The potential of in silico approaches to streamline drug development

This position paper highlights the potential of in silico medicine, using computational modelling and simulation to aid drug discovery, development, and delivery. It calls for adaptation of in silico technology to be a standard practice to complement in vivo and in vitro approaches in healthcare through a collaborative ecosystem of stakeholders. 

The application of in silico methods before animal testing or clinical trials to obtain insights can inform decision making and thus optimise clinical trial design and patient safety. In silico methods have been suggested to complement traditional evidence with digital evidence and therefore to reduce time, cost, and environmental footprint of the regulatory approval process. However, the impact of in silico methods in regulatory decision-making and post-market surveillance remains limited. There is a strong need to develop industrial infrastructure and regulatory framework...

Avicenna_Alliance_Pharmaceutical_Strategy_TF_white_paper_FINAL.pdf (pdf, 2 MB) download

Avicenna Alliance Glossary of Terms for Computer Modeling and Simulation

There are occasional confusions and diverging opinions possibly leading to misunderstanding in the use of some In Silico concepts in the literature. To clarify our message, a team of academic and industry members of the Avicenna Alliance, led by Martha De Cunha Maluf-Burgman from Edwards Lifesciences, is proposing a definition of words regularly used in the ‘In Silico’ literature to clarify the meaning of the terms we are using in our publications.

This Glossary is a first release with a first short list of definitions; more concepts will be defined, and existing definitions may be adjusted in future updates of this document.

Avicenna_Alliance_Glossary_of_Terms_for_Computer_Modeling_and_Simulation.pdf (pdf, 701 KB) download

The Role of Artificial Intelligence within In Silico Medicine

A range of authors across academia and industry, representing both the Avicenna Alliance and the Virtual Physiological Human Institute, have produced a new white paper on the potential of computer modelling and simulation in healthcare, with a particular focus on the role of Artificial Intelligence, that is intended to stimulate policy making, regulatory thinking and research strategies in this exciting space.

The past decade has produced overwhelming evidence about the importance of digital healthcare: well-defined clinical endpoints utilizing novel digital biomarkers can quantify the evolution of individuals’ health status; this approach will lead to predictive and prescriptive capabilities in many cases.  This white paper discusses the potential of #computer modelling and simulation in healthcare, generally referred to as “in silico medicine”, with a particular focus on the role of Artificial Intelligence (AI).    ...

AI_in_health_-_White_Paper.pdf (pdf, 1 MB) download

Toward a Regulatory Pathway for Using In Silico Trials in CE Marking Position Paper

A team of researchers of the In Silico World project, including several key Avicenna Alliance members, led by Prof. Francesco Pappalardo (University of Catania), Avicenna Alliance’ Pharmaceutical Strategy TF Co-Chair, recently published a Position Paper in IEEE Journal of Biomedical and Health Informatics (J-BHI). In Silico Trials (IST) plays a growing role in the development of new medical devices. This position paper reviews the current system for IST and recommends that the EU regulatory system should innovate to avoid more innovative companies to focus on other large markets.

Toward_a_Regulatory_Pathway_for_the_Use_of_in_Silico_Trials_in_The_Ce_Marking_of_Medical_Devices.pdf (pdf, 623 KB) download

Members of the European Parliament call EU Health Commissioner to place in silico medicine on her policy agenda from 2021 onwards!

On 22 June, a group of five Members of the European Parliament (MEPs) sent a letter to Commissioner for Health, Stella Kyriakides to call for action on computer modelling and simulation (CM&S).

The new Avicenna position paper on in silico evidence in the regulatory approval of medical devices is out!

The Avicenna Alliance is proud to announce the recent publication of its new position paper entitled Ensuring the Quality of in silico Evidence: Application to Medical Devices. This document provides a broad explanation of the opportunities and benefits of in silico methods while also drawing attention to the urgent need for a harmonised regulatory approach supporting the acceptance of in silico evidence included in device submissions. The paper then outlines a risk-based framework for establishing the credibility requirements of in silico evidence used during regulatory decision-making.

Avicenna_Alliance_Position_paper_in_silico_evidence_application_to_Medical_Devices.pdf (pdf, 1 MB) download

Page 1 of 4.

Avicenna Alliance news

Welcome to our new member MDsim!

We are delighted to welcome our new member MDsim!

MDsim is a health-tech start-up, based in Luxembourg, active in the In-Silico Medicine. 

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Mapping the use of computational modelling and simulation in clinics: A survey

Computational modelling and simulation (CM&S) can be used in medicine to mimic biological processes with the goal of...

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Nathalie Virag is the new Avicenna International Affairs Working Group Leader!

Nathalie Virag, Ph.D is a Distinguished Scientist at Medtronic Corporate Technology & Innovation. She has more than 25...

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Second release of Avicenna Glossary now available!

This Glossary is a second release with an extended list of definitions; more concepts will be defined and existing definitions may be adjusted in...

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We are delighted to welcome France Biotech as a new Avicenna Partner

Founded in 1997, France Biotech is an independent association, uniting the country’s leading innovative health companies and their...

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The potential of in silico approaches to streamline drug development

This position paper highlights the potential of in silico medicine, using computational modelling and simulation to aid drug...

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DON'T LOOSE THE AVICENNA DAYS 2023 !!!

We will give the entire healthcare community an exhaustive update on recent progress and achievements related to the adoption and deployment of in silico method...

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Avicenna Alliance Observer at IMDRF meeting in Brussels

The Avicenna Alliance had received the honor to be invited as an Observer to the International Medical Device Regulators Forum (IMDRF) meeting...

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Avicenna Alliance meets with MEPs in Strasbourg

During the European Parliament’s plenary session that took place in the second week of March, Avicenna had the unique opportunity to visit the European...

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Welcome RBF Morph!

Welcome to our new member RBF Morph! Based in Monte Compatri, Rome, RBF is a pioneer and leader in mesh morphing, a key technology used in engineering simulation.

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Mimesis is a new Avicenna member!

We are truly delighted to welcome Mimesis as a new Avicenna member!

Mimesis is an innovative start-up, founded in 2020 as a spinoff of the University of Catania,...

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Shiny Martis is the new Pharmaceutical Strategy TF Co-Chair

We are delighted to welcome Shiny Martis as the new Pharmaceutical Strategy TF Co-Chair.

Shiny is Academic Partnership and Customer...

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Numalogics is a new Avicenna member

We are honored to welcome Numalogics as a new Avicenna’s member!
Numalogics is a Montréal-based privately held company priding itself on its world-class...

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Congratulations to our new Working Group Leaders!

We are delighted to welcome Cécile Rousseau and Martha De Cunha who have been elected as new Working Group Leaders of the Avicenna's 

In Silico... find out more ›

In Silico Application (ISA) Working Group

Digital evidence can and must be used for regulatory approval in all parts of the world. The Research & Technology Working Group has made huge progress,...

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Working Group Leaders elections

Our warmest congratulations to Liesbet Geris and Mark Palmer for their reappointment as Working Group Leaders of the Avicenna's Research & Technology Working Group and...

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We are delighted to welcome NumeriCor as a new Avicenna member!

NumeriCor is a leading cardiac electrophysiology and mechanics modelling company providing end-to-end simulation control. 

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Avicenna Alliance Glossary of Terms for Computer Modeling and Simulation

There are occasional confusions and diverging opinions possibly leading to misunderstanding in the use of some In Silico...

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THE ROLE OF ARTIFICIAL INTELLIGENCE WITHIN IN SILICO MEDICINE

A range of authors across academia and industry, representing both the Avicenna Alliance and the Virtual Physiological Human Institute,...

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Toward a regulatory pathway for Using in Silico Trials in CE Marking of Medical Devices

 

A team of researchers of the In Silico World project, including several key Avicenna Alliance members, led...

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Avicenna Alliance response to the ICHE11A Consultation

The Avicenna Alliance strongly supports and welcomes the ICH’s proposed goal of harmonizing methods and strategies for improved paediatric drug...

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Avicenna Alliance Feedback to the European Health Data Space Call for Feedback

The Avicenna Alliance welcomes the proposal for the EHDS. The Alliance is a multistakeholder group with the mission of...

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We are honored to welcome Zimmer Biomet as a new Avicenna’s member!

Zimmer Biomet is a global medical technology leader with a comprehensive portfolio designed to maximize mobility and improve...

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Avicenna Alliance Response to 2023 Stakeholders' Targeted Consultation on EU4Health

The Avicenna Alliance stressed the need for further support and guidance for digital evidence from in silico...

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New Avicenna APAC Task Force

A new Task Force joined the International Affairs Working Group!

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Cécile De Coster is the new Avicenna Pharmaceutical Strategy Task Force Co-chair

We are proud to welcome Cécile De Coster as the new Avicenna Pharmaceutical Strategy Task Force co-chair!

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Avicenna Alliance goes on growing by welcoming Edwards Lifesciences as a new member!

Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and...

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Avicenna Alliance is honoured to welcome Alfasigma as a new member!

Privately owned, Alfasigma is one of the leading Italian pharmaceutical companies, present in over 90 countries, through...

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EU-funded project successfully develops AI software that grows and treats cancerous tumors 

The Horizon Europe 2020 project EVO-NANO (Evolvable platform for programmable nanoparticle-based cancer...

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In silico used to validate Omicron variant detection method! 

The Joint Research Centre (JRC) has developed a new method to detect the Omicron variant of COVID-19, which differs in its nucleic acid...

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The priorities of the upcoming French Presidency of the Council of the European Union - what’s new for Avicenna? 

The French Presidency of the Council of the European Union is due to start on 1...

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New Avicenna UK Insilico Regulatory Innovation Task Force

The Avicenna International Affairs Working Group adds a new task force to its structure.

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In Silico in Innovation – again!

The European Innovation Council (EIC) has released its second wave of “start-up champions” to receive funding for innovations through the EIC Accelerator. The EIC...

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Avicenna Alliance meets with MEPs to discuss in silico medicine

On 7 October, Dr. Liesbet Geris (Research Professor in Biomechanics and Computational Tissue Engineering at the Universities of Liège &...

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The Joint Research Centre advocates for a “paradigm change” to in silico research methods!

For the second week in a row, the Joint Research Centre (JRC) – part of the European Commission’s EU Science...

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The European Commission Joint Research Centre publishes a public knowledge base of non-animal models used in immuno-oncology

The Joint Research Centre (JRC), which is part of the European...

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The State of the (European) Union

On 15 September, Commission President Ursula von der Leyen delivered her second State of the Union speech at the European Parliament in Strasbourg. She took stock of...

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The BECA Beat 

The European Parliament’s Special Committee on Beating Cancer (BECA) met for the first time in September of 2020. BECA was established to create actionable recommendations for Member...

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Avicenna Alliance prepares for the next EU policy session 

As September begins, politicians have returned to their EU posts and are preparing for what will be a busy few months for health policy. The...

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Joint Research Centre of the Commission launches report on national strategies for Artificial Intelligence!

The Joint Research Centre of the European Commission (JRC) recently published a new report...

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Conference of the Slovenian Council Presidency addresses digital twin technologies and digitalisation in healthcare!

On 15 and 16 July, the Slovenian Presidency of the Council of the European Union ...

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WHO issues first global report on use of AI in healthcare

Artificial Intelligence (AI) applications in health innovation are rapidly increasing, reflecting the potential of these technologies to...

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Slovenian Presidency of the Council of the EU launches its six-month programme!

On 1 July, for the second time since joining the EU in 2004, Slovenia has taken over the Presidency of the Council of...

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Members of the European Parliament call EU Health Commissioner to place in silico medicine on her policy agenda from 2021 onwards!

On 22 June, a group of five Members of the European Parliament...

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Our new position paper on in silico evidence in the regulatory approval of medical devices is out!

The Avicenna Alliance is proud to announce the recent publication of its new position paper...

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Happy 5th Anniversary to the Avicenna Alliance!  

5 years ago, based on the very enlightening Avicenna Roadmap Project Report, the Avicenna Alliance was established at the suggestion of European...

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EU New Medical Device Regulation now in force! In silico mentioned for the first time

After a one-year postponement following the COVID-19 pandemic, the European Commission’s Medical Devices...

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The European Commission adopts Communication on Europe's global approach to cooperation in research and innovation

On 18 May, the European Commission adopted a Communication on its global approach...

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Avicenna Alliance provides feedback on the European Commissions’ roadmap for the revision of the EU general pharmaceuticals legislation

On 27 April, the Avicenna Alliance has submitted its feedback...

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