In the early stages of drug development, preclinical testing often sets the pace—and cost—of the entire pipeline. What if your team could eliminate weak candidates earlier, accelerate preclinical testing, and improve trial success rates—without added regulatory complexity? The DART solution delivers exactly that. By combining in vitro/ex vivo human microphysiologies, models with AI, DART helps pharmaceutical and biotech organizations reduce timelines, cut costs, and generate more reliable preclinical data—without the ethical and operational burden of animal testing.

Animal studies are no longer just an ethical challenge—they’re a financial inefficiency. DART offers a faster, smarter alternative that supports confident go/no-go decisions while keeping development moving forward, in-house, and on budget.

How DART Works

Human stem cells reconfigured as well-characterized hMPS are exposed to the test drug.
AI models assess hMPS responses using high-resolution techniques.
Results are translated into toxicity, safety, and efficacy metrics as per the protocol.
Insights are delivered in days—not weeks—without the cost and complexity of animal models or any other transformed cell-line based assessments (performed just for the sake of documenting with no real value).

By leveraging cutting-edge image and descriptive analytics, molecular profiling, machine learning in biological models, DART delivers reliable answers early—allowing better decisions downstream.

What Makes DART Different?

Unlike standalone wet-lab or organ-chip platforms, DART merges human-relevant biology with advanced AI and cloud automation—delivering fast, high-volume meaningful insights that scale with your pipeline.

Human Stem Cell Based Models: Developed with Transcell Biologics, these models capture real human physiological responses.
AI-Driven Analysis: Machine learning models identify subtle effects that often go undetected in animal studies.
Cloud-Based Deployment: Results are generated, visualized, and shared digitally—without requiring specialized hardware or internal data science teams.
Integrated Feedback Loop: DART continuously learns from new data, refining predictions over time in batch testings.

This all-in-one model means faster results, greater transparency, and lower overhead—without compromising scientific rigor – A revolutionary enterprise solution supporting seamless real-time pharma and biopharma assessments.

Why DART Matters: Measurable Time and Cost Savings

Across the drug development lifecycle, DART is proving to be a high-impact solution:

DART in Action: Real Business Impact

Use Case	Time Saved	Approximate Cost Savings	Additional Benefit
Molecule Screening	30% faster	$1.2M saved	Improved lead prioritization
Biologics Batch Testing	60% faster	$2M annually	WHO-compliant, scalable workflows
Clinical Trial Recruitment	40% faster	$500K saved	Better patient matching
Biosimilar PD based Testing	25% faster to FDA	$1.5M saved	Zero animal testing required with waivers on clinical phases

Beyond these high-impact wins, DART’s flexibility makes it valuable across the entire development lifecycle—from early discovery and preclinical safety assessments to batch testing for biologics, biosimilars, and cell and gene therapies. Whether you’re optimizing candidate selection, reducing reliance on animal models for pharmacological metrics, or enhancing quality control, DART helps teams make smarter, faster decisions at every stage of development.

What About Regulatory Approvals?

It’s a fair question—and one we hear often. Historically, regulatory bodies like the FDA required animal testing before human trials. But that has changed.

Thanks to the FDA Modernization Act 2.0, passed in 2022 with continued momentum seen in 2025, the U.S. no longer mandates animal testing for new drug approvals—paving the way for validated alternatives like DART. The FDA is already reviewing industry submissions built on New Approach Methodologies (NAMs), and updates to global standards are encouraging the use of AI-supported in vitro/ex vivo models. While some traditional assays may still be required, the shift toward NAMs is clear—and industry-backed.

Regulators in Europe, Japan, India, Brazil, and Canada are following suit, signaling a coordinated move toward more ethical, efficient testing models. As momentum builds, platforms like DART are not just aligned with where the industry is headed—they’re helping shape what’s next.

High-Impact Use Cases That Don’t Require Regulatory Approval

While DART is increasingly used to support formal regulatory submissions, its greatest near-term value lies in high-impact applications that require no regulatory involvement. These non-regulatory DART use cases offer fast, measurable ROI while significantly improving early R&D efficiency. Whether you’re evaluating molecule libraries or fine-tuning clinical development plans, these workflows enable internal teams to make better decisions, faster—without triggering regulatory reviews or delays.

Early-Stage Screening and Lead Optimization

Rapid in vitro/ex vivo testing of multiple drug candidates using hMPS-based models to evaluate toxicity risks, and mechanism-of-action indicators.
- Helps eliminate weak candidates early, reducing time and cost spent on non-viable leads
- Supports data-driven prioritization of promising compounds for further development
- Requires no external submission, enabling high-throughput, iterative screening cycles
Outcome: Faster go/no-go decisions at the top of the pipeline—with greater confidence in human biology relevance.
Biologics Batch Testing

Non-animal-based immunogenicity, potency and biosafety testing for monoclonal antibodies, vaccines, or other biologics using digital assays leveraging human stem-cell based systems.
- Complements or replaces legacy in vivo batch release protocols internally
- Supports internal quality control and consistency checks at scale
- Reduces reliance on animal facilities and outsourced testing centers
Outcome: Significant cost savings, faster batch release cycles, and improved scalability in biologics manufacturing.
Residual Toxicity Profiling for Biosimilars (If required)

In vitro/ex vivo toxicity assessments of biosimilar compounds using DART to detect potential off-target or lingering effects.
- Enables internal validation before formal bioequivalence studies
- Supports process optimization and de-risks clinical submissions
- Helps identify subtle differences in formulation or impurities early
Outcome: Accelerated internal alignment and reduced downstream surprises—without triggering additional regulatory processes.
Clinical Trial Design & Patient Cohort Selection

Use of DART-generated response data (PK/PD) to refine trial protocols, identify optimal biomarkers, and select the right patient subpopulations.
- Improves patient matching and likelihood of clinical response
- Reduces recruitment timelines and minimizes early-phase failures
- Enables more personalized and targeted trial planning
Outcome: Higher trial success rates and lower costs in Phase I/II studies—with improved reproducibility and fewer protocol amendments.
Mechanism-of-Action (MoA) Validation

Use of hMPS + AI analytics to evaluate target signaling pathways, gene expression changes, and phenotypic behavior in response to drug exposure.
- Provides internal confirmation that a drug candidate is acting as intended
- Supports research presentations, investor reports, or pre-IND documentation
- Identifies off-target effects or unintended pathways early
- Enhances the commercial value of the drug candidate for any out-licensing interests
Outcome: Sharper scientific insights and faster de-risking of drug candidates—prior to costly clinical investment.

All of these use cases can be executed entirely within your organization—no regulatory approval required. By accelerating feedback loops, reducing outsourcing costs, and improving internal decision-making, DART becomes more than a testing platform—it becomes a strategic advantage across your development pipeline and programs.

Why Partner with Quantiphi?

Quantiphi brings together deep AI expertise, ethical wet-lab partnerships, and real-world deployment experience to help life sciences organizations activate DART quickly and at scale.

We offer:

End-to-end enablement – from discovery workshops to scalable, production-ready deployments.
Flexible models – cloud-based, on-premise, or outsourced lab execution
Trusted partnerships – with Transcell Biologics (hMPS platforms sourcing) and global pharma innovators.
Proven impact – 2,500+ AI projects delivered, 300+ life sciences professionals, certified across AWS, Google Cloud, Nvidia, and Microsoft Azure.

Whether you’re exploring a proof of concept or embedding DART into your pipeline, we’ll guide you every step of the way.

Let’s Explore What DART Can Do for You

Ready to reduce timelines, improve efficiency, and move toward ethical science—without regulatory delays? Let’s build a smarter, faster, and more responsible drug development process—together.

Schedule a 30-minute discovery session with our DART experts or contact us directly at appliedai@quantiphi.com

Learn more about DART: https://quantiphi.com/digital-animal-replacement-technology/

How DART Works

What Makes DART Different?

Why DART Matters: Measurable Time and Cost Savings

What About Regulatory Approvals?

High-Impact Use Cases That Don’t Require Regulatory Approval

Early-Stage Screening and Lead Optimization

Biologics Batch Testing

Residual Toxicity Profiling for Biosimilars (If required)

Clinical Trial Design & Patient Cohort Selection

Mechanism-of-Action (MoA) Validation

Why Partner with Quantiphi?

Let’s Explore What DART Can Do for You