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Clinical Research and Biological Resources Paul Hofman Nice Hospital-related Biobank BB-0033-00025 French National Biobank Infrastructure FHU OncoAge University of Nice Sophia Antipolis, France UCA IDEX jedi www.oncoage.org FHU Shanghaï, 15-17 October Journée de la Recherche Clinique en Cancérologie Aix-en-Provence, 18 Janvier 2017
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Page 1: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Clinical Research and Biological Resources

Paul Hofman

Nice Hospital-related Biobank BB-0033-00025French National Biobank Infrastructure

FHU OncoAge University of Nice Sophia Antipolis, France

UCA IDEX jediwww.oncoage.org

FH

U

Shanghaï, 15-17 October

Journée de la Recherche Clinique en CancérologieAix-en-Provence, 18 Janvier 2017

Page 2: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 3: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 4: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

IFTAB, 24 mars 2011

• Le Monde du 16 juin 2014

– Biobanques : le patient

recomposé

• Les Echos du 27 janvier 2011

– Les biobanques montent en

puissance

• Médiapart du 16 décembre 2008

– Les biobanques ou

l’indispensable démocratisation

des collections de ressources

biologiques humaines

• Libération du 25 novembre 2006

– Biobanquier, un métier d'avenir

Biobanking A major issue for today and tomorrow

Page 5: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 6: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

16 juin 2014

Page 7: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

JDD, sept 2016

Page 8: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 9: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

..

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..

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...

More than 2000 biobanks all around the World !

.

. .

.

.

. ... .

...

A permanent increased number of biobanks

.....

. ..

Page 10: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

More than 400 biobanks !

Page 11: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Tumor Biobanks in France

Page 12: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

The French network of biobanksMore than 90 biobanks

Infrastructure Biobank Projectwww.biobanques.eu

Page 13: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

(International Society for Biological and Environmental Repositories)

International Societies of Biobanking

Page 14: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 15: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

High number of biobanks & strong competition

What is the key for a success story?

Page 16: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Core structure funding of biobanks in France

• From 2004 until 2013:

– French NCI (INCa) for frozen tumor samples

– Inserm for frozen non tumor samples

• From 2014 until now:

– DGOS* for both tumor and non tumor samples

• Budget according to:– Certification (S96-900 and/or ISO 15189) or not (+/- 30%)

– Stockage activity

– De stockage activity

*No scientific activity assessment and no « in site » evaluation

Page 17: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 18: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Related to defined clinical trials and/or « dedicated clinical

research projects »

The different « sources » of human biologicalsamples for the development of research projects

Collected prospectively in the biobank for a «large declared

project »

Collected retrospectively from«requalification of samples» following patient taking care

BiobankCIC/CRC

Storage

De

stru

ctio

n

Re

qu

alif

icat

ion

BioathologyLab

Re

qu

alification

Page 19: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 20: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

• To get public-public partnerships

• To get public-private partnerships

• To get higher visibility for the institutions

• To get an open option for financial support project

• To integrate consortia and expert networks

Page 21: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Current context

Strong impact of using bioresources in translational research projects

Dramatic use of biological resourcesin scientific projects

Page 22: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 23: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

THBMontreal

Page 24: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

RAS PI3K

MEK mTOR

AKTBRAF

Cetuximab, Panitumumab,

Matuzumab

EML4/ALK fusion protein

Nucleus

IGF-IRFGFR EGFR HER2

MET

EGF HGF

IMC-A12CP-751.87

PD173074

LKB1

Downstream cellular effects

PTEN

Gefitinib, Erlotinib, HKI-272, CI-1033

Neratinib, XL647

First generation EGFR-TKIs

Monoclonal antibodies

AfatinibLapatinib

PF-00299804

TranstuzumabSCH-900105

XL147LY294002

MK 2206

ARQ-197PF-02341066XL184

Second generation EGFR-TKIs

SirolimusDeferolimusEverolimusTemsirolimus

TipifarnibLonafarnib

ISIS 2503

SorafenibGSK2118436

CI-1040PD-0325901

AZD6244GSK1120212

Crizotinib

BEZ 235GDC-0980PF-04691502PKI-587PI-103

Dual PIK3CA/mTOR inhibitors

A couple of target therapies in lung carcinoma

Ilie and Hofman, CMC

Page 25: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Stratified medecinein cancer patients

The right drug The right patient The right time

The right costThe right approach

Page 26: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Stratified medecinein cancer patients

The right drug The right patient The right time

The right costThe right approach

The right sample (s) !

Toward biomarkerdiscoveries

Page 27: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Immunotherapy is more than a sudden substantial overturning in cancer patient taking care

Page 28: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 29: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 30: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

http://www.biobanques.eu/fr/meeting-2016

Page 31: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Biobanking 1.0Number of biospecimens

Biobanking 2.0Quality of biospecimens

& associated data

Biobanking 3.0Person related dataStakeholder’s needs

Sustainability

1990-2005

2005-2015

2015-….

Page 32: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 33: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

How to demonstrate than a cancer biobank can be an efficient platform for researchers?

How to be attractive?

Page 35: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Contributors for the establishement of indicators

Nice University

Véronique Hofman

Elodie Long

Marius Ilie

Kevin Washetine

ESBB Past President

Robert Hewitt

BRIF members

Laurence Mabile

Anne Cambon

Barbara Parodi

Infrastructure Biobank

Georges Dagher

Bruno Clément

French NCI INCa

Pascal Bouchet

Page 36: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

How to select an efficient Cancer Biobankfor setting up a research project ?

• 1. Performance indicators related to quality

• 2. Performance indicators related to activity

• 3. Indicators related to scientific productivity

• 4. Indicators related to external dissemination

Hofman et al, Biopreservation & Biobanking, 2013

Page 37: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...
Page 38: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

TOTAL= X PTS /250 PTS

200-250= Excellent (A+)

150-200= Very good (A)

120-150= Good (B)

100-120= Moderate (C)

<100= Weak (D)

Hofman et al, Biopreservation & Biobanking, 2013

Page 39: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Cambon-Thomsen A, Thorisson GA,, Andrieu S, Bertier G, Hofman P

Boeckhout M, Hewitt R, Kauffmann F, Mabile L

Increasing the Quality of Bioresource for Research Activity

Page 40: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Actors involved in the complex « World of bioresources » !

Mabile L, Hewitt, R, Hofman P, Cambon-Thomsen A. Gigasciences, 2013

Creation of a unique identified number (a Biobank ID )

Page 41: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Type : 426KB PNG

Next Generation is everywhere

Page 42: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Next Generation Biobanking

Page 43: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

• Implementation of person related complex data

• Implementation of « new » data (NGS) associated to samples

• Enabling multidimensional molecular profiling in personalized/stratified medicine

• Dynamic strategy for the assessement of stakeholder’s needs

• Set up biobankonomics

• Obtained an international accreditation (CAP, ISO 15189, UK NEKAS)

The main issues for an NGB

Page 44: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Expert pathologists Expert biologists

Expert bioinformaticians

and biostatisticians

Expert administrativestaff

Expert data managers

Page 45: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

BiopathologyLiquid biopsy

laboratory

Computingmodeling

Quality assuranceQuality control

Genomics

Page 46: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Dynamic strategy

To be able to useboth retrospective and

prospective collected samples

Provide a permanent medicaland scientific watch

Focused activity on one or two well managed pathologies

Diversify the sources of biospecimen for the

same cohort of patients

Set up public-private partnerships

Anticipation is required

Page 47: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Next Generation Cancer Biobanking

Tissue/liquid samplesmonitoring

Integration of molecular biology

big data

Availability of associated

virtual images

Dynamic primary cultures

and PDX

1 432

Page 48: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 49: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Hospital-Integrated Lung Tumor Biobank of the Nice University (BB-0033-00025)

A member of the Canceropole PACA Biobank Network

(www.biobank-paca.com)

Page 50: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

A couple of milestones of the Nice University Biobank

• 2003 Grants of the French Ministery of Health & Inserm

• 2004 Integration in the French Lung Cancer Biobank Network

• 2005 Member of the Biobank PACA (Marseille-Nice)

• 2007 RFID implementation

• 2008 Establishment of a Master course for Biobank Management

• 2009 Certified by the S96-900 norm

• 2010 Member of the ESBB, BBMRI, and Infrastructure Biobanque Project

• 2011 Member of the Bioresource Research Impact Factor group (BRIF)

• 2012 Member of the IRCAN research Center and of the Labex Signalife

• 2012 Major partnership with Genentech, Roche, Sanofi & Myriad Genetics

• 2013 Accredited according to the ISO 15189 Norm

• 2015 Member of the Oncoage consortium (www.oncoage.org)

• 2016 Creation of the Master Biobanks and complex data management

Page 51: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

**Nice Biobank

French Network of Lung Cancer Biobanks

*

**

** *

Grenoble Biobank

Toulouse Biobank

Bordeaux Biobank

Tenon Biobank

Strasbourg Biobank

Caen Biobank

Nancy Biobank

*Marseille

www.biobank06.com

Page 52: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Diversity of bioresource available from lung cancer patients

FFPE tissues &tissue microarrays

Frozen tissues

Plasma & sera

DNA & RNA

Page 53: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Clinical and Biological DatabaseLung cancer tumors

(Cohort of 7087 patients)

Blood Tissues

Plasma/serumCTCs & DNA

DNARNA/miRNA

Tissue microarrays

Frozen FFPE

Clinical database (LH)

499 items

Pathological database (LB)

249 items

Molecular biology database (LM)

150 items

Dat

aB

iore

sou

rce

s

Page 54: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Data Management

Gross macroscopyHistology

Patient Consent

Paraffin Blocks

« in mirror »

ControlsImages

RNA Quantity/Quality

MolecularBiologyTreatment

Outcome

Clinical datas

Central databaseCresalys

Pathology

Tissuemicroarrays

automatisationquantification

Frozen specimenTumoral/ non tumoral

Reseach

Dynamic strategy

Page 55: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Core facility integrated in the Biobank

Laser Capture Microdissection

IHC/ISHCTCs

ftDNADNA arrays

miRNA arrayscGH arrays

TMAs

Primary cultures and other biofluids(pleural effusion)

Pyrosequencing Molecular biologyNGS

SequenomBioinformatic

Page 56: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

0

20

40

60

80

100

120

140

160

180

2009 2010 2011 2012 2013

Cumulative

Impact factor /

Year

S96-900 &

ISO15189 norm

Index

Budget Balance

Dynamic Strategy 4 Main monitoring indicators of the Lung Biobank

Publications: Cumulative impact factor per year

Sustaining of the certification and accreditation

De-stocking-storage index

Budget Balance

Re

lati

ve n

um

be

rs

6763

89 92

68

0.21

0.17

0.33

0.38

0.34

20162015201420132012

Page 57: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

NGS for lung cancer biospecimens

Integration of genomic information for samples collected in the biobank

Page 58: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Implementation of the GeneReader NGS system (Qiagen) (2016)

Performance evaluation in comparison with PGM platform

Page 59: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

TMA Grand Master (3DHISTECH) - high-throughput TMAs

Page 60: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Digital PathologyCorresponding virtual images available

Page 61: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Culture room for primary cultures establishment/xenograft

Page 62: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Intellectual Property (potential future patents) should be discussed through the contract

and before sending samples

Page 63: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Nice/BRIF Number: BB-0033-00025

First biobank in France for the item« ratio, number of samples/publications »

Page 64: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Usefulness of Radio Frequency IDentificationExperience of a single institution (CHU of Nice)

Page 65: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Gross macroscopy

Cytology

Immunohistochemistry

Laundry

Meeting room

Tissue specimen sectioning room

Pneumatic tube

Recording data

ENTRY

ENTRY

Integrative pathology model Optimization of the processes

www.biobank06.com

Surgical room

Biobank Area

Reader Reader

Reader

Reader

Reader

A B

C

D

E

BANK

RFID Readers

Page 66: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Innovation in biobanking best practices

DNA room temperature storage (collaboration with Imagene)

Efficient method for long-term room temperature storage of DNA

Nice Biobank, July 2016*

* 12578 aliquots of DNA from the lung cancer collection

Page 67: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

LPCE – Biobank

Page 68: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

LPCE – Biobank

Page 69: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Academic partners Academic partnersPrivate partners Private partners

Nice University Lung Biobankworking as an Expert Center

(scientific collaborations/research)

Nice University Lung Biobankworking as a Biorepository

(accommodation/simple provider)

Genentech (US)Roche Ventana (US)Qiagen (Germany)Genzyme (US)Sanofi Aventis (Fr)Servier Oncology (Fr)IBM & ST Micro (EU)Biomérieux (Fr)Transgene (Fr)Myriad Genetics (US)Merck (US)Imagene (Fr)

CNRS UMR 7284Inserm U1081CNRS UMR 7275Inserm U981Inserm U911Inserm U674CLCC Leon BerardParis DescartesFudan Cancer ChinaMünchen UniversitatHelmholtz CenterIARC LyonCEA ParisIGR Villejuif

Tissue Solutions Ltd (UK)Transhit Biomarkers (Can)Oncodesign (Fr)Debiopharm (Swi)Transgene (Fr)Roche (US)Dako (US)Astellas (Jpn)Empire Genomic (US)ImmunocoreQiagen

None

2014-2016

Page 70: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

IRCAN

UNS

CAL

CHUN

IPMCIBV

HCL

LYON

NICEAREA

PARISCEA

ESPICINRIA

LEGEND

Clinical Centers

Research Centers

CLB

IGR

IARC

LP2M

www.oncoage.orgNetwork

Director P Hofman

2016-2019

« To better understand the relationships betweenaging phenomenon and cancer »

Workpackage 1: Lung Diseases in Elderly

Page 71: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Ischemic heart disease

Cerebrovascular disease

Lower respiratory infection

Diarrheal disease

Perinatal disorders

COPD

Tuberculosis

Measles

Road traffic accidents

Lung cancer

Estimated mortality

worldwide

COPD: Major healthcare issue

6th

3rd

1990 2020

10th

5th

* Source: Murray CJL, Lopez AD. Lancet;349;1269-76.

Page 72: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Agenda

• Introduction

• Which bioresource availability for the development of a research program?

• Why a biobank is an inescapable structure for translational and clinical research?

• Main current and future recommendation for the use of bioresources for research

• Experience from the Nice Hospital

• End-points

Page 73: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

How to use easily cancer bioresources from biobanks for a research project ?

Why such a gap ?

Page 74: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

A lung Cancer Biobankworking as an Expert Center

(scientific collaborations/research project)

A lung Cancer Biobankworking as a Biorepository

(accommodation/simple provider)

or

1

2

Page 75: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

The Turn Around Time

Partner request………………………Delivery of samples

Page 76: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Bioresources Request

WHO ? WHAT ?

Request analysis :Database queryTechnical feasibilityFinancial feasibility

Application rejected

Application accepted

Notification to the client

Contract proposal

ApprovalApplication rejected

Formalization of contracts,Signature of contracts

Billing request and follow up

Parnters (public or private)

Head of the Biobank

Head of the Biobank, ManagerClients

Data ManagerPathologist

Head the BiobankPhycisiansScientific commiteeBioethic commitee

Clients,Head of the BiobankPathologist

Head of the BiobankLegal institution representative

Clients,Head of the Biobank,Manager,Legal institution representative

yes

email acknowledging receipt of the application

No

Bioresources destocking

Shipment

Biobank technicians and engineers

Head of the BiobankLegal institution representativeManager

Workflow from the partner request to the delivery

of the bioresources

currently in:

Legal & Ethical issues

Page 77: Clinical Research and Biological Resources€¢ 2016 Creation of the Master Biobanks and complex data management * * Nice Biobank French Network of Lung Cancer Biobanks * * * *** ...

Meet the criteria to be an attractive 3-0 biobank for public-private partnerships

1) Indicators demonstrating the « good value » of biological samples and clinical associated data2) Certification and accreditation of the biobank, according to international recommendations3) Strict and transparent governance of the biobank4) In-house expertises and strong R&D capacity5) Willingness, tool and capacity to collaborate and develop multicenter projects

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Goulot d’étranglement (2) Le « coût des échantillons »

Human sample pricing : Is it a bottleneck and a taboo subject ?

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Recovery cost* for biological resources evaluated by the French NCI

(March 2010)

(INCa, www.e-cancer.fr)

*These costs do not includethe biobank expertise

(pathologist work, data managementthe cost of transport…)

2008 !

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2014

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How to easily get access tobiological resources for clinical

and translational research programs?

End-Points

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Criteria to get a out standing Lung Cancer Biobank

Biopsies ou pièces opératoires

Research Productivity

Ethics StandardsQuality of samplesAccreditation &Certification

Grants and financial supports

Toward a high Bioresource Research Impact Factor (BRIF) for Biobanks The assessment of the value of a collection

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From a labyrinthine system to an effective model

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Sustainable Business PlanA Key Issue for an Academic Biobank

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Creation of a virtuous circle

Quality of health care

Biobanking

Financial support

Research & Development

Publications

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The biobanker

A new, specific andpromising job of the future!

WWW.univ-coted’azur.fr/masterbiobank

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