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 & IdentificationSpecies SelectionTarget Binding AssaysDisease State Modeling & PathophysiologyTarget Safety Assessment (Initial)Target Identification & ValidationDisease Linkage / Genetic AssociationFunctional Genomics (CRISPR / RNAi Screening)In Vitro PharmacologyMoA Reconstruction & Pathway AnalysisHigh-Throughput Screening (HTS)Fragment-Based Lead Discovery (FBLD)Multiomics Data Analysis & IntegrationHit-to-Lead (H2L) IdentificationDrug Toxicity Prediction (In Silico)In Vivo PharmacologySAR StudiesLead Optimization & Candidate SelectionFinal Species SelectionTarget Safety Assessment (Updated)
▼Toxicology
13 activities·11 yrs
Preliminary Tox (Dose Tolerance)Tox Dose Stability AnalysisGeneral Tox / Protocol DevAdverse Outcomes Pathways (AOP) MappingSafety PharmacologyImmunotoxicology StudiesGenotoxicity (Ames, Micronucleus)Phototoxicity & Skin SensitizationChronic Tox StudiesDART (Dev & Repro Tox)Juvenile ToxicologyDART — Phase III WindowCarcinogenicity Studies
▼ADME / PK-PD / Bioanalytical
13 activities·11 yrs
Bioanalytical Method DevPK/PD Study (Preclinical)Metabolism (Non-GLP)Bioanalytical PK — GLPMetabolism (GLP)Mass Balance / QWBAAllometric Scaling & FIH Dose PredictionBioanalytical PK — ClinicalBioequivalence & Bioavailability StudiesPK/PD Analysis — Phase IIPharmacokinetic Data AnalysisClinical DDI StudiesPK/PD Analysis — Phase III
▼Immunogenicity & Modality-Specific
0 activities·
▼CMC — Analytics
15 activities·11.5 yrs
Preliminary DevelopmentRegulatory / Analytical StrategyRef Standard Prep & Qual.Crystalline Form & Polymorph ScreeningSalt Selection & Solubility EnhancementMethod DevelopmentImpurity Characterization & GTI AssessmentQualification (GMP)Catalyst & Solvent Residue AnalysisSupport / Assay RobustnessForced Degradation & PhotostabilityExtractables & Leachables (E&L)Pre-Validation / PerformAssay Validation & ReportsBLA/NDA Prep & Support
▼CMC — Process & Formulation
17 activities·17 yrs
Preliminary Process DevRoute Scouting & Process ChemistryPreliminary Formulation DevPre-Formulation & StabilityNon-GMP ManufactureGMP ManufactureDS/DP Characterized at Kilo-ScaleDrug Product Opt. & ImageProcess RefinementGMP Release & ICH StabilityContainer Closure Selection & CompatibilityProcess Opt. & Scale-upTech Transfer to Comm. MfgProcess Validation (PPQ)Tech Transfer Validation (DS/Analytical/DP/Pkg)Supply Chain / Pkg / LabelCMC Variation Management (Post-Submission)
▼Clinical Development
15 activities·16 yrs
Initial TPP (iTPP) DefinitionFIH Study DesignNatural History StudiesMABEL / NOAELPhase I — SAD TrialsExploratory Clinical TrialsPhase I — MAD TrialsPhase IIa — PoP/PoCAdaptive / Platform DesignPhase IIb — Dose Confirm.TPP Update — Post Phase IIPhase III — RegistrationalLong-Term Extension (LTE) StudiesPhase IIIb — Peri-ApprovalPhase IV / Post-Market
▼Clinical Operations
11 activities·9.5 yrs
CRO / Vendor SelectionSite Selection & FeasibilityEDC / eCOA / ePRO BuildIRB / IEC / EthicsInvestigator Meeting & TrainingDSMB / DMC FormationCentral Lab ServicesClinical Supply Logistics (Cold Chain)Patient RecruitmentDiversity & Inclusion Recruitment PlanDCT / Hybrid Trial
▼Biomarkers & CDx
4 activities·11.3 yrs
Biomarker Analysis (Preclin.)Biomarkers / CDx — Ph I–IIReagent Dev / Clin. SamplesBiomarkers / CDx — Ph III
▼Market Research & Insights
19 activities·17 yrs
Epidemiology AssessmentCompetitive Landscape AssessmentTreatment Paradigm / Standard of CarePatient Journey MappingStrategic Demand Forecast (Initial)Market Sizing & Opportunity AssessmentUnmet Needs Research (Qualitative)Product ForecastingBehavior & Attitudes ResearchSegmentation ResearchStrategic Demand Forecast UpdatesMessage TestingPrimary Packaging ResearchSecondary Packaging ResearchCompetitor Defense StrategyPre-Launch ATU TrackingLaunch Readiness TrackingNew Market Entry ResearchPost-Launch ATU Tracking
▼Data Mgmt & Biostatistics
7 activities·14.5 yrs
Database Design & BuildData Management PlanStatistical Analysis PlanData Cleaning / DB LockInterim AnalysesRWE (Real World Evidence) Data MiningISS / ISE Preparation
▼Regulatory Affairs
20 activities·11 yrs
Orphan Drug DesignationIND/CTA PreparationReport GenerationPre-IND / Scientific AdviceBreakthrough / Fast TrackEnd of Phase I Meeting ScheduledPediatric Study PlanNon-Proprietary Naming (INN / USAN)Regional Reg. StrategyEnd of Phase II MeetingEnvironmental Impact AssessmentLabeling Development (USPI / SmPC)REMS / Risk Mgmt PlanProprietary Naming (Brand Name)Pre-Licensure Meeting (Type B)BLA/NDA/MAA PrepPre-Approval Inspection (PAI) ReadinessAdvisory Comm / ODACeCTD CompilationBLA/NDA/MAA Finalization
▼Safety & Pharmacovigilance
8 activities·14.5 yrs
Safety Database BuildSUSAR / SAE ReportingSignal DetectionDSUR / PBRER PrepRisk Management PlanPharmacovigilance Plan In PlacePatient Safety & SupportPost-Market PV
▼Market Access & HEOR
17 activities·14.5 yrs
COGS Initial EstimateDeliverability Assessment (Initial)Early Economic ModellingDefine Commercial StrategyPayer Archetyping & SegmentationHealth Econ ModelingGlobal Value Dossier (GVD) DevelopmentCOGS UpdatesDeliverability Assessment UpdatesReference Pricing AnalysisPayer Strategy DevPricing StrategyHTA Dossier PrepPayer Value Stories & Objection HandlingRWE StrategyFormulary & Access EvidenceMock Payer Negotiations
▼Commercial & Launch
13 activities·6.8 yrs
Publication StrategyKOL Mapping & MSLDevelop Comm. EvidenceBrand Strategy & PositioningLaunch Budget Prediction (Initial)Field Force SizingDistribution & ChannelPatient Services / HubSpecialty Pharmacy & Channel Strategy3PL ContractingLaunch Budget Prediction UpdateLaunch SequencingCommunicate Comm. Value
▼Post-Approval & Lifecycle Mgmt
15 activities·9 yrs
Indication Sequencing StrategyGeographic Expansion StrategySerialization / DSCSA Track-and-TraceComparative Effectiveness / H2H TrialsValue-Based ContractingMLR Review ProcessLifecycle Management / Repurposing StrategyGeographic Rollout (EU / Japan / EM)Gross-to-Net (GTN) ManagementSunshine Act / Open Payments ReportingPMRs / PMCs ExecutionAnnual Reports & CMC Post-Approval ChangeseCTD Lifecycle MaintenancesNDA / sBLA Filings (Line Extensions)LOE / Biosimilar Defense Strategy
▼Business Development & Licensing
13 activities·17 yrs
Business / Portfolio Strategic ReviewInorganic Growth StrategyPartner / Target Identification & AssessmentPartner Selection Plan In PlaceCommercial Diligence & ForecastingFinancial Deal ModelingAsset / Company ValuationDeal BenchmarkingSynergy AssessmentEvaluation of Deal TermsNegotiation SupportCommercial Partner IdentifiedOut-Licensing / Partnering (Post-Launch)
▼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)Coverage & Financial TrackerGlobal Normative Guidance (GNG) Inclusion50% 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