Navigating the Ecosystem of Translational Science (NETS)

Navigating the Ecosystem of Translational Science (NETS)



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
Combined Federal Campaign (CFC)
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