Biobanks the system and how it can be utilized
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Biobanks – the system and how it can be utilized. Nordic Health Research and Innovation Networks NRI Conference, May 12 th , 2014 Lena Brynne, Acting CEO SMB Research and innovation Stockholm County Council www.sll.se. Biobanks – the system. Definition:

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Biobanks the system and how it can be utilized

Biobanks – the system and how it can be utilized

Nordic Health Research and Innovation Networks

NRI Conference, May 12th, 2014

Lena Brynne, Acting CEO SMB

Research and innovation

Stockholm County Council

www.sll.se


Biobanks the system

Biobanks – the system

Definition:

Biobank – an organizedcollectionof human biological material and associated information stored for one or more purposes

Some examples;

  • Population biobanks (Includeslife-style, clinical and environmentaldata)

  • Academic research biobanks

  • Research biobanks withinlife science/ biotech industry

  • Health care biobanks

  • Commercial biobanks

  • Non-commercial biobanks

Health

Care

LifeScience

Academia

ClinicalPractice


Biobanks sample collections

Biobanks – sample collections

Vary tremendous in size, scope and quality

Important

  • Informed concent

  • Ethical application and approval

  • High quality samples linked to clinical data collected at the right time

Clinical practice

Health care

Life science

Data analysis

Sampleanalysis

Sampling & storage

Ethics and regulation

Academic research


Utilizing the health care system for biobanking

Utilizing the health care system for biobanking

Biobanking

Chainofcustody, #sample handling for quality … and linkto data

Patient

Plasma

Serum

Whole blood

DNA

RNA

Blood pressure

Age

Gender

Labresults

Quality

registries

Patient records

Glucose

Lipids


Biobanks sample collections1

Biobanks – samplecollections

Health Care

Improveddiagnosis

New therapies

Prevention

Utilizingsamples from biobanks

  • Prevention

  • Improveddiagnosis

  • Individualizedtreatment

  • Subpopulations at risk

  • Increasedunderstandingofdisease progression and co-morbidities

  • Developmentof new diagnostic tests

  • Developmentof new drug

Disease

Diagnosis

Disease progression, co-morbidity

Healthy


Utilizing biobank samples to improve clinical practice

Clinical practice

Utilizing biobank samplestoimproveclinicalpractice

New therapies

Biobank sampleshavelimitedvaluesif not linkedtoclinical data

  • Personalized Health Care:

  • Chemotherapy

  • Radiation

  • Surgery

  • Immunotherapy

  • Cell cycle inhibition

Disease progression, co-morbidity


Biobanks life science

Biobanks – Life science

High quality samples linked to clinical data

Target Selection

Biology

Pathway

Target

Pharmacology

Target Engagement

Safety

Disease

Efficacy

Safety

Personalized Medicine

Life Cycle Management/ Launch

Discovery

Preclinical Development

Early Clinical

Development

Late Clinical Development

A knowledgecontinuum

Zhang, Pfister, and Meibohm. Concepts and Challenges in Quantitative Pharmacology and Model-Based DrugDevelopment. The AAPS Journal, Vol. 10, (4), 552-559, 2008


Biomarker classification map for building disease area and biomarker strategies

Biomarkerclassificationmap for buildingdisease areaand biomarker strategies

  • Biomarkers areplaying an increasinglyimportantrole in the developmentof new diagnostic tests and therapies

  • Wearemovingtowards a description for the conditionsbased on cellular and molecularlevel

Type 0

Genotype/

phenotype

Type 1

Drug

Concentration

Type 2

Target Occupancy

Type 3

Target Mechanism

Type 4A

PhysiologicalResponse

Type 5

Pathophysiology

or Disease

Process

Type 6

Outcome

Adapted from Danhof et al 2005 Pharmaceutical Research 22(9)1432

Type 4B

PhysiologicalResponse

PHC

PoM

PoC

PoP

PHC = Personalizedhealthcare

PoM = ProofofMechanism

PoP = Proofof PrinciplePoC = ProofofConcept


Building disease area and biomarker strategy

Building disease area and biomarker strategy

Focus on patient needs

DISEASE AREA STRATEGY

Unmetmedicalneeds

Scientist/ Project team

Target

Research plan

Study design

Line of sight

Clinical outcome

BIOBANK

Ethical & legal compliance

Tracking & Storage

Key biomarkers within ‘Line of sight’

Adapted from Danhof et al 2005 Pharmaceutical Research 22(9)1432

Type 0

Genotype/

phenotype

Type 1

Drug

concentration

Type 2

Target

Occupancy

Type 3

Target

Mechanism

Type 4A

Physiological

Response

Type 5

Pathophysiology

or Disease

Process

Type 6

Clinical outcome

L. Brynne


Generating new drugs to patients

Generating new drugs to patients

What type of Samples and Clinical Data are needed?

Personalized Healthcare/ Patient stratification

Disease

biomarker

Translational biomarker

Safety biomarker

Efficacy biomarker

Assaydevelopment & validation

Target identification & validation

Pathway biomarker

Unmetmedicalneeds

Scientist/ project team

Plasma

?

Phenotype data

Disease related data

Research data

Tissue biopsy

Cells

Whole organ

Liver

Urine

Demographicdata

Blood

BIOBANK

Ethical and legal compliance

Sample tracking and quality


T o increase the value of samples the 5r s

To increase the valueofsamples- The 5R’s

Right patient, subpopulation and control

Disease

Diagnosis

Right tissue / sample

Disease progression

Co-morbidityetc

Healthy

Right clinicaldata andbiomarkers

Right questionaire

Biomarkers in healthysubjects vs patients

Clinical data

Right time


Roadmap to build a knowledge continuum integration of the right data to drive

Roadmaptobuild a knowledgecontinuum– integration of the right data to drive…

Patient populations

New innovations and therapies …

Clinical practice

Health care

Analyticalplatforms

Life science

Quality

registries

Patient records

Academic research

Clinical trials

Academicresearch


Future integration of health care system and research is imperative

Future integration of health care system and research is imperative

Health Care

Patient

Research

Quality Registries

Biobanking

Clinical Trials

New medicines

Patient

Reserach

New diagnostics

Health Care

County Council

Clinical practice

Ethics

Personlized Medicine

Cost efficiency

Health economics


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