Tussentijds verslag dr. ir. Sofie Bekaert

SYMPOSIUM: DRUG RESEARCH UNIT FACILITATION THROUGHOUT THE TRANSLATIONAL PATH @GHENT PROF. DR. IR. S. BEKAERT

Dzau et al. (2013) NEJM 369, Transforming Academic Health Centers (AHCs) for an uncertain future AHCs need to increase the yields of research, accelerating

the translation of results into practice …in doing so requires establishing an effective ‘discovery-to-care continuum’ , by the creation of centers of clinical research…

… those centers can catalyze interdisciplinary collaborations and assemble resources into shared core services and facilities that offer natural economies of scale.

Intrinsic assets of Academic Health Centers (AHCs), such as access to biological samples and clinical data, should be better leveraged.

In the big data era, AHCs should strive to become ‘learning health systems’ by making clinical data research grade

Translational Biomedical research: challenges: AHC’s

Angus et al., JAMA, 2015 . Fusing randomized trials (RCTs) with Big data: the key to self-learning health care systems. True success may only come when health care delivery

systems are adequately motivated to answer research questions

Thus, RCTs and big data have complementary strenghts: RCTs offer causal inference and big data offers the potential for low cost, high-volume, nuanced answers with immediate feedback (=adaptation)

In the era of precision medicine, there is a desire for estimates of treatment effects for individual patients

Adaptive clinical trials which incorporates rules to adjust aspects of the trial during enrollment, are well suited for answering those questions

Translational Biomedical research: challenges: AHC’s

Translational Biomedical research: challenges: AH’s and … multiple helix?

Courtesy of Kurt Zatloukal, BBMRI.eu Reproducibility? (data) Sharing versus privacy?: F(indable) A(ccessable)

I(nteroperable) R(eusable) = FAIR principle Secondary use of data/samples? Consent and/or research as route to lawfull processing Liability? Standards and accreditation? Changing regulatory environment? Structural funding? sustainability?

Fig 2. Estimated US preclinical research spend and categories of errors that contribute to irreproducibility. (Freedman et al. Plos Biology, June 2015)

Ioannidis JPA (2016) Why Most Clinical Research Is Not Useful. PLoS Med 13(6): e1002049.

KCE Trials program

Bimetra: Translational research @ Gent: mission

Bimetra facilitates and integrates different aspects of translational biomedical research acting as a central point of contact (CPOC) to catalyze translational research from bench to bedside and from bedside to community and hence leveraging economical and societal valorization.

Basic research

Preclinical research

Clinical research Care

Bimetra is the Clinical Research Centre from Ghent University Hospital in collaboration with Ghent University.

Bimetra = central point of contact 10

Research

Vali-dation

Valor-isation

Basic research

Preclinical research

Facilitation from BEDSIDE to

Bimetra: Translational research @ Gent: vision

Bimetra Clinics: CPOC clinical trials

Central Point Of Contact (CPOC):

Investigator-initiated • Advice and submissions EC / CA • insurance • monitoring (TIV, visits, EoTV) • safety Reporting • NCE contract preview and -filalisation

Commercial (industry-initiated) research:

= COE: • Advice third parties • COE contract preview and -finalisation

Strategic policy and liaising activities: Internal

• UZ Gent (central): JuriDi, FiDi, HR, EC • >40 depts.

External • UGent (central): TechTransfer, Financ dept, • FAGG, KCE, RUZB/CHAB • >140 companies & clinical sites

Bimetra Clinics: CPOC clinical trials

68% submissions vs. 2012

2015: 1720 NCE + 622 COE = 2342

+18% vs. 2014

2014: 1440 NCE + 548 COE = 1988

+18% vs. 2013

2013: 1173 NCE + 506 COE = 1679

+21% vs. 2012

2012: 880 NCE + 513 COE = 1393

Status 30/06/2016 vs. 30/06/2015:

859 (+16%) NCE + 423 (+35%) COE submissions

Bimetra Biobank: CPOC Biobanking

High quality biobank facility to stimulate translational biomedical research.

• Keywords: • Transparency • Collaboration • Autonomy (no centralised model)

• use of certain minimal datasets (MDS) linked to biospecimen

• Use of service level agreements (SLA) and Material transfer agreements (MTA)

• Access flows and service-cost models

Focus: academic research with translational finality • Prospective collections • Possible intake of important historical collections • High quality all-round service provider for biobanking:

• Sample preparation, storage and post processing • Translational data management • Biobank service support center

Biobank initiatives: at best…

High quality repositories Annotated samples Collaborative model Harmonized QA/QC Economy of scale Harmonized guidelines/rules

= Biological back end of data driven collaborative biomedical research

Biobanks: What?

First introduction definition Biobank: Law 19th December 2008 and adjustments ‘Wet houdende diverse bepalingen inzake gezondheid’, dd. 29.03.2013; dd. 22.06.2016

concerning access and use of human body material for clincial application on human subjects or for scientific research purposes (‘inzake het verkrijgen en het gebruik van menselijk lichaamsmateriaal met het oog op geneeskundige toepassing op de mens of het wetenschappelijk onderzoek):

27° « biobank » : structure that stores and provides human body material exclusively for scientific research purposes, and which use is not intended for any (therapeutic) application on human subjects. (de structuur die menselijk lichaamsmateriaal bewaart en ter beschikking stelt, uitsluitend voor wetenschappelijk onderzoek en dat niet bestemd is voor enige toepassing op de mens)

Biobank initiatives: at best…

Bimetra BIOBANK: CPOC phenotype management & access

1 harmonised guideline (Flemish Biobank Initiative) Based upon:

ISO9001 OECD Best Practice Guidelines for Biological Resource Centers OECD Guidelines on Human Biobanks and Genetic Research Databases Toekomst: ISO-norm voor biobanken (betrokken in ISO working group) (ISO15189 & ISO17025: test labs

NOT biobanks) 45 ULT (-80°C) freezers

“tailormade” airconditioning Double monitoring control: device independent alarms

Focus: academic research with translational finality Establishing a central point of contact for phenotype management & access

Prospective collections Possible intake of important historical collections High quality all-round service provider for biobanking:

Sample preparation and storage Translational data management Biobank service support center

Minimal data sets < standardisation Flemish Biobank Initiative < based on general accepted minimal data parameters for

samples (SPREC codes) combined with essential parameters from BRISQ Recommended by

Biobank initiatives: local participation

Biobank initiatives: international participation

Currently ~500 Biobanks connected

Flemish Biobank Network: hub-and-spoke model 23

5 Locally installed components : • Each biobank can make

pseudonymized data available from one or more local Biobank Information Management Systems through its local Opal

• and can make aggregated results of a subset of the variables available to the central catalogue

Flemish Biobank Network: ICT infrastructure 24

1 central catalogue of biobank samples:

• mapping different datasets and subsets from autonomous database systems

• enabling aggregated query results and

threshold induced notifications for participating researchers

• publish with Mica web portal

Flemish Biobank Network: facts and figures

Results to date: 4 decentral biobank facilities linked via

central ICT-backbone

Harmonized quality management system cfr international standards

Harmonized ethical-legal framework

>30.000 cases uploaded: 227.990 by 2016

5% cases used in research

collaborations: ~16% by 2016

= Biological back end of data driven collaborative biomedical research

Cardiovascular diseases

Metabolic disorder s

Viral infectious diseases

Immune mediated inflammation

Oncology

Neurodegenerative diseases

COPD/Asthma

Reproductive medicine

Rare diseases

Ageing

5 selected focus

biobanks

xx biobanks proposed for later

integration

Hepatotropic disorders

Sudden Cardiac Death

Rheumatoïde arthritis Inflammatory bowel Disease

Diabetes

Demonstrated scientific excellence Research collaboration Available patient populations Valorisation potential High quality samples + data

Flemish Biobank Network: focus biobanks

Flemish Biobank Network: ICT infrastructure 27

Future development: Opal-Opal data sharing Specific datasets shared through a system of “remote views

Bimetra TDM: CPOC Translational Data Management

Consulting Best practices BIMS, privacy, traceability, sharing Clinical/Biobank/meta data collection, processing,

management Integration throughout the sample/data process

flow (‘cradle to grave’)

Use of selected LIMS tool Project-specific customization Software validation Data linkage /data sharing

Evaluation software translational data management Clinical data management systems Protocol design software

Networks CRC / Biobanks Data sharing policy Management central ICT backbone / catalogue

Project tracking

Lab software

Sample storage

Patients

Clinical trial

EHR4CR

OpenClinica, REDCap

Bimetra TDM: service

Esperity

Sample locator BE node BBMRI directory

CMI backbone, Mica, Opal

Basic research

Preclinical

research

Digitale pathologie

Jira (admin + service desk)

Bimetra Valorisation: CPOC translational innovation

Funding/ R&D

Project Results

Protection Project results

Validation Valorisation

Bimetra networking: sharing and linking beyond UZGent

Biobanking networks Translational initiatives and networks EU-H2020:

ESFRI: BBMRI.EU ?EATRIS, ECRIN, ELIXIR

EIT Health big data’:

Champion program EHR4CR (biomedical) innovation initiatives Industry Government PATIENT PARTICIPATION

Patient information Patient recruitment Patient engagement

Bimetra networking: coördinatiecellen

Research

Validation

Valorisation

Medical Devices

Contact: www.bimetra.be 33

Prof. Sofie Bekaert Head of dept. Bimetra sofie.bekaert@uzgent.be Philippe Van Rompaey, PhD Bimetra Clinics Philippe.vanrompaey@uzgent.be

Veronique T’Joen, PhD Biobank Manager veronique.tjoen@uzgent.be Lieven Vaneeckhaute Bimetra TDM Lieven.vaneeckhaute@uzgent.be

Tussentijds verslag dr. ir. Sofie Bekaert

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