Research
My research aims to improve the access of newborn babies and children to high quality medicines. This has included studies of dosing, safety, and efficacy of 15 medicines (contributing to writing 5 paediatric investigation plans); excipient kinetics; manipulations of medicines; the assessment of adverse drug reactions; and the value of age-appropriate formulations.
I believe that the coherent integration of the design and conduct of clinical trials is key to improving the quality of medicines. He works to develop efficient medicines research infrastructure in Europe and globally as Chair of the European Network for Paediatric Research at the European Medicines Agency (EnprEMA) (2013 – 2019), Convenor of the European Paediatric Clinical Trials Research Infrastructure, co-Director of the International Neonatal Consortium and as co-Coordinator of the Collaborative Network for European Clinical Trials For Children (conect4children, c4c), now CEO of the non-profit that will sustain the work of c4c.
Better Medicines for Children and Babies
1. Research Infrastructure for paediatrics
With a focus on medicines for children and babies, I work across Europe and develop global interoperability for paediatric research networks
2. High quality medicines for children
Develop methods and improve the evidence base for manipulations of dosage forms, pharmacoeconomics of off-label/unlicensed medicines
2. Regulatory science in children and babies
Expedite development of new and existing medicines through methods that can be shared between studies
I have contributed to a number of regulatory submissions to EMA / FDA (PIPs, IND etc.)
Clinical drug development in neonates
Early Phase drug development in neonates, including
Phase 0 (microdose / tracer)
Phase 1 (first in human / first in age group)
Phase 2 (dose finding / efficacy)
Phase 3 (effectiveness)
Phase 4 Pharmacovigilance: methodology of case evaluation neonates
Neonatal follow-up of participants of trials recruiting during pregnancy
Research infrastructure in Europe and globally
Building on experience with the Medicines for Children Research Network (MCRN) and its successor organisation (National Institute for Health Research, Children's Theme) I have developed links between national and speciality paediatric research networks.
I co-lead a €140 million public private partnership to set up a pan-European paediatric clinical trials network, conect4children, funded by IMI2.
We have set up a Dutch non-profit to sustain this work, conect4children.eu
This includes building collaboration at national, European and global levels with industry and academia, taking account of the voices of children, young people and their families.
Research groups
- Miscarriage and Preterm Delivery
Research grants
MICA: Meeting global need to improve newborn care through real-world-health-datafacilitated, digital-technology-supported randomised clinical trials
MEDICAL RESEARCH COUNCIL
April 2023 - March 2025
Bicarbonate for AcidosiS in very preterm babies: a randomised clinical trial: The BASE Trial
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
January 2023 - March 2029
Sibel Gunduz 20159527 bench fees
TURKISH MINISTRY OF NATIONAL EDUCATION
December 2021 - November 2025
European Joint Programme on Rare Diseases (EJP RD)
EUROPEAN COMMISSION
January 2019 - August 2024
COllaborative Network for European Clinical Trials For Children (Conect4Children, C4C)
EUROPEAN COMMISSION
May 2018 - April 2025
Infradev - European Paediatric Translational Research Infrastructure (ID-EPTRI)
EUROPEAN COMMISSION
January 2018 - April 2020
The efficacy and mechanism of surfactant therapy in infants with life threatening Bronchiolitis: the Bronchiolitis Endotracheal Surfactant Study (BESS).
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
February 2018 - May 2025
AZithromycin ThErapy for Chronic lung disease (AZTEC): A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
January 2018 - January 2022
A randomized trial comparing oral misoprostol alone with oral misoprostol followed by oxytocin in women induced for hypertension of pregnancy (MOLI study)
MEDICAL RESEARCH COUNCIL
April 2018 - June 2023
Paediatric Clinical Research Infrastructure Network (PedCRIN)
EUROPEAN COMMISSION
January 2017 - June 2021
Amino acid composition of parenteral nutrition for neonates
NATIONAL UNIVERSITY OF MALAYSIA (MALAYSIA)
January 2016 - January 2019
RECAP (RandomisEd trial of Cerclage, Arabin pessary and vaginal Progesterone)
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
December 2014 - September 2017
How does treatment with thyroxine for 6 weeks postnatally given to preterm infants born under 28 weeks gestation affect the hypothalamic-pituitary adrenal axix, somatic growth, meylination of white matter and the volumes of key brain structures? An exploratory randomised double blinded placebo controlled clinical trial
MEDICAL RESEARCH COUNCIL
March 2007 - May 2010
Clinical Fellow in Paediatric and Neonatal Clinical Trials
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
February 2012 - July 2013
TINN 2
EUROPEAN COMMISSION
January 2011 - December 2015
NIHR Medicines for Children Research Network
DEPARTMENT OF HEALTH & SOCIAL CARE (UK), KING'S COLLEGE LONDON (UK)
April 2010 - March 2017
Global Research in Paediatrics (GRIP)
EUROPEAN COMMISSION
January 2011 - June 2017
A randomised controlled trial of prednisolone for women with recurrent miscarriage and high levels of uNK cells in the endometrium.
THE MOULTON CHARITABLE FOUNDATION (UK)
August 2008 - December 2012
Treatment of late onset bacterial sepsis caused by Vancomycin susceptible bacteria in neonates and infants aged under three months (NeoVanc)
EUROPEAN COMMISSION
February 2014 - July 2020
European Study of Neonatal Exposure to Excipients (ESNEE)
MEDICAL RESEARCH COUNCIL
January 2011 - March 2014
MerseyBeat- Best Evidence, Application and Translation of Research. Obesity in pregnancy a prospective cohort study
LIVERPOOL PRIMARY CARE TRUST (UK)
April 2009 - December 2012
Adverse Drug Reactions in Children.
DEPARTMENT OF HEALTH & SOCIAL CARE (UK)
December 2007 - April 2013
TINN Trial EU FP7
EUROPEAN COMMISSION
November 2008 - October 2015
Neocirculation (NEOCIRC)
EUROPEAN COMMISSION
September 2011 - August 2018
Research collaborations
Prof. Matthew Peak
Paediatric Medicines Research Unit
Alder Hey
Improve medicines for children
Prof. William Hope
Pharmacometrics of antibiotics for neonates
Dr. Dan Hawcutt
Adverse Drug Reactions in Children
Development of methodologies to assess ADRs in children
Prof. Tony Nunn
Alder Hey
NIHR RfPB Grant. MODRIC: MOdifications of Drugs Required in Children
Prof. Carlo Giaquinto
University of Padova
Development and co-ordination of an FP7-funded Network of Excellence to enhance Global Research in Paediatrics
Prof. M. Sharland / Dr. P. Heath
St George's Hospital Medical School
Prof. S. Kotecha
University of Cardiff
Professeur Evelyne Jacqz-Aigrain
CIC 9202 INSERM
FP7 funded project: Treat INfection in Neonates.
Dr. Dharani Hapangama
Biology of endometriosis