November 2019

Avicenna Monthly Newsletter 

Key highlights

  • New von der Leyen Commission gets approval from the European Parliament 
  • Nine European governments launched the International Horizon Scanning Initiative to strengthen their power to negotiate medicine prices with the pharmaceutical industry
  • Avicenna Alliance letter to Australian Minister Andrews calling for international support CM&S 
  • Pharma industry publishes recommendations on the optimisation of paediatric orphan medicines development in the EU 
Policy Updates

New European Commission approved by European Parliament

On 27 November the European Parliament has approved the Ursula Von der Leyen’s Commission, receiving 461 votes in favour, 157 against and 89 abstentions. The vote on the new Commission was originally foreseen to take place during the Parliament’s plenary session in Strasbourg on 23 October, but due to the rejections of several Commissioner-designates and the complexity of nominating new candidates, this was delayed to 27 November.

General Analysis

  • This vote concluded a historically difficult process of Commissioner hearings by the European Parliament, which saw the rejection and replacement of a total of three Commissioners-designate: Rovana Plumb from Romania, Laszlo Trocsanyi from Hungary and Sylvie Goulard from France were replaced by respectively Adina-Ioana Vălean, Olivér Várhelyi and Thierry Breton.
  • The lengthy approval process caused the start of the new Commission to be delayed until 1 December.
  • Before the difficulty Von der Leyen encountered during the Commissioners-designates hearings, she had been elected by the European Parliament as President of the Commission in July by a very narrow margin (383 members voted in favour, 327 against, and 22 abstained).
  • The new European Commission consists of 27 members (the United Kingdom did not nominate a candidate).
  • President Ursula von der Leyen placed strong emphasis on the gender balance in her College of Commissioners with 12 Commissioners women and 15 men. During her introductory speech, Von der Leyen also drew attention to the diverse backgrounds of the new Commissioners.
References to health
  • During President Von der Leyen’s speech ahead of the Parliamentary vote, she underlined her dedication to several specific priorities for the next five years.
  • Von Der Leyen argued that the number of cancer cases across Europe are rising and promised that Europe will take the lead in the fight against cancer. She repeated that Stella Kyriakides, Commissioner for Health, will launch an ambitious Europe Beating Cancer Plan in the beginning of 2020.
  • Von der Leyen also mentioned that digitalisation is key to making progress in medicine and that Commissioner Margrethe Vestager will be in charge of this portfolio.
Stella Kyriakides (EPP) - Portfolio: Health
Stella Kyriakides has been a member of the House of Representatives of the Republic of Cyprus since 2006. She has personal experience with cancer, having gone through it herself, and refers to herself as a patient advocate. She was President of the European Breast Cancer Coalition Europa Donna from 2004-2006 and has been President of the National Committee on Cancer Strategy since 2017. She also has professional experience as a clinical psychologist for children and adolescents.

Ms Kyriakides will work under the guidance of the Executive Vice-President for the European Green Deal on issues relating food safety, animal and plant health, and the Vice-President for Protecting our European Way of Life on public health matters.  

The other biggest objective of Ms Kyriakides’ mandate is the preparation of Europe’s Beating Cancer Plan, which is supposed to be a support tool for member states to improve national cancer prevention and care systems.  She will also need to coordinate with the Horizon Europe Mission Board on Cancer in the creation process of the Europe’s Beating Cancer Plan.

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 medicinal, 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”.  

French Health Minister announces ''Health Data Hub''

On 18 November, the French Health Minister Agnès Buzyn announced the official launch of the Health Data Hub in France on 1 December. This project, which has its origins in the Villani report on artificial intelligence (AI) in 2018, will bring together health data from all over France in a centralised data base. It will also collect new administrative data from French health insurance cards and clinical data from hospitals and treatment centres.
The aim of this new Health Data Hub is to facilitate projects of public interest; data will be hosted on a secure platform which will provide project holders with technological and human resources.
The French Government has already selected several projects based on a call for proposals, welcoming a diversity of projects from the public and private sectors, which will use the data to improve epidemiology, personalised treatment information and help evaluate the therapeutic effectiveness of medications in real time.
The project responds to a long-standing need in France. Currently, access to health data in the country is governed by different bodies and systems and is often fragmented. According to the Government, requests for access and matching data sometimes take several years to complete. The Health Data Hub will resolve these problems by creating a single database to ensure that health data in France can be used more effectively and constructively.

Europe’s new supercomputing centres can start building high-performance computers 
On 26 November, the representatives of eight EU supercomputing centres met in Strasbourg to take further steps towards the implementation of the European Joint Undertaking (EuroHPC). Hosting agreements were signed between the representatives, to start the procurement process for the purchase, installation and maintenance of the computers which should start by the end of 2019.
Supercomputers are intended to support science, industry and the public sector in R&D which requires high computing power with the aim to make progress in the fight against climate change and the development of new medicines. They are expected to become operational during the second half of 2020 for European users from academia, industry and the public sector.

Launch of the Horizon Scanning Initiative (IHSI) 

On 29 October, nine European governments launched the International Horizon Scanning Initiative to strengthen their power to negotiate medicine prices with the pharmaceutical industry. The initiative entails the creation of a central transparent database containing information on new medicines and medicines under development, which should inform governments’ decisions on pricing and reimbursement.  

The IHSI is formed by nine European countries including Belgium, the Netherlands, Denmark, Ireland, Luxembourg, Norway, Portugal, Sweden and Switzerland that will share, through a common database, information on the pricing of innovative medicines and medicines under development.

The Members of the IHSI expect that a common database will allow them to better assess the impact of potentially expensive medicines. It will collect data from different source , including clinical studies, scientific literature as well as financial data from companies and investors from the pharmaceutical sector. The development of the database and cross-border knowledge aims at empowering the participating countries in national and international price negotiations with the industry.

The IHSI launch implies the start of a new international partnership between European governments on medicines prices. This initiative reflects the political will to wield bargaining power in price negotiations with the pharmaceutical industry.

The success of the IHSI is contrasting with the lack of endeavour from European Member States, unable to find a common position on the European Regulation on Health Technology Assessment (HTA) presented by the European Commission in January 2018, with the aim to strengthen EU-level cooperation for assessing health technologies including new medicines and certain medical devices.

Avicenna Alliance letter to Australian Minister Andrews

The Avicenna Alliance sent a letter to the Australian Minister for Industry, Science and Technology Karen Andrews MP asking to contribute to international discussions on how to ensure that computer modelling and simulation (CM&S) can help enable the healthcare sector to improve patient safety.
Today the issue is not that rules are too strict or too loose, the problem is there are no rules at all. The Avicenna Alliance is advocating globally for a policy framework that can enable in silico medicine in a manner that can raise safety standards in clinical trials, improve the lives of rare disease patients and reduce costs to researchers.
In previous decades guidance has been provided for Good Manufacturing Practices and Good Distribution Practices. Today, Members of the Avicenna Alliance are in need of “Good Simulation Practices”.
The letter sent by Thierry Marchal, Secretary General of the Avicenna Alliance is enquiring as to whether Minister Andrews would lend her support to raising the issue at the international level so that Good Simulation Practises can help enable the healthcare sector, save taxpayer money and improve patient safety.

 Pharma industry recommendations on the optimisation of paediatric orphan medicines development in the EU 

On 20 November a blog article entitled “Orphan drugs & paediatrics medicines: how to deliver for children with rare diseases”, written by Thomas Kühler (Head Global Regulatory Science & Policy EU/AMEE at Sanofi), that was published on the European Federation of Pharmaceutical Industries and Associations (EFPIA) website.

According to Thomas Kühler, there is an overlap between paediatric medicines development and research on orphan medicines because 75% of rare diseases are known to affect children.

The blog article is based on a scientific article entitled “Orphan Medicines for Pediatric Use: A Focus on the European Union” which describes the challenges that developers of orphan medicines are facing with the paediatric indications, discusses the interplay between the Orphan Regulation and the Paediatric Regulation and provides recommendations on how to optimise paediatric orphan medicines development under the current EU regulatory framework.

The authors list five recommendations on the optimisation of paediatric orphan medicines development:
  1. Increase interaction between PIP development and orphan designations by potential exploration of the paediatric use of existing medicines, where the adult indication is under development (e.g. in paediatric oncology);
  2. Expand the use of more innovative approaches, such as modelling and simulation or extrapolation;
  3. Consider alternatives to randomised controlled studies in small populations e.g. alternative design options, disease registries, digital technology to generate real-world data/real-world evidence, or remote decentralised clinical trials;
  4. Improve the identification and prioritisation of unmet paediatric needs to have a common basis for strategic decision for instance through an inventory of disease-based unmet paediatric medical needs; 
  5. Enhance the integration of regulatory systems, such as scientific tools and methods to generate evidence, and the use of regulatory processes and incentives, as well as optimised international alignment.

Thomas Kühler and pharma industry representatives argue that the implementation of both Regulations can be further improved through changes and collaborative research programmes, in support of the European Medicines Agency and European Commission action plan on paediatrics published in 2018.

Scientific and Regulatory News
Call for Expression of interest for expert panels on medical devices

A Call for Expression of interest for clinical, scientific and technical experts on medical devices and in vitro diagnostic medical devices was published by the European Union on 7 November. This call for expression was an important opportunity for people willing to be involved and advise the European Commission on the implementation of EU regulation on medical devices or in vitro diagnostic devices. The deadline for applications was  24 November.

The European Commission has announced that respective expert panels will cover twelve areas of interest: screening, cardiovascular/lymphatic system, orthopedics, traumatology, rehabilitation, rheumatology, neurology, respiratory, anesthesiology, intensive care, endocrinology and diabetes including insulin delivery systems, general and plastic surgery, dentistry, obstetrics and gynecology including reproductive medicine, gastroenterology and hepatology, nephrology and urology, ophthalmology as well as in vitro diagnostics.

The expert panels of the Joint Research Center are providing non-binding advice to the Member States, the European Commission and Notified Bodies. However, their recommendations may have influence the further evaluation and development of the regulative act. More importantly, Expert panels can be used as instruments to articulate issues occurring in terms of implementation of the Regulations.

Funding Opportunities
Revised version of Orientations towards the first Strategic Plan for Horizon Europe

The European Commission published the revised version of Orientations towards the first Strategic Plan for Horizon Europe.
In its revised orientation paper, the Commission maintains that new key R&I orientations under the health cluster will support activities aiming at :
“New data-driven approaches, computer models and -simulations and other digital solutions are developed, translated and optimised for the prevention, health care and person-centred care, including smart data infrastructures and AI-based data analytics.”
Moreover, among the five co-funded European Partnerships that are proposed for the first four years of Horizon Europe under Cluster Health, we note that the Commission is planning to fund a partnership on ‘Personalised Medicine’ as of 2023.
This revised version is the result of the process of co-design that took place over the summer and autumn 2019 through:    

  • a web-based consultation (open to the whole world) that collected 6,806 answers between 28 June 2019 and 4 October 2019;
  • meetings and exchanges between the Commission’s services and almost 4,000 stakeholders during the European Research and Innovation Days (24-26 September 2019).

A specific report on the web-based consultation and on the European Research and Innovation Days was also published and mentions the following under the section on 'Unlocking the full potential of new tools, technologies and digital solutions for a healthy society':
“In order to reinforce impact, Research and Innovation should cover technologies that blur the lines between the physical, digital, and biological (Hybrid Health Technologies). A stronger use of the personalised medicine approach was advocated, as well as an improved and careful use of health data and attention to cybersecurity issues, modelling (of humans, organs); Social care and support solutions for disabilities, substances of human origin (SoHOs), first in-man clinical trials.”

Events and Webinars
Must read papers as recommendation
Omics data and CM&S providing more insight into Parkinson’s disease

An Integrated Analyses of Microbiome and Longitudinal Metabolome Data which revealed Microbial-Host Interactions on Sulfur Metabolism in Parkinson’s Disease which was published on  12 November and co-written by Ines Thiele, Professor in Systems Biomedicine at the National University of Ireland.

This publication represents a systems medicine approach towards understanding metabolic changes occurring during the progression of Parkinson's disease and the potential role of the human gut microbiota in participating in those changes. Importantly, it demonstrates how different omics data can be used, together with computational modelling, to obtain further insight into a complex disease.
The key results are:

  1. longitudinal trajectory of metabolites associated with the interconversion of methionine and cysteine via cystathionine differed between PD patients and controls;
  2. dopaminergic medication showed strong lipidomic signatures;
  3. taurine-conjugated bile acids correlated with the severity of motor symptoms, while low levels of sulfated taurolithocholate were associated with PD incidence in the general population; and
  4. computational modeling predicted changes in sulfur metabolism, driven by A. muciniphila and B. wadsworthia, which is consistent with the changed metabolome. “
if you wish to read more about this analysis please have a look here.

Advances in the detection of the postoperative progress of abdominal aortic aneurysm  
A study published in Frontiers in Bioengineering and Biotechnology by a team of researchers from BCN MedTech with the VICOMTech Foundation in San Sebastian, the BioDonostia Health Research Institute and Donostia University Hospital, offers a promising methodology for post-operative CTA time-series registration and subsequent aneurysm biomechanical strain analysis, which correlates with the patient’s long-term prognosis.

Please read full press release here
Simulation with 3D reconstructions of conventional bone densitometry offers enhanced discrimination of fracture risk by osteoporosis
According to a study published recently in the advanced edition of the journal Bone whose authors are members of the BCN MedTech research group; the company Galgo Medical, a UPF spin-off, the QUAES-UPF Chair, and the CETIR radiological centre.
Please read full press release here.
New hypotheses on the role of the cartilaginous endplates in intervertebral disk degeneration
Posited by a study published on 19 September in the journal Frontiers in Physiology that led by Jérôme Noailly, with Carlos Ruiz Wills and Miguel A. González Ballester, all members of BCN MedTech, as co-authors, together with researchers at the University of Oulu in Finland.
Please read full press release here.  
A computational model simulates the clinical evolution of Chronic Obstructive Pulmonary Disease
This is the first result of the project INSPIRE, funded by the Spanish Ministry of the Economy and Competitiveness, and aims to create advanced computational models to improve the early detection of COPD. A paper by the SIMBIOsys research group, directed by Miguel Ángel González Ballester, ICREA research professor, in collaboration with the Department of Biomechanics and Mechanobiology at BCN MedTech is published in Frontiers in Physiology.
 Please read full press release here.  
In silico Optimization of Left Atrial Appendage Occluder Implantation Using Interactive and Modeling Tools 
Please read full article here.  
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