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19

Number of Biopharma Companies Worked With

51

Number of Projects Worked On

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Preclinical Services

Hollow-fiber models for infectious disease, oncology, immune system, and safety with 3D human organotype models.
Publication

Quantitative Clinical Forecasting

Mathematical models to predict performance in clinical trials for clinical trial design and adaptive clinical trial design.
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Clinical Trials & Research

Perform clinical trials and research in North America and 28 African countries. Modeling to support clinical trials and dose selections.

Quantify. Predict. Cure.

Integrating laboratory experiments, mathematical models, morphism mapping, and machine-learning/A.I. to predict:
-Rates of Response in Patients
-How Many Patients Will Respond
-Optimal Duration of Therapy
-Doses to Minimize Failure & Resistance
-Personalized Therapy

Preclinical Lab & Math Modeling Solutions

-Will drug be efficacious in humans? If so, at what dose? -Are there potential toxicity risks that can be identified early? If so, at what dose?
-Are there potential opportunities to improve efficacy through drug combinations? If so, what drug(s) and doses?
-How best to align our regulatory strategy, pre-clinical and clinical plans to mitigate risk?
-Demonstration of commercial viability of drug to investors & partners

Helping Clients

Our predictions have been highly accurate through Phase III studies and beyond.
-Accurately predict efficacy and toxicity signals during preclinical phase
-Preclinical prioritization of assets
-Optimal drug doses for combinations using factorial design
-Reduce drug development timelines using our quantitative forecasting
-Data and models that we have generated has been used by clients throughout the regulatory process by international regulatory bodies
-We can help clients identify potential collaborators and investors

Reduce Risk, Increase Success

Unique Biotech CRO for Drug Discovery, Development & Clinical Trials

Customized preclinical model technologies mathematically mapped to patients for quantitative prediction of patient responses, response rates, and optimal doses and toxicology with >90% accuracy.
Model Uses Include:
-Optimized clinical trial design, including sample size and adaptive designs
-Identify and develop biomarkers to optimize clinical trial design and provide biology-driven clinical trial therapeutic endpoints

-Custom-made hollow fiber technology and 3D human organoids combined with advanced ‘omics, bulk and single cell sequencing for drug discovery, biomarkers, IP strengthening/submission, safety, and IND submissions.

  • Help clients evaluate assets for efficacy, safety and optimal dosing in the clinic early in the preclinical stage
  • Saves client’s time and money by identifying non-efficacious or toxic assets before entry into the clinical
  • Improves patients’ lives by identifying biomarkers and optimal trial/adaptive trial design reducing the number of patients required for clinical trials
  • Unique team of laboratory scientists and mathematical modelers who are also clinicians, pharmacometricians, physicians, and veterans of the pharmaceutical industry.
  • Develop proprietary translation methods and map out early in the drug development where in the clinical space the client’s products will land decades later
  • Special insight into mitigation of resistance and toxicity in the clinic that can be affected during the preclinical stages
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