June 2020

Avicenna Monthly Newsletter 

Key highlights

  • The Avicenna Alliance has been accepted as official EMA Stakeholder!
  • Avicenna Members produce and publish a brand-new position paper on AI & Big Data while providing feedback on the European Strategy for Data
  • The Avicenna Alliance shares Members’ feedback on the European Commission’s White Paper on Artificial Intelligence
  • The European Commission publishes the Roadmap to the Pharmaceutical Strategy and opens public consultation
Avicenna Alliance News
Avicenna Alliance accepted as official EMA Stakeholder
It is with great pleasure that we announce that the Avicenna Alliance has been accepted as an official Stakeholder of the EMA!
For some perspective, there are an estimated 25,000 lobbyists in Brussels engaging with various authorities; the healthcare community is one of the largest. EMA is very selective while choosing the organizations they are engaging with more formally: Avicenna is now one of the only 33 organisations granted EMA stakeholder access.

What does this mean for Avicenna? 
  • Increased legitimacy when engaging with governments and institutions;
  • Direct access to EMA consultations and meetings open only to EMA Stakeholders;
  • Greater ease of access and a more comfortable working arrangement with key EMA officials.
Thank you to all Members who have helped Avicenna achieve the level of notoriety needed to be recognised as a trusted partner of the EMA and reach this important milestone!
Avicenna publishes a brand-new position paper on AI & Big Data while providing feedback on the European Strategy for Data
We are proud to announce that on 29 May, the Avicenna Alliance has submitted Members’ feedback to the European Commission’s public consultation on the European Strategy for Data.

While providing Members’ feedback to the Commission’s survey on Data, the Alliance has released a brand-new position paper on “AI and Big Data effective readiness, a privacy-enhancing pathway to data access” which has been developed by members of the Avicenna Alliance from medtech, pharmaceutical, software and life science industries and scientific community from academia.

This position paper applies both to the Public Consultations on a European Strategy for Data and the White Paper on Artificial Intelligence and constitutes the starting point for a much-needed discussion on how the policy framework governing AI & Data in the health care sector.

Do you want to read more about the position paper developed by the Avicenna Alliance Members on AI & Data? Please have a look here.

Do you also want to have a look at the feedback provided by the Avicenna Alliance to the European Commission? You will find the Members’ common answer to the public consultation here.

Avicenna provides feedback on the European Commission's White Paper on AI

We are pleased to report that on 12 June, the Avicenna Alliance has submitted Members’ feedback through the European Commission’s public consultation on its White Paper on artificial intelligence.

Following the publication of a new policy package, including the European strategy for data and White Paper on artificial intelligence, the European Commission launched a consultation period to gather views from stakeholders on its White Paper on artificial intelligence until the 14 June.

Members of the Avicenna Alliance were eager to provide feedback to this important publication and therefore started working on an Avicenna Alliance white paper on ‘’the role of artificial intelligence within in silico medicine”. Given the great interest shown by the members of the Alliance and the time necessary to respond to the European Commission's public consultation on AI, it was decided to produce a provisional executive summary on “The role of Artificial Intelligence within in silico medicine “ as an introduction to the white paper to be published later in 2020 to provide feedback to the European Commission.

The Avicenna Alliance is therefore proud to share with you the common feedback provided to the European Commission’s survey!
Launch of the Avicenna Members Webinars series
In June, the Avicenna Alliance kicked off its new Members webinar series with a webinar organised by Medtronic entitled "Medtronic’s Approach to In Silico Trials”. 

The Avicenna International Working Group Leader, Markus Reiterer and his colleagues Mark Palmer, and Benyamin Grosman from Medtronic have presented Medtronic’s approach to in silico trials and more particularly to virtual patients suffering from diabetes.
This first Members’ webinar has been covered by a great success with reaching the limit of 100 participants! The Avicenna Alliance thanks very much the three presenters for their efforts in preparing this great webinar and for sharing their knowledge and expertise in computer modelling and simulation!
From now, monthly webinars for Avicenna Members will be organised to enable both companies' members and VPH Institute members to better and share their knowledge about their main activities and expertise in therapeutic areas for in silico medicine!
SAVE THE DATE Next Avicenna Members Webinar Monday 6 July

Save the Date for the next Avicenna Members webinar hosted by Professor Liesbet Geris from VPH Institute (University of Liège and University of KU Leuven) which will take place on 6 July at 16:00 (CET)!
Prof. Geris will provide Avicenna Members  with her presentation entitled “In silico tools for skeletal tissue engineering from bench to bedside”. 

Do you want to take part in these webinars’ series, access the recordings or join as an attendee?
Become Member of the Avicenna Alliance and contact Thierry Marchal, Secretary-General of the Alliance!
Policy Updates
Commission publishes the Roadmap to the Pharmaceutical Strategy and opens public consultation
On 2 June, the European Commission published its Roadmap to the Pharmaceutical Strategy and opened a feedback period until 7 July. Moreover, on 16 June, the European Commission launched the online public consultation on the Pharmaceutical Strategy for Europe running until 15 September.

The consultation allows experts and stakeholders to contribute and express their opinion through a questionnaire on the best ways to address pharmaceutical-related issues in the EU.
The overall goal of the pharmaceutical strategy initiative is to help ensure EU’s supply of safe and affordable medicines to meet patients’ needs and support the European pharmaceutical industry to remain an innovator and world leader.
Concerning the Roadmap, the Commission identified seven main challenges that need to be tackled, namely:
  1. A rapidly changing global context which can have a major impact on access to medicines in the EU;
  2. Unequal access to medicines that are not always affordable for patients and national health systems across the EU;
  3. Shortage of medicines;
  4. Innovation efforts are not always aligned to public health and health systems’ need;
  5. Challenges for the EU pharmaceuticals innovation ecosystem;
  6. Technological and scientific developments may challenge the regulatory framework and consequently lead to unintended barriers to needs-driven innovation;
  7. The way environmental risks are addressed needs to be improved.
The initiatives taken under the Strategy will aim to meet the following 4 core objectives:
  1. Ensure greater access and availability of pharmaceuticals to patients;
  2. Ensure affordability of medicines for patients and health systems financial and fiscal sustainability;
  3. Enable innovation including for unmet medical needs in harnessing the benefits of digital and emerging science and technology while reducing the environmental footprint;
  4. Support EU influence and competitiveness on the global level, reduce direct dependence on manufacturing from non-EU countries, seek a level playing field for EU operators.
The publication of the EU Pharmaceutical Strategy Roadmap is highly relevant for all Avicenna Members because it announces several other activities (both legislative and non-legislative) in the pharmaceutical sector, as well as in the field of health, more generally.

The Avicenna Alliance is now preparing the actions that will be taken to provide the European Commission with a joint Avicenna Alliance input and feedback. The Avicenna Alliance feedback will be shared throughout social networks. Stay tuned!
Commission published a factsheet on the new objectives of the Digital Europe Programme
On 4 June the Commission published a factsheet to provide more information regarding the new objectives of the Digital Europe Programme funded under the next Multiannual Financial Framework (MFF) for 2021-2027, the next long-term EU budget. The Programme will aim to increase the EU's international competitiveness, as well as develop and reinforce Europe's strategic digital capacities in 5 spheres while leading the green transition towards climate neutrality by 2050 and ensuring technological sovereignty. 

With a budget of €8.2 billion, the Digital Europe Programme aims to build the strategic digital capacities of the EU and facilitate the wide deployment of digital technologies, to be used by Europe’s citizens, businesses and public administrations.

This Programme aims to trigger investments by the EU, Member States and industry for the next 7 years in 5 spheres between which the programme is divided, which include the following actions deemed to also impact the digitalisation of the health sector:
  1. €2.4 billion for high performance computing (HPC)
  2. €2.2 billion for artificial intelligence (AI)
  3. €1.2 billion for digital technology across the economy and society
  4. €600 million for advanced digital skills
  5. €1.8 billion for cybersecurity
Through the  Digital Europe Programme, the Commission will support investments for specific innovative solutions such as supercomputers and AI. These technologies are seen as the driving forces for providing the EU with its own independent and competitive technology supply and achieve excellence in innovation for areas of public interest such as health, environment and security.
WHO's draft European Programme of Work and opens consultation for stakeholders!
The World Health Organisation (WHO) published the Draft European Programme of Work, 2020–2025 (EPW), which was developed with the endorsement of the Twenty-seventh Standing Committee of the Regional Committee for Europe. This has been titled “United action for better health in Europe”.

The EPW sets out a vision of how the WHO Regional Office for Europe can help Member States’ health authorities rise to the health challenge posed by COVID-19 and potentially exacerbated by Brexit. The Regional Office will maximise the impact by uniting the efforts of other partners, enhancing country focus, and directing support to Member States’ health leadership, and aligning with the shared core priorities.
An open consultation on this programme has also been made available until 18 July 2020 by the WHO’s regional European office. It aims to gather feedback from all actors on how the EPW can be implemented successfully. 
This is a great opportunity for all Avicenna Members to take part in this open consultation as this programme may direct the work in the field of health within Europe for the next 5 years!

          EU Health Ministers discuss new European Health Programme

On 12 June the EU’s Health Ministers held an exchange of views on the EU4Health programme (the new European stand-alone programme introduced by the Commission at the end of May).

The European Commission presented the EU4Health Programme to the EU Health Ministers. They outlined the need to create strategic stockpiles of protective personal equipment (PPE), medicines and medical devices, as well as a reserve of healthcare staff. The Health Commissioner stated that the programme will contribute to the fight against cancer, will aim to reduce the number of antimicrobial-resistant (AMR) infections and to improve vaccination.

Although the programme represents a response to the COVID-19 crisis, EU Ministers were clear that the balance between crisis-related actions and long-term public health objectives needs to be ensured.

Several countries representatives mentioned it is essential to ensure better sharing of data on cross-border health threats and to ensure availability and affordability of medicines, medical devices, and personal protective equipment (PPE). As the outbreak has highlighted the need for an autonomous supply of critical goods, Ministers pointed out the need to work towards achieving health sovereignty of the EU.

Further digitalisation of health systems to improve primary care and hospital capacities were identified as another important priority of the programme. The issues of interoperability, cybersecurity, and development of artificial intelligence (AI) in the field of prevention and diagnosis and patient follow up were pointed out as essential.

The Avicenna Alliance is pleased to notice that EU Member States are inclined to use this new health programme as a tool to foster the digitalisation of healthcare systems in Europe.

Scientific and regulatory news

                The European Commission, EMA and FDA  2020 bilateral regulatory dialogue meeting

Senior Officials from the European Commission (DG SANTE), European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June. During this virtual two-day meeting, the regulatory authorities reviewed their ongoing joint initiatives, discussed strategic priorities for the coming years and identified collaboration to be further strengthened in medical products areas, including issues related to COVID-19. 

The European Commission (DG SANTE), EMA and FDA have discussed five main topics, in particular:

  1. Sharing of experience and common challenges to facilitate the development, review and availability of COVID-19 vaccines;
  2. Opportunities for cooperation on individualised/bespoke therapies for ultrarare diseases (e.g. gene therapies (advanced therapies/ATMPs); oligonucleotides) to jointly address their scientific and regulatory challenges;
  3. The development of a roadmap for international collaboration in the field of real world evidence (RWE) use to support regulatory decisions in the fight against COVID-19;
  4. The expansion of the Mutual recognition agreement (MRA) of good manufacturing practice (GMP) to include veterinary medicines, vaccines and plasma-derived products by July 2022.;
  5. Cooperation and information sharing on orphan and paediatric medicines, especially in the area of data analysis for the characterisation of rare diseases.

Given the medical emergency presented by COVID-19 and the importance of international cooperation to deal with this global pandemic, the topic figured prominently on the agenda of the bilateral meeting. Against this backdrop, cooperation between regulatory bodies across the Atlantic has been strengthened to ease the exchange of best practices and prepare the ground for joint actions on COVID-19.

Funding opportunities

                       The IMI launched the last calls for proposals under the IMI2 programme

On 23 June, the Innovative Medicines Initiative (IMI) launched the last Calls for Proposals under the IMI2 programme. The submission deadline (for full proposals for IMI2 - Call 22, and short proposals for IMI2 - Call 23) is 29 September 2020.

The IMI2 – Call 22 is a single-stage Call for Proposals designed to support research activities that will build on, and add value to, results from certain ongoing IMI2 projects. The goal is to provide additional support to certain existing projects to allow them to build on their achievements and maximise the impacts of their work.

The IMI2 – Call 23 is a standard, two-stage Call for proposals covering the following topics:

  • Returning clinical trial data to participants: To study participants within a GDPR compliant and approved framework.
  • Antimicrobial resistance (AMR): Modelling the impact of monoclonal antibodies and vaccines on the reduction of AMR. This topic is part of IMI’s AMR Accelerator programme.
  • Neurodegenerative disease: A platform to advance neurodegenerative disease biomarker research, for accelerating discovery and validation to support therapeutics development for neurodegenerative diseases.
  • Tacking cancer through artificial intelligence (AI): To select the most advanced and optimal treatment for patients with solid tumours in Europe through AI.
  • Rare diseases (RD) diagnosis: Shortening the path to RD diagnosis by using new-born genetic screening and digital technologies.
  • Patient adherence: Understanding patient adherence to treatment based on behavioural model of factors affecting it.

This is a great opportunity for Members of the Avicenna Alliance, especially academics and SMEs who are active in the pharmaceutical sector to participate in the last calls for proposals under the IMI2 programme!

Events and webinars

            Webinar reflection on the GDPR, with participation the of the European Commission 

On 18 June, the Forum Europe  hosted an  event on “GDPR: 2 years on, What has been achieved? What challenges remain”.

The event was held on the occasion of the second-year anniversary of the General Data Protection Regulation (GDPR), and invited stakeholders to reflect on its implementation. They discussed a number of aspects of relevance which include the matter of GDPR during the COVID-19 pandemic, the issue of consent and the relationship between e-Privacy and GDPR:

  • GDPR in the context of the current pandemic. GDPR has become more relevant in the COVID-19 context, as digital solutions play a key role in the management of the pandemic, particularly when it comes to ensuring the trust of the public. For instance, the question of contact tracing apps was discussed.
  • Consent – accountability, transparency, and trust. It was mentioned that while GDPR protects the users, its content is not always clear to the general public. It was highlighted that there was a need for user empowerment and consent-centric online services and that access to easy and free services in exchange of personal data is not in itself a negative thing provided there is transparency, user knowledge, and clear consent.
  • E-privacy vs GDPR. Although the event was mostly focused on GDPR, there were discussions of the ePrivacy Regulation, highlighting the interaction and overlap of the two legislative files. It was said that users struggle to understand the links between these two files and Ms Saastamoinen mentioned that the Commission should play a role in clarifying their relationship.

Throughout the event, Ms Saastamoinen emphasised that the Commission’s upcoming evaluation of the GDPR will aim to determine whether the GDPR is fit for purpose, but it is too soon to determine whether the file will need to be reopened. This statement indicates that the Commission is not looking to introduce concrete changes to the regulation itself but focus on ironing out the issues that have been afflicting it since it entered into force two years ago.
For more information, a recording of the event is available here, and you can follow the twitter discussion here.

                                       Join the MaSCBIO Science Days 2020 in July 2020

The Maastricht Centre for Systems Biology (MCSBio) from Maastricht University is organising from Monday July 6 to Friday July 10 from 15.00-17.00 CET, the MaSCBIO Science Days 2020!

This annual event will take place under 5 online sessions and is a nice opportunity for students, scientists, and policy makers interested in systems biology and bioinformatics to discuss the great science conducted in this area.
The theme of  this year’s meeting is: Celebrating five years of MaCSBio: Looking back, looking forward.
The event program contains:

  1. An introduction to what Systems Biology actually is;
  2. Master’s students thesis presentations ;
  3. Two great keynotes ;
  4. Engaging workshops ;
  5. and talks from MaCSBio PhD alumni.

To read the full program and to know more about the event speakers please have a look here. Registrations are open here until 5 July!
Please feel free to spread this invitation to researchers in your organisation/company and people in your network who might be interested in this event.
This is a great opportunity for Avicenna Members who are interested as well as active in systems biology and bioinformatics!

                                                    Registration to VPH2020 Conference

From 24 to 28 August 2020, the 2020 edition of the VPH Conference series entitled “Virtual Physiological Human: when models, methods and experiments meet the clinic” will take place virtually!

This edition will be held online (in the context of the COVID-19 pandemic), with a special day on modeling and simulations for COVID-related applications on August 24th, followed by satellite workshops on August 25th, before the conference per se on August 26th - 28th 2020. The whole program has been revised to accommodate interactive participation from various time zones, and all the oral sessions will also be recorded and accessible in replay mode (for registered participants).
The registration platform is now open! Please follow this link to register.
The registration fees are as follows (online participation only):

  • Regular: 90€ / students 50€
  • VPH Institute members: 45€ / students 30€

Note that the VPH2020 registration process allows you to become a member of the VPH Institute at a discounted rate!

Must read paper as recommendation

               HLG Report: Supporting the Transformative Impact of RIs on European Research 

On 25 June, the European Commission published the final report of the High-Level Expert Group to Assess the Progress of ESFRI and Other World Class Research Infrastructures Towards Implementation and Long-Term Sustainability.

This report by an independent group of experts carries out a thorough assessment of EU support to the preparatory phase and implementation of pan-European Research Infrastructures, looking at the evolution of funding instruments and formulating recommendations for ensuring the long-term sustainability of the European Research Infrastructure system.

The report also includes assessments of 43 individual Research Infrastructures on their progress towards implementation and long-term sustainability from the lifecycle perspective.
To read the full report, please click here.

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