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Navigating the Ecosystem of Translational Science (NETS)

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Hypotheses Disease Pathophysiology Therapeutic Targets Cell Lines Animal Models Biorepositories Basic Science Biomedical Informatics Data Repository Genotypes Phenotypes Molecular Pathway HTS Assay Hits Approved Compound Assay Development Compound Libraries HTS System Misses Unapproved Compounds (NCE/NME) Lead Compounds Compounds for Pre-clinical and Clinical Studies Chemistry, Manufacturing & Control Therapeutic Discovery & Nonclinical Research Medical Chemistry Non-GLP Studies Acute Toxicology In vitro / in vivo Pharmacology Safety Dose Efficacy/Proof of Concept cGMP Manufacturing GLP Pre-clinical Studies PK (ADME) Pharmacology Long Term Toxicology (ongoing) Sustained Product Availability Approved Therapy IND Application FDA: Reporting Meetings Amendments NDA or BLA Rejected Application New Indication Insurance Coverage & Reimbursement Registries Clinical Cohorts Identification of Subpopulations Clinical Cohort Development, Clinical Research and Regulatory Requirements Researcher/Investigator IRB Approval Recuitment Informed Consent Participants Enrollment Updated Natural History Standard of Care Access to Therapies Incorporation into Clinical Practice Phase 4 (Post-marketting) Responder, Non-responder Study Sponsor Contractual & Legal Agreements Qualified Investigator & Study Staff Clinical Trial Natual History Studies Outcome Measures Therapeutic and Clinical Endpoints Clinical Trial Planning & Preparation Trial Design Phase 1 Clinical Trials (PK, Safety, Dose) Phase 2 Clinical Trials (Safety, Efficacy, Dose) Phase 3 Clinical Trials (Safety, Efficacy) Discontinue Biospecimens
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