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January 2020

Avicenna Monthly Newsletter 

Key highlights

  • Avicenna membership reaches 20 in Q1 2020;
  • Avicenna Alliance nominated as a member of the European Commission's "eHealth Stakeholder Group"
    The European Commission publishes its Work Programme for 2020;
  • Key highlights of the draft version of the White Paper of the European Commission on Artificial Intelligence;
  • Australian Minister answers letter sent by the Avicenna Alliance
Welcome to new Avicenna Members!
The Avicenna Alliance is proud to announce the newest additions to its list of members:
 
Digital Orthopaedics
Currently, orthopedic surgeons and doctors have no reliable approach to analyze foot and ankle pathologies and evaluate the chances of success of treatment options.


Digital Orthopaedics’ platform 3DOXpert dramatically transforms and improves patient treatment and outcome thanks to a series of services.
3DOXpert is the ideal companion for specialists who are less familiar with foot and ankle interventions. It will guide them towards the best results thanks to simulation, digital twin technology and artificial intelligence.
 
Find out more about Digital Orthopaedics…


 
Mediolanum Cardio Research (MCR) Srl

Mediolanum Cardio Research (MCR) Srl is an independent Contract Research Organisation (CRO) established in Milano (Italy) since 2002 MCR have gained extensive experience in regulatory authorizations and reporting, project management, monitoring, data management and statistics for sponsored and no-profit clinical trials both pharmacological and Medical Devices.
 
MCR has also internally developed an electronic CRF (called IDAS), compliant with FDA 21 CFR part 11 and GDPR. In addition, MCR has an internal Core-lab specialised in QCA readings.
 
MCR is proud to be partner of the Horizon 2020 InSilc project (In-silico trials for drug-eluting BVS design, development and evaluation. Project 777119). One of MCR tasks is to identify and elaborate on the regulatory aspects which have to be fulfilled in order to have in silico trials accepted as part of the clinical assessment of new coronary stents. The adoption of modelling and simulations entails ethical issues and methodological constraints: being member of the Avicenna Alliance could provide an exceptional opportunity to gain and to provide contribution to the development of guidelines for a proper adoption of in-silico clinical trials.     
 
Find out more about Mediolanum Cardio Research…


 
Dassault Systèmes

Dassault Systèmes is a global leader in sustainability. Our purpose is to provide business and people with 3DEXPERIENCE universes where they can imagine sustainable innovations capable of harmonizing product, nature, and life. 

The Dassault Systèmes 3DEXPERIENCE Platform is the first end-to-end scientific and business platform, connecting the dots between people, ideas and data; combining modeling, simulation, data science, artificial intelligence and collaboration in the virtual world to achieve sustainable innovation for life sciences companies catalyzing the next generation of patient-inclusive therapeutics

Find out more about Dassault Systèmes…
Policy Updates

The Programme of the Croatian Presidency of the Council of the EU

From 1 January 2020 to 30 June 2020, Croatia will hold the Presidency of the Council of the EU. The core objectives of the Croatian Presidency of the Council of the EU, which gathered the European head of State or Governments,are further detailed in a specific programme.
 
The priorities presented in the programme of the Croatian Presidency are driven by the motto “A strong Europe in a world of challenges” and are based on four main priority pillars:

  1. A Europe that develops - Balanced and sustained development of the Union and its Member States;
  2. A Europe that connects - Networked economy and used potentials;
  3. A Europe that protects - A safer Union and its citizens;
  4. An influential Europe - Global leader and strong partner to neighbours.
 
With regards to public health, the Croatian Presidency will focus on:
  • Promoting cooperation amongst Member States on organ donation and transplantation following the “Croatian model”;
  • Enhancing lifelong healthcare to face the burden of ageing population and the increased prevalence of chronic non-communicable diseases;
  • Continuing working on an agreement for the Regulation on health technology assessment.

The Spanish government creates a State Secretariat for Digitalisation and AI

The Spanish government created a State Secretariat for Digitalisation and Artificial Intelligence (AI), within the Ministry of Economic Affairs and Digital transformation.

During the first Cabinet meeting that took place on 14 January, the Ministerial departments were restructured. For the coalition government, Nadia Calviño was appointed as the new Minister of Economic Affairs and Digital transformation. For the first time, this Minister will include a Secretariat for Digitalisation and AI. The new State Secretariat will oversee the proposal and execution of the Government's policy for digital transformation and the development and promotion of AI.

By adopting this new structure, the new Spanish government aims to develop concrete actions for a better implementation of digital services and AI at a national level. Specifically, in the healthcare sector, it is expected that Nadia Calviño will address, together with the new appointed Health Minister, Salvador Illa, the current digital policy challenges of the National Health System. The new State Secretariat for Digitalisation and Artificial Intelligence will be key in planning new policies affecting also digitalisation of healthcare.

Draft version of the European Commission’s white paper on AI

On 16 January 2020, a draft version of the white paper of the European Commission on artificial intelligence has been leaked: Structure for the White paper on artificial intelligence – a European approach. The draft version of the white paper focuses on the existing and future comprehensive legislative framework for artificial intelligence and the access to data and specific policy actions in support of the development of artificial intelligence in Europe.
 
Several measures are put forward by the European Commission to solve key issues related to the policy and legislative framework:

 

  1. Limitations of scope as regards fundamental rights;
  2. Limitations of scope with respect to products. Services based on artificial intelligence (e.g. health services) are not taken into account in the EU product safety legislation;
  3. Uncertainty as regards the division of responsibilities between different economic operators in the supply chain;
  4. Changing nature of products. The integration of software into products can modify the functioning of products during their lifecycle;
  5. Emergence of new risks (cyber threats, personal safety risks, etc);
  6. Difficulties linked to enforcement;

 
The leak of the Commission’s draft white paper follows a period of public discussion on how to deal with the future challenges of Artificial Intelligence. The Commission draft white paper on artificial intelligence is in line with the willingness of EU Member States to tackle the EU industries backlog in the field.
 
However, the paper outlines a quite severe and hard approach regarding the use of AI in the public sector and foresees the establishment of high AI standards when it comes to transparency and accountability. This is not surprising following the careful approach the Commission took when first looking into ethical aspects of AI as well its approach to build trust in a human-centric AI.
 
Different objectives will be implemented through regulatory proposals and policy actions during the mandate of the European Commission.

Draft version of the European Commission’s white paper on AI
 

On 16 January 2020, a draft version of the white paper of the European Commission on artificial intelligence has been leaked: Structure for the White paper on artificial intelligence – a European approach. The draft version of the white paper focuses on the existing and future comprehensive legislative framework for artificial intelligence and the access to data and specific policy actions in support of the development of artificial intelligence in Europe.
 
Several measures are put forward by the European Commission to solve key issues related to the policy and legislative framework:

  1. Limitations of scope as regards fundamental rights;
  2. Limitations of scope with respect to products. Services based on artificial intelligence (e.g. health services) are not taken into account in the EU product safety legislation;
  3. Uncertainty as regards the division of responsibilities between different economic operators in the supply chain;
  4. Changing nature of products. The integration of software into products can modify the functioning of products during their lifecycle;
  5. Emergence of new risks (cyber threats, personal safety risks, etc);
  6. Difficulties linked to enforcement;

 
The leak of the Commission’s draft white paper follows a period of public discussion on how to deal with the future challenges of Artificial Intelligence. The Commission draft white paper on artificial intelligence is in line with the willingness of EU Member States to tackle the EU industries backlog in the field.
 
However, the paper outlines a quite severe and hard approach regarding the use of AI in the public sector and foresees the establishment of high AI standards when it comes to transparency and accountability. This is not surprising following the careful approach the Commission took when first looking into ethical aspects of AI as well its approach to build trust in a human-centric AI.
 
Different objectives will be implemented through regulatory proposals and policy actions during the mandate of the European Commission.

Advocacy
The Avicenna Alliance nominated as a member of the European Commission's "eHealth Stakeholder Group"
 
On 3 February, Thierry Marchal, Secretary-General of the Avicenna Alliance has been informed that the Alliance has been nominated as a member of eHealth Stakeholder Group which provides advice and expertise to the European Commission’s DG for Communication Networks, Content and Technology (DG CNECT).

This marks a big step for the representation and recognition of the Alliance within the health community and by the European Commission! 

From March 2020, Thierry Marchal will be representing the Avicenna Alliance among the stakeholder group with a 3 year mandate. 

The Avicenna Alliance will have an enhance availability to understand the state of play and discuss different initiatives and policy dossiers with the European Commission, and more specifically DG CNECT and SANTE. More importantly, the Alliance will be able to provide the Commission with recommendations to move forward on eHealth in the EU!  

Congratulations to Thierry Marchal for his successful application!

If you wish to learn more about the eHealth Stakeholders Group, please have a look here

Australian Minister answers letter sent by the Avicenna Alliance

The Australian Minister for Industry, Science and Technology, Karin Andrews has answered the letter sent by the Avicenna Alliance with the purpose to exert Ministerial pressure on the regulator group with which the Alliance need to get into contact within Australia to raise the issue of good simulation practices.

Minister Andrews was convinced enough to provide the Avicenna Alliance with key referrals which we were looking for to reach out further to Australian regulators and discuss the need for a global policy framework for computer modelling and simulation (CM&S) in the healthcare sector.

In her letter, Ms Andrews referred us to her colleagues at the Australian Therapeutic Goods Administration (TGA) which are responsible for considering the work of the International Medical Devices Regulators Forum (IMDRF) to assist the global harmonisation and reduced regulatory burden.

Minister Andrews also stressed the need to contact the Australian Government Growth Centre for MTP sector (MTP Connect) as the Centre is working with sector participants across the MTP value chain to identify and address regulatory challenges.

Avicenna Alliance puts forward questions to EU Expert Panel on effective ways of investing in health

On 17 December the European Commission launched a survey inviting stakeholders to put forward questions for the newly appointed Expert Panel on effective ways of investing in health.

The Avicenna Alliance took this opportunity to put forward questions/issues the Alliance Members believe should be further explored and discussed by the EU experts in 2020.

Please have a look at the questions the Avicenna Members believe the European Experts should address in 2020

Scientific and regulatory news

Key conclusions of the workshops on common European data spaces

On 17 December, the European Commission’s DG CONNECT published the reports and conclusions of 10 workshops on ‘common European data spaces’ that took place from July to November 2019 in the EU.

The workshops brought together experts mainly from the private and the public sectors to identify the specific challenges in sectors and the commonalities as regards the conditions for the creation of common European Data spaces, which are digital areas with the scale to enable the development of new products and services based on data.

With regard to the health sector, the most notable consensus is the need to make available anonymised health data would enable data sharing for many purposes, including machine learning and development of innovative data based products and services.

The results of these discussions now support the preparation of the Digital Europe Programme and Connecting Europe Facility 2021-2027 Work Programmes, but also feed into the reflections on future data policy actions of the European Commission.

If you want to have further information regarding the topic, please check the full analysis here.

EDPS has released a preliminary opinion on data protection

On 6 January 2020, the European Data Protection Supervisor (EDPS) has released a preliminary opinion on data protection and scientific research. In its preliminary opinion, EDPS recalls that the risks can be high when it touches upon sensitive data on health. In this backdrop, EDPS advances several recommendations to face challenges regarding the application of GDPR to scientific research:

  1. Data protections authorities should engage more closely with ethical review boards. Independent ethical committees could consider which activities qualify as genuine research;
  2. The development of codes of conduct at EU rather than national level are preferable since it would contribute to harmonization;
  3. The organisation of a debate on the public interest ground for scientific research.

 
The application of GDPR to health data is a controversial subject. Indeed, on 17 December, the European Commission’s DG CONNECT published the reports and conclusions of 10 workshops on “common European data spaces’ that took place from July to November 2019 in the EU. Interestingly, major stakeholders whom reunited in a conference organised by BigMedilytics project, shared the view that the GDRP is a barrier to health data and that a bigger empowerment of patients is needed in this regard. They called on the European Commission to look into the idea of health data donation as this would, according to them, allow a better access to patients health data.

Report on ‘Evolving Data-Driven Regulation’ published by HMA-EMA

On 20 January the joint Big Data Task Force (BDTF) of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), a coordinated regulatory network of EU Member States’ competent authorities, published a report on ‘Evolving Data-Driven Regulation’.  This report aims to support the European medicines regulatory network evolve its approach to data use and evidence generation so that big data can be better used for innovation and public health.

The report makes many recommendations for the European medicines regulatory network, but identified ten of these as priority such as the establishment of an EU framework for data quality and the setting up of a sustainable platform for EU healthcare data.

This report represents Phase II of the BDTF, and builds on Phase I by including prioritisation and practical suggestions. The Phase I report was published in 2019 and reviewed the Big Data landscape while identifying opportunities regarding medicines regulation. Phase II was drafted in parallel to public consultations on Phase I.

Phase II and its practical recommendations will inform decision-making of the HMA and EMA and will contribute to the European medicines regulatory network’s EU Network Strategy 2025. Therefore, these recommendations and practical suggestions can shape the European medicines regulatory network’s work for the upcoming years, and consequently affect EU decision-making on the subject.  

International news

WHO defines the top 13 global health challenges for the new decade  

 The World Health Organisation (WHO) has released a list of 13 urgent global health challenges to be addressed in the upcoming ten years. The list is a call for governments, communities and international agencies.
 
The WHO aims to set as priorities in the global health agenda the main challenges affecting all the population, encouraging countries across the globe to put policies in place so as to ensure public health through equitable and affordable services and with the collaboration of industries, researchers and governments.
 
Interestingly, the WHO is not merely concerned about investment in health system, but also about economic, political and environmental actions.
In this regard, WHO stresses the need to continue to act together across policies and sectors, as challenges are interconnected and do not depend only on health systems to be achieved. The vision of WHO is that effective health actions to address the challenges can only be ensured once effective policies to improve the financial and social barriers affecting health are put into place.
 
With the deadline for the 2030 Sustainable Development Goals approaching, the United Nations Assembly underscored that the next 10 years are the “decade of action”.

 Funding opportunities

IMI's call for proposals for funding in cancer, vaccines, and others

On 21 January, the Innovative Medicines Initiative (IMI) launched a new call for proposals with funding opportunities in the areas of drug resistance in cancer, tuberculosis, vaccines, proton therapy, psoriatic arthritis and drugs based on proteins. This call has a total budget of EUR 273 million.
 
The call for proposals supports research and development in a number of priority areas. Through either (1) financial support or ‘in kind’ support such as researchers’ providing their expertise for a set period of time; or  
(2) by providing access to research facilities or resources.
 
For stakeholders involved in the fields of interest outlined above, this call can prove to be a good opportunity for them to secure additional resources.
 
Additionally, the call for proposal also indicates the EU’s priority areas at a European level.
The Call is in line with the Commission’s priorities in health of beating cancer and will contribute to the Commission’s goals by facilitating collaboration between leading experts from universities, small companies, patient groups and diverse industries.

 Details on how to submit can be found here on the Participant Portal Horizon 2020 Online Manual. Please note that applicants need to have an EU login account and their organisation must be registered as a beneficiary.

  • Stage 1 submissions have opened on 21 January 2020 and close on 21 April 2020.
  • Stage 2 submission deadline if 5 November 2020.
Avicenna Members News
Novadiscovery raises series A financing to scale its in silico clinical trial platform – Debiopharm leads the round with EUR 5 million  

We are proud to announce that Avicenna Member, Novadiscovery, which performs in silico trials for pharma and biotech companies has closed the first 5 million euros of a 7 million euros Series A funding round with Debiopharm.
 
Novadiscovery will use the funding to scale its in silico clinical trial simulation platform Jinkō® in a software as a service (SaaS) model and develop further disease models, enabling its clients to directly conduct their in silico trials, and to develop its presence on the US market, the largest market globally for drug development. While Jinkō® is indication-agnostic, over the past decade it has been notably deployed in immuno-oncology, orphan diseases, metabolic diseases and cardiotherapy.
 
Nova’s  hybrid approach to run in silico clinical trials presents several benefits, one of which being that it can operate in data-poor environments, which is the biggest hurdle more conventional AI approaches are facing. The computer modelling & simulation of drugs, diseases and virtual patients yields high value applications spanning the entire R&D spectrum, from systematic target combination exploration to late-stage trial size reduction through the characterization of optimal responder profiles.  From an ethical point of view, Nova’s approach helps ensure that patients benefit from the most satisfactory therapeutic response and in the best possible time.
 
If you want to have further information, please check the full article here.


CADFEM Medical organises seminar on Simulation in the approval process of medical devices
 
For a broader application of in silico approaches, it is important to learn how they can best be used. The seminar will provide you with the theoretical and practical basics for the application of simulation in conformity assessment and for the technical documentation of medical devices.

The next dates are:
18.02.20, Grafing near Munich, (Germany)
19.05.20, Aaadorf, (Switzerland)
04.11.20, Berlin, (Germany)
Registration here
VPH 2020 Conference -  Abstracts submission deadline 7 February 2020

The VPH2020 conference invites submission of extended abstracts by 7February 2020!

Please note that you need to create an account and login before initiating the submission process.


The VPH conference series offers a platform to present research related to the Virtual Physiological Human and more broadly to Computational Systems Biomedicine, as well as applications in clinical settings, underpinning the move towards predictive personalised medicine.

The 2020 edition is organized by Inria and partners (AP-HP, Ecole Polytechnique, INSA Lyon, Sorbonne Université), and will be held on the Jussieu Campus of Sorbonne Université in Paris, August 26 - 28 2020.

Read more about the VPH 2020 Conference
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Avicenna Alliance news

The Avicenna Alliance co-organises a public workshop at the FDA on good simulation practices in health technologies

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The Avicenna Alliance nominated as a member of the European Commission's "eHealth Stakeholder Group"

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Avicenna Alliance puts forward questions to EU Expert Panel on effective ways of investing in health

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