September 2019

Avicenna Monthly Newsletter 

Key highlights

  • Avicenna Secretariat attended the European Parliament Plenary Session and met with new Members of Parliament in Strasbourg 
  • Avicenna and VPH Insitute were represented at the European Research & Innovation Days organised by the European Commission and had several meetings with Commission Staff
  • The Commission President put forward her EU health priorities for the five upcoming years in a mission letter addressed to the Commissioner candidate for Health, Stella Kyriakides
Policy Updates

Ursula von der Leyen's health priorities

On 10 September, Ursula von der Leyen, European Commission President, provided the candidate Commissioner for HealthStella Kyriakides (Cyprus) with a mission letter in which the Commission President sets out her expectations and underlines missions on which the new Health Commissioner should concentrate her efforts during her mandate. 

In comparison with the previous Commissioner for health, Ms. Kyriakides  will have an increased scope of work  as she will work on medical devices and medicine, which previously fell under the competence of the Internal Market and Industry Commissioner Elżbieta Bieńkowska. More precisely, Ms Kyriakides  is expected to implement the new regulatory framework on medical devices, with the “aim of protecting patients and addressing new and emerging challenges”.  

 Ursula von der Leyen requested the Health Commissioner candidate to focus her efforts on the following actions:

  1. To ensure Europe’s supply of affordable medicines by supporting European pharmaceutical industry; 
  2. To focus on the effective implementation of the new regulatory framework on medical devices; 
  3. To make the most of potential of e-health by working on the creation of a European Health Data Space to promote health data exchange and support research; 
  4. To implement the European One Health Action Plan against Antimicrobial Resistance and work internationally to advocate for a global agreement on the use of and access to antimicrobials;  
  5. To prioritise communication on vaccination; 
  6. To put forward Europe´s Beating Cancer Plan to support Member States to improve cancer prevention and care. This plan should: (a) propose actions at every key stages of the disease; and  b) be closely linked with the research mission of cancer in the future Horizon Europe Programme.  
Call for interest for civil society representatives in the EMA's Pediatric Committee (PDCO)

The Commission launched an open call for expressions of interest for the role of Civil Society Representatives for the European Medicines Agency’s Pediatric Committee (PDCO).

Among the available positions, the Pediatric committee is looking for 3 members and alternates that represent health professionals. They will be responsible for presenting the needs of practitioners, clinicians, pharmacists or other health professions on realistic implications of pediatric research projects.

Understanding of pediatric matters is needed, as well as proven experience in representing healthcare professions, such as being member of a professional organisation.
We believe that among the Avicenna Alliance, some of you might be interested in submitting their candidacy before 25 October.

More information on this call for interest can be found through this document and this link.

Online consultation to shape Horizon Europe's priorities open until 4 October

Members and more particularly the VPH Institute Members are warmly invited to take part in the online consultation and provided feedback on the Commission’s orientation paper in preparation for its 2021-2024 Strategic Plan for Horizon Europe. This was is an important opportunity to highlight the need for funding of CM&S technology for the upcoming four years under Horizon Europe. 
You can contribute to co-designing and help shaping the future research and innovation investment by responding to this questionnaire. It takes approximately 20 minutes to respond! 

A Call for an Industrial Strategy for Europe

On 10 September, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published a call for an industrial strategy for Europe that can drive Europe’s health and growth and realise the region’s potential to be a world leader in medical innovation. The call was launched during a debate on the future of Europe’s pharmaceutical strategy organised by Friends of Europe.

In light of Ursula von der Leyen’s statement that ‘’A sustainable Europe is one that opens up opportunities, innovates, creates jobs and offers a competitive edge to its industries.’’, EFPIA outlines five areas where European decision-makers should focus to foster Europe’s growth and drive Europe’s health:

  1. Maintaining a world-class system for the approval of new treatments 
  1. Better innovation policies to enable Europe to lead in research and development (R&D)
  1. A digital Europe that will support patients in their healthcare journey
  1. A smart trade agenda that supports EU competitiveness and access
  1. Policies to preserve the environment

This initiative may be interpreted as a way to influence the definition of the Commission Work Programme for the years to come.

Scientific and Regulatory News
Short-listed finalists of the Horizon Impact Award 2019

On 20 September, the ten finalists of the Horizon Impact Award 2019 have been short-listed by the European Commission. The prize honours projects that have a societal value and have been funded under Horizon 2020, by the EU research and innovation programme. Among the selected finalists, we have noted some R&I projects in the healthcare sector:  

GLYCOHEALTH (Germany) In the context of the project sugar molecules, glycols, were used to produce new vaccines. It has been proven that sugar vaccines can help in the fight against multi-drug resistant hospital bacteria.
MANNO-CURE (Germany) During the research period of October 2010 to March 2014, researchers focused on the development of a long-term drug therapy that aims to treat Alpha-Mannosidosis which is a rare disease. The drug that already entered the market is the first evidence-based therapeutic intervention for the treatment of Alpha-Mannosidosis.
MC4D-LA (Spain) Within the project, 3G networks were developed in rural areas in South America benefiting 3000 people that are now connected to telemedicine systems.
PREHDICT POOLED (the Netherlands) The overarching objective of the research was to determine prerequisites and strategies for vaccination. As such, the project has pushed forward new HPV-based screening guidelines to ensure early detection of cervical cancer that is caused by HPV.
News from inside the Avicenna Alliance
Avicenna Secretariat down to Strasbourg for Plenary week

With a 60% turnover in the new European Parliament and a new European Commission, the need for outreach is greater than ever. The now confirmed revision of orphan medicinal products legislation and paediatrics makes this all the more pressing.

The Avicenna Alliance Secretariat met with a range of MEPs and Advisors to stress the need for in silico medicine to form part of the next revision of these key legislative files and for the Commission to work with the FDA towards Good Simulation Practices at an international level.
Of particular interest was the meeting with Ms.Metz (Greens, Luxembourg) which proved to be very positive with her agreeing to table a written question to the European Commission and to help push the issue of modeling and simulation during her term.

In particular, she understood the importance of positioning CM&S as an industry/market friendly issue and a means of ensuring research translates to market as opposed to a purely animal testing reduction issue.

Avicenna will continue to follow up and build momentum for legislative changes that would drastically accelerate the uptake of computer modelling and simulation in healthcare.
Avicenna present at the European Research & Innovation Days
The European Research and Innovation days was a three-day event in Brussels, during which researchers, academics, businesses, decision-makers and parliament representatives from Europe and beyond took part in a co-design process to shape the priorities and strategic plan for the first four years of Horizon Europe, due to start in 2021.

The Avicenna Alliance and the VPH Institute were both well represented at the European Research and Innovation Days on 26 September. In the time of one morning, we had the chance to meet with several staff members of European Commission's DG Research & Innovation (DG RTD) who were genuinely interested in helping to put in silico forward in Horizon Europe, the next research and innovation programme.

Also on other policy sides, the Commission staff was willing to help the Avicenna Alliance and VPH Institute to get in contact with the right persons regarding the use of CM&S for paediatrics, orphan medicinal products and the implementation of the medical devices regulation.

This research and innovation days were a perfect opportunity for the Avicenna Alliance and VPH Institute to show their interest in the next R&I programme of the EU and to explain to EU policy makers what are the next steps to unblock the use of computer modeling and simulation behind research purposes.
Events and Webinars

Horizon Europe: New Parliament, New Commission, New Agenda

‘Horizon Europe: New Parliament, New Commission, New Agenda’ was an event organised by Science Business which took place on 10 September. Among the invited speakers, Commission and Parliament representatives shared their views on the future actions to be taken on cancer, research and innovation as well as artificial intelligence.

During a panel discussion on “Strategic planning: Co-creating Horizon Europe”, participants from the academic and private sectors covered a broad range of topics concerning the Horizon 2020 legacy including the GDPR and healthcare technologies. There was also a panel on Artificial Intelligence, which outlines the importance importance of catching up with global AI developments.

ICH public meeting to review draft Guideline 'General Considerations for Clinical Trials'

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a global public meeting to review its draft E8 (R1) Guideline 'General Considerations for Clinical Trials' on 31 October in the US (Maryland).

The purpose of the public meeting is to provide information and solicit input from a broad range of non-ICH Member/Observer stakeholders on the draft revised E8 (R1) Guideline “General Considerations for Clinical Trials”. The meeting will be hosted by the Food and Drug Administration (FDA)  in Silver Spring, Maryland, United States of America, however it will be possible to webcast the meeting.
The European Medicines Agency (EMA) also recommends interested stakeholders to provide their comments on the draft version of the ICH guidelines via this template and to send it by 30 September to ich@ema.europa.eu    
For the Avicenna’s colleagues located in the US, this event represents a good opportunity to advocate for the inclusion of CM&S and its potential for exploratory studies in clinical trials.
Innovation Through Simulation in Healthcare

On the 11 October 2019 ANSYS, US FDA, and the Avicenna Alliance are organizing a roundtable discussion in Washington, focusing on modeling and simulation in the medical device and pharmaceutical industries.  

The goal of the meeting is to discuss opportunities and challenges when utilizing in silico approaches during development and regulatory review.  The event will be organized around 2 panel discussions, where senior leaders from the largest medical device and pharmaceutical companies will be sharing their experience and expectations.
Please register here to reserve your spot!
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