LENA Advisory Boards
LENA is supported by two Independent advisory boards – the Ethical and Scientific Advisory Board (ESAB) and the Data and Safety Monitoring Board (DSMB). Both advisory boards ensure the highest standard of research and monitor the progress of the project.
Whenever appropriate, the boards will consult the LENA consortium and make recommendations to improve scientific performance.
Ethical & Scientific Advisory Board (ESAB)
The Ethical and Scientific Advisory Board consists of four independent members with established international acknowledged expertise in the fields of paediatric cardiology, paediatric clinical pharmacology, modelling and simulation, and pharmaceutical technology.
The four experts represent key aspects of activities of the project as indicated by the work packages. Thus, the ESAB is in the position to ensure a high standard of research and monitor progress of the project by taking part in the annual General Assembly meetings. At the annual meetings of the LENA Consortium, regular courses on ethical matters will be organized by the ESAB members.
The ESAB will safeguard the project's compliance with all necessary ethical regulations by checking the ethical aspects of the study protocols and standards implemented for patient recruitment and prospective examinations.
The members are:
- Daphne T. Hsu, MD: Professor of Pediatrics, Albert Einstein College of Medicine, Division Chief, Pediatric Cardiology and Co-Director, Pediatric Heart Center at the Children´s Hospital at the Montefiore Medical Center, New York, USA. Dr. Hsu is a leading global expert in children´s heart failure and heart transplantation, and led the prospective multicentre study on enalapril in children with single ventricle physiology. She serves on the board of the Pediatric Cardiomyopathy Registry, the Adult Congenital Heart Disease Committee of the American Heart Association, and the Sub Board of Pediatric Cardiology of the American Board of Pediatrics.
- Imti Choonara, MD: Professor of Child Health, Faculty of Medicine and Health Sciences, The University of Nottingham, UK. Dr. Choonara is a leading paediatric clinical pharmacologist and was the founding Editor of ‘Paediatric and Perinatal Drug Therapy’, which is now the Drug Therapy section in the journal ‘Archives of Disease in Childhood’. His research interests include drug toxicity, clinical trials, and epidemiology of the use of medicines. He is currently Chair of the NIHR HTA Pharmaceutical Panel responsible for commissioning research on clinical trials of medicines in adults and children in the UK.
- Bernd Meibohm, PhD, FCP: Professor of Pharmaceutical Sciences and Associate Dean for Research and Graduate Programs, College of Pharmacy, The University of Tennessee Health Science Center, Memphis, TN, USA. Dr. Meibohm is an expert in modelling and simulation in adult and paediatric drug development and therapy, and is a Fellow of the American Association of Pharmaceutical Scientists (AAPS) and the American College of Clinical Pharmacology (ACCP). He is a member of the editorial boards of The AAPS Journal (Associate Editor), the Journal of Pediatric Pharmacology and Therapeutics, Les Annales Pharmaceutiques Françaises, and Die Pharmazie.
- Anne Juppo, PhD: Professor of Industrial Technology and Vice Dean of the Faculty of Pharmacy at the University of Helsinki, Finland. Dr. Juppo is an expert in Pharmaceutical Technology, with experience both in academia and industry. She has held scientific positions at Orion and AstraZeneca R&D before moving to the Division of Pharmaceutical Technology at the University of Helsinki in 2006. She is one of the leading experts in the pharmaceutical development of paediatric medicines and also veterinary medicines. Her broad expertise in academia and pharmaceutical industry comprises all types of solid dosage forms, including granules, pellets, tablets, capsules and also minitablets.
Data and Safety Monitoring Board (DSMB)
The fully independent DSMB consists of three experienced Researchers experts with combined expertise in paediatric cardiology and paediatric pharmacology, statistics and PK/PD modelling.
The advisory board oversees the development of procedures for the monitoring of study findings and detection of adverse events through the activities of work package 4 on Clinical Trial Management, Medical Monitoring and Safety, work package 6 on Statistics and Data Management, and work package 11 on Ethics & Dissemination to Parents, Patients and Society.
Patient data will be evaluated by this independent board consisting of the following members:
- Chair of the DSMB: Seema Mital, MD, FACC, FAHA, FRCP(C): Associate Professor of Pediatrics, Roma and Marvin Auerback; Professor of Developmental Biology and Congenital Heart Research, The Hospital for Sick Children, Faculty of Medicine, University of Toronto, Canada. Dr. Mital is an expert in paediatric cardiology, and has been the coordinating investigator in several multicentre trials for the Canadian Institute for Health Research and the NIH/NLHBI Pediatric Heart network consortium. She has considerable experience in the use of enalapril both for clinical and research purposes. Dr. Mital is Editor of the Cardiology Section of the journal ‘Pediatric Research’ and serves on the Editorial Board of the Journal of Cardiovascular Pharmacology.
- Willi Cawello, PhD is Principal Quantitative Scientist of the Global Statistical Services group within the UCB, Belgium. He is qualified as Mathematician and former Director of pharmacokinetics for the Schwarz Pharma, Germany, a company with international responsibility. Willi Cawello's expertise comprises bringing molecules and formulations to submission and approval since 30 years (nitrogycerin, estradiol, nicotine, oxybutynin, rotigotine). His publications include 3 text books and more than 140 full papers and abstracts in peer review journals. He is a member of the board of the German Association of Applied Human Pharmacology.
- Matitiahu Berkovitch, MD is Associate Professor in the Clinical Pharmacology and Toxicology Unit of the Department of Pediatrics in the Medical Faculty of the Assaf Harofeh Medical Center of the Tel-Aviv University in Israel. He is qualified as a Paediatric Clinical Pharmacologist and Toxicologist from the Sick-Kids Hospital in Toronto. He has been Prinicple Investigator of several clinical studies investigating drug therapy in children funded by the Ministry of Health in Israel. His publications comprise more than 200 hundred full papers and book chapters in peer reviewed journals and books. He has been active as Chairman, President and Vice President in several national and international pediatric societies.