Pre-IND Drug Development Pipeline

Pre-IND (~2 years, idealized): in silico selection → IND

Modality
Audience

Audience lens: showing the concept and the “why”, in plain language. Click any stage or gate to read its student view.

Timeline note: The medicinal-chemistry screening cascade dominates; CMC is a supporting lane and GLP toxicology is the late long pole.

Two stacked panels share one 8-quarter timeline. The top panel is a Gantt of development stages grouped into workstream lanes; the bottom panel shows candidate attrition, aligned to the same timeline. Stages and gates are interactive — focus one and press Enter to read its details for the selected audience.

Development timeline

Q1Q2Q3Q4Q5Q6Q7Q8Discovery & ScreeningCascadecritical pathCharacterizationEnabling / CMCTranslational &RegulatoryTarget Identification & ValidationTarget Identification & Vali…In Silico Selection / Virtual ScreeningIn Silico Selection / Virtua…In Vitro ScreeningIn Vitro ScreeningHit-to-LeadHit-to-LeadLead OptimizationLead OptimizationIn Vivo EfficacyIn Vivo EfficacyCandidate SelectionCandidate SelectionMOA ConfirmationMOA ConfirmationADME / DMPKADME / DMPKPK / PDPK / PDBiomarker DevelopmentBiomarker DevelopmentExploratory ToxicologyExploratory ToxicologySafety PharmacologySafety PharmacologyGLP Toxicology (IND-enabling)GLP Toxicology (IND-enabling)Formulation DevelopmentFormulation DevelopmentCMC / Manufacturing (Route & Scale-up)CMC / Manufacturing (Route & Scale-up)Pre-IND Meeting (FDA)Pre-IND Meeting (FDA)Human Dose Projection / FIH Dose SelectionHuman Dose Projection / FIH…IND Preparation & SubmissionIND Preparation & Submission

Candidate attrition funnel

≈10,000In silico ranking: 10,000 → 100100In vitro potency & selectivity filter: 100 → 3030Hit-to-lead triage: 30 → 1010Lead optimization filter: 10 → 44In vivo efficacy filter: 4 → 33Candidate nomination: 3 → 11IND-enabling safety gate (passfail)GO / NO-GOsingle survivor

Attrition counts are schematic, order-of-magnitude teaching values — not literal. Real small-molecule libraries span ~10⁴–10⁶; the visible funnel starts lower for legibility.

Timeline caveat: Real preclinical timelines frequently run several years; the 8-quarter window is a compressed teaching frame.

Stage · Discovery & Screening Cascade

Lead Optimization

Purpose
Iteratively refine lead compounds to balance potency, selectivity, ADME, and safety.
Student view

Chemists redesign molecules over many cycles, tweaking structure to improve the whole package, not just potency. It overlaps heavily with testing.

Educational and idealized. Funnel counts are schematic, order-of-magnitude teaching values, not literal. Not regulatory, medical, or investment advice.