April 2020

Avicenna Monthly Newsletter 

Key highlights

  • The Avicenna Alliance published new Members’ Case Studies on in silico medicine;
  • The EMA puts forward key recommendations on modelling and simulations in its new Regulatory Science Strategy to 2025;
  • The European Commission's updated 2020 Work Programme was leaked;
  • Postponing of the date of application of the European Medical Devices Regulation.
News from Members
The Avicenna Alliance published new case studies on insilico medicine
The Avicenna Alliance is proud to announce that new Member’s case studies on in silico medicine have been published on the Avicenna website!
Computer modelling and simulation (CM&S) plays a key role in improving healthcare systems worldwide. Treatment efficacy and patient safety are the cornerstones of the work performed by our Members.

These Avicenna Member’s case studies are essential as they provide concrete examples of what can be done with CM&S in healthcare. The goal of the Alliance is to shed light on the potential that has yet to be unleashed by modelling and simulation!
This is a great opportunity for those who are eager to learn more about all the opportunities brought by in silico medicine.

We would like to thank the following Avicenna Members: Johnson & Johnson, Exploristics, Mimesis, Novadiscovery and the Rizzoli Orthopaedic Institute for their very valuable contributions!
Launch of the KerusCloud2 platform
Avicenna Member, Exploristics is pleased to announce the global launch of the next generation of his software, KerusCloud2 !

For over ten years now, Exploristics has been providing a targeted statistical approach to fast track clinical development, increasing study success while reducing risks and costs. Given the impact of COVID-19 on clinical trials worldwide, salvaging disrupted trials and accelerating the development of treatments for unmet clinical need has never seemed more urgent.

Many of Exploristics’ clinical programme support solutions are built around the transformative KerusCloud study simulation platform; the statistical software is able to assess multiple aspects of clinical study design and analysis in parallel so studies can achieve statistically and clinically meaningful outcomes.

Following the platform’s success, Exploristics decided to build a new statistical software with additional functions and characteristics. The powerful new KerusCloud2 offers:
  • Enriched functionality for defining sub-populations with different data characteristics
  • Increased processing power with up to 96 parallel cores for a single simulation
  • A new ability to share projects across organisations
  • An enhanced user experience with simpler flows and an intuitive modern interface
  • Improved interactive graphics facilitating extensive exploration of results and data features
  • Best in class cloud security with multi-factor authentication
To mark the launch, Exploristics will be hosting a series of webinars and workshops discussing the unique benefits offered by KerusCloud2, both in planning new trials and in making the most of available data from disrupted ones.

More details to follow about these late May webinars and workshops!
The 2nd level Master on In Silico Trials has been postponed
In light of the latest developments of the COVID-19 pandemic, the University of Bologna has decided to postpone the timeline of its Professional Master Programme II level in “In Silico Clinical Trials”.

The new key changes are the following:
  • Applications deadline is postponed to 5 October 2020;
  • Registration deadline is set for 9 November 2020;
  • Lecture will start on 4 January 2021.
The International Master on In Silico Trials is a 2nd level master open to students with a master’s degree in engineering, physics, mathematics, or computer science, and it will train up to 30 specialists in In Silico Trials per year starting from the Academic Year 2020-2021.
If you are interested in this academic project, please look at the Master programme here.
For more information regarding the application process and the fees, please visit the page here.
If you have any questions regarding the registration procedures or the academic programme, please write an email at info@insilico.world.
This master programme organised by the University of Bologna is a great opportunity for students interested in in silico clinical trials as it aims at providing new professional figures that will strengthen expertise around in silico technologies!
International School on In Silico Trials goes completely online
The International School on In Silico Trials organised by the University of Bologna, in collaboration with the VPH Institute and the Insigneo Institute, will completely be held through an online platform!

The three-day intensive International School on In Silico Trials specifically targeted for decisions-makers in medical industries, research hospitals, contract research organisations, regulatory agencies and notified bodies will no longer be an in-person event but will take place virtually.

This summer school is still due to take place from 7 to 9 September 2020  and the lectures will be exclusively online!

As the configuration of the International School on In Silico Trials has been changed, the organisers of this summer school decided to reduce participation fee of €1,100 for companies member of the Avicenna Alliance.

Usually companies pay €1500 and not-for profit entities pay €750. The participation fee for VPHi members is of €500.

If you are interested in following intensive lectures on In Silico Trials, please find more information regarding the programme here and the registration here.

The international School on In Silico Trials will offer a systematic, non-technical review of the strengths and weaknesses of in silico trials. This is a great opportunity for interested parties to have a better and deeper understanding of the threats and opportunities that modelling and simulation presents!
Policy Updates
Launch of the European COVID-19 Data Platform
On 20 April the Commission together with EU Member States and several partners, including EMBL’s European Bioinformatics Institute (EMBL-EBI) and research partners such as ELIXIR, launched a European COVID-19 Data Platform to enable the collection and sharing of reference data and specialised datasets to accelerate COVID-19 research.

The launch of the platform, part of the ERAvsCORONA Action Plan, marks another milestone in the EU's efforts to support researchers in Europe and around the world in the fight against the coronavirus outbreak.

The platform will provide an open European and global environment where researchers can store and share datasets, such as DNA sequences, protein structures, data from pre-clinical research and clinical trials, as well as epidemiological data.

The European COVID-19 Data Platform will consist of two connected components:
  • SARS-CoV-2 Data Hubs, which will organise the flow of SARS-CoV-2 outbreak sequence data and provide comprehensive open data sharing for the European and global research communities;
  • COVID-19 Data Portal, which will bring together and continuously update relevant COVID-19 datasets and tools, will host sequence data sharing and will facilitate access to other SARS-CoV-2 resources.
The launch of the European COVID-19 Data Platform is a great opportunity for stakeholders involved in research activities related to COVID-19. This initiative enables them to collaborate with other researchers and upload, access and analyse COVID-19 related reference data!

Please visit the page here for further information regarding the entry processes!
The European Commission's updated 2020 Work Programme was leaked
On 15 April the European Commission’s updated 2020 Work Programme was leaked in the media. The document lists the Commission’s activities that are being maintained, delayed or postponed due to the COVID-19 pandemic.

List of relevant files affected by the reshuffling
  • The follow-up to the White Paper on Artificial Intelligence, including on safety, liability, fundamental rights and data may be postponed to Q1 2021;
  • The Communication on the Future of Research and Innovation and the European Research Area, which was originally planned for 16 June may also be delayed;
  • Europe’s Beating Cancer Plan may also incur delay.
  • The Pharmaceutical Strategy for Europe (Q4 2020) is maintained as the strategy is judged as very pertinent and needs to reflect lessons learnt from COVID-19;
  • The Report on the application of the General Data Protection Regulation (GDPR) is still planned for Q2 2020. This is considered essential and should reflect the COVID-19 crisis;
This new 2020 Work Programme will take over from the original 2020 Work Programme (annexes) published on 29 January.
Key highlights of the EU Health Ministers videoconference of 15 April

On April 15  the EU Health Ministers videoconference  organised by the Croatian Presidency discussed the COVID-19 situation and the measures that have already been taken. They also started exchanging views on the de-escalation of these measures.

Main points discussed during the meeting
  • According to the Croatian Presidency, the main objective of the measures is to minimise infections and the number of deaths. Member States (MS) said they are willing to follow the principle of solidarity. They also agreed that adequate capacities of health systems are crucial and that exit strategies should be rolled out in a coordinated and sustainable manner.
  • Commissioner for Health and Food Safety Stella Kyriakides presented the Guidelines on the optimal and rational supply of medicines. These guidelines aim at avoiding shortages on the EU market during COVID-19 outbreak.
  • MS Health Ministers stated that joint work on therapeutics and research on vaccines is of key importance.
  • MS Health Ministers recalled that information-sharing and cooperation between Member States in the field of health, in particular on surveillance, risk assessment, risk management and countermeasures to COVID-19 are essential. They also agreed that it is necessary to ensure coordination to prevent spill-over and negative effects from one Member State to another when de-escalation of measures is introduced.
Since the start of the COVID-19 pandemic, several steps have been taken by the Croatian Presidency of the Council of the EU in order to coordinate the EU's response. Extraordinary Health Council meetings were held on 13 February and 6 March, and two other videoconferences were held on 7 February and 12 March which centred around tackling the challenges presented by coronavirus crisis.

        The Commission has launched a roadmap on the General Data Protection Regulation (GDPR)

Two years after the entry into application of the General Data Protection Regulation (GDPR), the Commission will be reporting on its application across Member States.

On 1 April, a Roadmap was launched by the Commission and in parallel with a period for stakeholder feedback  until 29 April. During that period, stakeholders were able to share their input with the Commission, which will ultimately feed into the Commission’s report on the GDPR. 
The Commission’s Roadmap explains that the Commission’s Report will look to evaluate the application of the GDPR in particular as regards international transfer of personal data to third countries and the cooperation and consistency mechanisms between national data protection authorities.
The publication of this Roadmap comes as no surprise as the Commission had announced in their 2020 Commission Work Programme –  specifically in the field A New Push for European Democracy – that they would be reviewing GDPR and would work to develop a Commission Report on the application of the General Data Protection Regulation during the second quarter of 2020.

Mauro Ferrari resigned from his position as President of the European Research Council (ERC)

On 7 April 2020, Mauro Ferrari resigned from his position as President of the European Research Council (ERC). This was announced after that on Friday 27 March, all 19 active members of the ERC’s Scientific Council individually and unanimously requested Mauro Ferrari to resign. A statement by the ERC’s Scientific Council was publicly released on 8 April. 

Four main reasons were advanced by the 19 active members of the ERC’s Scientific Council:
  1. A complete lack of appreciation for the raison-d’être of the ERC to support excellent frontier science;
  2. A lack of engagement with the ERC;
  3. Support personal initiatives and promote his own ideas within the Commission without consulting or tapping into the collective knowledge of the Scientific Council;
  4. Extensive work associated with his involvement in multiple external enterprises which proved to be incompatible with the mandate of President of the Scientific Council.
In contrast, Professor Ferrari has stated that the main reason for his resignation is that the Scientific Council did not support his call for the ERC to fund a special initiative focused on the COVID-19 virus. He also referred to strong internal political disagreements and a general disappointment regarding how the EU has handled the COVID-19 crisis.
Scientific and regulatory news
The EMA puts forward key recommendations on modelling and simulations in its new Regulatory Science Strategy to 2025 
On 31 March, the European Medicines Agency (EMA) published its Regulatory Science Strategy to 2025. The new RSS sets out the EMA’s strategic thinking for the advancement of regulatory science over the next five years, incorporating human as well as veterinary medicines.

The overall aim of this document is to identify the actions regulators can take to advance public health and ensure optimal pharmaceutical regulations in the coming years.
To this end, the RSS identifies 5 key goals:
  1. catalysing the integration of science and technology in medicines development;
  2. driving collaborative evidence generation;
  3. advancing patient-centred access to medicines;
  4. addressing emerging health threats and availability/therapeutic challenges;
  5. enabling and leveraging research and innovation in regulatory science;
Under each of the following goals, the EMA lists a set of core recommendations and corresponding supporting actions
It is interesting to see that EMA has issued specific recommendations to optimise the capabilities in modelling, simulation and extrapolation through 7 concrete actions. This is a major development compared to the draft RSS published by the EMA in December 2018 which only underlined 3 actions with regards to the optimisation of capabilities in CM&S!

           Postponing of the date of application of the European Medical Devices Regulation

On 25 March the European Commission announced the intention to postpone the date of application of the MDR for one year due to the COVID-19 emergency and called on the Parliament and Council to adopt this quickly given the initial date of application of 26 May 2020.

Consequently, the European Parliament adopted a Regulation in a plenary session on 16-17 April, and the Council on 22 April which entered into force on the same day. This Regulation postpones the entry into force by one year of the Regulation of the Medical Devices Regulation (MDR). 

As such, the date of application of the MDR has been postponed to 26 May 2021, and other related provisions (e.g. Commission’s notice on Eudamed and the obligation for the Member States to notify the Commission on the rules on penalties for infringement of the MDR) have also been postponed for one year.
The postponement of the date of application of the MDR must be understood as a strategic move initiated by the European Commission as  to let the industry focus on ensuring the supply of medical devices and personal protective equipment in order to tackle the COVID-19 outbreak.

Funding opportunities

The Commission extended deadlines for proposals submission in H2020 Societal Challenge 1:                            Health, demographic change and wellbeing due to the COVID-19 pandemic  

On 2 April the Commission extended deadlines for proposals submission in H2020 Societal Challenge 1: Health, demographic change and wellbeing due to the COVID-19 pandemic. The submission deadline for proposals for several calls and topics is postponed from 22 April 2020 to 18 June 2020. 

In its Work Programme 2018-2020, under the topic health, demographic change and wellbeing,  Horizon2020 offers one relevant grant under the Call SC1-DTH-2018-2020: Accelerating the uptake of computer simulations for testing medicines and medical devices.

Main objectives of the Call SC1-DTH-2018-2020

  • The specific challenge of this call is accelerating the uptake of individualised computer simulations in the regulatory evaluation of medicines and/or medical devices to become closer to the market ;
  • The proposed computer modelling solutions will be the result of a multidisciplinary effort and should also explore and inform of the reasons for failure should the drug or medical device be found not efficient or safe and will suggest improvements ;
  • The proposal should provide appropriate indicators to measure its progress and specific impact in areas such as patient safety, clinical trials and testing.

We invite VPH members who are interested in this opportunity to first see if they meet the eligibility and admissibility conditions described in Annex B and Annex C of the Work Programme. To start the submission process please follow the instructions here.
The access to this grant is a great opportunity for researchers as it would provide them with new additional resources to accelerate the uptake of computer simulations for testing medicines and medical devices!

Events and webinars

                     Pan-European Hackathon to develop innovative solutions for COVID-19

On 24, 25 and 26 April, the European Commission and EU Member States have organised a  pan-European Hackathon “EUvsVirus” to connect civil society, innovators, partners and investors across Europe to develop solutions to COVID-19 related challenges. 
The Hackathon is a sprint-like event for computer programmes and subject-experts to collaborate intensively and develop solutions to solve covid-19 related challenges. The initiative was structured around 6 categories of challenges, including health that need short-term solutions in relation to COVID-19.
The #EUvsVirus Hackathon  took place on 24, 25 and 26 April and over 20,900 participants joined this initiative led by the European Innovation Council. Over 2,150 solutions were submitted in areas including health and life (898). Germany (389), Italy (320) and Spain (315) submitted the highest number of solutions, which range from a ‘modular micro factory’ to a ‘natural language processing system for medical reporting’.
The event, which involved over 380 volunteers, 2,400 mentors and over 800 partners, brought together people of 141 different nationalities, as well as different areas of expertise and backgrounds. 
‘Winning’ solutions in each challenge area will be announced on Thursday 29 April at 11:00 (CET) during an #EUvsVirus online award ceremony aired here. Winners will be invited to join a European Innovation Council COVID Platform, which will be launched on 30 April to facilitate connections with end users, such as hospitals, and provide access to investors, foundations and other funding opportunities from across the EU.
This initiative was a great opportunity for Avicenna Members based in the Europe, to discuss with the European policymakers, stakeholders and Member States representatives software applications and solutions to tackle the COVID-19 crisis.

Must read paper as recommendation

     The European Parliament Think Tank released a briefing on EU imports and exports                                                        of medical equipment in the context of the COVID-19

On 21 April the European Parliament Think Tank released a briefing on EU imports and exports of medical equipment in the context of the COVID-19 outbreak. This briefing is highly relevant as it gives us details on the EU trade flows in medical products as well as on the new EU restrictions on exports of medical products.

Main points of the briefing

EU trade flows in medical products before the COVID-19 outbreak

  • In 2019, the total EU trade (imports plus exports) in medical products represented 9.3 % of total EU trade. The EU is a net exporter in all four categories of medical products (medical equipment, medicinal supplies, personal protection and pharmaceuticals), with net exports totalling €123 billion (0.9 % of EU gross domestic product – GDP). Total exports of medical products amounted to €251 billion (11.8 % of EU merchandise exports). In 2019, total imports of medical products amounted to €128 billion (6.6 % of EU merchandise imports).
  • EU imports of medical products are highly concentrated. In each product category as few as five countries provide at least 72 % of EU imports. In addition, just four countries, namely Switzerland, the US, the UK, and China, provide between 65 % (medical equipment) and 76 % (pharmaceuticals) of EU imports.
  • Exports are more dispersed and although the four countries just mentioned are significant export destinations, Russia ranks among the EU's five largest export destinations in all four categories.
Decisions taken by the EU to address third country’s restrictions on exports of medical products
  • With the COVID-19 outbreak, many third countries have implemented either de facto or legal restrictions on exports of medical products ;
  • On 15 March, the European Commission itself introduced Implementing Regulation (2020/402) on authorisation requirements for exports of personal protective equipment outside the European Union (EU). It came into effect on 21 March. The Regulation targets protective equipment in particular, namely protective spectacles and visors, face shields, mouth–nose-protection equipment, and gloves. The implementing Regulation 2020/402 was legally binding until 26 April 2020;
  • Implementing Regulation 2020/402 excludes the UK from any export restrictions since EU law is still applicable (with some exceptions) to the UK during the transition period. Furthermore, amending Implementing Regulation 2020/426 excludes member countries of the European Free Trade Association (EFTA) from export restrictions, as well as the Faroe Islands ;
  • In response to the shortage of medical products, EU Member States have been taking emergency initiatives in collaboration with the EU to produce and distribute medical products, especially personal protection and artificial respiratory equipment, as existing producers have been unable to meet the skyrocketing worldwide demand.

If you wish to read more about this briefing please have a look here!

   JRC technician engineers a 3D-printed valve for emergency ventilator masks

Due to the Covid-19, most of the European Commission’s Joint Research Centre (JRC) laboratories are closed and the scientists are working from home. More precisely, JRC researchers are working on many aspects linked to the Covid-19 crisis. At the JRC’s technical and support services, they were able to help the local communities and health services in any possible way.

With this background, technician engineers used a 3D-printer to produce valves for emergency ventilator masks for use at a local Italian hospital. The valves can be used in the emergency ventilator masks, which were developed by the Italian company Isinnova by converting snorkelling masks.

The JRC’s technical workshop is also exploring methods for testing the quality and air tightness of other valves that are being offered to healthcare institutions.

Various services of the JRC have made spontaneous efforts to support the local services.
If you wish to read more about this news please have a look here!

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