuticsUniversity of Bath

 
NFotaki
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
CTuleu

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
SCharlton
Minitablets: Manufacturing, Characterization and Future Opportunities

Ron Smith, Principal, Pharmawyze, LLC
RSmith

The Phillips-Medisize Mini-tablet Dispenser

Bjørn Knud Andersen, Director Front-End Innovation, Phillips-Medisize

 

BKAndersen
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
Klein
Development of an oral infant friendly Amphothericin B formulation

Ragna Berthelsen, Associate Professor, University of Copenhagen
Berthelsen



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

Konstantopoulos
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

FLiu

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

DHawcutt

Development and Characterization of Pediatric Formulations

Kingsley Iyoha, Director, Development, Pharmaceutical Sciences, Quotient Sciences

KIyoha
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

Rahim
Excipient Selection for Pediatric Drug Products

Kevin Hughes, Regulatory Affairs and QA Manager, Colorcon Ltd.
KHughes
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.

Santangelo
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
Kavallaris