4th EUFEMED Conference
25-26 May 2023 - Berlin (Germany)
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Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
25-26 May 2023 - Berlin (Germany)
Mastering the New Time Pressure on Human Pharmacology
Focused strategies based on lessons learned in the pandemic
Version October 2022; All times are in CEST
During the afternoon attendees including exhibitors can book hop-in rooms for small groups or one-on-one discussions
Subject to change without notice, Status 08/05/2023. Please click on the plus + for more content.
13:00 - 18:00
Conducting human challenge trials: COVID-19 and beyond…
Chairs: Henri Caplain, France; Jan de Hoon, Belgium
13:00 – 13:10
Welcome
Henri Caplain, France
13:10 – 13:25
General introduction: Challenge studies, what’s in a name?
Jan de Hoon, Belgium
13:30 – 13:55
Challenge studies with infectious agents
Emma Smith, United Kingdom
+ 10 min Q&A
14:05 – 14:30
Challenge studies with infectious agents: pro, cons and ethical aspects
Hugh Davies, United Kingdom
+ 10 min Q&A
14:40 – 15:05
Challenge studies in asthma
Harun Badakhshi, Germany
+ 10 min Q&A
15:15 – 15:45
Break
15:45 – 16:10
Challenge studies with immunological stimulants
Matthijs Moerland, The Netherlands
+ 10 min Q&A
16:20 – 16:45
Challenge agents in target engagement models
Jan de Hoon, Belgium
+ 10 min Q&A
16:45 – 17:15
General discussion and closing remarks
08:00
Registration
08:45
Welcome and Introduction by the President
Tim Hardman, UK
Session 1
09:00 - 10:30
How to assess risk from pre-clinical to clinical research more efficiently | Experiences and suggestions
Chairs: Jan de Hoon, Belgium; Rob Zuiker, The Netherlands
09:00
09:35
10:15
Moderated plenary discussion with the speakers
10:30
Break
Session 2
11:00 - 12:30
Challenges in healthy volunteers and patient recruitment for human pharmacology trials - Experiences and Suggestions
Chairs: Izaak den Daas, The Netherlands; Yves Donazzolo, France
11:00
Studies in healthy volunteers: Evolution in recruitment of healthy volunteer trials, before, during and after the pandemic
Jelle Klein, Belgium
Main challenges for the inclusion of patients in phase I trials
Izaak den Daas, The Netherlands
„Why I took part in a clinical trial“ – Results from a motivation survery amongst Polish healthy volunteers
Agnieszka Kulesza, Poland
Ethical challenges in recruitment for phase I trials
Yves Donazzolo, France
11:45
Moderated plenary discussion with the speakers: How to improve the situation?
12:30
Lunch-Break
Session 3
14:00 - 15:30
Posters and Short Presentations on topics of translational pharmacology
Chairs: Kerstin Breithaupt-Grögler, Germany; Erik Mannaert, Belgium
6 Selected Short Presentations
10 minutes (presentation) + 5 minutes (discussion),
Election of the Winning Short Presentation and Poster
14:00
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
14:15
Can TRPA1-Antagonists Solve The Unmet Medical Need For Chemotherapy-Induced Peripheral Neuropathy?
Heleen Marynissen
14:30
Optimising paediatric medicines development through early selection of the best accepted formulation with a scientifically sound composite endpoint method
Viviane Klingmann
14:45
Piloting new patient centric sampling approaches in phase-1 clinical trials
Jorien Gilops
15:00
Healthy Volunteers in Distress: Creating A Guideline For Implementation Of Emergency Mock Trainings In A Phase I Clinical Pharmacology Unit
Thomas De Ridder
15:15
Feasibility Assessment Of The BD Rhapsody™ Single-cell RNA-sequencing Platform On Liver Fine-needle Aspirates And Blood Of Healthy Volunteers
Jonathan Janssens
15:30
Break
Session 4
16:00 - 17:30
Increasing Digitalisation in Human Pharmacology Studies Management: Helping or Hindering Speeding-up clinical trials? – Experiences and Suggestions
Chairs: Sybille Baumann, Germany; Henri Caplain, France
16:00
16:40
Moderated plenary discussion
17:30
End of Day 1
from 17:30
Get-Together
with celebration of 30th Anniversary of AFPT
and interactive Tabletop presentations of innovative tools and methods
17:30 - 20:00
GET-TOGETHER
17:45
Welcome by the EUFEMED President and the AGAH President
17:30
Meet & Greet at the Ground Floor
18:30
AFPT 30th Birthday celebration: Speech by Henri Caplain, Preisdent AFPT
19:15
Award Ceremony
Meet & Greet
Session 5
09:00 - 10:30
Innovative Trial Approaches to Move Efficiently from FiM to Patient Participants – Experiences and Suggestions
Chairs: Paul Goldsmith, UK; Joachim Höchel, Germany
09:00
POM – It is all about proof of mechanism
Fabienne Schumacher, Germany
09:20
From Celecoxib to Gene Editing – Experiences of a London based first in human principal investigator
Jörg Täubel, UK
09:40
Fair consent processes in early phase research – striking a balance between benefits and harms
Hugh Davies, UK
10:00
Moderated plenary discussion
10:30
Break
Session 6
11:00 - 12:00
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
11:00
Presentation of the new regulatory support toolbox for early (clinical) development and beyond
Bettina Ziegele, Germany
11:30
Moderated plenary discussion: How can these options best be used for innovative early pharmaceutical medicines development by academia, large and small pharma companies?
12:00
Lunch
Session 7
13:30 - 15:00
Ensure Efficiency of Collaboration between Sponsors and Clinical Trial Units under the Clinical Trial Regulation – Experiences and Suggestions
Chairs: Tim Hardman, UK; Jelle Klein, Belgium
13:30
How can CROs support big pharma as well as small biotech companies in their CTR submission
Sybille Baumann, Germany
Sponsor and CTU communication during the dossier preparation and trial authorisation process – Experiences from sponsor and site perspectives
Emma Meijer, The Netherlands
14:15
Moderated plenary discussion
15:00
Closing Remarks and Farewell from the President Elect
Jan de Hoon, Belgium
15:10
End of the Conference
Preliminary
Programme >>
CSi Hamburg GmbH
Goernestraße 30
20249 Hamburg (Germany)