October 2019

Avicenna Monthly Newsletter 

Key highlights

  • The Avicenna Alliance welcomes its newest member, the Belfast-based Exploristics!
  • EFPIA publishes online content calling for a High Level Forum on Access to Health Innovation, as well as the need for cross-border access to clinical trial
  • Hearings for the Commissioner-designates. including those for Health, Stella Kyriakides, and Innovation and Youth, Mariya Gabriel, took place in the European Parliament highlighting the priorities for the next European Commission
  • The European Commission continues to promote the InSilc project, an in silico trials platform for the development of drug-eluting BVS.

Policy Updates

Chair of Horizon Europe cancer mission board steps down

Image result for harald zur hausenOn 8 October, Professor Harald zur Hausen, Nobel Laureate in Medicine resigned as Chair of the Horizon Europe Mission Board for Cancer. He expressed his regrets of having to relinquish his post and stated it was for personal reasons.
Consequently, the European Commission announced appointed Professor Walter Ricciardi as the new chair of the Cancer Mission board. He is a Professor of Hygiene and Public Health at the Università Cattolica del Sacro Cuore in Rome.
Dr Bettina Ryll, Founder of the Melanoma Patient Network Europe, was also appointed as a new Member of the Cancer Mission Board to maintain the number of Board Members up to 15 persons. She is the Founder of the Melanoma Patient Network Europe and becomes the second patient representative joining the Cancer Mission Board after the nomination of Ms Anne Lise Ryel from The Norwegian Cancer Society on 30 July.
The Members of the Cancer Mission Board are currently preparing a list of recommendations containing the future identified priorities of the Horizon Europe Programme and the identified regulatory challenges that should be tackled on Cancer. This document is expected to be presented to the Commission and published in the first quarter of 2020.

Hearings of the Commissioner-designates

During the two first weeks of October, the candidates for posts as European Commissioners, at the top of the European Union’s executive faced three-hour public hearings in the European Parliament. During this hearings, each of the nominees proposed by their national governments, were seeking to acquire a portfolio crafted by President-elect, Ursula von der Leyen, and faced questions on their suitability for a post in the Commission in general, as well as on their specific competence for the portfolio allocated to them.
Main Highlights of Stella Kyriakides - Health Commissioner-designate
1. Ms Kyriakides’ priorities are cancer, access to medicines, food safety, mental health, digitalisation, tackling antimicrobial resistance (AMR) and hazardous chemicals, and animal and plant wellbeing.

2. The Commission will endorse a ‘One Health approach’ to consider health in all policies, e.g. European Green Deal.

3. In five years’ time, Ms Kyriakides’ hopes to reduce cancer through the Beating Cancer Plan and to allow access to healthcare for all EU citizens through increased European cooperation via the Health Technology Assessment (HTA) network.

4.No reference was made to the future Multiannual Financial Framework, e.g. specific figures for how much should be spent on particular areas of research or improving access to healthcare.

Main Highlights of Mariya Gabriel - Innovation and Youth Commissioner-designate

Image result for mariya gabriel1.  Ms Gabriel’s priorities are research funding, AI, promotion of SMEs, regional development, international partnerships and the Horizon European budget.

2. The Commission will establish a new European Innovation Council as part of Horizon Europe, the ambitious €100 billion research and innovation programme to succeed Horizon 2020.

3. Ms Gabriel intends to bridge the gap in research and innovation between Western Europe and Central and Eastern Europe via extra funding, in addition to collaborating with every Member State via the launch of a comprehensive information campaign.

4. Ms Gabriel will collaborate with other Commissioners, particularly those with the portfolios of ‘A Europe fit for the Digital Age’, ‘The European Green Deal’ as well as ‘The Internal Market’

New European Commission will take office on 1 December, at the earliest

The new start date of the next European Commission has provisionally been set for 1 December, instead of the expected 1 November, according to Jaume Duch Guillot. the European Parliament’s spokesperson.
This is because the list of nominations for commissioner-designates is not yet complete. President-elect Ursula von der Leyen this week formally nominated France’s Thierry Breton and Hungary’s Olivér Várhelyi as members of her College of Commissioners, but she has yet to accept a candidate from Romania, where the government collapsed two weeks ago.
This could mean further delays for the incoming Commission. The European Parliament will have to finalise all hearings on the new candidates in order to allow a final vote on the new Commission at the end of November. If that timetable can’t be held, von der Leyen’s entry into office will most likely be delayed to January.


EURACTIV Interview on Animal testing

On 25 October, an interview between Euractiv and Dr. Julia Fentem, the head of Unilever’s Safety and Environmental Assurance Centre (SEAC),  was published in Euractiv’s special report on “Alternatives on animal testing”.  In this interview, Ms. Fentem calls the European Chemical Agency (ECHA) and the European Commission’s Joint Research Centre to play an increased role in meeting the requests of EU citizens and industry in order to minimise mandatory animal testing in Europe. Funding shall hereby be eliminated for all mammalian studies and accumulated to fund advanced research on new approach methodologies (NAMs) as previously seen in the USA.  

The interview aims to promote the development of a legislative framework for the 3R approach by relevant EU stakeholders. It also calls EU policy makers to restructure the funding of mammalian studies to research that focuses on NAMs.  

Moreover, the interview has been published in the context were the missions and funds included within the European Union’s Horizon Europe are defined and a new European Commission constituted. As such, the stakeholder events indicated below shall be used as a platform to build alliances and increase awareness on alternatives to animal testing.  

EFPIA publishes article entitled "Living with rare diseases: hope for the future, access today

On 22 October, the director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Nathalie Moll published an article entitled “Living with rare disease: hope for the future, access today”. This articles reflects previous research and policy developments in the field of rare diseases. More importantly, the article outlines the position of the European pharmaceutical industry trade association, which calls on policy makers to stick to the European Orphan Medical Products (OMP) Regulation that is currently in place and focus on the access to treatments of rare diseases in national health systems.

Ms. Moll calls on the establishment of a High Level Forum on Access to Health Innovation to create an ideal platform to push the discussions among regulators, health system partners, industry and governments about new treatments of rare diseases.  She also emphasises that the opening of the OMP Regulation is not sufficient to address the lack of access to new treatments for rare diseases as the regulation has been proven to generate innovation. Other policy measures than the OMP addressing the access of treatments of rare diseases into national health systems need to be carefully chosen as the OMP does not address the given access challenges sufficiently. 

New EFPIA blog entry dealing with the need for cross-border access to clinical trials.

On 10 October, Ingrid Klingmann, Chairman of the European Forum for Good Clinical Practice (EFGCP),  published a guest blog entry on the website of the European Federation of Pharmaceutical Industries and Associations (EFPIA) entitled “How big is the need for cross-border access to clinical trials?”. Within the entry, the author advocates for the development of a guideline on best practices to cross-border access to clinical trials, which is endorsed by the research consortium that was established by EFPIA in the context of the revision of the cross-border health directive.
In the context of cross-border clinical trials, the guideline on best practises shall:

  1. encourage member states to support neighbouring country healthcare solutions;
  2. add the topic on the stage of European Research Networks;
  3. define the needs for clarifying the patient liability insurance conditions;
  4. define recommendations on social security and healthcare conditions; as well as
  5. clarify the role of patients’ home country treating physician.

In regard of the establishment of the new Commission as well as the development of policy priorities for the next five years, the claim for the development of a guideline on best practices to cross-border access to clinical trials by relevant stakeholders in the field of research and healthcare is intended to put the topic on the agenda of relevant EU policymakers.

Scientific and Regulatory News
Commission guidelines on Good Clinical Practice specific to ATMPs
On 10 October the European Commission published some guidelines on Good Clinical Practice specific to Advanced Therapy Medicinal Products – ATMPs (C(2019) 7140 final). The 15-page document lists the Commission’s guidelines on several topics regarding the research and development of ATMPs including clinical trial design, non-clinical studies, quality and safety instructions, traceability, and sample retention.

When it comes to medical devices, the guidelines specify that if an ATMP incorporates a medical device (“combined ATMP” and medical devices that are otherwise an integral part of the investigational ATMP), the Investigators Medicinal Product Dossier (IMPD) should contain:

· information on the characteristics, performance and intended use of the device; and

· information whether the medical device part(s) comply with the relevant general safety and performance requirements provided for under the new Medical Devices Regulation. When this is not the case (e.g. the medical devices used in an investigational combined ATMP are in an investigational phase as well), a justification should be provided as to the suitability of the medical device for the intended use, having due consideration to the relevant general safety and performance requirements.

Where applicable, the cover letter should contain a list of medical devices which are to be investigated in the clinical trial but which are not part of the investigational medicinal product or products, together with a statement as to whether the medical devices are CE-marked for the intended use. In addition, the Protocol should contain summary information on the characteristics, performance, intended use of the device and its regulatory status.

International News
WHO signs MoU with International Generic and Biosimilar Medicines Association

The Director General of the World Health Organisation, Dr. Tedros Adhanom Ghebreyesus and the Chair of the International Generic and Biosimilar Medicines Association, Jim Keon, signed a memorandum of understanding to promote the use of generic and biosimilar medicines on 22 October. With the signing of the agreement, the WHO highlights the increasing role of the pharmaceutical industry to maintain tools that facilitate the registration of biosimilar and generic medicines. The agreement shall minimise the “burden of clinical trials for biosimilars, speeding up registration and increasing access”.
The memorandum of understanding on biosimilar and generic medicines increases the cooperation between the WHO and the pharmaceutical industry focusing on biosimilar and generic medicines. In light of the agreement, the pharmaceutical industry agrees helping the WHO to maintain a tool that facilitates the registration processes of generic and biosimilar medicines. As such, it contributes to the WHO’s overall strategic planning to support the access to biosimilar and generic medicines supporting a more sustainable and cost efficient global medicines coverage.
With the agreement in place, the WHO paves the path to increase the number of clinical trials of biosimilar and generic medicines that ultimately could boost the registration and access of these medicines to the market.
European Connectivity Forum
The European Political Strategy Center (EPSC) of the European Commission has launched the Europa Connectivity Forum. This will be a regularly held conference, bringing together participants from European and regional institutions, national governments, parliaments, business and civil society. Its purpose is to promote connectivity between Europe and other world regions concerning all sectors.
The first edition on 27 September was dedicated to EU-China/Asia Relations and showcased how China has set up a government-to-government ‘connectivity platform’, resulting in China negotiating agreements to conduct projects in European countries. Some Member States have reciprocated this as result, by investing in Chinese factories.
In addition, the EU and China jointly set up a co-investment fund that is providing substantial support for projects in seven European countries.
Funding Opportunities
InSilc project promoted by the European Commission

The European Commission has published an article promoting the EU-funded InSilc project aiming to create an in silico clinical trials platform for designing and developing drug-eluting BVS. The project is funded by the Commission within the Horizon 2020 research and innovation programme.
 Twelve partners from ten different countries, including universities, medical centres, research centres including members of the VPH Institute, and enterprises as Avicenna Members FEops and Boston Scientific, participate in the project, providing the necessary experience to ensure the success of the project in all its stages of development.
InSilc project develops an in silico clinical trial platform for designing, developing and assessing drug-eluting bioresorbable vascular scaffolds (BVS), by building on the comprehensive biological and biomedical knowledge and advanced modelling approaches to simulate their implantation performance in the individual cardiovascular physiology.
The entire article can be found here and the InSilc project website can be found here.
Members News
Welcome to Exploristics!
The Avicenna Secretariat is happy to announce the newest addition to its list of members: Exploristics!
Based in Belfast, Exploristics provide world-class analytics through specialised software products and services to pharmaceutical and life sciences sectors.
Exploristics are the developers of KerusCloud, a cloud-based statistical modelling and simulation software platform that increases the likelihood of success of drug development through better pipeline strategy and improved clinical trial design. Creating virtual patient populations with assumptions obtained from literature or historical data, KerusCloud helps to reduce the length, size and costs of a trial by finding the optimal study design to meet scientific objectives.
Exploristics also offer statistical consultancy services covering strategic decision making, study design and reporting, amongst other analytical and quality related services.
Please find more about our newest member on their website here.
Join In Silico World!
Avicenna Alliance Board Member, Professor Marco Viceconti has created a Community of Practice, hosted on the Slack platform, called “In Silico World”.

This Community of Practice on in silico has been established with the aim to collaboratively develop and share best practices in In Silico Trials. The goal with be to tackle the lack of established industrial best practices around the use of modelling and simulation, especially within the regulatory process, and to foster the adoption of in silico medicine technologies.

The Avicenna Secretariat would like to encourage Members who have an interest in the topic of In Silico trials and that are committed to gaining knowledge, to join the 'In Silico World’ platform on Slack and to contribute to the achievement of shared goals.

If you are interested in joining the “In Silico World” platform, please send an email to Roberta De Michele: roberta.demichele2@unibo.it

Avicenna Alliance has a LinkedIn page

Following the successful launch of Slack, the Alliance’s new online instant messaging platform, we are happy to announce that Avicenna now has its own LinkedIn page.
We encourage you all to start using this page to promote the work of the Avicenna Alliance. Similarly to our Twitter account, please feel free to tag this page in any of your interactions on LinkedIn, where you can also share your news, reports and successes in relation to our work. 
Events and Webinars

EU Conference on Modelling for Policy support in Brussels

The Joint Research Centre of the European Commission is organising a EU conference on modelling for policy support entitled  “Modelling for Policy support: Experiences, challenges and the way ahead” that will take place on 26 and 27 November in Brussels.

We believe that this event is of particular interest for Avicenna Members based in Belgium as the event will bring together stakeholders involved in modelling activities.
The main aim of the conference is to address common challenges and solutions concerning the use of models to support policy making. The conference will be a platform to get in touch with relevant stakeholders in the field to share expertise as well as best practices. Moreover, this event is a good hook to share the Avicenna Alliance’s position and vision with actors in the field including representatives of the European Commission.
Should you be interested in participating in this event, the registration is open until 15 November here. The preliminary programme for the day, can be found here.
Event - Strategies for innovation in life sciences

On 3 December, ‘Strategies for innovation in Life Sciences’ will be an event hosted by the Eurogroup for Animals and the Finnish Presidency of the EU Council”. It will consist of an exhibition and roundtable discussion and will be hosted by Finnish MEP and former chair of the Animal Welfare Intergroup, Sirpa Pietikäinen. Liesbet Geris, Avicenna Working Group Leader, will attend as well as the Avicenna Secretariat.
The discussions will focus on how scientists and institutions can find ways to develop and promote non-animal testing methods, in addition to organ-on-chip technologies. It will include presentations from the EC’s Directorate-General for Research and Innovation and from the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM).
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