INTRODUCTIE: PROFIEL EN FUNCTIE Biobank: opportunities, support and service models

Bimetra biobank: principles Goals: Offer high quality biobank facility for those who may need it and can benefit from it No movement towards centralisation of all collections For strategic collections General aspects Keywords: Transparency Collaboration Autonomy (no centralised model) Based on use of certain minimal datasets (MDS) linked to samples Use of service level agreements (SLA) and Material transfer agreements (MTA) Access flows and service-cost models Biobank request forms: available on the website ( 2

Opportunities and support Processing of delivered HBM materiaal Storage of HBM according to predefined quality norms, in monitored and controlled settings 3 Aliquoting/dividing of samplesSerum preparation Blood separation proceduresFreezing procedures RNA/DNA extractionFFPE and cryosections Room temperature (18-24°C)-80°C (±10°C) 4°C (2-8°C)LN 2 vapor phase -30°C (±4°C)LN 2 liquid phase

Opportunities and support Sample tracking and data management: SLims Every sample < unique ID < coded link Pseudonimity/anonimity  act as intermediate trusted third party < decoding key Collaborating partners: free read-only account for view on samples Sample tracking from cradle to grave (with audit trail) Minimal dataset registry and coding cfr TBB template or CMI template Exchange of sample data through IT-connection with the Belgian Virtual Tumorbiobank (NKP) Exchange of sample data through IT-backbone connection with CMI Sample preparation for sample release: Sample queries and lookup, sample processing for release MTA in collaboration with Bimetra Clinics/JuriDi Temperature controlled transports of samples 4 FFPE- and cryosectionsDry/wet ice

Bimetra biobank: minimal datasets Minimal datasets < standardisation TBB < based on required reporting data Additional sample specific data related to sample history 5 SSIN numberDelay to storageLaterality of tumor GenderAutopsy material?Morphology of tumor Date of BirthAvailable materialsBehaviour (invasiveness) Consent statusTechnical remarksDegree of differentiation Sample ID numberSample typepTNM code Biopsy reference numberSample localisationOther oncological remarks Storage conditionsLocalisation of primary tumor

Bimetra biobank: minimal datasets Minimal datasets < standardisation CMI < based on general accepted minimal data parameters for samples (SPREC codes) combined with essential parameters from BRISQ Recommended by 6

Bimetra biobank: minimal datasets Minimal datasets < standardisation Examples SPREC codes: BLDACDABNND Whole blood – collected with acid citrate dextrose – pre-centrifugation delay of less than 2 h at RT – centrifugation: < 3000 g with braking at RT 10 to 15 min – no second centrifugation – no post centrifugation delay – storage in cryotube of 1-2 ml at temp: -85°C< x <-60°C CLNSRGXDZZZNC Cells from a non blood specimen type (dissociated tissue), viable – surgical excision – warm ischemia time unknown – cold ischemia time minutes – not further defined stabilization medium – fixation time is not applicable – storage in cryotube of 1-2 ml in liquid nitrogen 7

Service models Different service-cost models Background: Limited funds from several initiatives for certain procedures within biobanking context No commercial goal Models: 1. Tumor related biobanks Partial funding through Federal initiative (NCP 27) 2. CMI focus biobanks Limited funding Flemish initiative (CMI) 3. Strategic U(Z)G collections Strategic local lines 4. Basic service-cost model 8

Service models: Different service-cost models Based on “Basic service-cost model” < marginal cost Other cost models Certain discounts Related conditions/obligations E.G. tumor related cost model: Samples are publicly viewable/available through the virtual tumor biobank network Samples are released through the TBB access flow (TKO adviesraden) Minimal dataset TBB must be followed E.G. CMI strategic collection: Acknowledged as strategic CMI collection CMI samples are publicly viewable/available through the CMI backbone catalogue Samples are released through the access flow defined for the CMI collection Minimal dataset CMI must be followed 9

Basic service-cost model: samples in Example 1: Researcher A wants to store serum, plasma, blood and PAXgene tubes in the biobank for a granted and EC approved project Amount of participants: 200 Sample specifications: Serum: collection of 2 blood tubes < request for storage of 5 cryotubes of 1 ml Plasma: will be delivered pre-aliquoted ready to freeze, 4 cryotubes of 1 ml 1 blood-EDTA tube / participant, delivered ready to freeze 1 PAXgene tube / participant, delivered ready to freeze (3 months storage) 10 collections days, dry ice needed Cost analysis: Sample preparationserum preparation + aliquoting2,22 €/original sample444 € Storage costCryovials (max 2 ml) S + P0,50 €/sample/year900 € Blood tubes1,00 €/sample/year200 € PAX-tube1,00 €/sample/year50 € Additional costsDry ice (3 deliveries for 10 collection days) Dependent on amount192 €

Basic service-cost model: samples in Example 2: Researcher A wants to store blood samples (-80°C) and cells in LN2 for a granted and EC approved project Amount of samples: 200 Sample specifications: Blood: aliquoted, ready to freeze, 4 * 1,5 ml cryovial Cells: 2 * 1 ml cryovial Cost analysis: Storage costCryovials (max 2 ml) B0,50 €/sample/year400 € Cryovials (max 2 ml) LN2 cells0,25 €/sample/year + LN 2 partial cost 100 € + ?

Tumor biobank service cost model Example 3: Researcher B wants to store serum, urine, blood and biopsy samples from renal cancers (150 participants) in the biobank for a granted and EC approved project Serum: collection of 2 blood tubes < request for storage of 5 cryotubes of 1 ml Urine sample: aliquoting to cryotubes of 4 ml, max 3 tubes (3 months storage) 1 blood-EDTA tube / participant, delivered ready to freeze Biopsy samples < flow through pathology (residual material): 3/tumour + 1 N reference Cost analysis: Sample preparationSerum preparation + aliquoting1,15 €/original sample172,5 € Aliquoting urine2,02 €/original sample303 € Biopsy processing and freezingNo cost (covered NKP)/ Storage costCryovials (max 2 ml) S0,25 €/sample/year187,5 € Cryovials (max 4 ml) U0,33 €/sample/year37,125 € Blood tube0,63 €/sample/year94,5 € Biopsy storageNo cost (covered NKP)/

CMI service cost model: samples in Example 4: Researcher C (CMI strategic collections) wants to store serum aliquots (-80°C) and cells in LN 2, in the biobank for a granted and EC approved project Sample specifications: 500 samples S C Serum: 4 * 1ml cryovials, delivered ready to freeze Cells: 2 * 1 ml cryovials, delivered ready to freeze (LN2) Cost analysis: Storage costCryovials (max 2 ml) S0,25 €/sample/year125 € Cryovials (max 2 ml) (LN 2 ) C 0,33 €/sample/year + LN2 partial cost 33€ + ?

Samples out Different options depending on type of collection, combined with who is requesting the material Requested by researchers from the project itself Other interested parties: Researchers not related to the specific biobank Companies Bring into contact with each other No sample release without explicit approval Cost model out: dependent on collaboration < MTA Marginal cost Partial cost-fee model Full cost model

Samples out: sample access flows Basic service-cost model: Samples specifically collected for project “reserved” Researchers from project can request samples anytime No additional costs, unless for additional procedures/transports

Samples out: sample access flows TBB collections: TBB access flow (supported by stakeholders)

Samples out: sample access flows Strategic CMI collections: comparable to TBB flow, with specific advisory board of specialists