Dr. Annagrazia Altavilla, lawyer (Ph.D. Sciences-Ethics/HDR), is the Chair of TEDDY Network and responsible for international relations of the Espace Ethique PACA-Corse (AP-HM / Aix-Marseille University). Former Professor (PAST) at Aix-Marseille University, she is a consultant/expert of the Council of Europe within the framework of the Strategic Action Plan on Human Rights and technologies in biomedicine (2020-2025) and an expert in the COE-EU Project CP4Europe.
As a legal advisor and researcher, she has developed a long-standing experience in the field of European Health Law and Bioethics. Annagrazia Altavilla, a former member of the Pediatric Committee (PDCO) of the European Medicines Agency (EMA), is an expert/legal adviser in several EU/IMI-funded projects. Ms. Altavilla is a member of the Board of Directors of the European Association of Health Law (EAHL) – representative for France – as well as a member of several scientific and organisation committees of conferences and summer universities organized across Europe. She is also a member of the Ethics Committee of the French Agency of Public Health (Santé Publique France). Ms. Altavilla is the author of a book and many national and international publications and reports for the European institutions. Speaker invited to several conferences in 16 countries as well as in European Institutions, she has also lectured in Italian, French, Spanish, Belgium, and Polish universities.
Board’ member and scientific coordinator of the Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus, President of the Scientific committee of the Italian Network for paediatric clinical trials (INCIIPIT), funder and Board’ member of TEDDY (Task-force in Europe for Drug Development for the Young-EU FP6),
Scientific Co-Coordinator and Board’ member of the European Paediatric Translational Research Infrastructure (EPTRI-ID), Chair of the Communiation and Dissemination Committee in c4c and Scientific Counsellor of the Italian Thalassemia Foundation ‘L. Giambrone’.
PhD in Paediatrics and PhD in Clinical and Laboratory Haematology. Former Professor of Paediatrics, Paediatric oncology-haematology and Regulatory Science at University of Bari and other Universities. Former member of the Italian Ministry of Health – Commissione Unica del Farmaco, “Commissione Nazionale del Sangue” and “Commissione per la Sperimentazione Clinica” of the “Gene Therapies”, Committee at the Italian Prime Minister’ Office as well as member of the CONI Antidoping Committee. She was also member of the “Comitato Prezzi e Rimborsabilità” of the Italian Ministry of budget (CIPE). She was member of the “Commissione Farmaco e Bambino” appointed to Agenzia Italiana del Farmaco (AIFA), contributing to set up the Paediatric Medicines lists of off-label drugs of interest for children for compassionate uses, From 2006 to 2011, member of the Paediatric Committee (PDCO) at the European Medicine Agency (EMA), of the EMA-SmPC Advisory Group and of the PDCO working group for updating Paediatric Therapeutic Needs Lists. Former member and Vice-President of the “Commissione Sanità” of the Italian Parliament, she was also member of the ‘Environment and Health Committee’ of the European Parliament, where she founded the EU Parliamentary Inter-Group on Health that she has coordinated for 5 years.
She acted as coordinator or Scientific Board member in several paediatric trials and drug developmental plans, both industry and public-funded. Moreover, she has provided regulatory consultancy ended in PIP or Orphan Designation at EMA. She is referee of several international journals and author of more than 130 indexed publications mainly dealing with orphan drugs, paediatrics, regulatory issues.
Donato Bonifazi (MEcon), is an economist specialised in European Project Management and a certified Project Manager (CEPAS n. 9/2016). He is Trial Leader of two EU-funded Projects (DEferiprone Evaluation in Paediatrics and GAbapentin for Paediatric Pain, both funded within the FP7-Health), each involving more than 20 clinical centers from all over Europe and some Mediterranean countries. He is President of AICRO, the Association of Italian Contract Research Organisations and member of the Paediatric Working Group of the EUCROF (European Clinical Research Organizations Federation). He is also member of the Working Group “Clinical Trial Preparedness” at the Enpr-EMA (the European Network of Paediatric Research at the European Medicines Agency) and coordinator of the TEDDY – European Network of Excellence for Paediatric Clinical Research, an independent Research Network (category 1 network member of Enpr-EMA), composed by 50 partners from 20 EU and non-EU countries aimed at facilitating the performance of good quality paediatric studies and research. Donato Bonifazi is Project coordinator of EPTRI (European Paediatric Translational Research Infrastructure – GA 777554, INFRADEV-1-2017) aimed to create the framework for a new Research Infrastructure (RI) intended to enhance technology-driven paediatric research in drug discovery and early development phases to be translated into clinical research and paediatric use of medicines. He is also involved in the PedCRIN (Paediatric Clinical Research Infrastructure Network – GA 731046, INFRADEV-3-2016) project as WP3 Leader, dedicated to the development of tools to facilitate paediatric clinical trials.
Dr. Inmaculada Calvo Penadés is Head of the Pediatric Rheumatology La Fe, Valencia, Spain. Associate professor of the department of pediatrics at the University of Valencia. Vice president 1st of the Spanish Pediatrics Association from 2017-2021. Vice president of the National Pediatrics Commission of the National Council of Health Specialties of the Ministry of Health, social Services and Equality. Specialist Section of Pediatrics European Union Medical Specialist (UEMS) since April 2019. Member of the PAEDIATRIC RHEUMATOLOGY INTERNATIONAL TRIALS ORGANIZATION (PRINTO) with involvement in multicenter projects and clinical trials in the field of Pediatric Rheumatology. President of the Pediatric Rheumatology Spanish Society (SERPE) from 2002 to 2012. Member of the Scientific Council of ORPHANET-SPAIN from October 2010. Research focused in juvenile idiopathic arthritis, autoinflammatory and autoimmune diseases. Participation in patients and families associations in the scientific committees. Coauthor and collaborator in numerous national and international publications. Participation as speaker in several meetings and conferences.
Maria Cavallo holds a Master of Fine Arts. She designs and leads animated film workshops for children and adolescents, at schools and paediatric hospitals. She is an expert in communication with paediatric patients and she was involved in the preparation of informative packages and assent forms in several European projects, including within the TEDDY Network. Since 2017, she acts as the team leader for the KIDS Bari, the first Young Persons Advisory Group in Italy, which is part of the TEDDY Kids groups.
Roseline Favresse, Research, Policy & Initiatives Director, EURORDIS with 18 years of experience gained in NGOs, Ministries, and international and European organisations (COE, UN, IHCCI – Council for International Cooperation, Prime Minister, IPEMED). Former regional Coordinator, in charge of International Affairs of the French Foundation for rare diseases – Fondation maladies rares, she coordinated the Foundation’s involvement in the European Joint Programme on Rare Diseases, as well as the development and implementation of an online academic programme on Rare Diseases Research, developed in a series of MOOCs (Massive Open Online Course. She was also in charge of France’s South-East Region, including top-tier research and clinical centers in Marseille, Montpellier, and Nice. She has in-depth experience in managing multi-stakeholders R&D projects and international cooperation projects in Health.
Segolene Gaillard is a Clinical Project Manager, methodology adviser in Paediatrics and rare diseases. She is working in the Clinical Investigation Centre of Lyon in close collaboration with the pediatricians of the Hospitals of Lyon. Segolene Gaillard is involved in the development of the methodology and protocol of academic and industry projects. She is member of a French ethic Committee as methodology expert. Coordinating the RIPPS network, Segolene Gaillard is also participating to the activities of EnprEMA. Since 2015, Segolene Gaillard is leading the group Kids France (Young Persons Advisory Group), co-funder of eYPAGnet (European Young Persons Advisory Group network). Kids France is ensuring active participation and expertise of young people in pediatric clinical research. Segolene Gaillard is the French “Patient and parent involvement (PPI)” leader in the Pedstart network. Her phD work is about involving young people in clinical research, allowing the voice of children and young people to be heard, and the evaluation of the impact of these YPAGs on pediatric clinical research and on children and young people themselves. Since February 2021, Segolene Gaillard is coordinating the regional network of rare diseases in the Auvergne-Rhône-Alpes area, a platform dedicated to improving knowledge and visibility of healthcare and research expertise in the area.
Begonya Nafria Escalera is Patient Engagement in Research Coordinator at Sant Joan de Déu Chidren’s Hospital (Spain). She has long experience in the field of the involvement of patients and families in research initiatives. She has also a personal story as a caregiver and patient advocate because is the sister of a young adult with cerebral palsy.
Her areas of expertise are focused in paediatric patients involvement in research and specifically in the field of clinical trials. She is currently a PhD student in the patient involvement in paediatrics field.
Other relevant background of her profile is: Fellow of EUPATI (first cohort), Coordinator of eYPAGnet (European Young Patients Advisory Group Network – www.eypagnet.eu), Coordinator of Kids Barcelona (www.kidsbarcelona.org), member of Children’s Medicines Working Party of EFPGCP, member of the Patients and Families working group of EnprEMA and chair of the working the working group of bross-border access to clinical trials.
Coordinator of the cross-cutting theme of patients involvement in Conect4Children project (pan-European paediatric clinical trials network). The main aim of all the activities leaded or participated by Begonya is to achieve a better quality of life for the paediatric patients thanks to research and new therapies.
Dr. Solange Corriol-Rohou, a pulmonologist/immuno-allergist by training, joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune franchise. Over the past 20 years, moving from the French Medicines Agency/EMA and academia to the pharmaceutical industry, she has gained strategic experience in drug development. She is quite active within EFPIA, ICH and IMI, and passionate about paediatric drug development. As a board member of EFGCP, involved in the EFGCP Children Medicines Working Party, she is used to organise the EFGCP Annual Paediatric conference and is actively involved in the Good Lay Summary Practice Road Map Initiative.
Christine Woods (Vice President iCAN) is an Atlanta, Georgia -based healthcare IT human resources and management professional, currently working for the highest-ranking healthcare IT services firm on the INC 5000 list. More importantly, Ms. Woods is a wife and mom to two amazing young adults currently pursuing really big dreams. In addition to enthusiastically touting the virtues of electronic medical records, Ms. Woods also enjoys reading historical fiction, volunteering at her kids’ school, and coffee. So much coffee. Her educational and professional background includes a B.S. in Communications from the University of Tennessee – Knoxville, a master’s degree in Healthcare Administration in process with Johns Hopkins University, and a prior career in television news. Ms. Woods is proud to have been a part of iCAN since its inception and is excited for the future!