occasion Who are w e A CDO or C ontract D iagnostics O rganization HQ Irvine California Founded 2008 Founders Philip D Cotter Mathew W Moore 2 CDO What is a CDO ID: 1043769
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1. About the Companymay 2017 │ occasion
2. Who are we?A CDO or Contract Diagnostics OrganizationHQ: Irvine California Founded: 2008Founders: Philip D. Cotter, Mathew W. Moore2CDO
3. What is a CDO? A unique animal. There is only one.One partner. Complete IVD development resource. We integrate and synchronize all development activities3It’s like a CRO except, in DiagnosticsProcess efficiency, start to finishDrug / IVD alignment of priorities and activitiesSpeed to regulatory approval / market entryExperts in all IVD service areas CDO
4. As a CDO, we bridge gaps In resources. In capabilities. In expertise. What you don’t have, we do. We help you get to your destination.4
5. How can a CDO help you?Companion Dx DevelopmentBy solving logistical complexities associated with multi-partner outsourcing Simplifying — one call when timelines or priorities changeDedicating — skilled project manager to guide you through all phases of your project5IVD DevelopmentBy solving gaps in resources and expertise to augment your needsOffering— Comprehensive menu of servicesIntegrating —globally accredited / certified clinical services laboratory
6. Integrated and discrete services6Integrated development, discovery through regulatory approvalDiscrete development projects and services in clinical, regulatory and laboratory servicesGMP IVD manufacturingComprehensive menu of IVD services and expertise for biopharma, biotech, medical communityCompanion DxIn-vitro DxCompanion & In-vitro DxOVERVIEW
7. How are we structured?7Seamless integration and coordination of service groupsContract Diagnostics Organization
8. Companion Dx development (IVD)8DEVELOPMENT PROCESS OVERVIEW
9. Co-development activities9DNA / RNAProteinMetabolite targetsScreening assayPredictive markerFinal marker selectionAssay dev, validation & platform selection/automationFinal kit designMulticenter, prospective trialsTrials mgmt. & supportAnalysis and meta-analysesReference trial testing services StrategyFile appropriate regulatory documents per timelineFDA interactionsKitting and manufacture for final clinical product
10. Unlike multi-resourcing, we are flexible and coordinate drug and IVD development activities. Co-development activities10When your timelines or priorities shift—as a single resource, we shift with you.
11. Integrated co-development pathways11R&DCompound SelectionPreclinicalPhase IPhase IIPhase IIIFDA drug filingPredictive marker screenRetrospective analysisStratify Phase IIStratify Phase IIIIdentify biomarkerDevelop screening assayFinal biomarker selectionFinalize assay on platformFinal kit designValidate in clinical TrialsRegulatory filing -approvalBiopharma R&D activitiesDx drug componentDx R&D
12. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service DivisionsResearch & DevelopmentClinical ResearchRegulatory & ComplianceGMP Contract ManufacturingClinical LaboratoryGLP Diagnostic Services12Frequently utilized services – all capabilities are not listed.
13. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service Divisions Research & DevelopmentBiomarker discovery (molecular, protein, other)Assay / kit development and validationPlatform evaluation and automationStudies to establish biological baselineBroad, multi-platform technology capability (without bias)LDT / custom development / clinical validation13
14. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service Divisions Clinical ResearchComplete clinical trial services, program management and supportClinical trial strategic consultingReference trial testing servicesClinical primary site testingAnalytical and clinical testingComplete data management program support14
15. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service Divisions Regulatory & ComplianceStrategy and FDA interactionsIVD PRE-IDE, PMA and all types of 510(k) filingsInternational regulatory filingsCompliance auditing and consultingCompliant labelingSoftware documentationThird party review by Accredited Persons (AP)15
16. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service Divisions GMP Contract ManufacturingCustom reagents, assays or final kits for research, clinical, final productMolecular / non-molecular IVD developmentOEM reagents, kit components or assaysCertificates of Analysis (COA)Sample collection kits16
17. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service Divisions Clinical LaboratoryCLIA, CAP, ISO, GLP, state and regulatory certification, accreditation and complianceHigh-complexity specialty testing resource (molecular / non-molecular)Broad, multi-platform capability (without bias)Pre-inspection auditing / readinessComplete resource and consulting for new start-upsMock inspections (CLIA, CAP, ISO)Provision of standard laboratory documentation (CLIA, CAP, ISO compliant)17
18. IVD development servicesOffering complete diagnostic development support, tailored to your needs. Service Divisions GLP Diagnostic ServicesNon-clinical testingPre-clinical testingGLP compliance consulting18
19. About our clinical laboratory servicesCLIA-certifiedCollege of American Pathologists (CAP) accreditedCalifornia licensureHigh level of knowledge, experience and expertise19ResearchDx maintains licensure, accreditation, certification and compliance where applicable to pertinent regulatory bodies and to local, state and federal laws.
20. Why choose us?20
21. Why choose us?21
22. Why choose us?22
23. Meet your team Mathew Moore PhD, PrincipalPhD, biotechnology, UNSW Sydney AustraliaExpertise: Technology assessment, molecular & non-molecular assay development, implementation, commercializationExperience: Clinical laboratory (15+ years), research, development, clinical trials, regulatory submissions and approvals23Philip Cotter PhD, FACMG, FFSc (RCPA), PrincipalPhD, biomedical sciences, Mt. Sinai NYExpertise: ABMG board-certified; licensed laboratory director (CA, FL, NJ, NY, TN); cytogenetics and molecular geneticsExperience: Clinical laboratory, regulatory affairs (CLIA, CA, ISO, NY); >100 publications in human genetics
24. Meet your teamShelly Gunn MD PhD, CMO, Laboratory DirectorMD and PhD, molecular biology, UTHSCSA Medical School, San Antonio TXExpertise: Board-certified in clinical pathology; CA, TX, NY medical licensure; NY state certificate of qualification in molecular and cellular tumor markersExperience: Medical laboratory director, 15+ years24Louis Ferland PhD, PMP, VP Clinical Research ServicesPhD, molecular biology, PMP certification (PMI)Expertise: Project management, technical writingExperience: Project management, clinical research, regulatory affairs, research and development
25. Meet your teamJayne Scoggin BA, CT(ASCP), CG(ASCP),Director Quality ManagementCytotechnology University of Oklahoma Health Sciences Center, Oklahoma City, OKExpertise: CA Cytogenetics and cytotechnology licensure Experience: Clinical laboratory science, quality management / quality assurance, laboratory operations and regulatory affairs (30+ years)25Suman Verma, BAMS, PhDDirector, Genomic ServicesMD, PhD, Molecular biology and biochemistryExpertise: Development, validation of molecular assays (CAP/CLIA)Experience: Next gen sequencing, qPCR, Sanger, genotyping, control material development
26. And, the rest of your team . . .26
27. Capability: project management27Every project has dedicated project management to guide the process and ensure timely resultsKey contact for integrated team services and client interactionCompanion Dx pathIVD assay development pathCustom IVD development pathBiomarker research and discoveryClinical research and management Regulatory filings and servicesClinical laboratory servicesPlatform selection and automationAssay verification and validationContract manufacturingExamples of project paths and discrete projectsintegrated resources
28. Capability: IVD development28Extensive technical expertise for discovery, development Molecular and non-molecular Biomarker discovery, screening Broad, multi-platform without bias for testing and analysisDiverse sample types, method dependent: blood, plasma, bone marrow, fresh tissue, FFPE, other body fluidsNext-gen sequencing, high-density arraysDNA or RNA extraction, storage, preservationCell culture, molecular genetics, cytogenetics, oncologyProteomic and biochemical applicationsFISH (commercial, custom probes)Genotyping, expression, microarray, multiplex qPCRDNA methylationData and bioinformaticsintegrated resources
29. Capability: IVD development29Preclinical development support offering screening technologies to establish a biological baselineA few of the technologies offered . . .Enzyme activity and inhibitionDrug compound detectionInvestigations for reversibility of enzyme inhibitionSubstrate profiling, analyzing selectivity of enzymes and other proteinsNGS panel, exome, and whole genome analysisTranscriptome analysisFlow cytometry, multiplex ELISA, mass-spectrometryMultiplex qPCR panels integrated resources
30. Capability: clinical research30Clinical research services cover full clinical program support as well as discrete trial servicesIntegrated with regulatory services to develop strategy, associated required documentationIntegrated with clinical laboratory services to support testing needs/requirementsProgram SupportClinical and regulatory strategyPre-IDE developmentPredicate determinationProgram design, implementation, oversightRegulatory filings and submissions, interactionsTrial SupportSite selection, qualification, agreementsIRB, ethics committee, external and internal Sample procurement, collection, processingStudy, site documentation, development, managementSite monitoring and management, all phases and closeoutBiostatistics, data capture (EDC) and managementintegrated resources
31. Capability: regulatory affairs31Regulatory services, consultingEstablished relationships and expertise interacting with regulatory agencies, both US FDA and international Regulatory strategy aligned with project goalsIVD PRE-IDE, PMA, various types of 510(k) filingsInternational filingsTechnical writing, dossiersCompliance auditing and consultingCompliant labelingSoftware documentationThird party review by APintegrated resources
32. Capability: clinical laboratory32High complexity clinical laboratory services and consultingCLIA, CAP, ISO, GLP, state and regulatory certification, accreditation and complianceCA licensedBroad, multi-platform testing without biasMolecular, non-molecular, genetic and esoteric testingClinical trial reference and testing servicesValidation of custom or client-specific assays for clinical research or clinical trialsPre-inspection auditing, readiness; audit responses (CLIA, CAP, ISO)CLIA, CAP, ISO compliant laboratory documentationGLP diagnostic services for non or pre-clinical testing, consulting integrated resources
33. Capability: clinical laboratory33These widely-used instrument systems (platforms), and more are supported for assay testing and validationintegrated resources
34. Capability: custom IVD development34Integrated resources dedicated to development of custom productsTailored approach, using your preferred platforms for discovery needs – no instrument biasPlans and executes to priorities and timelineMolecular, non-molecular biomarker discovery or your marker(s) Reagents, componentsAssay developmentKit assembly and labelingGMP manufacturingOEMCertificates of analysisLDT development, clinical validationintegrated resources
35. Outsourcing to multiple vendors— historically challengingVendorWhy a CDO?35New Drug DevelopmentDiagnostic DevelopmentVendorVendorVendorVendorVendorVendorStrategies, priorities, goals may change during drug or IVD developmentChange at any step in the process can cause a downstream shift, affecting multiple resources and timelinesPartnering with large Dx can create strategic complexity and limit opportunity to explore best methodologies and platforms for commercial applicationsVendorVendorVendor
36. New business model that aligns and integrates drug development and IVD diagnostic pathsWhy a CDO?36Drug-diagnostic co-development concept guidance document, FDA, 2005. For all project phasesSingle, integrated resourceSingle point of contact Dedicated project managerSingle resource flexibility and adaptability to changing prioritiesCDO Advantage
37. Companion Dx development (IVD)37PROCESS OVERVIEW
38. We know your path . . .38You are hereYour goal
39. . . . we’ve been there39Single-Diagnostic ResourceExpertiseExperienceLeadershipAll Phase Project ManagementCapabilities
40. Diverse Development Capability: Technologies and Methods40
41. Capability: genomics technologiesNext Generation SequencingIllumina MiSeq, MiSeqDx & NextSeq 500Ion Torrent PGMQiagen GeneReaderExome, Transcriptome, cfDNA, single-cell RNA/DNA Seq, Single-cell lowpassOncology and Custom panels41Quantitative Real-Time PCR (qRTPCR)Qiagen Rotor-Gene Q MDxApplied Biosystems 7900HTApplied Biosystems QuantStudio6 Commercial and custom assaysDiverse sequencing and genomic technologies for use in IVD development—oncology, infectious and inheritable diseases
42. Capability: genomics technologies42Microarray TechnologyAgilent Microarray scanner (G2600D)Affymetrix GeneChip CNV, SNP, Methylation, ExpressionFISH: RNA or DNAAll commercially available probesCustom probe design and manufactureRUO, IUO and GMP manufacturedDiverse sequencing and genomic technologies for use in IVD development—oncology, infectious and inheritable diseases
43. Cell Sorting and EnrichmentFACSSillicon Bio DEPArray, DEPArray NxTIndividual tumor and stromal cell recovery from FFPE and CTC samplesCapability: cell and tissue methodologies43Anatomic pathology, liquid cell sorting and enrichment, and cytogenetics techniques deployed for various applications, particularly oncologyFlow CytometryBeckman Coulter FC500Commercial and custom flow panel for hematology and lymphoid malignanciesBiomarker detection
44. Cell Culture100+ characterized control cell lines for Oncology applications FFPE control cell block preparationControl DNA/RNA preparationCapability: cell and tissue methodologies44Anatomic pathology, liquid cell sorting and enrichment, and cytogenetics techniques deployed for various applications, particularly oncologyAnatomic PathologyMetasystems Metafer imaging stationCarl Zeiss Auto ImagerIHC, H&E on FFPE and Frozen tissuePathology review and macro-dissection
45. Microplate ReadersTecan GENios ProDynex MRXCapability: support technologies45Diverse technologies support IVD development and scale-up activities that may require automated DNA extraction and liquid-handling systemsELISA (Immunoassay)Direct and Sandwich ELISAIdentify and qualify commercial fit for purpose ELISA kits for PK & PD studiesWide applicability for assay development Analyte detection e.g., cytokines
46. Capability: support technologies46Diverse technologies support IVD development and scale-up activities that may require automated DNA extraction and liquid-handling systemsAutomationHamilton Star, Microlab StarQIACube QIASymphony SPScale-up applications
47. Mass SpectrometryProteomicsGenomicsCapability: support technologies47Diverse technologies support IVD development and scale-up activities that may require automated DNA extraction and liquid-handling systemsAutomationHamilton Star, Microlab StarQIACube QIASymphony SPScale-up applications