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NCI Resources for the Development of Early Stage Cancer Technologies Mark D. Lim, Ph.D. [email protected] Montreal In Vivo 2010 June 8, 2010 US National Cancer Institute Stimulating innovation by reducing risk Discovery and Validation: Access to high-quality biospecimens Office of Biorepositories and Biospecimen Research Early stage technology development Program for Innovative Molecular Analysis Technologies What is a biospecimen? Window into the health of an individual Identification of targets for drug development, treatment and prevention Identify biologic variations that determine drug efficacy and drug toxicity Defining markers for susceptibility, screening and reoccurrence Validation of new therapeutics and diagnostics Blood is a complex biospecimen • Travels through all tissues in the body • 60,000 miles of vessels • Important for tumor growth and metastasis • Readily collected in the clinic Numerous Roles: • delivery of nutrients • removal of metabolites • delivery of oxygen • removal of carbon dioxide • immune response • response to injury • etc… Complex Composition: Biologically active! • red blood cells • white blood cells • platelets • almost every protein • genomic transcripts • etc… Office of Biorepositories and Biospecimen Research Tissue Variables: Antibiotics Other drugs Type of anesthesia Duration of anesthesia Arterial clamp time How wetemperature tell biologic Timecan at room Temperature of room Type of fixative Time in fixative Rate of freezing Size of aliquots Blood Variables: • Patient Health, Hydration, Diet • Medications • Patient Position • Tourniquet time duration • Gauge of needle • Order of draw fact from biologic artifact? • Type of tube, additives • Serum vs plasma vs whole blood • Processing Procedure • Processing Temperature • Centrifuge Speed • Centrifuge Temperature • Storage Temperature • Freeze-thaw Office of Biorepositories and Biospecimen Research The historical focus of NCI funding Patient Medical/ Surgical Procedures Acquisition Handling/ Processing Storage Distribution Scientific Analysis 8. Biobanks By ALICE PARK Inside Huntsman Cancer Institute's vaults: Pancreatic tumors on ice. Lance W. Clayton for TIME Folks at the National Cancer Institute (NCI) are heading up an effort to establish the U.S.'s first national biobank — a safe house for tissue samples, tumor cells, DNA and, yes, even blood — that would be used for research into new treatments for diseases…. By fall, the group hopes to have mapped out a plan for a national biobank; the recent stimulus showered on the government by the Obama Administration might even accelerate that timetable. March 12, 2009 Restocking Unused Sample NCI Best Practices • Evidence-based, data-driven technical and operational standards to ensure quality and enable reproducible molecular analysis • High-quality biospecimen annotation with pathological and clinical data • Biospecimen access through a timely, centralized peer review process • Ethical and privacy compliance through a chain of trust with research participants “Living document” updated to stay current with state-of-the-science and policies • State-of-the-art informatics systems to track biospecimens, associated data, and research participant informed consents • Communication and outreach efforts, particularly with investigators, to ensure greatest impact http://biospecimens.cancer.gov An International Effort Standardisation and improvement of generic pre-analytical tools and procedures for in-vitro diagnostics • 4 year project from EU’s FP7 Programme (9 M Euros) • 16 partners from 11 different European Countries • 7 private research companies (ex: QIAGEN, Dako, Aros, etc.) • 8 public research organizations (ex: Technical University Munich, IARC) • Europrean Standards Organization (CEN) • Trials 1) SPIDIA-DNA - evaluation of DNA quality/quantity from whole blood sample 2) SPIDIA-DNAplas – evaluation of DNA quality/quantity from whole blood sample plus the evaluation of DNA quality/quantity/integrity from plasma sample 3) SPIDIA-RNA – evaluation of RNA quality/quantity/stability from whoel blood Sample http://www.spidia.eu Biobanks KAUST Biobank (Saudi Arabia) National; Disease-based; to support biomedical research Estonian Genome Project National; Population-based UK Biobank National; Population-based; Aged 45-69 GenomEUtwin (Finland) International; Population-based; Twin cohorts BBMRI Pan-European; Network of existing and de novo biobanks (population, twin, and clinical/control cases) Biobank Japan National; Hospital-patient based recruitment; Focused mainly on common diseases and supporting pharmacogenetics research Singapore Tissue Network National; Tissue and DNA Bank to facilitate translational and population research for Singapore; Collects, processes, and disseminates tissue samples for specific research projects caHUB Principles • Standardized biospecimen collection and distribution procedures • Standardized data sets and data vocabulary • Harmonized approached to ethical and legal issues – Standardized consent, MTAs • Transparent governance and business models – Transparent access policies • Large well-designed specimen sets for a variety of research questions How can caHUB serve your needs? …dialogue is just beginning Working with NIST – standards for pharma and biotech - biomarker discovery/validation efforts based on stored blood samples Trans-institute Trans-agency International PPP GTEx NIST SPIDIA Patient Advocacy NIH Office of Rare Diseases NCI IMAT Program Mission: Revolutionize the state-of-the-science by stimulating the early-stage development of next generation molecular and cellular analysis technologies Goals: • Innovation - Support out-of-the-box approaches for analyzing cancer • Interdisciplinary - Support highly innovative technology development projects from all communities • Proof-of-concept - Support general innovative technology approaches and prototype development (application) http://innovation.cancer.gov Unique Attributes of IMAT • Emphasis on high-risk, high-impact, and high-payoff technology development • Investigator-initiated to identify unmet need and provide solution • Emphasis on technology development (vs. traditional hypothesis-driven) • Milestone-based, with performance milestones that quantitatively address measures such as specificity, sensitivity, speed, and similar performance parameters • Staged process requiring quantitative evidence of progress or feasibility before advancement to the next stage • All communities (industry/academic, international) are invited to apply • Review process focused on improvement over state of the art - approach IMAT Themes “Innovative Technology Development” RFA-CA-10-005 Modified R21: 3 years and $500K in direct costs No preliminary data required Quantitative milestones are required “Emerging Technology Development” Early stage development- R21: 2 years and $275K in direct costs No preliminary data required - Quantitative milestones are required RFA-CA-10-003 Advanced development- R33: 3 years and no budget cap Proof of concept data required RFA-CA-10-004 IMAT Themes “Innovative Technology Development” RFA-CA-10-005 Modified R21: 3 years and $500K in direct costs No preliminary data required Quantitative milestones are required “Emerging Technology Development in Biospecimen Sciences” Early stage development- R21: 2 years and $275K in direct costs No preliminary data required - Quantitative milestones are required RFA-CA-10-001 Advanced development- R33: 3 years and no budget cap Proof of concept data required RFA-CA-10-002 U.S. Small business opportunities NCI SBIR Development Center - http://sbir.cancer.gov/ PHASE I – R41, R43 – Feasibility Study – $100K and 6-month (SBIR) * – or 12-month (STTR) Award PHASE II – R42, R44 • Full Research/R&D • $750K and 2-year Award (SBIR & STTR) * • Commercialization plan required Phase II Bridge Award PHASE III • Commercialization Stage • Use of non-SBIR/STTR Funds * Note: Actual funding levels may differ by topic. Non-traditional/Interdisciplinary approaches David Beebe, Ph.D. (Engineering - Univ. Wisc. Madison) R21 Microfluidic Channels for High Density, High Performance Culture Assays Gregory Faris, Ph.D. (Applied Physics - SRI International) R21 Signatures for Functional Optical Imaging of Cancer Stuart Lindsay, Ph.D. (Biophysics - Arizona State Univ) R21 Mapping Epigenetic Modifications at the Nanoscale: Aptamers for Microscopy David Nolte, Ph.D. (Physics - Purdue) R21 Highly Multiplexed Assays on the BioCD for Acute Lymphocytic Leukemia Supported projects in the market Jonathan D. Oliner, Ph.D., Affymetrix Reverse-Engineering Signal Transduction Networks (R43 - 1998) Gary Latham, Ph.D., Ambion, Inc. (RNA Later) Enzymatic Tools for Degrading Tissue and Preserving RNA (R43 - 2001; R44, 2005-2007) Robert H. Daniels, Ph.D., Quantum Dot Corp. (Invitrogen) Sensitive, Multiplexed Analysis of Breast Cancer Markers (R44 - 1999) Darren Link, Ph.D., Raindance Technologies Exon Specific Sequencing of Whole Genomic DNA (R21 –2007) Supporting Canadian Innovation University of Toronto Shana O. Kelly, PhD Development of DNA-templated IR quantum dots Scott Tanner, PhD Development of (Prototype) Bead Array Flow Cytometer with Mass Spectrometer Detection Univ. of Toronto Spinout Rolls Out New Biomarker System with Eye on Bead Array Market Genome Web – May 21, 2010 Industry-based innovation Implementation of innovative RNA sample quality control methods Collaboration between BioTrove (Life Technologies) and University of Toledo High-throughput oncogene mutation detection in human cancer Based on Sequenom Technology Releasable Antibodies for Multiplexed Analysis of Cancer Biomarkers Transformative HTS cell migration assay for rapid screening of cancer therapeutic Advanced Technology for Assaying Cancer-Drug Resistance miRNA Profiling in Fixed Cancer Samples Now part of Applied Biosystems Other NCI Opportunities Check websites or contact program official for updated information Division of Cancer Biology Integrated Cancer Biology Program (ICBP) Tumor Microenvironment Network (TMEN) PAR-09-026 Division of Cancer Control and Population Sciences Methods and Technologies Branch Division of Cancer Prevention Early Detection Research Network (EDRN) Division of Cancer Treatment and Diagnosis Cancer Imaging Program (http://imaging.cancer.gov) Exploratory Studies in Cancer Detection, Diagnosis and Prognosis (R21, PA-08-267) Developmental Research in Cancer Prognosis and Prediction (R21,R33, PA-09-158) Exfoliated Cells and Circulating DNA in Cancer Detection and Diagnosis (R21, PA-09-238) Avenues for Public-Private-Partnerships 1. Identify a scientific or clinical problem better answered in partnership than alone! 2. Partnership Options: * Established directly between the NIH (as a whole or through one or more ICs) and one or more outside entities. * Developed via the Foundation for NIH (FNIH). * Involve one or more other charitable foundations. 3. Discuss how to structure the relationships to optimize the science. 4. Memorialize the PPP goals and structure in a MOU and clear it appropriately. Rules for NIH PPP Science driven Rigorous Fair Inclusive Compliant with Federal law, regulation and policy Priority to the agency http://ppp.od.nih.gov/ Biomarkers Consortium • Facilitate the development and validation of biomarkers using new and existing technologies • Help qualify these biomarkers for specific applications in diagnosing disease, predicting therapeutic response, or improving clinical practice • Generate information useful to inform regulatory decisionmaking • Make consortium project results broadly available to the entire scientific community www.biomarkersconsortium.org Websites NCI Office of Biorepositories and Biospecimen Research (OBBR) http://biospecimens.cancer.gov NCI Program for Innovative Molecular Analysis Technologies (IMAT) http://innovation.cancer.gov NIH Public Private Partnerships Office http://ppp.od.nih.gov/ Additional questions? [email protected]