testing of pancreas cancer in world of the ngs … · 2020-01-30 · cancer patient matching...

TESTING OF PANCREAS CANCER IN WORLD OF THE NGS CONVENTION

Marc Van den BulckeCancer Centre

Sciensano

Diegem, 11 January 2019

1. Implementation of NGS in routine diagnostics in oncology at national level (including pancreascancer)

2. iPCP for sustainable development of complexNGS application in Healthcare Systems

3. IPAAC, EC Cancer Mission and EU Beat Cancer Plan

Three topics

BGDO Annual Meeting 2020 | Advances in Pancreaticobiliary Cancers Testing for Pancreatic Cancer in the world of the NGS convention Marc Van den Bulcke

Implementation of NGS in routine diagnostics in oncology in Belgium (2016-2020)

RoadbookACTION 1 Establish a commission: Commission Personalized Medecine (ComPerMed)ACTION 2 Development of guidelines for NGS use in (hemato)-oncologyACTION 3 Development of criteria for NGS use in (hemato)-oncologyACTION 4&5 Develop and organize a benchmarking trial and EQA for NGS use in (hemato)-oncology

ACTION 6 Implement NGS registration, storage and data managementACTION 7 Provide NGS education and trainingACTION 8 Informed consent, legal and ethical implications of NGS use in (hemato)-oncology

molecular diagnosticsACTION 9 Pilot study ‘NGS use in routine diagnostics’ACTION 10 Build on hospital networks for NGS use in (hemato)-oncology

GOVERNANCE

ELSI


Cancer Patient Matching framework : Part I

PATIENT A

Medical dataImageBiopiesSurgery

…NGS profileArt 33.ter

MOC/MTB

Treatment

NGS registerPITTER

Cyto histo PRCR….

HEALTHDATA

Match

PATIENT B

PATIENT C

Treatment/outcome

Treatment/outcome

Relevant information

Hospital X

Hospital Y

Cancer Patient Matching framework : Part II

Clinical Trialregisters

Matchingtrial


On December 27, 2019, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals LP) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma, as detected by an FDA-approved test, whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.

Annex of NGS Convention: Pancreas cancer

Pancreaskanker

Op FNA, in geval van de aanwezigheid van een cyste GNAS (exon 8, exon 9)

Awaiting approval

Cancer epidemiology

Pancreatic cancer is the 12th most common cancer worldwide, with 458,918 new cases in 2018 alone.With the worst survival rate of all the most common cancers, it is the seventh leading cause of cancer death, and less than 3% of patients with metastatic disease survive more than five years afterdiagnosis.Early diagnosis of pancreatic cancer is difficult, as often there are no symptoms until it is too late. Around 80% of patients are diagnosed at the metastatic stage.


NGS/WGS and Pancreas Cancer

Priestley, P., Baber, J., Lolkema, M.P. et al. Pan-cancer whole-genome analyses of metastatic solid tumours. Nature 575, 210–216 (2019) doi:10.1038/s41586-019-1689-y

Voorstel GOVERNANCE

Dag-dagelijkse werking in overleg met ‘Stuurgroep/Comité de pilotage’ (Min Volksgezondheid/SPF santé, RIZIV/INAMI, Sciensano)

± 3 maandelijks

Jaarlijks Activiteitenrapport/Actieplan (2 rapporten incluis budget)

Goedkeuring door ‘Begeleidingscomité/Comité d’accompagnement’ (Niveau politique (exec + legislative) + stakeholders)

Annuel (2e of 3e maand)

Goedkeuring door Verzekeringscomité (jaarlijks)

:EC Pre-Commercial ProcurmentNext-Generation-Sequencing in

Healthcare applications(acronym: oncNGS )

Cancer Centre - Sciensano

PRIVATE PUBLIC PARTNERSHIP IN ONCOLOGY


iPCP NGS in Healthcare (Horizon 2020 program)

Scope:

Aim to develop integrated solution for testing, analysing, reporting and storage of Next-Generation-Sequencing medical data within routine healthcare diagnostics

oncNGS: 11 million euro

Key challenges

Accessibility to all citizensStandardization from “Analyte to DATA”Timely platform conversionIP/Regulatory compliance (FtO, IVD, GDPR, ISO,…)InterdisciplinarityPrivate Public Partnership Cost


oncNGS PCP partnership

• The challenge will consist in providing:

(1) efficient molecular DNA/RNA profiling of tumour-derived material in liquid biopsies by means of (2) pan-cancer tumour marker analysis kit including NGS analysis integrated with (3) an ICT decision support system including test interpretation and reporting.

• EU Member States (MS) PCP requirement: at least 3 EU MSProposal: Be, Fr, It, Sp, Ger

• Procures (= Test buyers)At least two Local hospitals or private licensed medical labsProposal: about 40 hospitals and PH institutes in total

Start date: 01 January 2020 (5y project)

OncNGS PCP PlayersBUYERS (Lead procurer and procurer)

Supporting entities, third parties, interested entitiesTENDER

SupplierA

SupplierB

SupplierD

SupplierC

D

A

B

C

A

D

C

Chip

ClinVal

IT


WP1 and WP6

Phase 0

TECH specIP FTO

Business CasePrior Notification

StrategyCE IVD strategy

GDPR implicationsTender

Eval. Com (citeria,members)

Dessimination

PRECO

MMER

CIAL

TENDE

R

Phase 1Solutiondesign

Sup ASup BSup CSup D

DesignEvaluationCommittee(D EVC)

Phase 2Prototype development

Analytical testing

Sup ASup CSup D

Phase 3Pre commercial device

Clinical testing

Sup ASup D

Anal. testEvaluationCommittee(A EVC)

PrototypeEvaluationCommittee(P EVC)

Y01 Y04Y03Y02 Y05

WP3

WP2WP5

WP4WP3

WP5

WP4WP3

WP5

WP4

WP3

WP5

oncNGS PCP

EC Joint Action iPAAC

WP4 – Sciensano, Belgium


Joint action on cancer control

Joint Action? Joint activities carried out by the European Union and one or more Member States.

iPAAC is a collaboration between 44 partners out of 24 EU Member States.

History of Joint Action on Cancer control:- EPAAC & Cancon: development of evidence based policy recommendations & guidelines;

- iPAAC: step further• Support the implementation and sustainability of innovations in the field of

cancer control • Facilitating mutual learning between countries

Exchanging comprehensive information on implementation experience

Belgian Cancer Center Sciensano

IPAAC WP4 « ROADMAP »

Agreed Roadmap concept:

« An IT ‘mutual learning’ instrument’ as a supportive frameworksupport where relevant information on implementation of innovativecancer policies is available in a structured way »

The iPAAC roadmap aims at offering to responsibles of cancer controlpolicy implementation with 1°) access to innovative approaches incancer control/care in the EU MS and 2°) supporting them indeveloping and implementation their local cancer control measures oractions


IPAAC Roadmap IT-tool concept

1P

1P

1PDOC

DOC

DOCVIEW

(Implementation) One Pagers(roadbooks, actions, pilots, …)

Repository

1P

1P

PancreasCancer

1P

1P1PNational

ComprehensiveCancer Control

Policy

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

DOC

Guidelines, Recommendations, Reports, ….

1P

1P

1P

1P

REPORT: “INTEGRATION IN NATIONAL POLICIES AND SUSTAINABILITY”

Content: under development within the JA (collaborative action by the JA WP leaders, JA partners, MS and EC)

Suggested elements:

• SWOT analysis on the overall iPAAC Roadmap development process• Identification of common challenges/opportunities between MS for further collaboration at EU level• Identify research partners to address gaps/challenges

• Link to Mission on Cancer and the EU Beating Cancer plan initiatives• Bridge with other JA activities (JARC, Infact, EuNetha, Inequalities, Frialty, ….)• Link with other EU projects/initiatives (JRC ECRN, JRC ECIBC/ECICC, EU-ERNs, 1M Genomes,,….)• Develop proposal for post-iPAAC governance of the Roadmap


2. A clear direction: targeted, measurableand time boundReduce by 50%the progression of the diseaseby 2030

5. Multiple, bottom up solutions:Simultaneousprojects >

4. Cross disciplinary, cross sectoraland cross actor innovation:

3. Ambitious but realistic researchand innovation actions:

EC MISSION EXAMPLE:DECREASING THE BURDEN OF DEMENTIA

1. Bold, inspirational with wide societalrelevanceCurrently 10.5 million Europeans affected

(Mazzucato Report)

1 2 3 4

Oct. 21,22, 2019Board meeting 3

Sept.3, 2019Board meeting 1

1. Introduction to &discussion on missioncancer by EC DG2. Presentation of boardmembers3. First exchange of ideas.Role of infections inprevention4; Choice of workingmethodology

5

First interactionwith SPC subgroups

Sept. 26, 2019

First interactionwith StakeholdersSept. 25, 2019

Open debate with 100stakeholders on

Understand EtiologyTreat PreventSurvivorship

Consensus on PrioritiesCollection open

questions

20 MS representedExchange of views onadded value of the

missionsimplementation atEuropean level

Presentation of Missionand Assembly Roles

Sept. 25 26, 2019Board meeting 2

Nov.19 20, 2019Board meeting 4

Dec. 12,13 2019Board meeting 5

1. Deliverable onbrief description ofmission outline.2. Preparing citizenengagementmeeting.3. PreparingAssemblymeeting.

1. Agreement onthemes/approaches towardsamission outline.2 Agreement on first citizenengagementmeeting andoutreach in/with3 Agreement on foresightstudy to support the Board’swork.4. Work with Assembly.

Second interactionwith SPC subgroups

Dec, 13, 2019

Review & discussNational cancer plans

National Citizens engagement

1. Presentation of Cancer relatedDGs policy activities

2. Identification of 4 WGs:

UnderstandTreat Prevent

Survive3. Identification of Citizens’engagementWG4. Working wiith Assembly

1. Potentialthemes/approachestowards amission outline(challenge target andactions)2. Methods toOutreach in/with SPCmembers3. Citizen engagementstrategy4. Presentation ofForesight Platform

Mission on Cancer


EU BEATING CANCER PLAN?

iPAAC WP 5 Dec 2019

Speech in the European Parliament Plenary Session Ursula von der Leyen (27 November 2011)

President elect of the European Commission

Europe will take the lead in the fight against cancer.Early next year, Stella Kyriakides, will launch an ambitious cancer plan. She is the rightperson to make sure that Europe’s Beating Cancer Plan helps to reduce the sufferingcaused by this disease.

I want you to put forward Europe’s Beating Cancer Plan to support Member States toimprove cancer prevention and care. This should propose actions to strengthen ourapproach at every key stage of the disease: prevention, diagnosis, treatment, life as acancer survivor and palliative care. There should be a close link with the researchmission on cancer in the future Horizon Europe programme.

Sciensano• Aline Hébrant• Els Van Valckenborgh• Pauline Wurstemberger• Gordana Rajcevic• Wannes Van Hoof• Chloé Majeur• Laure Bakker• Regine Kiasuwa• Kris Vranken• Marijke Pauwels• Johan Van Bussel• Aline Antoniou• Thomas Delcourt

Collaborators

RIZIV-INAMI• Anouk Waeytens• Waltruda Van Doren• Koen Desmet• Pieter Geentjes• Els Soete• Marleen Louagie

FOD-VVVL/SPF santé• Saskia Van den Bogaert

Cancer Register• Helène Antoine-Poirel• Nancy Van damme


• https://www.compermed.be/• https://www.wiv-isp.be/QML/• https://healthdata.sciensano.be/• https://www.riziv.fgov.be/nl/professionals/verzorgingsinstellingen/laboratoria/Paginas/oncolo

gie-terugbetaling-moleculair-biologische-ngs.aspx• http://kankerregister.org/• https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza#authorisation-details-

section• https://ec.europa.eu/digital-single-market/en/public-procurement-innovative-solutions• https://www.ipaac.eu/• https://ec.europa.eu/info/horizon-europe-next-research-and-innovation-framework-

programme/mission-area-cancer_en• https://ec.europa.eu/health/non_communicable_diseases/events/ev_20200204_en

Relevant websites

THANKS


testing of pancreas cancer in world of the ngs … · 2020-01-30 · cancer patient matching...

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