Target Identification

• Proteomics
• Bioinformatics
• Functional Genomics
• Assay Development
• Deep Sequencing

Target Validation

• Functional Genomics
• Proteomics
• Assay Development
• Compound Synthesis
• Statistics and Data Mining

Compound Screening

• High throughput screening
• High-content screening
• Data mining of screening data
• Computational chemistry and structural biology
• Fragment based screening
• Compound libraries

Hit Triage

• Potency determination
• Similarity Analysis
• Purity Determination by LC-MS
• Small molecule NMR

Chemical Lead Optimization

• Compound Synthesis
• Cheminformatics

Cellular and Molecular Pharmacology

• Cellular Disease Models
• Selectivity Profiling
• Potency Determination
• Binding Affinity

Drug Mode of Action Determination

• Functional Genomics
• Next Gen Sequencing

Cytotoxicity

• Hepatotoxicity
• Genotoxicity
• Mitochondrial Toxicity

Activity Testing

• Potency determination
• Selectivity Profiling

Crystallography for Lead Optimization

• Structural biology (crystallography, NMR)-biomolecule
• Structural biology (crystallography, NMR)- small molecule

ADME for Lead Optimization

• In vitro triage studies
• CYP panel
• In Vivo Pharmacokinetics (PK)

PK and PD Method Development

Toxicology for Lead Optimization

• Mouse toxicology - dose finding study
• Mouse toxicology -7, 21-day
• Blood Chemistry

Biomarkers for Lead Optimization

• Proteomics
• Biomarker Assays

Efficacy Testing

• In vivo
• In vitro

non GLP safety testing

• Mouse Toxicology
• Dose Range Study
• Mouse toxicology -7, 21-day

GLP safety testing/IND enabling

• Biomarker Development
• Mouse Toxicology
• ADME
• Initial Rodent Pharmacokinetics (PK)
• Pharmacodynamics (PD) Assay development

Synthesis and Manufacturing

• GMP Process Chemistry
• Compound Formulation
• Pharmaceutical Quality (CMC)

Regulatory Preparation and submission

• Document Preparation

Phase I

• Clinical Development

Phase II

• Clinical Development

Phase III

• Clinical Development