Progetto Classificazione condivisa per il settore scienze della vita del Cluster Alisei

10.02.2016

Relazione del Gruppo di Lavoro

Francesco Mazzini - Distretto Toscano Scienze della Vita Alberto Baldi - Bioindustry Park Silvano Fumero

Vera Codazzi - Assobiomedica Laura Cerni - Consorzio per il Centro di Biomedicina Molecolare

Gianluigi Zanetti - CRS4 Gerardo Lancia - Lazio Innova

Cecilia Maini - Aster Alessandra Mallano - Istituto Superiore di Sanità

Matteo Santoro - Polo Regionale Ligure Ricerca E Innovazione Roberta Lauro - Campania Bioscience

Filippo d'Arpa - Distretto Tecnologico Sicilia Micro e Nano Sistemi Roberto De Cani - Fondazione Regionale per la Ricerca Biomedica

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Progetto Classificazione comune settore scienze della vita

del Cluster Alisei Il progetto nasce con l'obiettivo di elaborare una proposta di classificazione del settore scienze della vita, condivisa da tutti i soci del Cluster Alisei, come strumento indispensabile per una mappatura delle competenze e dei soggetti attivi nei diversi territori, utilizzando formati comuni che facilitino lo scambio di informazione e l’elaborazione di progetti tra i vari membri del cluster. Classificazioni esistenti Gli ambiti oggetto della classificazione sono sia il comparto produttivo e dei servizi sia quello della ricerca nel settore delle scienze della vita, che comprende il farmaceutico, i dispositivi medici, la nutraceutica e gli alimenti funzionali, le applicazioni biotech e quelle ICT per il settore, e i servizi correlati. È stata quindi effettuata un’analisi delle classificazioni di riferimento nazionali e internazionali, con l’obiettivo di allinearsi per quanto possibile a standard già consolidati e verificarne le possibilità di utilizzo per gli scopi del progetto. Esistono diversi esempi di classificazione, sia sul versante imprese sia su quello ricerca, non tutte pubbliche e accessibili gratuitamente, molte delle quali relative ad un ambito specifico del settore. Sono state quindi esaminate le classificazioni ritenute più rilevanti per la realizzazione del progetto (Tabella 1), delle quali viene riportata una breve descrizione di seguito: - La Global Industry Classification Standard (GICS) è un sistema di classificazione universale di settori industriali sviluppato da Standard & Poor's e MSCI Barra per categorizzare a livello globale le imprese, e fornire così agli operatori finanziari un supporto standardizzato per analisi di mercato sui vari settori. É costituita da 10 ambiti principali declinati in ulteriori 3 livelli di dettaglio. L'Healthcare è uno degli ambiti di primo livello, declinato in Health Care Equipment & Services e Pharmaceuticals, Biotechnology & Life Sciences, ma procedendo nelle sottocategorie la classificazione del settore che si ottiene è piuttosto generica. Sistema del tutto analogo, anche nel livello di dettaglio, è l'International Standard Industrial Classification of All Economic Activities (ISIC), definito dalla Divisione Statistica delle Nazioni Unite, giunto alla quarta revisione con gerarchia a 4 livelli, in cui è presente anche una guida dettagliata delle attività industriali ricomprese in ciascuna sottocategoria. Passando a classificazioni più specifiche, per il settore dei dispositivi medici, per sua natura molto variegato e composito, troviamo sistemi molto strutturati e sempre più armonizzati a livello

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internazionale per facilitare la gestione e il monitoraggio dei dispositivi a livello globale. In particolare: -Global Medical Device Nomenclature (GMDN): è il sistema di riferimento per l'identificazione dei dispositivi medici, ampiamente riconosciuto a livello internazionale, costituito dal nome identificativo del dispositivo, da un codice univoco e da una breve descrizione. É utilizzato dalle autorità sanitarie regolatorie, ospedali, produttori e fornitori di dispositivi medici, con lo scopo di armonizzare a livello globale l'identificazione dei dispositivi con una terminologia univoca, e facilitare quindi la sorveglianza post market e la gestione tecnico-amministrativa dei dispositivi da parte degli healthcare providers Il nomenclatore GMDN sarà alla base del database europeo dei dispositivi EUDAMED, in fase di completamento, ed è molto strutturato, contenendo migliaia di termini di riferimento. - Anche il Ministero della Salute, nelle revisioni della Classificazione Nazionale dei Dispositivi (CND, ultimo decreto nel 2013) si è allineato con la GMDN, in considerazione del crescente riconoscimento internazionale di questo strumento e del suo prossimo utilizzo come riferimento di identificazione dei dispositivi medici nella Comunità europea, integrandola laddove ritenuto opportuno con tipologie e terminologie addizionali. Andando nella stessa direzione, il Ministero ha adottato per i dispositivi medico-diagnostici in vitro la classificazione EDMA (European Diagnostic Manufacturers Association), per la quale sono rilasciate ad ogni revisione le tabelle di correlazione con la GMDN. L'ambito farmaceutico riporta classificazioni in genere correlate alla struttura chimica del principio attivo, al metodo di produzione (sintesi chimica, biologici, estrazione da prodotti naturali), all'effetto fisiologico o all'organo bersaglio, al meccanismo di azione, e in alcuni casi con combinazioni diverse di questi criteri. Sono state esaminate: - Anatomical Therapeutic Chemical (ATC) Classification System: sviluppato dal Collaborating Centre for Drug Statistics Methodology della World Health Organization (WHO), il sistema ATC categorizza i principi attivi dei farmaci in base all’apparato/organo su cui essi esercitano l’azione terapeutica e in funzione delle loro proprietà chimiche e farmacologiche. Ogni principio attivo è generalmente associato ad un codice univoco a 5 dimensioni, in cui spesso il secondo, terzo e quarto livello sono utilizzati per identificare le classi farmacologiche, e l'ultimo identifica la componente chimica. L'Osservatorio sull’impiego dei medicinali (OsMed) di AIFA fa riferimento alla ATC nella redazione del suo rapporto annuale. Un sistema analogo, basato anch'esso su una classificazione anatomica, ma con un minor livello di dettaglio, viene mantenuto e utilizzato dalla European Pharmaceutical Market Research Association (EphMRA).

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- Dal canto suo, per la registrazione dei farmaci l'FDA usa una classificazione della classe dei farmaci basata su 3 attributi, dimostrati scientificamente; meccanismo di azione, effetto fisiologico e struttura chimica. A questi viene associato un ulteriore attributo, la "Established Pharmacological Class" (EPC), che deve avere chiara validità farmacologica clinica, oltre che scientifica, fornendo un livello di dettaglio piuttosto specifico per ogni farmaco. Per quanto riguarda la classificazione dell'ambito nutraceutico, non ci sono standard affermati. Il concetto stesso di nutraceutico non ha un contesto normativo proprio, e le sostanze che vengono associate alla nutraceutica sono variegate e rispondono a normative diverse, ciascuna per il proprio settore industriale, dai fitoterapici, agli alimenti funzionali, agli integratori alimentari, alle vitamine. Alcune di queste sostanze possono anche essere inquadrate come dispositivi medici. Nella letteratura scientifica e nelle fiere di settore (ad es. Vitafoods in tabella 1), le categorie in genere utilizzate riguardano la classe o l'effetto del componente chimico (antiossidanti, vitamine, polifenoli, acidi grassi, ecc) o la natura od origine dei componenti (probiotici, estratti naturali, prodotti fitochimici, alimenti funzionali, ecc.)

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Tabella 1

Classificazione Ambito Disponibilità Riferimenti

Global Industry Classification Standard (GICS)

Tutti Protetto da copyright

https://www.msci.com/documents/1296102/1339060/GICS_map2014.xls/c8c13aa8-2f22-44d2-9881-0b1c9a49b16c

International Standard Industrial Classification of All Economic Activities (ISIC)

Tutti Protetto da copyright

http://unstats.un.org/unsd/cr/registry/regdntransfer.asp?f=135

Global Medical Device Nomenclature (GMDN)

Dispositivi medici

Gratuita solo per autorità

nazionali

https://www.gmdnagency.org/

-Classificazione Nazionale Dispositivi medici (CND) -Classificazione Min. Salute IVD – EDMA

Dispositivi medici

Accessibile (Creative

Commons)

http://www.salute.gov.it/portale/temi/p2_6.jsp?id=328&area=dispositivi-medici&menu=classificazione http://www.salute.gov.it/portale/temi/p2_6.jsp?lingua=italiano&id=13&area=dispositivi-medici&menu=classificazione

Anatomical Therapeutic Chemical (ATC) Classification System

Farma Gratuita per usi non

commerciali

http://www.whocc.no/atc/structure_and_principles/ http://www.whocc.no/filearchive/publications/2016_guidelines_web.pdf

FDA Established Pharmacological Class (EPC)

Farma Accessibile http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162549.htm http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/UCM428333.pdf

Alimenti particolari, integratori e novel food - Min. Salute

Integratori alimenti

funzionali

Accessibile http://www.salute.gov.it/portale/temi/p2_5.jsp?area=Alimenti%20particolari%20e%20integratori&menu=integratori

Vitafoods - Global nutraceutical event

Integratori/alimenti

funzionali

Protetto da copyright

http://www.vitafoods.eu.com/welcome/ingredients/exhibiting-ingredients http://www.vitafoods.eu.com/welcome/finished-products/exhibiting-finished-products

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Classificazione Ambito Disponibilità Riferimenti

International Classification of Diseases (ICD) – WHO

Patologie Accessibile http://apps.who.int/classifications/icd10/browse/2016/en

Health Research Classification Systems – Current Approaches and Future Recommendations (2011) – ESF

Ricerca ambito salute

NA http://www.esf.org/fileadmin/Public_documents/Publications/spb43_Health_Research_Classification.pdf

Medical Subject Headings (MeSH) Ricerca ambito salute

Accessibile https://www.nlm.nih.gov/bsd/disted/meshtutorial/meshtreestructures/ https://www.nlm.nih.gov/mesh/2016/download/2016MeshTree.pdf

-Field of Research - NHMRC - Australia -Australian and New Zealand Standard Research Classification (ANZSRC)

Ricerca ambito salute

Accessibile (Creative

Commons)

http://www.nhmrc.gov.au/_files_nhmrc/file/grants/rgms/Appendix%20B__Fields%20of%20Research.pdf http://www.abs.gov.au/ausstats/abs@.nsf/0/4AE1B46AE2048A28CA25741800044242?opendocument

Health Research Classification System – UKCRC

Ricerca ambito salute

Accessibile (Creative

Commons)

http://www.hrcsonline.net/sites/default/files/HRCS_Document.pdf

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Per la classificazione delle patologie, il riferimento internazionalmente riconosciuto è l'International Classification of Diseases (ICD) della WHO, Giunta alla decima revisione, è la classificazione internazionale delle malattie e dei problemi correlati, e rappresenta lo standard di classificazione per gli studi statistici ed epidemiologici, utilizzato da oltre 100 paesi, e costituisce anche un valido strumento di gestione di salute e igiene pubblica. Sono classificate oltre 2000 malattie e condizioni correlate attraverso una classificazione gerarchica a partire da 22 categorie patologiche. L'ambito patologico, descritto attraverso l'ICD, è quasi sempre presente nelle classificazioni degli ambiti di ricerca del settore delle scienze della vita A questo proposito, nel 2011 è stata pubblicata una review dei sistemi presenti fino a quel momento da parte dell'European Medical Research Councils. Alcuni dei sistemi indicati allora sono ancora attivi ed hanno ampliato la rosa di utilizzatori. In particolare abbiamo preso in esame il Medical Subject Headings (MeSH, National Library of Medicine, USA), il Field of Research (FoR, National Health and Medical Research Council, Australia), e l'Health Research Classification System (UK Clinical Research Collaboration, UK) - MeSH: è un enorme vocabolario ideato con l'obiettivo di indicizzare la letteratura scientifica in ambito biomedico, creato dalla National Library of Medicine (NLM) degli Stati Uniti, che continua a gestirlo. Il MeSH viene adoperato per l'indicizzazione degli articoli delle oltre 5000 riviste mediche presenti nel database bibliografico Medline/PubMed e nel catalogo dei libri della NLM. Nei database Medline o PubMed il contenuto di ciascun articolo è indicizzato con 10-15 descrittori, di cui solo uno o due termini indicano l'argomento principale. Il vocabolario è costituito da quasi 28.000 termini, organizzati gerarchicamente, dal più generale al più specifico, a partire da sedici categorie principali, ciascuna a sua volta suddivisa in diverse sottocategorie, identificate da numeri, sempre più specifiche a mano a mano che si procede in basso nei livelli. Inoltre, un dato descrittore può apparire in più punti dell'albero gerarchico, e quindi può essere descritto da più codici alfanumerici. - FoR: per la presentazione e il monitoraggio dei propri progetti di ricerca, il National Health and Medical Research Council australiano (NHMRC) ha estratto gli ambiti di ricerca relativi al settore salute dalla più universale classificazione della ricerca fatta congiuntamente dal governo australiano e neozelandese (Field of Research FoR, Australian and New Zealand Standard Research Classification - ANZSRC). Questo sistema descrive l'ambito scientifico di riferimento su 3 livelli (ad es scienze biologiche, genetica, neurogenetica), ed è utilizzata anche da SciVal, la piattaforma di Elsevier per la valutazione delle performance di ricerca basata sul database Scopus. Nella classificazione della ricerca, il FoR è accompagnato da una ulteriore dimensione relativa alla patologia oggetto della ricerca, basata sulla classificazione ICD della WHO, in alcuni casi fino al terzo livello.

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- HRCS: con scopi analoghi al FoR, i partners della UK Clinical Research Collaboration hanno sviluppato l'Health Research Classification System, anch'esso bidimensionale, con un descrittore relativo alla patologia (ma non si va oltre al primo livello della ICD), ed un secondo per l'attività di ricerca, intesa come obiettivo e/o ricaduta principale del progetto. Sono stati quindi individuati 8 ambiti principali, che vanno dalla ricerca di base, alla diagnosi, terapia, monitoraggio, fino alle policy correlate al sistema sanitario, ciascuna con alcune sottocategorie per un totale di 48. Per avere ulteriori termini di confronto, sono state esaminate anche le classificazioni utilizzate dalle principali fiere internazionali di settore. Inoltre, due dei membri di Alisei (bioPmed e il Distretto Toscano Scienze della Vita) hanno messo a disposizione le tassonomie del settore sviluppate internamente per la classificazione degli affiliati dei territori di riferimento.

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Elaborazione della classificazione condivisa

Per supportare una mappatura delle attività dei vari soggetti operanti nelle scienze della vita il gruppo di lavoro, sulla base delle proprie esperienze e il confronto con le classificazioni esistenti esaminate, ha individuato alcune categorie definibili attraverso tassonomie opportune e controllate. Non tutte le categorie proposte sono comuni ai due tipi principali di soggetto (imprese e enti di ricerca), ma sono state elaborate tassonomie specifiche per meglio descrivere le peculiarità dei diversi soggetti. Uno schema possibile del flusso di classificazione è riassunto in Figura 1.

Figura 1. Flusso di classificazione soggetti operanti nelle scienze della vita

Nel dettaglio, le CATEGORIE individuate COMUNI a tutti i soggetti sono: - tipologia del soggetto (impresa, ente di ricerca ecc.) - tipologia di attività (produzione, consulenze, ricerca e sviluppo, ecc.) - mercato sanitario/ambito di ricerca di riferimento (ambito patologico o servizi per la salute) - (macro)settore di riferimento (farmaceutico, dispositivi medici, ecc., includendo anche servizi e

attività correlate)

Tipologia del soggetto (impresa, ente di

ricerca ecc.)

Ambito di ricerca di riferimento nella salute

(ambito patologico o servizi per la salute)

Macrosettore di riferimento (farma,

dispositivi medici, ecc.)

Comparto produttivo e servizi

Attività specifica nel settore di riferimento

Dimensione impresa (micro, piccola ..)

Proprietà impresa (italiana, estera, mista)

Stadio di sviluppo (fase I-IV, validazione ecc.)

Settore scientifico di riferimento

Obiettivi e/o ricadute principali dell'attività di

ricerca

Tipologia di attività (produzione, servizi ..)

Mercato sanitario(ambito patologico o servizi per la salute)

Tipologia di attività (R&D)

Macrosettore di riferimento (farma,

dispositivi medici, ecc.)

Attività di ricerca

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Categorie specifiche del COMPARTO PRODUTTIVO E SERVIZI: - dimensione impresa (micro, piccola ecc.) - proprietà impresa (italiana, estera, mista) - attività specifica nel settore di riferimento (dispositivi medici/diagnostica IVD, ecc., inclusi i servizi

e le attività correlate)

Laddove lo si ritenga opportuno, può essere utile l’inserimento di un ulteriore descrittore riferito allo stadio di avanzamento dei prodotti, ad esempio per le start up, che non sono ancora presenti sul mercato ma stanno sviluppando il loro prodotto.

Per la classificazione dei servizi conto terzi degli enti di ricerca, inquadrabili come servizi per lo specifico settore di riferimento, si suggerisce l’utilizzo di alcuni termini della tassonomia dei Servizi ed attività correlate (si veda oltre, classificazione Attività specifica nel settore di riferimento, tabella 7a-c), come ad esempio i servizi analitici di caratterizzazione.

Categorie specifiche delle ATTIVITÀ DI RICERCA: - settore scientifico di riferimento (scienze biologiche, scienze chimiche, ecc.) - obiettivi e/o ricadute principali dell'attività di ricerca (ricerca di base, prevenzione, diagnostica,

ecc.) Imprese che svolgano attività di ricerca e sviluppo probabilmente sono meglio descritte attraverso le categorie specifiche del comparto produttivo, in quanto il loro ambito è in genere molto finalizzato e prossimo all'attività già svolta sul mercato dall'impresa. Se l'attività di ricerca a contratto è l'ambito predominante, l'impresa si configura come una Contract Research Organization, e quindi classificabile tra i servizi dell'attività specifica del settore di riferimento. Come passo successivo, si è quindi proceduto ad elaborare i termini delle varie categorie, partendo dalle due esperienze di classificazione messe a disposizione dal bioPmed e dal Distretto Toscano Scienze della Vita. I membri del gruppo di lavoro si sono confrontati sulle categorie, e hanno verificato e integrato le tassonomie, tenendo presenti le specificità delle attività dei propri affiliati e le terminologie utilizzate dalle classificazioni di riferimento esaminate ed accessibili. Per ciascuna categoria quindi sono state elaborate le tassonomie riportate nelle tabelle 2-9. Tutti i termini sono in lingua inglese, per facilitare il confronto con analisi e dinamiche a livello internazionale. Di seguito vengono forniti i dettagli sul razionale seguito nell’elaborazione delle tassonomie.

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Nell’indicare i termini di questa categoria, si è voluto andare oltre alla classica separazione “imprese e enti pubblici”, tenendo conto di alcune tipologie di soggetti che è utile poter differenziare ed individuare da subito, in quanto spesso destinatari di iniziative e agevolazioni specifiche (ad esempio, per le start up, nei bandi regionali, le agevolazioni fiscali ecc.).

Tipologia del soggetto (Organisation type)

Per le start up, è stato ipotizzato anche un ulteriore descrittore relativo all’ambiente da cui questa origina, il quale spesso determina dinamiche specifiche. Associato a questo può essere utile aggiungere una casella di controllo rispetto allo status di start up innovativa, secondo la normativa vigente.

Tabella 2. Tipologia del soggetto (Organisation type)

Organisation type

Company

Start up Start up(2nd level)

University Spin off from another company

Other public research organisation

Academic start up

Investor Non academic start up

Care facility

Other

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Con questa categoria si fornisce una classificazione di primo inquadramento sulle attività svolte dal soggetto, che possono essere anche più di una.

Tipologia dell’attività (activity type)

Tabella 3. Tipologia dell’attività (activity type)

Activity type

Manufacturing & sales

Distribution/Retail

Research & Development

Services

Active care (hospitals and other care facilities)

Other

Si tratta dei canonici farmaceutico, dispostivi medici ecc. Nell’indicare i settori principali in cui un soggetto opera, il biotech è stato ripartito esplicitamente sul farmaceutico (Biopharma : biologici, biosimilari ecc.) e sui dispositivi medici (Biotech: IVD, biomateriali ecc.), ma è anche implicitamente presente nel campo del food safety.

Settore di riferimento, inclusi i servizi e attività correlate (Main sector of activity, services and related activity included)

Ciascun settore ricomprende poi anche i servizi e le attività correlate ad esso specifiche. Il settore healthcare è stato introdotto per classificare anche le strutture pubbliche e private di assistenza sanitaria e i servizi collegati. Tabella 4. Settore di riferimento principale (Main sector of activity, services & rel. activity included)

Main sector of activity (services and related activity included)

Pharma / Biopharma Nutraceutics & food safety

Medical devices / Biotech Healthcare

ICT for Health / e-health Other

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Nel settore scienze della vita, le attività hanno tutte come obiettivo ultimo un impatto su una patologia, da un punto di vista terapeutico, diagnostico o di prevenzione. La categoria, organizzata a più livelli, serve a fornire quindi un’indicazione rispetto all’ambito patologico-sanitario che il soggetto affronta con la propria attività produttiva, consulenziale o di ricerca. Al primo livello, la tassonomia utilizzata è sostanzialmente equivalente al primo livello della classificazione internazionale delle malattie e problemi correlati ICD, con l’aggiunta dei servizi per la salute. Anche i livelli successivi riprendono in molti casi i termini usati nelle varie sottocategorie dell’ICD. In tabella 5 è riportato solo il primo livello, la tassonomia completa è consultabile in appendice.

Mercato sanitario/ ambito di ricerca di riferimento nella salute (Health market / health research area)

Tabella 5. Mercato sanitario/ambito di ricerca nella salute (Health market / health research area)

Health market / health research area (1st level )

Infectious and parasitic diseases (not classified elsewhere)

Digestive system diseases (Oral, gastrointestinal etc)

Cancer diseases

Skin diseases

Blood diseases

Musculoskeletal system diseases

Endocrine, nutritional and metabolic diseases

Genitourinary system diseases

Mental and behavioural disorders

Pregnancy, fetal development and neonatal conditions

Nervous system diseases (excl mental health disorders)

Congenital disorders and chromosomal abnormalities

Eye diseases Injuries, poisoning

Ear diseases Immune system (not classified elsewhere)

Vascular diseases Health services, public health and epidemiological research

Respiratory system diseases Other

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In ambito farmaceutico lo stadio di sviluppo di un prodotto è correlabile con lo stadio di avanzamento della sua sperimentazione clinica, e per questo ambito è stato quindi seguito questo standard. Per gli altri settori è stata formulata una tassonomia analoga. Una possibile alternativa è rappresentata dal Technoloy Readiness Level, sviluppato dalla NASA e utilizzato anche dalla Commissione Europea nei bandi di finanziamento, ma è più difficile da gestire per una mappatura.

Stadio di sviluppo (Product stage)

Tabella 6. Stadio di sviluppo (Product stage)

Product stage (pharma) Product stage (other sectors)

R&D R&D

Pre-clinical Preliminar Validation

Phase I Clinical Validation

Phase II Registering

Phase III On the market

Pending approval

On the market (phase IV)

Per la dimensione di impresa lo standard (EU recommendation 2003/361) è ben noto: micro, small, medium, large.

Dimensione impresa (Company size) e Proprietà impres (Property)

Si ritiene utile, per le analisi delle dinamiche del settore, classificare le imprese anche in base alla geografia della loro proprietà, con i seguenti termini: italian, not italian, mixed property. Nell’ottica della mappatura, un altro dato interessante è rappresentato dall’ambito territoriale (nazionale o multinazionale), che può essere indicato attraverso una casella di controllo opportuna.

Per ciascun macrosettore, sono state elaborate le classificazioni specifiche con diversi gradi di dettaglio. Ciascun settore ha poi una tassonomia relativa a servizi e attività correlate (si veda l'appendice), in cui la maggior parte dei termini sono comuni a tutti i settori, ma ci sono anche termini propri solo di un settore (ad es. Drug production per il farmaceutico). Fa eccezione la tassonomia dei servizi dell'ITC, che ha diversi termini propri di questo settore ed è quindi indicata

Attività specifica nel settore di riferimento (Specific activity in the main sector)

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a parte. Come già riportato, alcuni termini della tassonomia servizi possono essere utilizzati per classificare dei servizi conto terzi degli enti di ricerca.

La tassonomia dei dispositivi medici risulta quella più strutturata e con più dimensioni data la natura molto variegata e composita del settore, e si è attinto molto dalla classificazione CND ed EDMA accessibile dal Ministero della Salute, integrandole e adattandole allo scopo del progetto.

Per il settore farmaceutico, è stato adottato un approccio snello, considerata la vastità di meccanismi di azione, effetti fisiologici e classi chimiche, oltre alle difficoltà, in sede di mappatura, di classificare le aziende farmaceutiche che in genere producono farmaci per molte applicazioni.

Tabella 7.a Attività specifica nel settore di riferimento (Specific activity in the main sector)

Specific activity in the main sector Pharma / Biopharma (1st level) Medical devices / Biotech (1st level) Nutraceutics & food

safety(1st level) Biopharmaceuticals/Biotechnology Biomaterials Biosensors

Generics Diagnostics - Equipment and accessories Enzymes

Pharma raw materials (APIs & Excipients)

Diagnostics - IVD (equipment, kits and accessories)

Food analysis

Pharmaceuticals (Small molecules/Chemicals)

Diagnostics - Imaging equipment and processing

Food fermentation

Radiodiagnostic / contrast agents Electromedical and medical equipments Food safety

Radiopharmaceuticals Healthcare facilities furnishings, equipment and consumer goods

Functional Food/nutraceuticals

Services and Related Activities Laboratory Equipment Natural Extracts

Theranostic Physiotherapy and orthopaedics Nutritional physiology,dietetics

Others Services and Related Activities Probiotics

Other Starting cultures

Supplements/Food Integrators

Services and related activities

Other

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Per gli altri ambiti, ci si è basati sulle conoscenze dei vari settori da parte dei membri del gruppo di lavoro. Di seguito vengono riportati i primi livelli (ad eccezione dell’Healthcare che ha un solo livello), la tassonomia completa è consultabile in appendice.

Tabella 7.b Attività specifica nel settore di riferimento (Specific activity in the main sector)-segue

Specific activity in the main sector ICT for Health / e-health

(1st level) Healthcare (Health Care Services and Suppliers)

Services and rel. activities - ICT for Health

Administrative Information systems/software

Acute Care/Hospitals Advanced technological platform services

Archiving and documentation Clinical analysis & diagnosis Lab Communication systems

Bioinformatics/Big data analysis Clinical Engineering services Consulting services

eHealth, telemedicine Clinical Trial Services in care facilities

Data services

Imaging data analyisis (software/hardware)

Disease management ICT solutions (software & hardware)

Medical information systems / software

Healthcare distributors Investment / Financing

Mobile App / m-health Maintenance & repairs services IT infrastructure / computer hardware

Services and Related Activities Personal care services Multiplatform systems

Other Residential/Long Term Product delevopment/design

Retail Stores / Pharmacy Services Regulatory affairs

Scientific & technical instruments Research & development

Surgical services Web Marketing

Other Other

16

Tabella 7.c Attività specifica nel settore di riferimento (Specific activity in the main sector)-segue

Specific activity in the main sector : Services and related activities (pharma, med. dev., nutraceutics & food safety)

Advanced technological platform services

Distribution & supply Chain Packaging services

Analytical Services Fill & finish services Prototyping

Biobanking ICT solutions (software & hardware)

Regulatory Affairs

Clinical Engineering services Investment / Financing Research & development

CMO / Manufacturing services Maintenance & repairs services Screening services

Consulting Services Manufacturing systems production & design

Testing / validation services

CRO Material selection, design &mModelling studies

Other

Per la definizione dell’ambito scientifico in cui si muove l’attività di ricerca, è stata utilizzata la classificazione Field of Research (FoR) del NHMRC australiano, specifica per il settore salute, ed integrandola dove necessario con termini e sottocategorie di attività di ricerca non riportate nella FoR di NHMRC, ma presenti nella nomenclatura madre del FoR dell’ANZSRC. Di seguito viene riportato il primo livello, la tassonomia completa è consultabile in appendice.

Settore scientifico di riferimento (Field of research)

Tabella 8. Settore scientifico di riferimento (Field of research)

Field of research (1st level) Biological sciences Information and Computing Sciences

Chemical Sciences Intellectual property legal aspects

Economics Medical and health sciences

Education, teaching, specialist studies Medical ethics, bioethics

Engineering Physical Sciences

Environmental sciences Statistics

Food sciences Technology

Other

17

Come ulteriore dimensione per descrivere l’attività di ricerca oltre al FoR e all’Health research area, è stato ipotizzato anche l’uso della classificazione HRCS, adottata nel Regno Unito e in altri paesi per il monitoraggio dei progetti di ricerca nel settore salute. Si può così fornire una indicazione più dettagliata sugli obiettivi e sull’impatto che ha l’attività di ricerca nell’health research area di riferimento. Di seguito viene riportato il primo livello, la tassonomia completa è consultabile in appendice.

Obiettivi e ricadute principali dell'attività di ricerca (Main objectives and impact of the research activity)

Tabella 9. Obiettivi e ricadute principali dell'attività di ricerca (Main objectives and impact of the research activity)

Main objectives and impact of the research activity (1st level) Underpinning Research

Causes, risk od development of disease research

Prevention of Disease and conditions, and promotion of well-being

Detection, screening and diagnosis

Development of treatments and therapeutic interventions

Evaluation of treatments and therapeutic Interventions

Management of diseases and conditions

Health and social care services research

Other

18

Considerazioni conclusive

Nella formulazione di tassonomie per la classificazione di un settore ampio come quello delle scienze della vita, nei suoi diversi aspetti di attività produttive, servizi e ricerca, si è cercato di bilanciare il livello di dettaglio con i potenziali utilizzi delle informazioni così classificate, la facilità d’uso e le criticità nel reperimento delle informazioni stesse, oltre che cercare, per quanto possibile, l’impiego di termini e strutture già riconosciute e standardizzate. Infatti, è opinione del gruppo di lavoro che una mappatura del settore abbia uno scarso tasso di risposte (la così detta redemption) se la sua popolazione è lasciata ai soli soggetti mappati, come già evidenziato in precedenti esperienze. Verosimilmente, saranno quindi i vari membri del Cluster a dover popolare la mappatura e quindi utilizzare la classificazione, e la possibilità di scendere nel dettaglio può diventare un punto critico in funzione della facilità nel reperimento delle informazioni e delle risorse disponibili. A questo proposito, il gruppo di lavoro propone che tutti i partecipanti alla mappatura utilizzino la classificazione almeno al primo livello per le tassonomie più complesse (Specific activity in the main sector, Health market / health research area), lasciando discrezionalità nell’andare più in profondità in base alle proprie possibilità. Gli ulteriori livelli delle tassonomie già identificati (e riportati nell’appendice), sono da considerarsi comunque il punto di riferimento laddove si possa scendere nel dettaglio, o se, a una verifica della mappatura, ci si rendesse conto che le informazioni così classificate sono troppo generiche. Si tenga presente che la classificazione proposta contiene solo le categorie che si ritiene poter descrivere con termini controllati (obbligati); per una mappatura, a questi vanno aggiunte altre informazioni a testo libero (anagrafica, sito, descrizione prodotti e attività ecc.) e tramite caselle di controllo (tipo vero/falso). Un'altra tassonomia non esplorata ma da valutare può essere l'offerta di piattaforme e servizi avanzati di ricerca disponibili verso l'esterno da parte degli enti di ricerca. Sempre in chiave mappatura, altro punto critico, oltre alla reperibilità delle informazioni, è il loro aggiornamento nel tempo, problematica che ha un peso non indifferente per le attività di ricerca, i cui ambiti possono variare con cinetiche più veloci rispetto al comparto produttivo e servizi. La classificazione è da considerarsi non esaustiva e non statica. Occorreranno revisioni periodiche e la possibilità da parte dei membri di suggerire termini integrativi, con modalità da definire. Allo stesso modo, resta da definire una “guida esplicativa all’uso” della classificazione, che chiarisca il significato dei termini non ovvi di per sé, in particolare fornendo esempi rispetto a cosa è ricompreso nei termini utilizzati.

19

Appendice – Tassonomie complete delle categorie

Tassonomia A1. Tipologia del soggetto (Organisation type) Tassonomia A2. Tipologia dell'attività (Activity type)

Organisation type Activity type

Company Active care (hospitals and other care facilities)

Start up Start up (2nd level) Distribution/Retail

University Spin off from another company

Manufacturing & sales

Other public research organisation Academic start up Research &

Development Investor Non academic start up Services Care facility Other Other

Tassonomia A3. Settore di riferimento principale Tassonomia A4. Stadio di sviluppo

(Main sector of activity) (Product stage)

Main sector of activity (services and related activity included)

Product stage (pharma)

Product stage (other sectors)

Pharma / Biopharma R&D R&D

Medical devices / Biotech Pre-clinical Preliminar Validation

ICT for Health / e-health Phase I Clinical Validation Nutraceutics & food safety Phase II Registering Healthcare (Services and suppliers) Phase III On the market Other Pending approval

On the market (phase IV)

20

Tassonomia A5: Mercato sanitario/ ambito di ricerca di riferimento nella salute (Health market / health research area)

Health market / health research area (1st level )

Health market / health research area (2nd level )

Infectious and parasitic diseases (not classifies elsewhere)

Antimicrobial/antibiotics resistance

ARhropod-BOrne / zoonotic bacterial infections (dengue, scabies etc)

Bacterial infections Bloodstream infections Central Nervous System Infections Childhood immunisable disease Fungal Infections Helminth parasitical infections Hepatitis Herpes virus HIV/AIDS Hospital acquired infection (incl Golden Staph) Influenza Malaria Nervous system viral infections (incl Encephalitis and

Meningitis) Other parasitic infections Rheumatic Fever RNA virus Viral Infections Other Cancer diseases Adrenal Gland Cancers Anal Cancer Angiogenesis Benign neoplasms Bladder cancer Bone and connective tissue cancers Brain cancers Breast cancer Cancer cachexia Cancer induced hypercalcemia Cervical cancer Childhood cancers Colorectal & bowel cancer Dysplasia Endometrial cancer Esophageal cancer Gall bladder and Biliary Tract Cancer Head and neck carcinoma Leukemia Liver cancer

21

Health market / health research area (1st level )

Health market / health research area (2nd level )

Cancer diseases (continued) Lung cancers Lymphomas Malignant Ascites Malignant Pleural Effusion Melanoma and other skin cancers Myelomas Neuroendocrine Tumor Ocular Cancer Ovarian Cancer Pancreatic Cancer Pituitary Gland Cancer Prostate cancer Renal Cancer Sarcomas Stomach cancer Testicular cancer Therapy Induced Side-effects Thymoma Thyroid Cancer Uterine cancer Other cancers Other endocrine cancers Other haematological cancers Blood diseases Anaemia & haemophilia Blood Coagulation disorders Bone marrow diseases Erythrocyte disorders Hemochromatosis Leukocyte disorders Platelet disorders Spleen diseases Other hematological diseases Endocrine, nutritional and metabolic diseases

Adrenal gland disorders

Amyloidosis Cystic Fibrosis Diabetes Complications Diabetes insipidus Diabetes mellitus - gestational Diabetes mellitus type 1 Diabetes mellitus type 2 Genetic endocrine disorders Genetic Metabolic disorders Gonadal disorders Hormonal issues Lipid Metabolism disorders

22

Health market / health research area (1st level )

Health market / health research area (2nd level )

Endocrine, nutritional and metabolic diseases (continued)

Metabolic Acidosis

Metabolic Endocrine disorders Mineral Metabolism disorders Nutrition and diet Obesity Ovarian disorders Parathyroid gland disorders Pituitary gland disorders Thyroid gland disorders Uric Acid Metabolism disorders Other endocrine disorders Other metabolic disorders Mental and behavioural disorders Anxiety disorders (obsessive compulsive, panic, phobias

etc) Childhood mental health & behavioural issues Depression and related disorders (bipolar etc) Eating disorders Learning, speech or memory related disorders Schizophrenia, Personality related disorders Substance Abuse Other mental health issues Other psychotic, psychosocial and affective disorders Nervous system diseases (excl mental health disorders)

Alzheimer’s disease and dementias

Balance disorders Epilepsy Migraine Motor Neuron disease Multiple sclerosis and other demyelinating diseases Muscular dystrophy Nerve development or regeneration Neurological injuries (brain, spinal cord etc) Neuropathy Parkinson’s disease Pervasive development disorders (autism, Rett's

syndrome etc) Sleep disorders Genetic Neurofibromatosis Stroke – neurological aspect Other neurodegenerative disorders Other Neurological disorders

23

Health market / health research area (1st level )

Health market / health research area (2nd level )

Eye diseases Amblyopia, strabismus Blindness Cataract Conjunctival disorders Corneal disorders Diabetic retinopathy Eye surgery Eyelid disorders Genetic ophthalmic disorders Glaucoma Intraocular Pressure Lens development Macular degeneration Myopia Ocular infections Ocular inflammatory disease Ocular neovascularization Optic nerve disorders Photophobia Retinal disorders Scleral disorders Uveitis Vitreous hemorrhage Other Ear diseases Ear Infections Deafness Ear surgery Hearing (Sense Organ and Sensory System Disorders) Hearing aids Labyrinthitis and other diseases of inner ear Mastoiditis Otitis Otosclerosis Tinnitus Tympanic disorders Vertiginous syndromes ear related Vestibular disorders Other Vascular diseases Blood pressure disease Heart diseases Cardiovascular Failure Cardiac inflammatory diseases Arteries diseases Cardiomyopathy Diseases of veins, lymphatic system not elsewhere

classified

24

Health market / health research area (1st level )

Health market / health research area (2nd level )

Vascular diseases (continued) Blood vessel clotting Rheumatic heart disease Cerebrovascular diseases Cardiovascular surgery Cardiac Arrhythmia Risk factors for heart disease Other Respiratory system diseases Asthma Chronic obstructive pulmonary disease Cough Cystic fibrosis Emphysema Genetic gespiratory diseases Infant respiratory distress syndrome Lung surgery Nasal/pharyngeal disorders Pleural cavity diseases Pulmonary vascular diseases Respiratory failure and respiratory distress syndrome Respiratory tract infections (bronchitis, pneumonia etc) Restrictive Lung diseases Rhinitis Sleep apnoea Smoking related respiratory issues Other pulmonary disorders Other respiratory issues Digestive system diseases (Oral, gastrointestinal etc)

Abdominal diseases

Acidity disorders Anorectal disorders Bowel diseases (Crohn’s, IBS, diverticulitis etc) Celiac disease Colitis & cystitis Dental pathologies Diarrhea & dysentery Dyspepsia Esophageal and swallowing disorders (also reflux) Gastroenteritis & gastroduodenitis Gastrointestinal Motility disorders Genetic Gastrointestinal disorders Hepato-Biliary diseases Hernia Inflammatory gastrointestinal diseases Malabsorption Nausea and Vomiting Necrotizing Enterocolitis (NEC)

25

Health market / health research area (1st level )

Health market / health research area (2nd level )

Digestive system diseases (continued) Oral Cavity disorders Pancreatic diseases Peptic and other ulcers Peritoneal diseases Salivary Gland disease Upper and lower gastrointestinal bleeding Other gastrointestinal infections Skin diseases Acne Alopecia Burns and scarring Cutaneous Lupus Erythematosus Dermatitis, dermatosis Erythema & ichthyosis Genetic Skin disorders Psoriasis Skin aging Skin infections Skin rare disease Skin ulcers Skin wounds Other skin related Musculoskeletal system diseases Achilles Tendonitis Adhesive Capsulitis Arthritis (also autoimmune) Avascular necrosis Bone growth and regeneration issues Bone loss Bone metabolism disorder Carpal tunnel syndrome Chronic back pain Connective tissue disorders Fractures Genetic muscular disorders Joint or bone tissue replacement issues Lateral Epicondylitis Muscle atrophy and sarcopenia Muscle or limb movement issues Muscular dystrophies Musculoskeletal infections Musculoskeletal related surgery Myasthenia gravis Osteoporosis Sciatica Spinal or lumbar issues Sprains and strains Other

26

Health market / health research area (1st level )

Health market / health research area (2nd level )

Genitourinary system diseases Balanitis Benign prostate disease Bladder disorders Breast disorders Dialysis Female reproductive system diseases Female Sexual dysfunction Glomerular disorders (nephritis, nephrosis etc) Hirsutism Inflammatory genitourinary diseases Male reproductive system diseases Male Sexual dysfunction Pelvic Inflammatory disease Sexually transmitted infections Urinary incontinence Urinary infections Urinary system disorders Other genital diseases Other kidney diseases Other urinary diseases Pregnancy, fetal development and neonatal conditions

Menopausal disorders

Birth trauma and asphyxia Contraception Fetal development Infant and neonatal lung conditions Infertility, in vitro fertilisation Maternal health Menstrual disorders Neonatal disorders Obstetrics Pregnancy Prematurity Sepsis and septicaemia (bacterial infections of the

circulating blood) Other fetal development conditions Other neonatal conditions Other pregnancy condtions Congenital disorders and chromosomal abnormalities

Birth defects – all otherwise not specified

Brain development defects Chromosomal anomalies Congenital heart disease Craniofacial defects – cleft lip/palate Digestive system issues

27

Health market / health research area (1st level )

Health market / health research area (2nd level )

Congenital disorders and chromosomal abnormalities (continued)

Down Syndrome

Hearing Myopathies Skeletal defects Spina bifida/neural tube defects Urogenital tract malformations Vision defects Other congenital malformations Injuries, poisoning Burns and corrosions Fractures fixation Frostbite Injuries involving multiple body regions Injuries to the abdomen, lower back, lumbar spine and

pelvis Injuries to the ankle and foot Injuries to the elbow and forearm Injuries to the head Injuries to the hip and thigh Injuries to the knee and lower leg Injuries to the neck Injuries to the shoulder and upper arm Injuries to the thorax Injuries to the wrist and hand Injuries to unspecified part of trunk, limb or body region Occupational/environmental injury Poisoning by drugs, medicaments and biological

substances Radiation Injury Toxic effects of other substances Trauma Other Immune System (not classified elsewhere) Allergy Autoimmune diseases not classified elsewhere (Lupus

etc) Immunodeficiency disorders Inflammatory Respiratory diseases Transplantation immunology Tumour Immunology Vaccine or immunisation issues Viral immunology Other

28

Health market / health research area (1st level )

Health market / health research area (2nd level )

Health services, public health and epidemiological research

Environmental health issues

Health economics Health ethics issues Health policy issues Health services effectiveness, training and

administration Health services, public health and epidemiological

research Health system issues related to cancer Intensive, critical or acute care Intensive, critical or acute care Mental health and psychosocial factors related to cancer Public and population health issues Public and population health related cancer issues Rehabilitation issues Other Others Alternative medicines and treatment Chronic Fatigue Syndrome Complications of medical and surgical care Dysgeusia Gene therapy Multiple Organ dysfunction syndrome Nutritional deficiency Plastic or reconstructive surgery Proteomics Radiography/Imaging Stem cell therapy Sudden Infant Death Syndrome Other

29

Tassonomie A6: Attività specifica nel settore di riferimento (Specific activity in the main sector)

Pharma - BioPharma

Specific activity in the main sector : Pharma / Biopharma

1st level 2nd level

Biopharmaceuticals/Biotechnology Antibodies & fragments Biomaterials and Tissue Regeneration Blood products Cell therapy, Stem cells Cytokines Gene therapy Growth factors Hormones Lipids Nucleic acids Proteins & Peptides Vaccines Other Delivery and formulation Generics Pharma raw materials (APIs & Excipients)

Pharmaceuticals (Small molecules/Chemicals)

Radiodiagnostic / contrast agents Radiopharmaceuticals Theranostic Services and related activities Si veda tassonomia A10 Others

30

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Biomaterials Biologicals Ceramics Glasses Metals Nanomaterials Polymers (synthetic and natural) Scaffolds Textiles Other Diagnostics - Equipment and

accessories Audiological diagnostic device

Blood flow measurement equipment Blood pressure equipment Cardiac catheterisation equipment Devices and accessories for neurological diagnosis Devices for sleep studies Electrocardiography (ECG) devices and accessories Electroencephalographs (EEG) Endoscopes and accessories ENT (ear, nose and throat) equipment and

accessories

Equipment for gynaecological diagnosis Equipment for urological diagnosis Ergometers Myography equipment and accessories Ocular diagnosis equipment and accessories Reflex testers Scales

31

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Stethoscopes Diagnostics - Equipment and

accessories (continued) Stimulation equipment for diagnostics

Thermography devices Thermometers Other

Diagnostics - IVD equipment, kits and accessories

Clinical chemistry Accessories and equipment for electrolytes analysis

Bilirubinometers Biosensors Body composition analysis (BCA) Devices and systems for glucose determination Devices and systems for haemoglobin determination Electrodes accessories and equipments Electrophoresis systems Enzyme analysis Equipment and accessories for urinary diagnosis Equipment for clinical chemistry Equipment for dry chemistry Genetic and molecular biology diagnostic tests Lab-on-chip Quality standards for clinical chemistry Rapid tests and POC for clinical chemistry Reagents & substrates Systems for lactate determination Other

32

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Diagnostics - IVD equipment, kits

and accessories (continued) Haematology, histopathology and related

Equipment and reagents for immunmodulators analysis

Equipment and reagents for immunohaematology Equipment for coagulation analysis Haematology and other cell counters Histocompatibility/tissue typing analysis Monoclonal antibodies for cell surface antigens

analysis Reagents for haematological analysis Reagents for haemostasis Reagents for histopathology and cytology analysis Systems for blood gas analysis Systems for blood sedimentation Other Immunochemistry, immunology (also infectious)

Allergies

Assays for pregnancy, fertility Equipment and accessories for microbiological

diagnosis Equipment and systems for HIV assay Hepatitis viruses assays Immuno assay systems Immunology test for bacteria determination Kits and accessories for auto-immune diseases

diagnostics Parasitles determination by infectious immunology Quality standards for immunological analysis

33

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Diagnostics - IVD equipment, kits and accessories (continued)

Immunochemistry, immunology (also infectious - Continued)

Quality standards for infectious diseases immunological analysis

Rapid tests in infectious immunology Rapid tests in immunochemistry Reagents and accessories for tumour markers assays Retroviruses assays Rheumatoid diseases tests Sepsis markers determination Specific organ function assays Specific proteins assays Systems and accessories for hormones analysis Systems and accessories for immunoglobulins/plasma

proteins analysis Therapeutic drug monitoring Thyroid function hormones determination Toxicological analysis Vitamin deficiency anemia tests Other Microbiology Bacteriology tests Mycology tests Parasitology Quality standards for microbiology applications Rapid tests for microbiology applications Virus cultures and assays Other

34

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Diagnostics - Imaging equipment and

processing Computer assisted tomographs (CT)

Electrical impedanz tomography (EIT) Magnetic resonance imaging (MRI) Microscopes used in image analysis Nuclear medicine equipment Systems for image documentation Ultrasound diagnostic equipment X-ray devices and accessories Other Electromedical and medical

equipments Anesthesiology, intensive care, respiration Anaesthetic equipment

Equipment for intensive care Incubators Oxygen equipment Patient monitoring systems Pulmonary function Respiration equipment Other Emergency medicine Emergency room equipment First-aid equipment Furnishing and equipment for medical treatment on

transport means Medical supplies units/ complete mobile units Rescue equipment and accessories Other

35

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Electromedical and medical

equipments (continued) Sterilisation Hot air apparatus

Sterilisation and disinfection equipment and accessories / autoclaves

Sterilisation disinfection services Other Surgery and OR accessories Catheters for surgery Cryosurgery equipment Disposable articles for surgeries Electrosurgical instruments Endoscopes for surgery and accessories Fibre optics equipment Laser surgery equipment Microscopes for surgery Operating room furnishing & accessories Operating tables Retinal detachment devices Scalpels, surgical knives Suction devices Surgical instruments, tools and accessories Vitrectomy devices Other

36

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Electromedical and medical equipments (continued)

Therapy and treatment equipment (not classified elsewhere)

Cardiac therapy equipment

Cryotherapy Dialysis equipment and accessories Electromagnetic wave equipment Electro-therapy equipment Equipment and accessories for treatments rooms Equipment for heat therapy Equipment for treatment with gases Extracorporeal circulation equipment and accessories Implants and prostheses (not orthopaedic) Infusion technology equipment Inhaler and aerosol devices Laser therapy equipment Lithotripsy equipment and accessories Neonatal care equipment Odontostomatology devices Ophtalmic devices Stimulation equipment for therapy Thermotherapy Transcutaneous nerve stimulation (TENS) Ultrasound therapy equipment Ultraviolet and infrared radiation equipment Other

37

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Healthcare facilities furnishings, equipment and consumer goods

Acupuncture equipment and accessories

Bandage materials Clock systems and time recording devices Clothing/shoes/Linen Cotton and synthetic wool Decubitus prevention products Devices for medication Disinfectants Disposable articles for hospitals Dressing for wounds, sores and ulceration Equipment and accessories for wards and

examination rooms

Equipment and furnishings for hospital rooms Furnishings, commodities and consumer goods Furnishings/Equipment for baby units Furnishings/Equipment for day rooms and

dining rooms

Incontinence and stoma aids Lighting systems and equipment Operating theatre textiles Recycling systems Sanitary installations Signposting systems for surgeries and hospitals Universal medical commodities Visual support systems Other

38

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Laboratory equipment Analytical equipment and accessories

Automatic dyeing units Centrifuges Cleaning equipment (laboratory) Cytology equipment and accessories Disposable articles for laboratories Drying equipment (laboratory) Evaluation appliances Filtration systems Homogenizers Incubators Laboratories microscopes Laboratory refrigerators and cooling systems Laboratory water purification systems Microtomes Osmosis equipment Pumps and valves for laboratories Rotatory evaporators Shaking and mixing units Other laboratory equipment Other laboratory items

Physiotherapy and orthopaedics Bandages and related (for Physiotherapy / Orthopaedics)

Bath treatment and accessories Compression therapy equipment Electromedical equipment for orthopaedics Electromedical equipment for physiotherapy

39

Tassonomia A7 - Specific activity in the main sector : Medical devices / Biotech

1st level 2nd level 3rd level Physiotherapy and orthopaedics

(continued) Implants and prostheses (Orthopaedic)

Orthopaedic shock wave therapy equipment Rehabilitation equipment and devices Training equipment Transport vehicles for those with handicaps Walking and mobility aids Wheelchairs Other orthopaedics equipment Other physiotherapy equipment

Other/Borderline Devices for cornea explantation and transplantation

Devices for personal care and protection Disinfectant, antiseptics and proteolitycs for

medical devices

Gas, liquid and viscoelastic fluids for ophtalmology

Glaucoma drainage and kits Lacrimal ducts devices Optical aids Protective and lubricant spray Solution for adhesive removal Solution for nasal irrigation Strabismus devices

Other

Services and related activities Si veda tassonomia A10

40

Tassonomia A8. Attività specifica nel settore di riferimento (Specific activity in the main sector)

Nutraceutics & food safety

Specific activity in the main sector : Nutraceutics & food safety

1st level 2nd level Biosensors Enzymes Food analysis Food fermentation Food safety Allergens GMOs Illicit coumpounds Pathogens Pesticides Toxins Veterinary drug

residues Other Functional food/ nutraceuticals

Natural extracts Nutritional physiology, dietetics

Probiotics Starting cultures Supplements/Food Integrators Services and related activities Si veda tassonomia A10 Other

Tassonomia A9 Attività specifica nel settore di riferimento (Specific activity in the main sector)

ICT for Health / e-health

Specific activity in the main sector : ICT for Health / e-health

1st level 2nd level

Administrative Information systems/software

Archiving and documentation ELN (Electronic laboratory notebooks)

Image management systems LIMS (Labinformation- and management

systems) Other

41

Specific activity in the main sector : ICT for Health / e-health

Bioinformatics/Big data analysis Chemometrics

Databases (DNA, Protein sequences, Literature, Molecular structures)

Data mining Evolutive strategies Knowledge mangement Modelling/Models/Simulation software Molecular bioinformatics (Genome

research, Agent development, Molecular structures)

Scientific software Software for drug certification Software for process optimization Other

eHealth, telemedicine Healthcare services Remote assistance Telemedicine Other

Imaging data analyisis (software/hardware)

Medical information systems / software

Mobile app / m-health Services and related activities Advanced technological platform services Communication systems

Consulting services Data services ICT solutions (software & hardware) Investment / Financing IT infrastructure / computer hardware Multiplatform systems Product delevopment/design Regulatory affairs Research & development Web Marketing Other

Other

42

Tassonomie A10: Attività specifica nel settore di riferimento (Specific activity in the main sector)

Healthcare

Specific activity in the main sector: Healthcare (Health Care Services and Suppliers)

Clinical analysis & diagnosis Lab

Clinical engineering services

Clinical trial services in care facilities

Disease management

Healthcare distributors

Maintenance & repairs services

Personal care services

Residential/Long Term

Retail Stores / Pharmacy services

Scientific & technical instruments (STI)

Surgical services

Other

43

Tassonomie A10: Attività specifica nel settore di riferimento (Specific activity in the main sector) - Services and related activities (PH,MD,NU)

Specific activity in the main sector : Services and related activities for pharma/biopharma (PH), medical devices / biotech (MD), nutraceutics & food safety (NU)

1st level 2nd level 3rd level Sector relevance Advanced technological platform services

MD, PH, NU

Analytical Services ADME & Toxilogical analysis MD, PH, NU Assays, analytical methods MD, PH, NU Biochemical analysis MD, PH, NU Biomolecular analysis MD, PH, NU Biosensors MD, NU Certified analytics/methods MD, PH, NU Chemometrics MD, PH, NU Genomics, proteomics, other -omics MD, PH, NU Immunanalytics MD, PH Laboratory quality control MD, PH, NU Materials characterization MD, PH, NU Method validation MD, PH, NU Microbiological analysis MD, PH, NU Microsystem technology/Lab-on-a-

chip/Micro fluidic MD, PH, NU

Physical-chemical characterization (UV,FLU, IR, Chrom, MS, NMR)

MD, PH, NU

Other Biobanking PH Clinical Engineering services

MD

44

Specific activity in the main sector : Services and related activities for pharma/biopharma (PH), medical devices / biotech (MD), nutraceutics & food safety (NU)

1st level 2nd level 3rd level Sector relevance CMO / Manufacturing services Chemical synthesis services MD,PH

Clinical & preclinical trial material MD,PH Drugs production Antibiotics PH Antibodies, growth factors,

cytokines PH

Biosimilars/ others biologics PH Blood factors PH Cell therapy, stem cells PH Generics PH Genetic material PH Hormones PH Immunotherapeutics PH Lipids PH Radiodiagnostic / contrast

agents PH

Radiopharmaceuticals PH Small molecules PH Theranostic PH Therapeutic proteins,

peptide & nucleic acids PH

Vaccines PH Other PH Electrical & Electronic components

& devices MD

45

Specific activity in the main sector : Services and related activities for pharma/biopharma (PH), medical devices / biotech (MD), nutraceutics & food safety (NU)

1st level 2nd level 3rd level Sector relevance CMO / Manufacturing services (continued)

Formulation & drug delivery Aerosol PH

Biopolymers PH Controlled release PH Creams PH Injectables/Liquids PH Liposomes PH Nano carriers PH Polymers PH Powders/Solid & Semi-solid PH Other PH

Material/biomaterial production MD,PH Mechanical/ mechatronic components &

devices MD

Molding and Casting Services MD Natural products extraction & purification PH, NU Pharma raw materials (APIs & Excipients) PH Photonic components & devices MD Plastics components & devices MD Probiotics & natural products for

supplements MD,PH,NU

Product assembly MD Scale-up MD,PH,NU Sensors & biosensors MD,NU Stability studies MD,PH Other

46

Specific activity in the main sector : Services and related activities for pharma/biopharma (PH), medical devices / biotech (MD), nutraceutics & food safety (NU)

1st level 2nd level 3rd level Sector relevance Consulting Services Business & development MD,PH,NU Data services MD,PH,NU Distribution & supply chain consulting MD,PH,NU Financial services / venture capital MD,PH,NU Formulation design MD Grants and partnership development MD,PH,NU ICT solutions (software & hardware) MD,PH,NU Internationalization MD,PH,NU IPR management &consulting MD,PH,NU Job placement, human resources MD,PH,NU Legal & regulatory services MD,PH,NU Marketing services MD,PH,NU Plant conception and design MD,PH,NU Product delevopment/design MD,PH,NU Scientific or expert information /

publications MD,PH,NU

Surveys / market analysis MD,PH,NU Technology and innovation consulting MD,PH,NU Technology transfer MD,PH,NU Temporay management MD,PH,NU Web marketing MD,PH,NU Other MD,PH,NU CRO Animal Facilities MD,PH,NU Biologic assay development MD,PH,NU Clinical trials MD,PH,NU Custom research services MD,PH,NU

47

Specific activity in the main sector : Services and related activities for pharma/biopharma (PH), medical devices / biotech (MD), nutraceutics & food safety (NU)

1st level 2nd level 3rd level Sector relevance CRO (continued) Drug discovery MD,PH GxP Facilities MD,PH Legal & regulatory services MD,PH

Pre-clinical Trials MD,PH Toxicological screening MD,PH Transgenic Animal Facilities MD,PH Other MD,PH Distribution & supply Chain

MD,PH,NU

Fill & finish services MD,PH,NU ICT solutions (software & hardware)

MD,PH,NU

Investment / Financing MD,PH,NU Maintenance & repairs services

MD

Manufacturing systems production & design

Bioprocess engineering MD,PH,NU

Custom manufacturing systems MD,PH,NU Lab systems MD,PH,NU Packaging & production equipment MD,PH,NU Patches & textiles MD,PH,NU Reactors/bioreactors MD,PH,NU Vial/capsule/syringe fillers MD,PH,NU Other production systems MD,PH,NU

48

Specific activity in the main sector : Services and related activities for pharma/biopharma (PH), medical devices / biotech (MD), nutraceutics & food safety (NU)

1st level 2nd level 3rd level Sector relevance Material selection, design & modelling studies

MD,PH,NU

Packaging services MD,PH,NU Prototyping, rapid prototyping

MD,PH,NU

Regulatory affairs MD,PH,NU Research & development MD,PH,NU Screening services MD,PH Testing / validation services

MD

Other MD,PH,NU

49

Tassonomia A11 : Settore scientifico di riferimento (Field of Research)

Field of Research

1st level 2nd level 3rd level Biological sciences Biochemistry and cell biology Analytical biochemistry

Biochemistry and cell biology not elsewhere classified

Bioinformatics Cell development, proliferation and death Cell metabolism Cell neurochemistry

Cellular interactions (including adhesion, matrix, cell wall)

Enzymes Protein trafficking Receptors and membrane biology Signal transduction

Structural biology (including macromolecular modelling)

Synthetic biology Systems biology Other Evolutionary biology Host-parasite interactions Biological adaptation Phylogenetics and comparative analysis Other

50

Field of Research

1st level 2nd level 3rd level Biological sciences (continued) Genetics Cell and nuclear division

Developmental genetics (including Sex determination)

Epigenetics (incl Genome Methylation and Epigenomics)

Gene expression (including Microarray and other genome-wide approaches)

Genetic immunology Genetics not elsewhere classified Genome structure and regulation Genomics Molecular evolution Neurogenetics Population, ecological and evolutionary genetics

Quantitative genetics (including disease and trait mapping genetics)

Other Metabolic biochemistry Amino Acids and Metabolites Carbohydrates Inorganic elements and compounds Lipids Nucleic acids

Proteins and Peptides (including Medical Proteomics)

Other

Microbiology Bacteriology Infectious agents

51

Field of Research

1st level 2nd level 3rd level Biological sciences (continued) Microbiology (continued) Microbial genetics

Mycology Virology Microbiology not elsewhere classified Other Plant biology Proteomics & ther -omics Physiology Animal physiology - Biophysics Animal physiology - Cell Animal physiology - Systems Comparative physiology Other Zoology Other about biological sciences

Chemical Sciences Analytical Chemistry (also clinical chemistry) Analytical spectrometry

Electroanalytical chemistry Flow analysis Immunological and bioassay methods

Instrumental Methods (excl. Immunological and Bioassay Methods)

Quality Assurance, Chemometrics, Traceability and Metrological Chemistry

Sensor technology (Chemical aspects)

52

Field of Research

1st level 2nd level 3rd level Chemical Sciences (continued) Analytical Chemistry (continued) Separation science

Other Bioinorganic chemistry Computational chemistry Medicinal and biomolecular chemistry Medicinal and biomolecular chemistry Biologically active molecules Biomolecular modelling and design Characterisation of biological macromolecules

Cheminformatics and quantitative structure-activity relationships

Medicinal and Biomolecular Chemistry not elsewhere classified

Molecular Medicine Proteins and Peptides Drug design and screening Drug delivery Other Macromolecular and materials chemistry Macromolecular and materials chemistry Physical-chemical characterisation of Materials Nanochemistry and supramolecular chemistry

Optical properties of materials Biopolymers preparation Polymers preparation (excl biopolymers)

53

Field of Research

1st level 2nd level 3rd level

Chemical Sciences (continued) Macromolecular and materials chemistry (continued) Modelling and design of materials

Other Organic Chemistry Organic Chemistry

Macromolecular and materials chemistry not elsewhere classified

Free radical, antioxidants chemistry Natural products chemistry Organic chemical synthesis Organic green chemistry Physical Organic Chemistry Catalysis and mechanisms of reactions Organometallic chemistry Other Physical Chemistry (including Structural) Thermodynamics and kinetics Colloid and surface chemistry Electrochemistry Solution chemistry Structural chemistry and spectroscopy Transport properties and Non-Equilibrium Processes Other

Radiochemistry

Other about chemical sciences

54

Field of Research

1st level 2nd level 3rd level Economics Health economics Econometric and statistical methods Economic models and forecasting Economic data analysis Market analysis Business and management Business intelligence Logistics and supply chain management Marketing Innovation and technology management Other about economics Education, teaching, specialist studies Engineering Biomedical engineering Biomedical engineering Biomaterials Biomechanical engineering Biomedical engineering Biomedical instrumentation Medical devices Biorobotics Rehabilitation engineering Scaffolds

Other Chemical engineering Chemical engineering

Membrane and separation technologies Process control and simulation

55

Field of Research

1st level 2nd level 3rd level Engineering (continued) Chemical engineering (continued) Industrial automation

Powder and particle technology Chemical and pharma plant design Other

Electronic and electromechanical engineering Electronic and electromechanical engineering

Circuits and systems Control systems, robotics and automation Sensors and biosensors (not optical) Microelectronics and integrated Circuits Photodetectors and optical sensors Photonics and electro-optical Engineering Signal processing Components for medical devices Microelectromechanical systems (MEMS) Other Engineering management Manufacturing engineering Manufacturing engineering CAD/CAM systems Flexible manufacturing systems Machining

Manufacturing management

Manufacturing processes and technologies (also mechatronics)

Packaging, storage and transportation

56

Field of Research

1st level 2nd level 3rd level Engineering (continued) Manufacturing engineering (continued) Micromanufacturing

Molding Manufacturing safety and quality Other Materials engineering (excl biomaterials) Materials engineering (excl biomaterials) Ceramics Glass Composite and hybrid materials Semiconductors Functional materials Polymers and plastics Metals and alloy materials Other Other about engineering Environmental sciences

Food sciences Food chemistry Food safety Food engineering Food nutritional balance Food packaging and preservation Food processing

57

Field of Research

1st level 2nd level 3rd level Food sciences (continued) Functional food and nutraceuticals

Food sciences not elsewhere classified Food biochemistry Other about food sciences

Information and computing sciences Computer-Aided-Surgery and Navigation Computer software Computer software Bioinformatics software Software engineering Computer system architecture Multimedia programming Remote monitoring app & software Data encryption Management software Other

Data analysis (big data, pattern recognition, data mining)

Distributed computing Distributed computing Mobile technologies Distributed and grid systems Cloud computing Web technologies

58

Field of Research

1st level 2nd level 3rd level Information and computing sciences

(continued) Distributed computing (continued) Networking and communications

Other Human-Computer Interface Image analysis & processing Information studies Information studies Health informatics Human information behaviour Information retrieval and web search Informetrics Social and community informatics

Organisation of information and knowledge resources

Records and information management (excluding Business records and information management)

Other

Information systems Information systems Computer-human interaction Conceptual modelling Database management Decision support systems Information systems management

59

Field of Research

1st level 2nd level 3rd level Information and computing sciences

(continued) Information systems (continued) Customer relationship management

Content management systems Information engineering Other Simulation and data processing Simulation and data processing Artificial life Computer vision Virtual reality and related simulation Adaptive agents and intelligent robotics Natural language processing Simulation and modelling Neural, evolutionary and fuzzy computation Other

Other about information and computing sciences

Intellectual property legal aspects

Medical ethics, bioethics

Medical and health sciences Anaesthesiology and pain Anatomy Cardiology and vascular medicine Clinical chemistry (diagnostics)

60

Field of Research

1st level 2nd level 3rd level Medical and health sciences (continued) Clinical microbiology

Clinical sciences not elsewhere classified

Complementary/Alternative Medicine Cognitive sciences Cognitive Sciences Cognitive science not elsewhere classified Computer perception, memory and attention Decision making Knowledge representation and machine learning

Linguistic processes (including speech production and comprehension)

Neurocognitive patterns and neural networks Other Dentistry Dentistry Dental materials and equipment

Dental therapeutics, pharmacology and toxicology Endodontics Oral and Maxillofacial surgery Oral medicine and pathology Orthodontics and dentofacial orthopaedics Paedodontics Periodontics Special needs dentistry Other

61

Field of Research

1st level 2nd level 3rd level Medical and health sciences (continued) Dermatology

Emergency medicine

Endocrinology (diabetes etc) and metabolism

Epidemiology Family practice Gastroenterology and hepatology General medicine Geriatrics and gerontology Haematology Health services and public healthcare Health services and public healthcare Aged health care

Care for disabled Child health

Environmental and occupational health and safety Epidemiology Family Care Health and community services Health care administration Health Counselling Health information systems (incl. Surveillance) Health promotion and communication Mental Health Preventive medicine

Primary Health Care

62

Field of Research

1st level 2nd level 3rd level

Medical and health sciences (continued) Health services and public healthcare (continued)

Public Health and Health Services not elsewhere classified

Residential client care Teleassistance, telemedicine Health technology assessment Health policy Other Health, toxicology and mutagenesis Human movement and sports science Human Movement and Sports Science Biomechanics

Human movement and sports science not elsewhere classified

Motor control Sports medicine Other Immunology, allergies, transplantation Immunology, allergies, transplantation Allergy

Applied immunology (including Antibody Engineering, Xenotransplantation and T-cell therapies)

Autoimmunity

63

Field of Research

1st level 2nd level 3rd level

Medical and health sciences (continued) Immunology, allergies, transplantation (continued) Cellular immunology

Humoural immunology and immunochemistry Immunogenetics (including genetic immunology) Immunology not elsewhere classified Innate Immunity Transplantation immunology Tumour immunology Vaccines Other Infectious diseases Intensive care Medical genetics (excluding cancer genetics)

Medical laboratory technology Medical microbiology Medical microbiology Medical Bacteriology Medical Infection Agents (including Prions) Medical Microbiology not elsewhere classified Medical Parasitology Medical Virology Other

64

Field of Research

1st level 2nd level 3rd level Medical and health sciences (continued) Medical physiology Medical physiology

Cell physiology Human biophysics Medical Physiology not classified elsewhere Exercise physiology Systems physiology Personalised medicine Neonatology, perinatology, child health Neonatology, perinatology, child health Neonatology Foetal development and medicine Paediatrics

Paediatrics and reproductive medicine not elsewhere classified

Perinatology Child health Other

Neurology (clinical)

Neurosciences Neurosciences Autonomic Nervous System Cellular Nervous System Central Nervous System

65

Field of Research

1st level 2nd level 3rd level Medical and health sciences (continued) Neurosciences (continued) Neurology and neuromuscular diseases

Neurosciences not elsewhere classified Peripheral nervous system Sensory Systems Learning, speech dysfunctions Other Nutrition and dietetics Nutrition and dietetics Clinical and sports nutrition Dietetics and nutrigenomics Nutrition and dietetics not elsewhere classified Nutritional Physiology Other Obstetrics and gynaecology Oncology and carcinogenesis Oncology and carcinogenesis Cancer cell biology Cancer diagnosis Cancer genetics

Cancer therapy (excluding chemotherapy and radiation therapy)

Chemotherapy Haematological tumours

Molecular targets

66

Field of Research

1st level 2nd level 3rd level

Medical and health sciences (continued) Oncology and carcinogenesis (continued) Oncology and carcinogenesis not elsewhere classified

Radiation therapy Solid tumours Cancer surgery Other Podiatry Psychiatry Psycology and psychotherapy Psycology and psychotherapy

Biological psychology (Neuropsychology, Psychopharmacology, Physiological Psychology)

Developmental psychology and ageing Educational Psychology Health, clinical and counselling psychology Personality, abilities and assessment Psychological methodology, design and analysis Sensory processes, perception and performance Sport and exercise psychology Other Pharmacology and pharmaceutical sciences Pharmacology and pharmaceutical sciences Basic Pharmacology Clinical Pharmacology and Therapeutics

Clinical Pharmacy and Pharmacy Practice

67

Field of Research

1st level 2nd level 3rd level

Medical and health sciences (continued) Pharmacology and pharmaceutical sciences (continued) Pharmaceutical Sciences

Pharmacogenomics

Pharmacology and Pharmaceutical Sciences not elsewhere classified

Toxicology (including clinical toxicology) Other Physical therapy and rehabilitation Ophthalmology and optometry Ophthalmology and optometry Ophthalmology Optical Technology

Optometry and Ophthalmology not elsewhere classified

Vision Science Other Oral medicine, pathology and surgery Orthopaedics Otorhinolaryngology Pathology, hystology Radiology and nuclear medicine

Rehabilitation and therapy (excluding physiotherapy)

68

Field of Research

1st level 2nd level 3rd level

Medical and health sciences (continued) Reproductive medicine and sexual dysfunctions Reproductive medicine and sexual dysfunctions

Reproduction, infertility Neonatology

Sexual dysfunction Genital organs Other

Respiratory medicine Rheumatology and arthritis Surgery Urology and nephrology Venereology Other about medical and health sciences

Physical Sciences Biological physics Classic and condensed matter physics Classic and condensed matter physics

Synchrotrons; Accelerators; Instruments and Techniques

Acoustics and acoustical devices, waves Fluid physics Nanomaterials Condensed matter imaging

Condensed matter characterisation technique development

69

Field of Research

1st level 2nd level 3rd level

Physical Sciences (continued) Classic and condensed matter physics (continued)

Electronic and magnetic properties of condensed matter

Soft condensed matter Other Surfaces, structural properties of condensed matter Medical physics

Optical physics Optical physics

Photonics, Optoelectronics and Optical Communications

Nonlinear Optics and Spectroscopy Lasers and quantum electronics Quantum Optics Other Other about physical sciences

Statistics Applied Statistics Biostatistics Biological Mathematics Statistical mechanics Other about statistics

Technology Agricultural biotechnology Agricultural Biotechnology Transgenesis

70

Field of Research

1st level 2nd level 3rd level

Technology (continued) Agricultural biotechnology (continued) Agricultural biotechnology diagnostics (incl. biosensors)

Agricultural molecular engineering of nucleic acids and proteins

Agricultural marine biotechnology Genetically modified plants and animals Other

Environmental Biotechnology Environmental Biotechnology Bioremediation

Environmental biotechnology diagnostics (incl. biosensors)

Other Industrial Biotechnology Industrial Biotechnology Biocatalysis and enzyme technology Bioprocessing, bioproduction and bioproducts Fermentation

Industrial biotechnology diagnostics (incl. biosensors)

Industrial microbiology Other Medical biotechnology Medical Biotechnology Gene and molecular therapy Medical biotechnology diagnostics

71

Field of Research

1st level 2nd level 3rd level

Technology (continued) Medical Biotechnology (continued) Medical molecular engineering of nucleic acids and proteins

Regenerative Medicine (including Stem Cells and tissue engineering)

Other Nanotechnology Nanotechnology Nanobiotechnology Nanotechnology (continued) Nanomedicine Nanotoxicology, health and safety Nanoelectronics Nanophotonics Nanofabrication, Growth and Self Assembly Nanoelectromechanical Systems Nanomanufacturing Nanomaterials Other Other about technology

72

Tassonomia A12: Obiettivi e ricadute principali dell'attività di ricerca (Main objectives and impact of the research activity)

Main objectives and impact of the research activity

1st level 2nd level 3rd level

Underpinning Research Biological development and functioning Bioinformatics and structural studies

Research that underpins (support) investigations into the cause, development, detection, treatment and management of diseases, conditions and ill health

Studies on normal biology including: Biological pathways and processes (incl. normal immune function)

Cellular and physiological structures and function Development and characterisation of model

systems Developmental studies and normal ageing Genes and gene products Molecular structures and function Other

Psychological and socioeconomic processes Development and characterisation of model systems

Studies that do not address health directly but cover issues that may have a connection with health and well-being including:

Individual or group characteristics and behaviours

Perception, cognition and learning processes Politics, economies and urban development Social and cultural beliefs Other

73

Main objectives and impact of the research activity

1st level 2nd level 3rd level

Underpinning Research (continued)

Chemical and physical sciences Bioengineering and biophysics

Research in chemical and physical sciences that may lead to the future development of diagnostic tools or medical treatments including

Chemical structures, interactions and properties

Condensed matter physics Material science

Molecular modelling Other Methodologies and measurements Development of biological, psychological and

socioeconomic research measures Development of novel underpinning research

measures and analytical methodologies including

Development of mapping methodologies and novel data comparison methods

Development of physical-chemical analytical methods

Development of statistical methods and algorithms for omics analysis

Other Resources and infrastructure (underpinning

research) Infrastructure to support research trials, networks, consortia and centres

Development and/or distribution of resources for use by the research community including equipment, cell lines, DNA banks, and genomic and proteomic sequence resources

Resources for the research community (equipment, cell lines, biobanks, omics data)

74

Main objectives and impact of the research activity

1st level 2nd level 3rd level Causes, risk od development of disease research Biological and endogenous factors Bioinformatics and structural studies

Identification of determinants that are involved in the cause, risk or development of disease, conditions and ill health

Identification and characterisation of endogenous factors known or suspected to be involved in the cause, risk or development of disease, conditions or ill health including:

Biological factors involved in degenerative processes, regeneration and repair

Biological factors involved in regeneration and repair

Biological factors involved in tumors formation, growth and metastases

Biological factors linked to ethnicity, age, gender, pregnancy and body weight

Cellular and physiological structures and functions

Complications, reoccurrence and secondary conditions

Development and characterisation of biological models

Endogenous biological factors or pathways involved in responses to damage by external factors

Endogenous biological factors or pathways involved in responses to infection

Genes and gene products Molecular structures and functions Other

75

Main objectives and impact of the research activity

1st level 2nd level 3rd level Causes, risk od development of disease research

(continued) Factors relating to enviroment, external causes

Chemicals

Environmental or external factors associated with the cause, risk or development of disease, conditions or ill health including:

Environmental surroundings

Infection by pathogens and studies of infectious agents

Nutrients Occupational hazards Physical agents Radiation and pollution Other Psychological, social and economic factors Cultural or religious beliefs or practices Research into psychological conditions, or

research into the cause, risk or development of disease, conditions or ill health associated with social, psychological and economic factors including:

Ethnicity, age and gender differences

Individual or group behaviours and lifestyle Socioeconomic factors Other Surveillance and distribution Epidemiological studies results

Observational studies, surveys, registries, and studies that track incidence, prevalence, morbidity, co-morbidity and mortality :

Observational studies data processing and results

Other

76

Main objectives and impact of the research activity

1st level 2nd level 3rd level Causes, risk od development of disease research

(continued) Research design and methodologies Development and evaluation of novel research

designs Development of aetiological and

epidemiological research designs, measures and methodologies including:

Development of analytical and statistical methods (incl. genetic studies)

Development of epidemiological research measurements including outcome measures

Methodological innovation and modelling complex epidemiological data

Other Resources and infrastructure (health care &

services) Infrastructure to support research trials, networks, consortia and centres

Resources for the research community (equipment, cell lines, biobanks, omics data)

Prevention of Disease and Conditions, and Promotion of Well-Being

Primary prevention interventions to modify behaviours or promote well-being

Behavioural, psychological, social and physical interventions

Research aimed at the primary prevention of disease, conditions or ill health, or promotion of well-being

Development, and evaluation of interventions to modify personal or group behaviours and lifestyles affecting health and well-being :

Public health policy, health communication and educational interventions

Risk associated with age, gender, cultural or religious practices

Risk behaviours associated with diet or physical activity

Risk behaviours associated with substances misuse (alcohol, drugs, etc)

Other

77

Main objectives and impact of the research activity

1st level 2nd level 3rd level Prevention of Disease and Conditions, and Promotion of Well-Being (continued)

Interventions to alter physical and biological environmental risks

Contraceptive devices

Development, implementation and evaluation of interventions surrounding physical, biological and environmental risk factors including:

Infectious agents

Occupational hazards and environmental surroundings

Physical and chemical agents exposure Policy, educational and physical interventions Radiation exposure Other Nutrition and chemoprevention Chemical contraceptives Research on chemopreventative agents and

health protective effects of nutrients including: Development, characterisation and mechanism of action of functional food

Development, characterisation and mechanism of action of supplements/nutrients

Testing and evaluation in model systems and clinical, applied and community settings

Other Vaccines Decision making, outcomes from vaccination and

evaluation of evidence to inform policy Research on vaccines for prevention of disease

including Development, implementation and evaluation of vaccination programmes

Discovery, development and testing of vaccines Mechanism of action of vaccines Other

78

Main objectives and impact of the research activity

1st level 2nd level 3rd level Prevention of Disease and Conditions, and Promotion of Well-Being (continued)

Resources and infrastructure (prevention) Infrastructure to support research trials, networks, consortia and centres

Resources for the research community (equipment, cell lines, biobanks, omics data)

Detection, Screening and Diagnosis Discovery and preclinical testing of markers

and technologies Biological and psychological markers development

Discovery, development and evaluation of diagnostic, prognostic and predictive markers and technologies

Discovery, development and preclinical testing of novel markers (that may be derived from patient samples) and technologies for use in detection, diagnosis, prediction, prognosis and monitoring including:

Development and characterisation of models

Diagnostic and monitoring devices (excl.imaging) development

Diagnostic measures and methodologies development

Imaging techniques and devices development Predictive and diagnostic tests (Kit, IVD)

development Other Clinical evaluation of markers and

technologies Assessment of sensitivity, efficacy, specificity, predictive and prognostic value, reproducibility and safety

Testing and evaluation of markers and technologies in humans for use in detection, diagnosis, prediction, prognosis and monitoring in clinica or community:

Diagnostic and monitoring devices (excl.imaging) evaluation

79

Main objectives and impact of the research activity

1st level 2nd level 3rd level Clinical evaluation of markers and

technologies (continued) Evaluation of diagnostic models, methods and methodologies in clinical or applied settings

Imaging technologies and devices evaluation Predictive and diagnostic tests (Kit, IVD)

evaluation Other Influences and impact Attitudes and beliefs including cultural and

religious practices Studies investigating impact of screening and

factors affecting uptake including: Development, implementation and evaluation of interventions to promote screening including policy, education and communication

Genetic counselling and decision making Issues relating to gender, age and ethnicity Psychological, social and economic factors Other Population screening Evaluation of effectiveness, benefits and

economic evaluation Studies investigating population screening :: Feasibility studies, pilot studies and trials Impact on health services and policy issues Models of population surveillance Other Resources and infrastructure (detection) Infrastructure to support research trials,

networks, consortia and centres Resources for the research community

(equipment, cell lines, biobanks, omics data, informatic systems)

80

Main objectives and impact of the research activity

1st level 2nd level 3rd level Development of treatments and therapeutic Interventions

Pharmaceuticals Drug discovery (biopharmaceuticals, vaccines..)

Discovery and development of therapeutic interventions and testing in model systems and preclinical settings

Identification and development of pharmaceutical small molecules, therapeutic vaccines, antibodies and hormones including:

Drug discovery (small molecules)

Drug screening and development of delivery systems

Mechanism of action including side effects and drug resistance

Pharmacogenetics, prediction of genetic variation and responses to drugs

Testing in in vitro model systems Testing in vivo model systems Other Cellular, tissue and gene therapies Cell and stem cells therapy Discovery and development of cellular, tissue

and gene therapies including: Development of culture systems

Development of delivery systems Gene therapy In vitro fertilisation therapy Testing in in vitro model systems Testing in vivo model systems Tissue engineering Other

81

Main objectives and impact of the research activity

1st level 2nd level 3rd level Development of treatments and therapeutic

Interventions (continued) Medical devices Dressings, bandages

Discovery and development of medical devices including:

Implantable devices

Medical equipment for therapy Microwaves, ultrasound, laser and phototherapy

devices Mobility aids Physiotherapic equipment Prostheses Safety assessments and investigation of adverse

events Sterilisation and decontamination of equipment

or surfaces Testing in in vitro model systems Testing in vivo model systems Other Surgery Development of tools and equipment for surgical

interventions Development of surgical, obstetric and dental

interventions including Histocompatability, transfusions,

Mechanisms of recovery, tolerance, side effects including infection

Surgical techniques development Testing in in vitro model systems Testing in vivo model systems Transplantations and side effetcs Other

82

Main objectives and impact of the research activity

1st level 2nd level 3rd level Development of treatments and therapeutic

Interventions (continued) Radiotherapy Applicantion of microwaves, ultrasound, laser

and phototherapy devices Discovery and development of interventions

including: Development of delivery systems

Investigation of mechanisms of action and side effects

Radiobiology, radiotherapy, radioimmunotherapy, radiosensitisers,

Testing in in vitro model systems Testing in vivo model systems Other Psychological and behavioural Cognitive behavioural therapy, counselling,

therapy and social interventions Development of psychological and behavioural

interventions including: Drug therapy

Electro-convulsive, devices therapy Testing in model systems Other Physical therapies applications Dietetics, exercise Development of physical interventions : Mechanisms of action Occupational therapy Osteopathy therapy Physical therapies, physiotherapy Speech, learning therapy Testing in model systems Other

83

Main objectives and impact of the research activity

1st level 2nd level 3rd level Development of treatments and therapeutic

Interventions (continued) Complementary Hypnotherapy, meditation, massage and

homeopathy Discovery and development of complementary

approaches to conventional medical therapies including:

Mechanisms of action

Testing in model systems Other Resources and infrastructure (development of

treatments) Infrastructure to support research trials, networks, consortia and centres

Resources for the research community (equipment, cell lines, biobanks, omics data, informatic systems)

Evaluation of treatments and therapeutic

interventions Pharmaceuticals Assessing sensitivity, efficacy, specificity, relapse,

survival, therapeutic value, pharmacokinetics, reproducibility and safety

Testing and evaluation of therapeutic interventions in clinical, community or applied settings

Clinical application and evaluation of small molecules, therapeutic vaccines, antibodies and hormones in humans :

Phase I, II, III and IV trials

Small scale settings and pilot studies Studies monitoring response, outcome, drug

resistance and side effects Other

84

Main objectives and impact of the research activity

1st level 2nd level 3rd level Evaluation of treatments and therapeutic

interventions (continued) Cellular, tissue and gene therapies evaluation Cell and stem cells therapy

Clinical application and evaluation of cellular, tissue and gene therapies in humans including:

Evaluation of applied delivery systems

Gene therapy In vitro fertilisation therapy Phase I, II, III and IV trials Small scale settings and pilot studies Tissue engineering Other Medical devices evaluation Dressings, bandages Application and evaluation of medical devices

in humans in a clinical, community or applied setting including:

Implantable devices

Medical equipment for therapy Microwaves, ultrasound, laser and phototherapy

devices Mobility aids Prostheses Small scale settings and pilot studies Validation of design and post market surveillance Other Surgery evaluation Evaluation of surgical procedures (incl.

transplantations, tissue grafts and transfusions) Clinical and applied application and evaluation

of surgical, obstetric and dental interventions : Monitoring outcomes, side effects and rejection

85

Main objectives and impact of the research activity

1st level 2nd level 3rd level Evaluation of treatments and therapeutic

interventions (continued) Surgery evaluation (continued) Phase I, II, III and IV trials

Small scale settings and pilot studies Other Radiotherapy evaluation Evaluation of procedures using microwaves,

ultrasound, laser and phototherapy devices Clinical application and evaluation of

interventions in humans including: Monitoring side effects

Phase I, II, III and IV trials Radiobiology, radiotherapy,

radioimmunotherapy, radiosensitisers, Small scale settings and pilot studies Other Psychological and behavioural evaluation Cognitive behavioural therapy, counselling,

therapy and social interventions Application and evaluation of psychological

and behavioural interventions in humans in clinical, community and applied settings

Drug therapy

Electro-convulsive, devices therapy Phase I, II, III and IV trials Other Physical therapies evaluation Dietetics, exercise Testing and evaluation of physical

interventions in humans in a clinical, community or applied setting including:

Occupational therapy

Osteopathy therapy

86

Main objectives and impact of the research activity

1st level 2nd level 3rd level Evaluation of treatments and therapeutic

interventions (continued) Physical therapies evaluation (continued) Physical therapies, physiotherapy

Speech, learning therapy Other Complementary evaluation Acupuncture All aspects of testing, evaluation and provision

of complementary approaches to conventional medicine in humans in a clinical, community or applied setting including:

Attitudes and beliefs of patients and health care professionals

Hypnotherapy, meditation, massage and homeopathy

Issues relating to health and social services and health care delivery

Other Resources and infrastructure (evaluation of

treatments) Infrastructure support for clinical and applied research networks and trials, consortia and centres

Provision and distribution of resources related to clinical and applied therapeutic interventions

Management of diseases and conditions Individual care needs Assessment of social care and health services

needs Research into individual care needs and management of disease, conditions or ill health

Studies of patients and service user care needs including:

Behaviour affecting disease management (secondary prevention, compliance to treatment etc)

87

Main objectives and impact of the research activity

1st level 2nd level 3rd level Management of diseases and conditions (continued) Individual care needs (continued) Educational or communication interventions to

promote self-care or improve health care by carers

Impact on carers Management of acute and chronic diseases Management of long term morbidity and chronic

diseases Management of reproductive issues Psychological impact of illness Quality of life, management of side effects Rehabilitation (physical and neurological) Social and economic consequences of ill health Other End of life care Assessment of patient, service user and carer

needs Studies involving all issues related to palliative

care and end of life care including: Bereavement management

Pain management for terminally ill people Provision and evaluation of palliative and end of

life care services Quality of life for patients and carers Social, economic and policy issues Wvaluation of interventions for health and social

care professionals Other

88

Main objectives and impact of the research activity

1st level 2nd level 3rd level Management of diseases and conditions (continued) Management and decision making in

management of diseases Attitudes, beliefs and behaviours of health and social care professionals

Studies into all aspects of the management of diseases, ill health and conditions by health and social care professionals

Development of guidelines, interventions or models to assist decision making and management (identifying symptoms, predicting outcomes and identifying individuals at risk)

Educational interventions and communication practices

Investigation of decision making factors (diagnosis, treatment, referral and management strategies)

Testing and evaluating management regimes and strategies

Other Resources and infrastructure (disease

management) Development and/or distribution of resources and equipment for use by the community including informatics systems

Infrastructure support for trials, networks, consortia and centres

Health and social care services research

Organisation and delivery of services Access to health and social care and geographical variations in outcomes

Research into the provision and delivery of health and social care services, health policy and studies of research design, measurements and methodologies

Examining the organisation and provision of health and social care services and evaluating factors affecting the quality of care

Aevelopment and evaluation of interventions to improve services

Assessment of current and future health care demands

89

Main objectives and impact of the research activity

1st level 2nd level 3rd level Health and social care services research (continued)

Organisation and delivery of services (continued)

Effectiveness of different care settings and models of service delivery

Evaluating quality of care including patient safety issues

Evaluation of experiences of service users Organisation and management of services Workforce and career issues Other Health and welfare economics Cost effectiveness or economic feasibility of

implementing new interventions or technologies within health services

Economic evaluation of health and social care interventions and delivery:

Cost-benefit analysis of services including economic modelling

Development and evaluation of economic models of health care

Economic assessment of service productivity and outcomes

Health care costs Other Policy, ethics and research governance Dissemination and implementation of research

evidence Evaluation of local, regional and national

healthcare policy Impact of legislation Issues surrounding research subjects and donor

recruitment

90

Main objectives and impact of the research activity

1st level 2nd level 3rd level Health and social care services research (continued)

Policy, ethics and research governance (continued)

Research ethics including use of personal data and biological material, consent and confidentiality

Research governance and regulation processes including interpretation of guidelines

Synthesis and evaluation of evidence to inform policy

Other Research design and methodologies Analytical innovation, methodological research,

statistical methods and modelling Development of research designs and novel

methodologies for health care including treatment, management and health services research

Development and evaluation of research designs and methodologies

Development of methods of research assessment and evaluation

Development of research measurements including outcome measures

Other Resources and infrastructure (health services) Development and distribution of resources for

use by the community including informatics systems

Infrastructure support for networks, trials, consortia and centres