3rd EUFEMED Conference

28-30 April 2021 - virtual and interactive

Exploratory Development of Novel Therapeutic Approaches

Focused strategies based on lessons learned in the pandemic

LOGIN CONFERENCE SYSTEM

Version April 2021; All times are in CEST

During the afternoon attendees including exhibitors can book hop-in rooms for small groups or one-on-one discussions

Day 1, Wednesday, 28 April 2021

12:30

Dial-in open

12:45

Welcome by the President
Yves Donazzolo, France

12:50

Meet and greet of attendees and exhibitors at the virtual exhibition

Session 1
13:15-15:15

How to better prepare European early medicines development for future pandemics

Chairs: Yves Donazzolo, France; Tim Hardman, United Kingdom

13:15

Keynote Lecture

Drug discovery and early development strategies for prevention and treatment of virus infections (including repurposing)
Johan Neyts, Belgium

Small molecule antiviral drugs are available for the treatment of infections with herpesviruses, HIV, HBV and HCV as well as with influenza viruses. Yet for many other viruses that cause life-threatening infections, including SARS-CoV2 and other coronaviruses, there are no specific antiviral drugs available. Such drugs are urgently needed to help control the current outbreak.  I will discuss our efforts in drug repurposing for SARS-CoV2 and expand as well on our efforts to develop highly potent and specific inhibitors of the virus.

13:45

Innovative EU marketing authorisation strategies in times of a pandemic

Jordi Llinares Garcia (EMA), The Netherlands

14:15

The role of early phase data in the UK approach to market authorisation for SARS-CoV-2 vaccines

Kirsty Wydenbach (MHRA), United Kingdom

The current pandemic has made for interesting times for regulatory bodies throughout the world. The importance of early phase vaccine data will be discussed not just for marketing authorisations but from the time of first-in-human clinical trials. The UK perspective will be given, with an opportunity for delegates to challenge the information presented.

14:45

Panel and Open Forum discussion with speakers and the audience

15:15

Break and Networking with your colleagues and exhibitors

Session 2
16:00-17:30

Technology support to reduce the risks of pandemic effects on Phase1/2 trial performance

Chairs: Henri Caplain, France; Jorg Taubel, United Kingdom

16:00

Technologies in trial conduct (including tracing, testing, remote technologies for trials)
Elin Haf Davies, United Kingdom

16:30

Covid-19 the tipping point in GCP: From reactive to prospective and proactive quality and compliance management
Beat Widler, Switzerland

17:00

Panel and Open Forum discussion with speakers and audience

Day 2, Thursday, 29 April 2021

12:30

Dial-in open

12:45

Introduction into the day’s programme
Hildegard Sourgens, Germany

This Conference Day is dedicated to getting updates from researchers and service providers on particularly relevant innovations in early medicines development and on exchange of own experiences with colleagues in parallel sessions.

13:00-14:30

Parallel interactive Break-out Sessions, Round 1

Room 1

Benefit-risk evaluation of Advanced Therapy Medicinal Products (ATMPs) ‚Äď short- and long-term aspects
Henri Caplain, France; Oliver Galm, Germany; Bettina Ziegele (PEI), Germany 

This interactive session will give an overview of the regulatory framework for Advanced Therapy Medicinal Products (ATMPs) and an insight into the regulatory challenges on the way to the patient based on selected cases studies.

Room 2

How will working and training change after the COVID-19 experiences with travel and meeting restrictions?
Kerstin Breithaupt-Grögler, Germany; Tim Hardman, United Kingdom

This session addresses the impact of the Covid-19 pandemic on working practices and training in early pharmaceutical research and medicines development. How did we adjust to the abrupt change to established working routines and removal of formal infrastructures?

For most of us, travel, face-to-face meetings and the daily commute became a thing of the past. The public ‚Äėlockdown‚Äô cut personal communication with colleagues in the office or research unit. Confinement to the ‚Äėhome office‚Äô impaired team performance. Cancellation of conferences and workshops left us without the opportunity to establish new contacts, decreasing scientific and personal networking.

The new working landscape brought its own challenges and opportunities, with social engagement and openings for incidental networking abruptly being replaced with video calls and electronic outreach. Both team meetings and training/teaching became fully virtual. Those with pre-established electronic solutions experienced less disruption and valued potential advantages. International teams benefit from enhanced means of communication across continents. Virtual coffee breaks and lunches became weekly routine. Conferences appraised a ‚Äėdigital apero‚Äô to foster business networking. The pharmaceutical community rapidly adapted to this new ‚Äėbest‚Äô practice, maintaining functionality, managing workflows and keeping lines of communication open.

Which, if any, of the different ways of working will remain with the reducing threat of the pandemic? Will face-to-face communication be urgently needed to stabilize the functionality of project teams? Will increased work-related flexibility foster professional and personal success? This interactive session provides ample room for discussions with audience and chairs.

The session will address advantages and disadvantages of the new regulation with a focus on early phase studies and in particular monocentric phase I trials. Expected timelines and processes will be discussed with the participants. Furthermore, some national particularities in  regards to Ethic’s Committees will be discussed focusing on France, Germany and Belgium.

Room 3

Early phase clinical trials under the Clinical Trials Regulation: procedures and timelines
Yves Donazzolo, France; Katharina Schacke; Barbara Schug, Germany;
Thomas Sudhop (BfArM), Germany

This break-out session will provide insight into the practical procedures when applying for a clinical trial approval under the new regulation. Furthermore, maintenance aspects of the data base during the course of the trial shall be presented including submission of trial results and lay person summaries at the end.

The session will address advantages and disadvantages of the new regulation with a focus on early phase studies and in particular monocentric phase I trials. Expected timelines and processes will be discussed with the participants. Furthermore, some national particularities in  regards to Ethic’s Committees will be discussed focusing on France, Germany and Belgium.

Room 4

SARS-CoV2 vaccine development experiences ‚Äď Example of CanSino vaccine
Ayad Abdul-Ahad, United Kingdom; Dmitry Lioznov, Russia

14:30

Break

Session 3
14:35-15:45

Poster live Presentations

Chairs: Eric Mannaert, Belgium; Jens Rengelshausen, Germany

14:35

Development and Validation of an Age-Appropriate Measurement Methodology to Investigate the  Acceptability of New Oral Solid Drug Formulations in Young Children
Viviane Klingmann, Germany

14:45

Optimal risk mitigation ensures safe execution of phase 1 trials  in a COVID-19 pandemic context
Donald Benoot, Belgium

14:55

The Impact of the  COVID-19 pandemic on Phase 1 clinical activities
Jelle Klein, Belgium

15:05

Etodolac; add-on analgesic efficacy via TRPA1-interference?
Heleen Marynissen, Belgium

15:15

Inhibition¬† of the¬† capsaicin-induced dermal blood Ô¨āow by LY3316531,¬† a bispeciÔ¨Āc IL-23 and¬† CGRP monoclonal antibody
Dorien Bamps, Belgium

15:25

SDI-118, a Novel Procognitive SV2A Modulator: First-in-Human Randomized Controlled Trial Including  Assessment  of Target Engagement
Wouter Botermans, Belgium

15:35

Is stimulation of the  innate immune system by a TLR4 agonist as adjuvant to sublingual immunotherapy a future prospect to cure  peanut allergy?
Pierre-Francois Clot, France

from 14:35

Parallel track: scientific and methodology presentations from exhibitors

Chair: Hildegard Sourgens, Germany

14:35

Challenges of planning and conducting a FIM (First in Man) trial with a non-COVID19 investigational product at a Phase 1 Unit during the pandemic
Agnieszka Kulesza, Biokinetica Therapeutics S. A., Poland

Clinical trials, and early-phase studies in particular, are projects burdened due to their specificity with high organizational risk, safety issues concerning study participants, challenges related to the timelines, data collection, etc.

 

In a pandemic situation in which we have found ourselves for more than one year, conducting of early-phase clinical trials ‚Äď and particularly FiM trials – has become a great challenge for the sites, requiring ongoing daily assessment of COVID-19 risks and adaptation of risk mitigation plans and monitoring of its execution.

 

In the light of the imprecise and sometimes divergent requirements or guidance of national and regulatory authorities, bioethics committees, and sponsors, clinical units are facing a huge challenge to meet these expectations, while ensuring the safety of research participants, sites’ staff, and the continuity of daily activities relevant to research projects. In such a situation, it is necessary for all of the sites’ departments (medical, operational, recruitment, quality, regulatory, etc.) to work together and to maintain daily open communication with the sponsor, especially where it is necessary to take strategic decisions having an impact on the study outcome.

 

In my presentation I would like to briefly present the adaptive changes that have been undertaken by our clinical site unit considering both operational aspects and medical, laboratory, pharmacy-related, regulatory challenges as well as other instrumental solutions implemented by the site when conducting FiM trials during pandemic. Practical solutions showed in the form of case studies will be an important element of this presentation.

15:05

Fast and efficient conduct of exploratory clinical trials in patients in the realm of a Global Pandemic
Angela Bischoff, ARENSIA Exploratory Medicine GmbH, Germany

  • Key elements of successful Business Continuation Plan at ARENSIA¬īs research clinics
  • Patient recruitment across different therapeutic areas and management of ¬īsensitive¬ī patient populations
  • Future outlook for new trial designs and operational improvements following the lessons of the pandemic

15:45

Break and Networking with your colleagues and exhibitors

16:05-17:35

Parallel interactive Break-out Sessions, Round 2

Room 1

Benefit-risk evaluation of Advanced Therapy Medicinal Products (ATMPs) ‚Äď short- and long-term aspects
Henri Caplain, France; Oliver Galm, Germany; Bettina Ziegele (PEI), Germany 

This interactive session will give an overview of the regulatory framework for Advanced Therapy Medicinal Products (ATMPs) and an insight into the regulatory challenges on the way to the patient based on selected cases studies.

Room 2

How will working and training change after the COVID-19 experiences with travel and meeting restrictions?
Kerstin Breithaupt-Grögler, Germany; Tim Hardman, United Kingdom

Clinical trials, and early-phase studies in particular, are projects burdened due to their specificity with high organizational risk, safety issues concerning study participants, challenges related to the timelines, data collection, etc.

 

In a pandemic situation in which we have found ourselves for more than one year, conducting of early-phase clinical trials ‚Äď and particularly FiM trials – has become a great challenge for the sites, requiring ongoing daily assessment of COVID-19 risks and adaptation of risk mitigation plans and monitoring of its execution.

 

In the light of the imprecise and sometimes divergent requirements or guidance of national and regulatory authorities, bioethics committees, and sponsors, clinical units are facing a huge challenge to meet these expectations, while ensuring the safety of research participants, sites’ staff, and the continuity of daily activities relevant to research projects. In such a situation, it is necessary for all of the sites’ departments (medical, operational, recruitment, quality, regulatory, etc.) to work together and to maintain daily open communication with the sponsor, especially where it is necessary to take strategic decisions having an impact on the study outcome.

 

In my presentation I would like to briefly present the adaptive changes that have been undertaken by our clinical site unit considering both operational aspects and medical, laboratory, pharmacy-related, regulatory challenges as well as other instrumental solutions implemented by the site when conducting FiM trials during pandemic. Practical solutions showed in the form of case studies will be an important element of this presentation.

Room 3

Early phase clinical trials under the Clinical Trials Regulation
Yves Donazzolo, France; Katharina Schacke; Barbara Schug, Germany;
Thomas Sudhop (BfArM), Germany

This break-out session will provide insight into the practical procedures when applying for a clinical trial approval under the new regulation. Furthermore, maintenance aspects of the data base during the course of the trial shall be presented including submission of trial results and lay person summaries at the end.

The session will address advantages and disadvantages of the new regulation with a focus on early phase studies and in particular monocentric phase I trials. Expected timelines and processes will be discussed with the participants. Furthermore, some national particularities in  regards to Ethic’s Committees will be discussed focusing on France, Germany and Belgium.

Room 4

SARS-CoV2 vaccine development experiences ‚Äď Example of CanSino vaccine
Ayad Abdul-Ahad, United Kingdom; Dmitry Lioznov, Russia

17:35

“Participants’ Apéro“
Welcome by the President and Incoming President
Meet your colleagues and exhibitors virtually

Day 3, Friday, 30 April 2021

12:30

Dial-in open

12:45

Introduction into the day’s programme
Moderator: Ingrid Klingmann, Belgium

12:50

OXFORD Debate

Do we really need placebo in single ascending dose studies?
Chair: Ingrid Klingmann, Belgium
Speakers: Peter Dewland; Sven Van Dijkman, United Kingdom

13:35

Break and Networking in the virtual exhibition

Session 4
13:55-15:45

Trends in clinical trial designs

Chairs: Jan de Hoon, Belgium; Andreas Kovar, Germany

13:55

How can extrapolation between populations improve decision-making and speed-up early phase development using biostatistics?
Alice Gosselin; Caroline Petit, France

Extrapolation between populations is increasingly applied in drug development. It is a valuable tool to study a treatment in small populations and rare diseases. In early phase, good statistical inference is often challenging due to sparse data. However, existing information for other populations could be used to improve decision-making. Several statistical methods have been developed in early phase promoting translational research. Two examples illustrate different approaches for extrapolation, from adult population to pediatrics and from preclinical data to humans.

14:25

Preclinical and early clinical design challenges in ATMP development
Diane Seimetz, Germany

Advanced Therapy Medicinal Products (ATMPs) comprise medicines that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of severe conditions for which there are no appropriate therapies available today. With the authorization of the first chimeric antigen receptor (CAR)-T cells the field of cell and gene therapies has come to the adolescent stage1.

The development of ATMPs is associated with particular challenges. First, the product class is highly heterogeneous and standard development paradigms rarely apply. For example, in the case of autologous cell therapies the patient is closely involved in the manufacturing process of the investigational product by providing cells as starting material. In addition, the conventional clinical development paradigm consisting of several phases, such as phase 1, phase 2 and phase 3 may not apply. The first study could already lead into a pivotal study, depending on the effect size and safety profile. For preclinical development standard models are often missing and animal studies have limited relevance. Therefore, a thoughtful plan towards the first in human study including a diligent risk mitigation strategy is of utmost importance.

This presentation will address what is important for a smooth transition from R&D to the first in human clinical stage.

14:55

SARS-CoV-2 viral challenge study in healthy volunteers

Christopher Chiu, United Kingdom

Human challenge studies, in which volunteers are deliberately inoculated with infectious agents to study pathogenesis and host responses to infection, have played important roles in understanding immunity and early-phase efficacy testing of vaccines and therapeutics. Early during the COVID-19 pandemic, the possibility of developing such a system to accelerate product development was therefore raised. With their unique capacity to standardise and control viral strain, dose, mode and timing of exposure, SARS-CoV-2 human challenge can enable direct head-to-head comparison of different interventions as well as study the virological and immune responses at every stage of infection. However, establishing a human challenge model that is fit-for-purpose and responsive to the continually shifting pandemic landscape has never been achieved before, with difficult ethical questions that must be addressed. In this talk, I will discuss the background to SARS-CoV-2 human challenge and the considerations that led to the first such study being conducted. With the pandemic still causing major global outbreaks, I will discuss why human challenge is needed in this context and how it may contribute to emergency authorisation as phase III efficacy trials become increasing difficult to complete.

15:25

Panel & Open Forum discussion with speakers and the audience

15:45

Break and Networking with your colleagues and exhibitors

Session 5
16:05-17:55

Regulatory experiences with COVID-19 trials and authorisations

Chairs: Joop van Gerven, The Netherlands 

16:05

Fast track clinical trial authorisation today and under the Clinical Trial Regulation
Greet Musch, Belgium

16:35

Current status of COVID-19 antiviral therapeutics and plans for antivirals for future pandemic preparedness
Trevor M. Jones, United Kingdom

Following the identification of the causal pandemic virus ,COVID-19 SARS Cov-2 , there has been intense activity to find new and repurposed antivirals in addition to developing specific vaccines

Several are now in Clinical evaluation and many more in preclinical studies. Consortia have been established to addresses both the current pandemic and to be prepared for future pandemics

17:05

Success and failures in early vaccine development, experience with COVID-19 vaccines
Michael Pfleiderer, Germany

Emergence of the SARS-CoV-2 virus in Q3/Q4 2019 has confronted humanity with a pandemic scenario that only is comparable with the Spanish influenza pandemic occurring in 1918/1919. Several other influenza pandemics have occurred during the past hundred years, as well as numerous outbreaks caused by other newly emerging and re-emerging viral pathogens, none of them, however, manifesting as severe and life-threatening for the global population as the current one. Beyond the indefinite burden of disease, high case fatality rate and personal fates caused by the tremendous loss of lifes, there also is a major success story helping mankind to control a pandemic in an unprecedented pace by the development of safe and effective vaccines.

In the beginning of the current pandemic it was beyond the imaginable that it would indeed be possible to develop, license and deploy a wide range of SARS-CoV-2 vaccines in less than a year. Moreover, despite this incredible speed development and licensure of these vaccines was by no means shortcut. The same scientific standards applicable also for other vaccines were adhered to for any of the SARS-CoV-2 vaccines licensed in the EU and in the US. Based on a robust and functional regulatory system developed during the past 20 years providing a comprehensive yet flexible regulatory framework allowing access to numerous innovative medicinal products, the development of safe and effective SARS-CoV-2 vaccines was greatly facilitated without exposing a vaccinated population to undue risks.

Quite surprisingly, the most successful vaccines are derived from completely new manufacturing platforms developed by new key players while some of the more established vaccine manufacturing platforms (and manufacturers) were less successful.

Here we describe how the combination of innovative technologies and bullet proof regulatory standards helps the world to overcome a terrifying health threat within an unprecedented short period of time.

17:35

Panel & Open Forum discussion with speakers and the audience

17:55

Closing remarks from the Board

Conference days