Early Derisking for Liver Assessment
Identify hepatotoxicity risk using human-relevant liver models, including advanced spheroid and cellular systems.
HUMAN SAFETY NAMS
Early Derisking with Human Safety NAMs
Identify Safety Liabilities Before They Influence Candidate Selection
Early Derisking offers the most valuable safety insight: one generated early enough to change a decision.
During hit-to-lead and lead optimization, safety risks may already exist even when efficacy data appear promising. Human Safety NAMs help drug discovery teams identify potential liabilities earlier using human-relevant models designed to evaluate toxicity, immune activation, cytokine release, and organ-specific risk before candidate selection.
Whether developing small molecules, antibodies, bispecifics such as T-cell engagers, antibody-drug conjugates (ADCs), CAR-T, cell therapies, gene therapies, oligonucleotides or peptides early safety assessment enables more informed progression decisions and helps focus investment on candidates with the strongest overall potential
Why Safety Assessment Needs to Start Earlier
Drug discovery teams generate large amounts of efficacy, potency, and developability data before meaningful safety information becomes available. As a result, critical liabilities may remain undetected until substantial resources have already been invested.
Many safety-related failures are not caused by unexpected toxicities emerging late in development. They result from risks that were present much earlier but were not identified while meaningful course corrections were still possible. Early derisking helps shift safety from a late-stage gatekeeper to an early discovery decision driver.
Key Questions Discovery Teams Face
• Which lead series should move forward?
• Are safety liabilities emerging alongside efficacy?
• Can identified risks be eliminated?
• Which candidates warrant additional investment?
• Are there human-specific safety concerns that may not be visible in traditional models?
Lead Optimization
Small Molecule Programs
Supporting Better Lead Optimization Decisions
For small molecules, safety assessment is most impactful when integrated directly into discovery workflows.
Human-relevant screening panels can identify potential liabilities across organ systems commonly associated with clinical toxicity, providing comparative data that supports lead prioritization, structure-activity relationship (SAR) efforts, and candidate selection.
By evaluating safety signals alongside potency and pharmacology, discovery teams can better differentiate compounds, guide optimization strategies, and support more confident candidate selection.
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Human-relevant screening panels can identify potential liabilities across organ systems commonly associated with clinical toxicity, providing comparative data that supports lead prioritization, structure-activity relationship (SAR) efforts, and candidate selection.
By evaluating safety signals alongside potency and pharmacology, discovery teams can better differentiate compounds, guide optimization strategies, and support more confident candidate selection.
Small molecule types tested thanks to early derisking NAMs
Model selection is guided by mechanism of action, target biology, modality, compound characteristics, and anticipated clinical safety risk, ensuring that studies remain relevant to discovery-stage decisions.
These approaches can be applied across diverse small molecules programs, including:
• Oncology therapeutics
• Immunology therapies
• CNS therapeutics
• Precision medicines
• Targeted therapies
Understand Human-Relevant Risk Earlier
Many biologics interact with human-specific targets, tissues, and immune pathways that may not be adequately represented in traditional models.
Human Safety NAMs help generate early safety insights directly from human-relevant systems, allowing teams to investigate risks before advancing candidates into more resource-intensive stages of development, such as IND-enabling studies.
Evaluate Risks That Matter for Biologics
Safety assessments can be tailored to investigate:
• Cytokine release
• Immune activation
• On-target toxicity
• Off-tumor effects
• Tissue-specific cytotoxicity
• Multi-organ responses
This approach is particularly valuable for monoclonal antibodies, bispecific antibodies such as T cell engagers, ADCs, CAR-T therapies, and other advanced therapeutic modalities.
Biologics evaluated under early derisking:
Human Safety NAMs can support safety assessment across a broad range of therapeutic platforms.
• Monoclonal antibodies
• Bispecific antibodies, such as T cell engagers
• Antibody-drug conjugates
• CAR-T therapies
• Cell therapies
• Gene therapies
• Oligonucleotides
• Peptide therapeutics
Turn Safety Data into Better Portfolio Decisions
Early Safety Assessment should inform decisions, not simply generate additional data.
By integrating safety findings with pharmacology, developability, and mechanism-of-action information, teams can evaluate candidates based on a more complete understanding of risk and therapeutic potential.
Discovery Decisions Supported by Early Derisking
• Lead series prioritization
• Candidate ranking
• Portfolio optimization
• Risk mitigation planning
• Follow-up study design
• Resource allocation decisions
The result is greater confidence in candidate progression and reduced investment in programs with unfavorable safety profiles.
Why Partner with IQVIA for Early Derisking?
Discovery-Focused Approach
Designed to support candidate prioritization and lead optimization decisions rather than retrospective safety evaluation.
Human-Relevant Models
Primary human cells, iPSC-derived models, organoids, and co-culture systems designed to better reflect human biology.
Small Molecule and Biologics Expertise
Integrated support across both traditional and advanced therapeutic modalities.
Multi-Organ Safety Assessment
Evaluate risk across multiple biologically relevant tissues through a unified safety assessment strategy.
Actionable Safety Insights
Generate data intended to inform progression, optimization, and investment decisions while opportunities to influence outcomes still exist
