MADIA Workshop result - Bologna, Italy

Workshop Bologna

The Consortium organised a stakeholder workshop “Nanotechnologies and Smart Systems for the Early Diagnostics” on June 11 – 12, 2019 in Bologna. Several actors in the field of healthcare and diagnostics were engaged.

The figure below shows the stakeholders based on the organization and country of origin:

 


The key messages outlined in the stakeholder´s workshop were: 

Parkinson's Disease, Alzheimer disease and other less common neurodegenerative diseases

An account of the challenges in diagnosing of neurodegenerative diseases. Those classify in diseases with motor dysfunctions (e.g. Parkinson’s disease), cognitive dysfunctions (e.g. Alzheimer’s disease), and motocognitive dysfunctions (e.g. Lewy body dementia). A classification exists also on by main protein abnormality (e.g. α-synuclein, β-amyloid, Tau protein). Due to the complexity of the diagnosis of these disease at the early stage, better knowledge and use of biomarker indicators might facilitate and complement traditional neuropsychological testing.

Nanotechnology, plasmonics and microfluidics: challenging applications in clinical diagnosis

Early diagnostics might find its holy grail in liquid biopsies in plasma. Combinations of discoveries in surface plasmon resonance imaging, nanotechnology and droplet microfluidic might make it possible to diagnose complex disease with a blood test. The H2020 project ULTRAPACAD showed potential for the diagnosis of cancer using DNA markers in the blood. One of the current challenges is being able to capture the relatively rare biomarkers in the early stage of the disease

Virtual Supermarket, a smart diagnostic procedure

 

Self-diagnosis of neurodegenerative the disease is becoming a reality through “Serious Games”, which are videogames specially designed to quantify behaviours which might be revealing the onset of a disease. Further development goes towards designing software and tools which are  both elderly-friendly and predictive enough to be complementary to traditional neuropsychological testing

Alzheimer’s Aβ Oligomers: new insights into nanobody-based detection and targeting

Nanobodies, which are antibodies capable to penetrate inside human cells, have high potential as imaging tools for the detection of biomarker indicators of neurodegenerative diseases

Lab-on-chip platforms for chemical and biological analysis

Advanced lab-on-a-chip platforms based on a simplified microfluidic architecture allows for portable and highly-sensitive detection of biomarkers which would normally require bulkier assays and equipment. INESC-MN is working on a simple device for detecting gamma-interferon in blood for antibody and therapy monitoring.

Wearable diagnostic devices: the new frontier for medical care

From the industrial standpoint, there is high interest in wearable diagnostic devices exchanging real-time information through the Internet of Things. The closed-loop glucose monitoring systems are currently one of the most important market drivers in this field. Silicon and derivatives are very attractive materials for wearable applications since they offer integrated technologies and smart sensor devices such as silicon photomultipliers. The challenges in the field are clinical validation and regulatory approval (currently there a very few products that are authorized for the market),  selection of biomarkers, improvement of accuracy, system integration and data security. The estimated market opportunity is 150 million in 2016, 2.86 billion in 2025.

Possible strategies for EU research efforts

Good surrogate markers (i.e. biomarkers) are needed, in addition to early diagnosis, also to demonstrate that therapies are working. Multiple Sclerosis therapy, for example, can rely on powerful surrogate markers.

The regulatory burden is, however, a challenge for all the new technologies. Academia in research projects must engage early both the manufacturer and the regulatory agency, in order to clarify the requirements to enter clinical trials and, consequently, the market.

Ultrasensitive approaches and Fast & Simple approaches are not mutually exclusive. However, solutions must be tailored towards the intended end-users: emergency responders would favour Fast & Simple approaches that give a “yes or no” measurement, and wearable devices that produce a lot of data continuously might not require the same level of sensitiveness of an in-vitro one-time measurement.

Cooperation between academia, industry, civil society, policymaker and end users are going to be increasingly a requirement in European research projects. Consortia should include actors from all these groups. Neurodegenerative disease and early diagnosis are going to be topical in Horizon Europe, which is going to have a budget of 7.5 billion € for projects on health and wellbeing

Wearable organic biosensor for real-time monitoring of biomarkers

The next generation of wearables will include textile electronic sensors, such as chemical biosensors, which can be directly fabricated onto  fabrics, in apparel and clothing accessories. These wearables operate as real-time electronic devices rely on a very low amount of test liquid (e.g. sweat) and require a very low power supply.

Chemiluminescence-based biosensors for diagnostic applications in space missions

End-users of diagnostic devices may include categories with very special needs, such as astronauts operating in zero-G. Diagnosis requiring fluid specimens is particularly challenging, and non-invasive sampling is a requirement. Oral fluid sampling, lateral flow immunoassays and chemiluminescence detection  were exploited to develop a point-of-need biosensor used onboard the ISS for the measurement of salivary cortisol, which is a biomarker of chronic stress during long space missions

Regulatory: how to adapt your company to the new European Regulation

The new  European in-vitro Diagnostic Regulation will require the manufacturer of diagnostic devices to adapt. The transition period lasts from 2017 to 2022. The European Commission is implementing the European databank on Medical Device (EUDAMED) to guide the regulatory process. The new regulation expands the list of the IVDs covered to include high-risk devices, near-patient / point-of-care devices, and genetic tests. It introduces the figure of “sponsor” for clinical investigations, and new requirements for labelling, post-marketing surveillance and vigilance

 


 The invited speakers to the workshop were:

Andreas Lymberis

European Commission

Andreas Lymberis is a physicist, post-graduated with a PhD in biomedical engineering and sciences (1990, Paris, France). He worked for more than 20 years as a researcher/engineer and R&D manager in biomedical technology and health telematics. He is the Head of Sector "Wearables & Bioelectronics"​ at the European Commission since 2016

Antonio Ambrosi

University of Foggia

Antonio Ambrosi is a resident surgeon and professor at the University of Foggia

 

Beatrice Fraboni

University of Bologna

Beatrice Fraboni is a Professor of Physics. In 2000 she joined the Faculty of Physics at the University of Bologna where. Her research activity focuses on the analysis and characterization of electrical transport properties of organic and inorganic semiconducting materials and of advanced (bio)electronic devices.

Federica Lodato

Italian Red Cross

Federica Lodato is a Regional Secretary of the Italian Red Cross

Giovanni Fabbrini

Sapienza University

Giovanni Fabbrini is a Professor in Neurology and Psychiatry, and manager and responsible for the rare disease centre “Distonia e altri disturbi del mobimento dell´adulto” at the Hospital Umberto I in Rome.

Giovanni Meli

EBRI – European Brain Research Institute

Giovanni Meli Is an expert researcher in neuroscience, neurodegeneration and Alzheimer’s disease. He is Group Leader at the European Brain Research Institute since 2012. Giovanni and his group are carrying out an Alzheimer’s Association research grant on β-Amyloid peptide oligomer targeting. In addition to that, he collaborates to many national and international research projects, among which the Human Brain Project.

 

Giuseppe Spoto

University of Catania

Giuseppe Spoto is professor of analytical chemistry. He has been coordinating the EU project ULTRAPLACAD on early diagnosis of cancer

João Pedro Conde

University of Lisbon

INESC MN

João Pedro Conde is president of the Department of Bioengineering and professor at the University of Lisbon. He is co-responsible for the Thin Film MEMS and BioMEMS research group and a director of INESC Microsystems and Nanotechnologies.

Jonathan Fauerbach

Militeny Biotech

Jonathan Fauerbach is a group leader in the Chemistry department at Miltenyi Biotec. His group is focused on the research on magnetic and fluorescent nanomaterials, as well as conjugation strategies to biomolecules, and their applications on cell analysis, imaging and cell separation.

Luca Bracchi

Thema Srl

Luca Bracchi works since 2010 on development and commercialization of biomedical devices. Since 2017 he is Product Manager QA\RA (Quality Assurance \ Regulatory Affairs) at Thema-Med and helps companies to navigate the regulatory maze connected to the commercialization of medical devices.

Luca Selmi

University of Modena and Reggio Emilia

Luca Selmi is professor of electronics at the University of Modena and Reggio Emilia. He was the coordinator in several international research projects of the European Union and of the Italian Ministry for University Education and Research. He started and/or supervised research contracts with Semiconductor companies worldwide, including Philips, Infineon, STM, NXP

Magda Tsolaki

Aristotle University of Thessaloniki

Magda Tsolaki is professor of neurology and head of the neurology department at the Aristotle University of Thessaloniki. She the founder and chair of the Greek Alzheimer Association and the Greek Federation of Alzheimer’s Disease (AD) in 2007, and the director two Public Dementia Units for outpatients.

 

Mara Mirasoli

University of Bologna

Mara Mirasoli is a professor in analytical chemistry at the University of Bologna. She is the vice-director of the Chemistry Department and she is associated with the centres for industrial research on “Renewable sources, environment, sea, and energy”, and on “Aeronautics, space, and mobility” of the University of Bologna

 

Sabrina Conoci

ST Microelectronics

Dr Sabrina Conoci covered several R&D positions in the field of nano-molecular devices, biosensors and biotechnologies. She is currently R&D Manager of the Advanced Sensor Technologies team at ST Microelectronics

Silvia Pascale

Sorin Group Italia (LivaNova)

Silvia Pascale is a senior manager at Sorin Group Italia. There she has been involved in the management of more than 40 national and international research projects related to the cardiovascular system and biomaterials

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