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Pre-Conference Workshop Wednesday, May 24, 2023
| Conducting human challenge trials: COVID-19 and beyond… Chairs: Henri Caplain, France; Jan de Hoon, Belgium |
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| General introduction: Challenge studies, what’s in a name? Jan de Hoon, Belgium |
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| Challenge studies with infectious agents Emma Smith, United Kingdom |
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| Challenge studies with infectious agents: pro, cons and ethical aspects Hugh Davies, United Kingdom |
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| Challenge studies in asthma Harun Badakhshi, Germany |
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| Challenge studies with immunological stimulants Matthijs Moerland, The Netherlands |
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| Challenge agents in target engagement models Jan de Hoon, Belgium |
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| General discussion and closing remarks | |
Day 1 – Thursday, 25 May, 2023
Welcome and Introduction by the President Tim Hardman, UK |
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| How to assess risk from pre-clinical to clinical research more efficiently | Experiences and suggestions Chairs: Jan de Hoon, Belgium; Rob Zuiker, The Netherlands |
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| The pre-clinical perspective Stephanie Plassmann, Germany |
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| The clinical perspective Henri Caplain, France |
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| Moderated plenary discussion with the speakers | |
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| Challenges in healthy volunteers and patient recruitment for human pharmacology trials – Experiences and Suggestions Chairs: Izaak den Daas, The Netherlands; Yves Donazzolo, France |
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Studies in healthy volunteers: Evolution in recruitment of healthy volunteer trials, before, during and after the pandemic Jelle Klein, Belgium |
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Main challenges for the inclusion of patients in phase I trials Izaak den Daas, The Netherlands |
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„Why I took part in a clinical trial“ – Results from a motivation survey amongst Polish healthy volunteers Agnieszka Kulesza, Poland |
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Ethical challenges in recruitment for phase I trials Yves Donazzolo, France |
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| Moderated plenary discussion with the speakers: How to improve the situation? |
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| Lunch Break | |
| Early clinical proof of effect of inhaled lung therapies in Phase 1 : Evaluation of mode of action and drug deposition in the target organ of healthy subjects Johannes H. Nagelschmitz |
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| Can TRPA1-Antagonists Solve The Unmet Medical Need For Chemotherapy-Induced Peripheral Neuropathy? Heleen Marynissen |
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| Optimising paediatric medicines development through early selection of the best accepted formulation with a scientifically sound composite endpoint method Viviane Klingmann, Germany |
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| Piloting new patient centric sampling approaches in phase-1 clinical trials Jorien Gilops |
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| Healthy Volunteers in Distress: Creating A Guideline For Implementation Of Emergency Mock Trainings In A Phase I Clinical Pharmacology Unit Thomas De Ridder |
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| Feasibility Assessment Of The BD Rhapsody™ Single-cell RNA-sequencing Platform On Liver Fine-needle Aspirates And Blood Of Healthy Volunteers Jonathan Janssens |
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| Increasing Digitalisation in Human Pharmacology Studies Management: Helping or Hindering Speeding-up clinical trials? – Experiences and Suggestions Chairs: Sybille Baumann, Germany; Henri Caplain, France |
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Nextgen endpoints for clinical drug development Kristin Hannesdottir, United States; Jelena Curcic, Switzerland Digitalisation in early clinical trials: theory and practical examples |
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| Moderated plenary discussion | |
Day 2 – Friday, 26 May, 2023
| How to assess risk from pre-clinical to clinical research more efficiently – Experiences and suggestions Chairs: Paul Goldsmith, UK; Joachim Höchel, Germany |
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| POM – It is all about proof of mechanism Fabienne Schumacher, Germany |
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| From Celecoxib to Gene Editing – Experiences of a London based first in human principal investigator Jörg Täubel, UK |
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| Fair consent processes in early phase research – striking a balance between benefits and harms Hugh Davies, UK |
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| None fits all: (adaptive) scientific advice formats in the (innovative) pharmaceutical development process – Experiences and Suggestions Chairs: Ingrid Klingmann, Belgium; Dick de Vries, The Netherlands; Joachim Hoechel, Germany |
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| Presentation of the new regulatory support toolbox for early (clinical) development and beyond Bettina Ziegele, Germany |
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| Moderated plenary discussion: How can these options best be used for innovative early pharmaceutical medicines development by academia, large and small pharma companies? | TBA/TBC |
| Lunch Break | |
| Ensure Efficiency of Collaboration between Sponsors and Clinical Trial Units under the Clinical Trial Regulation – Experiences and Suggestions Chairs: Hardman, UK; Jelle Klein, Belgium |
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How can CROs support big pharma as well as small biotech companies in their CTR submission Sybille Baumann, Germany |
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Sponsor and CTU communication during the dossier preparation and trial authorisation process – Experiences from sponsor and site perspectives Emma Meijer, The Netherlands |
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