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Programme

This workshop will comprise inspiring presentations, followed by discussions aimed at tackling the main challenges in preclinical to clinical translation of paediatric CNS drug delivery devices, namely:

  • a lack of specific funding for prototype development and/or scale-up for clinical trials; 
  • difficulties in navigating the regulatory landscape; 
  • lack of accurate preclinical models; and 
  • increased need for multicentric working.

One outcome of these discussions will be the creation of a ‘Roadmap’ document for preclinical to clinical translation that we will share widely with the neuro-oncology community.

 

Monday 8th November 2021
13:00 -    14:00      

Lunch

14:00 -  14:15

Welcome and overview of workshop aims 

Mr Kristian Aquilina, Consultant Paediatric Neurosurgeon at Great Ormond Street Hospital, UK; Member of the ITCC Brain Tumour Group; Chair of the CBTDDC Clinical Trials Group

Dr Ruman Rahman, Associate Professor in Molecular Neuro-Oncology, University of Nottingham, UK; Chair of the CBTDDC

14:15 -  15:15

Accurate pre-clinical models for paediatric brain cancer drug delivery

Dr Marcel Kool, Head of The Embryonal Brain Tumor and Preclinical Research Group, KiTZ, Germany.

Previous meetings of the CBTDDC Clinical Trials Group have identified a lack of accurate preclinical models as one of the main challenges in preclinical to clinical translation of paediatric CNS drug delivery devices. In this session, Marcel will describe the models that his group create and open up the discussion to identify specific gaps that need to be addressed by research teams worldwide.

15:15 -  15:30 Refreshment break
15:30 -  16:30

Funding options for preclinical to clinical translation

Dr Roy Harris, Senior Adviser in Translational Research, Research Design Service East Midlands, UK

Previous meetings of the CBTDDC Clinical Trials Group have identified a lack of specific funding for prototype development and/or scale-up for clinical trials as one of the main challenges in preclinical to clinical translation of paediatric CNS drug delivery devices. In this session, Roy will detail the current options available in the UK, before opening up the discussion to include international funding schemes and the gaps that need to be addressed. 

16:30 -  16:45 Closure of Day 1 - Ruman & Kristian
   
19:00 -  22:00

Evening buffet

The Senate Chamber, Trent Building, University of Nottingham

 

 

Tuesday 9th November 2021
From 08:45

Tea / Coffee

09:15 - 09:30    

Introduction to Day 2 - Ruman & Kristian

09:30 - 10:45

Roadmap for preclinical to clinical translation – the backbones

Prof Anthony Chalmers, Chair of Clinical Oncology (Clinical Trials Research), University of Glasgow, UK

Anthony was a co-author on the 2019 report 'Delays in opening Brain Tumour Clinical Studies: An explanation of barriers and proposal of potential solutions'. In this session, he will share findings and recommendations from this report that are applicable to trials of CNS delivery devices for paediatric brain tumours.

10:45 - 11:00    

Refreshment break

11:00 - 12:15

Navigating the regulatory landscape  

Dr Joshua Savage, Tessa Jowell BRAIN MATRIX Senior Trials Manager and Early Drug Development Team Leader, Birmingham CRUK  Clinical Trials Unit, UK

Josh was a co-author on the 2019 report 'Delays in opening Brain Tumour Clinical Studies: An explanation of barriers and proposal of potential solutions'. In this session, he will share findings and recommendations from this report, and also give an overview of the steps involved in regulatory approval of CNS drug delivery devices for paediatric brain tumours.

12:15 - 12:45 

Multicentric working

Dr Madhumita Dandapani, Clinical Associate Professor of Paediatric Oncology/Neuro Oncology, The University of Nottingham, UK.

12:45 - 13:45

Lunch

13:45 - 14:45

Taking your research into clinical trials: a Q&A clinic

We will walk through real and current examples of preclinical research translation to help overcome bottlenecks to successful trial launch.

Featuring Prof Kathy Warren, Clinical Director, Pediatric Neuro-Oncology; Professor of Pediatrics, Harvard Medical School, Dana Farber Cancer Institute/Boston Children’s Hospital, US

14:45 - 15:00

Refreshment break

15:00 - 15:45

Revisiting the Roadmap

Further discussion following on from the progress made on Day 1, led by Kristian Aquilina.

15:45 - 16:00

Closing remarks and announcement of pump prime funding opportunity - Ruman Rahman