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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 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

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  1. 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

  2. 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

  3. 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

  4. 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 …

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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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