Drug Development Atlas

ModalitySmall Molecule

Discovery → Post-Market · 17-year window · 246 activities · 19 workstreams · Drag bars to reschedule · Drag edges to resize

Workstream
NON-GLP
GLP
PHASE I
PHASE IIA
PHASE IIB
PHASE III
PERI-APPR
POST-APPR / LCM
Year 1
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Year 2
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Year 3
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Year 4
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Year 5
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Year 6
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Year 7
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Year 8
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Year 9
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Year 10
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Year 11
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Year 12
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Year 13
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Year 14
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Year 15
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Year 16
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Year 17
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PCD
Pre-IND
IND/CTA
Go/No-Go (Ph I)
Go/No-Go (PoC)
End of Ph II
Go/No-Go (Ph III)
Decision to File
BLA/NDA Submit
Market Launch
LCM Start
▼Discovery & Pharmacology
20 activities·2.3 yrs
Concept Screening & IdentificationTarget Safety Assessment (Initial)Target Safety Assessment (Updated)Target Binding AssaysIn Vitro PharmacologyIn Vivo PharmacologySpecies SelectionFinal Species SelectionDisease State Modeling & PathophysiologyTarget Identification & ValidationDisease Linkage / Genetic AssociationMoA Reconstruction & Pathway AnalysisHigh-Throughput Screening (HTS)Hit-to-Lead (H2L) IdentificationSAR StudiesLead Optimization & Candidate SelectionFunctional Genomics (CRISPR / RNAi Screening)Fragment-Based Lead Discovery (FBLD)Multiomics Data Analysis & IntegrationDrug Toxicity Prediction (In Silico)
▼Toxicology
13 activities·11 yrs
Preliminary Tox (Dose Tolerance)Tox Dose Stability AnalysisGeneral Tox / Protocol DevSafety PharmacologyImmunotoxicology StudiesChronic Tox StudiesDART (Dev & Repro Tox)DART — Phase III WindowCarcinogenicity StudiesGenotoxicity (Ames, Micronucleus)Juvenile ToxicologyPhototoxicity & Skin SensitizationAdverse Outcomes Pathways (AOP) Mapping
▼ADME / PK-PD / Bioanalytical
13 activities·11 yrs
Bioanalytical Method DevPK/PD Study (Preclinical)Metabolism (Non-GLP)Metabolism (GLP)Bioanalytical PK — GLPBioanalytical PK — ClinicalPK/PD Analysis — Phase IIPK/PD Analysis — Phase IIIPharmacokinetic Data AnalysisClinical DDI StudiesMass Balance / QWBAAllometric Scaling & FIH Dose PredictionBioequivalence & Bioavailability Studies
▼Immunogenicity & Modality-Specific
0 activities·
▼CMC — Analytics
15 activities·11.5 yrs
Preliminary DevelopmentMethod DevelopmentQualification (GMP)Regulatory / Analytical StrategyRef Standard Prep & Qual.Support / Assay RobustnessPre-Validation / PerformAssay Validation & ReportsBLA/NDA Prep & SupportCrystalline Form & Polymorph ScreeningSalt Selection & Solubility EnhancementImpurity Characterization & GTI AssessmentExtractables & Leachables (E&L)Forced Degradation & PhotostabilityCatalyst & Solvent Residue Analysis
▼CMC — Process & Formulation
17 activities·17 yrs
Preliminary Process DevNon-GMP ManufactureGMP ManufactureDS/DP Characterized at Kilo-ScaleProcess RefinementPre-Formulation & StabilityPreliminary Formulation DevDrug Product Opt. & ImageProcess Opt. & Scale-upGMP Release & ICH StabilityProcess Validation (PPQ)Tech Transfer to Comm. MfgTech Transfer Validation (DS/Analytical/DP/Pkg)Supply Chain / Pkg / LabelRoute Scouting & Process ChemistryContainer Closure Selection & CompatibilityCMC Variation Management (Post-Submission)
▼Clinical Development
15 activities·16 yrs
FIH Study DesignMABEL / NOAELPhase I — SAD TrialsPhase I — MAD TrialsExploratory Clinical TrialsPhase IIa — PoP/PoCPhase IIb — Dose Confirm.Phase III — RegistrationalPhase IIIb — Peri-ApprovalPhase IV / Post-MarketAdaptive / Platform DesignInitial TPP (iTPP) DefinitionTPP Update — Post Phase IINatural History StudiesLong-Term Extension (LTE) Studies
▼Clinical Operations
11 activities·9.5 yrs
CRO / Vendor SelectionSite Selection & FeasibilityIRB / IEC / EthicsEDC / eCOA / ePRO BuildDSMB / DMC FormationPatient RecruitmentCentral Lab ServicesDCT / Hybrid TrialInvestigator Meeting & TrainingDiversity & Inclusion Recruitment PlanClinical Supply Logistics (Cold Chain)
▼Biomarkers & CDx
4 activities·11.3 yrs
Biomarker Analysis (Preclin.)Reagent Dev / Clin. SamplesBiomarkers / CDx — Ph I–IIBiomarkers / CDx — Ph III
▼Market Research & Insights
19 activities·17 yrs
Epidemiology AssessmentCompetitive Landscape AssessmentTreatment Paradigm / Standard of CarePatient Journey MappingMarket Sizing & Opportunity AssessmentUnmet Needs Research (Qualitative)Behavior & Attitudes ResearchStrategic Demand Forecast (Initial)Strategic Demand Forecast UpdatesProduct ForecastingSegmentation ResearchMessage TestingPrimary Packaging ResearchSecondary Packaging ResearchPre-Launch ATU TrackingLaunch Readiness TrackingPost-Launch ATU TrackingCompetitor Defense StrategyNew Market Entry Research
▼Data Mgmt & Biostatistics
7 activities·14.5 yrs
Database Design & BuildData Management PlanStatistical Analysis PlanInterim AnalysesData Cleaning / DB LockISS / ISE PreparationRWE (Real World Evidence) Data Mining
▼Regulatory Affairs
20 activities·11 yrs
IND/CTA PreparationPre-IND / Scientific AdviceBreakthrough / Fast TrackOrphan Drug DesignationPediatric Study PlanEnd of Phase I Meeting ScheduledEnd of Phase II MeetingPre-Licensure Meeting (Type B)Regional Reg. StrategyReport GenerationBLA/NDA/MAA PrepBLA/NDA/MAA FinalizationAdvisory Comm / ODACeCTD CompilationREMS / Risk Mgmt PlanNon-Proprietary Naming (INN / USAN)Proprietary Naming (Brand Name)Labeling Development (USPI / SmPC)Pre-Approval Inspection (PAI) ReadinessEnvironmental Impact Assessment
▼Safety & Pharmacovigilance
8 activities·14.5 yrs
Safety Database BuildSUSAR / SAE ReportingSignal DetectionDSUR / PBRER PrepRisk Management PlanPharmacovigilance Plan In PlacePost-Market PVPatient Safety & Support
▼Market Access & HEOR
17 activities·14.5 yrs
Define Commercial StrategyHealth Econ ModelingPayer Strategy DevHTA Dossier PrepPricing StrategyFormulary & Access EvidenceRWE StrategyGlobal Value Dossier (GVD) DevelopmentPayer Archetyping & SegmentationReference Pricing AnalysisMock Payer NegotiationsEarly Economic ModellingPayer Value Stories & Objection HandlingCOGS Initial EstimateCOGS UpdatesDeliverability Assessment (Initial)Deliverability Assessment Updates
▼Commercial & Launch
13 activities·6.8 yrs
Brand Strategy & PositioningKOL Mapping & MSLPublication StrategyField Force SizingDistribution & ChannelPatient Services / HubLaunch SequencingDevelop Comm. EvidenceCommunicate Comm. ValueSpecialty Pharmacy & Channel Strategy3PL ContractingLaunch Budget Prediction (Initial)Launch Budget Prediction Update
▼Post-Approval & Lifecycle Mgmt
15 activities·9 yrs
Indication Sequencing StrategyComparative Effectiveness / H2H TrialsGeographic Expansion StrategyGeographic Rollout (EU / Japan / EM)Value-Based ContractingGross-to-Net (GTN) ManagementSerialization / DSCSA Track-and-TraceMLR Review ProcessSunshine Act / Open Payments ReportingPMRs / PMCs ExecutionsNDA / sBLA Filings (Line Extensions)Annual Reports & CMC Post-Approval ChangeseCTD Lifecycle MaintenanceLifecycle Management / Repurposing StrategyLOE / Biosimilar Defense Strategy
▼Business Development & Licensing
13 activities·17 yrs
Business / Portfolio Strategic ReviewInorganic Growth StrategyPartner / Target Identification & AssessmentCommercial Diligence & ForecastingFinancial Deal ModelingAsset / Company ValuationDeal BenchmarkingSynergy AssessmentEvaluation of Deal TermsNegotiation SupportOut-Licensing / Partnering (Post-Launch)Partner Selection Plan In PlaceCommercial Partner Identified
▼Global Health & Access
11 activities·16 yrs
Global Access Agreement ExpectationGlobal Access Agreement In PlaceGlobal Access Agreement UpdatesLMIC Pricing StrategyWHO Prequalification (PQ) PreparationWHO Prequalification (PQ) SubmissionLaunch in First Country (LFC)Global Normative Guidance (GNG) InclusionCoverage & Financial Tracker50% Coverage AchievedTarget Market Share (TMS) Achieved
▼Combination Products & Device Engineering
15 activities·11.5 yrs
Device Concept AssessmentUser Needs & Acceptance ResearchDevice Design & Development Plan InitiatedDesign History File InitiatedDesign Input ReviewApplication & Process Risk AssessmentDesign Output ReviewFormative Human Factors StudyEngineering / Simulated-Use TestingDesign Verification & Validation ReviewsSummative Human Factors StudyDesign Transfer ReviewInstructions for Use (IFU) FinalizationDesign History File ClosedComplaint Handling Process Defined