ADAPT SMART Closing Meeting “Medicines Development in the Adaptive Era”

21-22 March 2018, Budapest

The IMI ADAPT SMART Closing Meeting “Medicines Development in the Adaptive Era” has taken place on the 21st and 22nd March 2018 in the Akadémia Klub (the Hungarian Academy of Sciences), Budapest, Hungary.

During this event the final results of the project were be presented and placed into the context of public health and sustainable pharmaceutical innovation in Europe and beyond.

As part of the programme,  MIT’s NEWDIGS hosted an interactive session to apply the learnings from ADAPT SMART to a case study. All audience members had the opportunity to contribute to the case study discussions.

The meeting ended with a look into the future of adaptive pathways beyond ADAPT SMART.

Programme:

15.30-16.30 Vörösmarty Hall Ground Floor Registration and coffee
16.30-16.35 Reading Room 1st Floor Welcome by André Broekmans (Coordinator ADAPT SMART), Director Escher, Lygature, The Netherlands
16.35-16.50 Reading Room 1st Floor Keynote: “The ways of innovation and regulatory science” Csilla Pozsgay, Director General, National Institute of Pharmacy and Nutrition (OGYÉI), Hungary
16.50-17:00 Reading Room 1st Floor Opening: “The ambition of ADAPT SMART”Hans-Georg Eichler (Project Leader ADAPT SMART), Senior Medical Officer, European Medicines Agency (EMA), United Kingdom
17:00-18.00 Reading Room 1st Floor Stakeholder reflections and panel discussion

Stakeholder Representatives:

  • Patient: Valentina Strammiello, Program Manager, European Patients’ Forum (EPF), Belgium
  • Regulator: Francesca Cerreta, Scientific Administrator, European Medicines Agency (EMA), United Kingdom
  • HTA: Wim Goettsch, Special HTA Advisor, Zorginstituut Nederland (ZIN), The Netherlands
  • Payer: Ad Schuurman, Senior International Officer, Zorginstituut Nederland (ZIN), The Netherlands
  • Industry: Solange Rohou (Deputy Project Leader ADAPT SMART), Senior Director Regulatory Affairs & Policy Europe, AstraZeneca, France
  • Academia/HCP: Bojan Vujkovac, Nephrologist, Slovenj Gradec General Hospital, Slovenia

Moderator: Duane Schulthess, Managing Director, Vital Transformation, Belgium

18.00-20.00 Vörösmarty Hall Ground Floor Networking drinks reception
08:30-09:00 Foyer 2nd Floor Registration and coffee
09:00-09:10 Grand Hall 2nd Floor Welcome – André Broekmans (Coordinator ADAPT SMART), Director Escher, Lygature, The Netherlands
09:10-09:20 Grand Hall 2nd Floor Introduction to the day and presentation of the case study – Facilitators
09:20-10:30 Grand Hall 2nd Floor Case study: background on MAPPS, beta thalassemia & defining a target population –  Facilitators with Hans-Georg Eichler (Project Leader ADAPT SMART), Senior Medical Officer, European Medicines Agency (EMA), United Kingdom and Mathieu Boudes, PARADIGM Coordinator, European Patients’ Forum (EPF), Belgium
10:30-11:00 Foyer 2nd Floor Coffee break
11:00-12:30 Grand Hall 2nd Floor Case study continued: Tools to ensure appropriate utilization & payer strategies – Facilitators with Jacoline Bouvy, Senior Scientific Adviser, National Institute for Health and Care Excellence (NICE), United Kingdom and Ad Schuurman, Senior International Officer, Zorginstituut Nederland (ZIN), The Netherlands
12:30-13:30 Krúdy Hall -1st Floor Lunch
13:30-14:15 Grand Hall 2nd Floor Case study continued: Prospective post-marketing planning– Facilitators with Hans-Georg Eichler (Project Leader ADAPT SMART), Senior Medical Officer, European Medicines Agency (EMA), United Kingdom
14:15-15:00 Grand Hall 2nd Floor Case study continued: Stakeholder commitment – Facilitators with Richard Barker, Founding Director, Centre for Advancement of Sustainable Medical Innovation (CASMI), Oxford University, United Kingdom
15:00-15:30 Foyer 2nd Floor Coffee break
15:30-16:00 Grand Hall 2nd Floor Conclusions & take-aways from case study – Facilitators
16:00-16:20 Grand Hall 2nd Floor Summary of IMI recommendations – Solange Rohou (Deputy Project Leader ADAPT SMART), Senior Director Regulatory Affairs & Policy Europe, AstraZeneca, France
16:20-16:30 Grand Hall 2nd Floor Closing remarks – Hans-Georg Eichler (Project Leader ADAPT SMART), Senior Medical Officer, European Medicines Agency (EMA), United Kingdom

Meeting Report:

IMI’s ADAPT SMART Draws to a Close, Outlines Path Forward for Continuing Early Stakeholder Engagement

March 23, 2018 – Budapest: On March 21st and 22nd, ADAPT SMART held its closing meeting at the Hungarian Academy of Sciences in Budapest, highlighting the programme’s achievements and next steps for delivery after the project’s conclusion.

For thirty-three months, ADAPT SMART had been focused on developing new processes for the implementation of Medicines Adaptive Pathways to Patients (MAPPs), which aim to foster access to beneficial treatments for specific, well-defined, patient groups with a high unmet medical need at the earliest appropriate time in the product life-span in a sustainable and affordable fashion. Given the challenges of access to new medicines in Central and Eastern Europe, Hungary was chosen for the ADAPT SMART closing meeting to help put MAPPs into practice across the entire EU.

Read the full report here

Slides:

Stakeholders panel 21 March:

(click on the name to download the slides)

  • Valentina Strammiello, Program Manager, European Patients’ Forum (EPF)
  • Francesca Cerreta, Scientific Administrator, European Medicines Agency (EMA)
  • Wim Goettsch, Special HTA Advisor, Zorginstituut Nederland (ZIN)
  • Solange Rohou, (Deputy Project Leader ADAPT SMART), Senior Director Regulatory Affairs & Policy Europe, AstraZeneca

Case Study 22 March:

Participation List:

Click here to download the participation list

Pictures:

2018-04-03T11:41:43+00:00