222ndENMC International Workshop:

Myotonic Dystrophy, developing an European consortium

for care and therapy

1 – 3 July 2016

*programme *
Friday 1 July 2016

12:30 - 14:00Lunch

14:00 - 15:00 Introductory Session

14:00 - 14:10 Welcome by dr. Alexandra Breukel, Managing Director ENMC

14:10 - 14:15Welcome Organisers

14:15 - 14:25Patient perspectives, Jeanette Charlton (UK)

14:25 - 14:35Patient perspectives, Alain Geille (Fr)

14.35 - 14:45Introduction to the Wyck foundation, John Porter (USA)

14:45 - 15:15Why establish a network for DM trials, examples from other conditions, Benedikt Schoser

Benedikt Schoser

15:15 - 19:00 The last five years, trial readiness, outcome measures and patient registries

15:15 - 15:30Imaging: Muscle MRI, Arend Heerschap

15:30 - 15:45Imaging: Brain MRI, Cornelia Kornblum

15:45 - 16:00Imaging: Skeletal muscle MRI, Arend Heerschap

16:00 - 16:30Coffee/Teabreak

16:30 - 16:45Outcome measures: Respiratory, Valeria Sansone

16:45 - 17:00Outcome measures: Cognitive outcomes, Giovanni Meola

17:00 - 17:15Outcome measures: Myotonia, Christopher Lindberg/David Hilton-Jones

17:15 - 17:30 Outcome measures: Muscle Strength and Function, Marie Kierkegaard

17:30 - 17:45 Outcome measures : Activity and cognitive outcomes, Baziel van Engelen

17:45 - 18:00Outcome measures: Biomarker and genetics, Darren Monckton

18.00 - 18.15Outcome measure: Sleep, Matthias Boentert/Antonio Atalaia

18.15 - 18.30Outcome measures: Lessons from OMMYD, Cynthia Gagnon

18.30 – 18.45Value of patient reported outcomes, Chad Heatwole

18:45 – 19.00Classification in DM1, a model for cohort stratification. How to stratify cohorts, Guillaume Bassez

19:00 – 19:30Discussion: OM selection, do we need a minimal dataset, characterisation and stratification Chari: Guillaume Bassez

20:00 Dinner

Saturday 2 July 2016

09.00 - 11.00Registries (cont. from Friday)

09:00 - 09:15Registries: Swedish national registry, Christopher Lindberg

09:15 - 09:30Registries: Serbian national registry, ReaDy, Vidosava Stojanović

09.30 - 09:45Registries: Danish national registry/cohort, John Vissing

09:45 - 10.00Registries: French national registry/cohort, Guillaume Bassez

10:00 - 10:15 Registries: A global review of DM registries “Naarden five years later”, Libby Wood Libby Wood

10:15 - 11:00Registries Discussion: the next steps to create a global registry, Hanns Lochmüller

11:00 - 11:30 Coffee/Teabreak

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11:30 - 12:00 What has been learnt from OPTIMISTIC; trial design, set-up, recruitment, retention, Baziel van Engelen/Shaun Treweek

12:00 - 12:30Discussion: How to make things better next time, what else need to be considered for sponsor led trials, all

12:30 - 13:00Discussion: how do we stratify patients into suitable cohorts, power calculations, what do we learn from unpublished data, what trial designs would be suitable, all

13:00 - 14:00 Lunch

14:00 - 15:00 Beyond the trails: what do we need to consider

14:00 - 14:30 Regulatory Interactions and post marketing surveillance, Pavel Balabanov

14:30 - 15:00 Discussion: Where do we start? Chair: Hanns Lochmüller

15:00 - 15:30 Coffee

15:30 - 17:00What has already been developed, what can we re-use?

15:30 - 16:00What are other European Networks Offering? What is the benefit of sharing data and samples existing structures e.g. RD-Connect, Rachel Thompson

16:00 - 16:30 What is required to share samples? Hanns Lochmüller

16:30 - 17:00 Discussion: How can the DM community use these infrastructures and tools? Chair: Baziel van Engelen and Benedikt Schoser

17:00 - 18:00Current and expected trials, an industry perspective

17:00 - 17:30ISIS/Biogen, Laury Mignon

17:30 - 18:00Discussion: What industry need to be trial ready, Chair: Benedikt Schoser

19.00Dinner

Sunday 3 July 2016

09:00 - 10:30Establish an European DM Consortium

Discussion: Structure and Governance

Chair: Benedikt Schoser, Baziel van Engelen

10:30 - 11:00Coffee

11:00 - 12:00Work plan

11:00 - 11:20Lay Summary and final patients comments, Alan Geille/Jeanette Charlton

11:20 - 11:40Full Workshop publication, Organisers

11:40 - 12:00General Discussion, Organisers

12:00 - 13:00End of meeting, lunch and departure of participants