Preclinical Research and Regulatory Support to Drive IND Approval

Precision starts accelerating therapeutic and diagnostic development even before the clinical stage, with preclinical research services designed to pivot your program efficiently into clinical development. Covering biomarker strategy, assay development, non-clinical computational modeling, and pre-IND/BLA strategy and regulatory support overall, Precision is purpose-built to advance drug and diagnostic development programs.

Preclinical Research and Regulatory Support to Drive IND Approval

Precision starts accelerating therapeutic and diagnostic development even before the clinical stage, with preclinical research services designed to pivot your program efficiently into clinical development. Covering biomarker strategy, assay development, non-clinical computational modeling, and pre-IND/BLA strategy and regulatory support overall, Precision is purpose-built to advance drug and diagnostic development programs.

Preclinical biomarker assay development

Precision supports preclinical studies with a focus on large molecule bioanalysis including immunogenicity and PK assays. We have experience running assays on samples from multiple species and excel at converting preclinical assays into clinical assays.

  • Immunogenicity
  • NAb/TAb Assays
  • PK Assays
  • Immune monitoring by Flow Cytometry or by our proprietary Epiontis ID technology
  • Sensitive analyte measurement using ELISAs and Luminex, MesoScale Discovery (MSD) and SIMOA platforms

Explore our Specialty Lab services >

Preclinical/non-clinical computational biology

Precision’s QuartzBio team transforms multiomic data into insights. We work with teams to leverage advanced analytics guided by domain experts with real-world biological understanding:

  • Perform target pathway selection
  • Identify and prioritize indications
  • Characterize Mechanism of Action (MoA)
  • Find out how QuartzBio’s preclinical/non-clinical modeling capabilities can support your development program by contacting us

Learn more about QuartzBio’s computational biology capabilities >

Scientific poster: Development and validation of a sensitive anti-PEG IgG assay

Pre-IND and BLA regulatory and strategy services

Precision’s regulatory experts can develop a comprehensive regulatory strategy, documentation, and can provide regulatory representation to support IND and BLA submission.

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Biomarker strategy development

Early development of a biomarker strategy informs the use of biomarkers in the clinic and supports clinical development .Precision’s integrated approach to therapeutic development means that we are well positioned to leverage preclinical biomarker assays and translational informatics into the clinical stage. From assay development and the logistics of sample collection and analysis, to trial design and the statistical analysis plan, the choice of biomarker and biomarker assay can impact every aspect of a study.

For this reason, we recommend developing a biomarker strategy early in development, even as early as during preclinical development, to ensure your assays and endpoints are practical and efficient when deployed at multi-site clinical study scales.Precision provides robust biomarker strategy development for effective and efficient clinical trials.

Proactive planning to optimize the use of biomarkers in oncology clinical trials

This white paper explains different types of biomarkers-diagnostic, prognostic, and predictive and how these biomarkers can be used in early phase studies to accelerate therapeutic development.

Discover how our preclinical research services can advance your drug or diagnostic development program

Discover how our preclinical research services can advance your drug or diagnostic development program

Services supporting preclinical development

Computational Biology

Domain experts from our QuartzBio team utilize integrated and harmonized data and tailored AI solutions to drive preclinical and clinical development, including patient stratification, signature development, predictive modeling of drug response, and MOA characterization.

Flow Cytometry

Acquire detailed insight into cell populations and subpopulations with multiplex flow cytometry, include advanced assays such as tetramer flow, phospho-flow, and receptor occupancy measurement.

Genomics

Find and monitor gene expression signatures, copy number variations, chromosome rearrangements, and other genomic events occurring in patient samples using NGS, NanoString, qPCR, ddPCR, and FISH/ISH.