Experience

From preclinical proof-of concept to IND-enabling studies, Virscio’s goal is to bring clarity and confidence to R&D investment decision making and improve the odds of clinical translation.  We fully support critical development stages, spanning preclinical strategy, protocol design, in-life study execution, sample processing, data analysis, study reporting and defining regulatory path, with a focus on in vivo primate efficacy and safety, pharmacokinetics, pharmacodynamics and therapeutic delivery.  Our capabilities are enabled by broad experience, including:

  • 30+ years of translational R&D experience
  • 80+ team with exceptional retention, many having decades of experience
  • 10+ MD and/or PhD Study Directors
  • 500+ industry preclinical study / program engagements
  • 30+ models validated and applied to therapeutic program development
  • Significant engagement with large pharma, venture-backed, and academic clients from around the world

Efficacy Models

Virscio has established nonhuman primate models that closely emulate human disease pathology, which we routinely employ in efficacy studies of small molecules, biologics, gene and cell therapies, medical devices and delivery technologies.

Prior to application to therapeutic candidate screening our models meet these strict characterization and validation criteria:

  • The clinically relevant disease pathology can be induced reproducibly within variability limits that allow candidate screening protocols to be conducted with the statistical power to permit specific discovery and development decisions.
  • The induced disease pathology can be modulated by a clinical standard of care intervention and/or the therapeutic target is present in the induced disease phenotype and can be measured or inferred through validated, correlated endpoints. 

Ophthalmology

  • Wet-age-related macular degeneration
  • Retinal neovascularization
  • Glaucoma
  • Uveitis
  • Optic neuropathy
  • Surgical inflammation
  • Myopia
  • Amblyopia
  • Cataract

Cardiovascular

  • Hypertension
  • Heart failure

Immunology

  • Adjuvant and Vaccine Development

Metabolism

  • Diet-induced obesity
  • Hyperlipidemia

Central Nervous System

  • Parkinson’s disease
  • Spinal cord injury
  • Schizophrenia
  • Dystonia
  • Behavior and Cognition

Delivery

  • MRI and ultrasound guided deliverySustained release devices
  • Gene therapy vectors
  • Cell therapies
  • All routes for small molecules and biologics

Preclinical Services

Virscio’s unique, unparalleled access to biologically clean primate population allows timely initiation of studies in treatment naïve or non-naïve animals of preferred age range, sex, weight and number, guided by specific research objectives.  By employing clinically relevant primate models, Virscio enables accurate characterization of human risk and response to therapeutic candidates to speed candidate selection, and increase the odds of clinical success.  Subject selection and model optimization further allow reduction and refinement of animal use.

Study Designs Conducted

  • Pharmacokinetics (PK)
  • Pharmacodynamics (PD)
  • Delivery Optimization
  • Safety Pharmacology
  • GLP Toxicology (acute and chronic)

Gene Therapy Evaluations

  • Neutralizing antibody guided recruitment
  • Target tissue delivery
  • Detailed biodistribution determinations
  • Pharmacodynamic endpoints
  • GLP safety

Safety Endpoints

  • Ocular
  • Central nervous system
  • Systemic
  • Clinical pathology
  • Histopathology
  • Imaging
  • Functional observational batteries
  • Toxicokinetic modeling
  • Therapy-specific endpoints

Biosampling

  • Serum
  • Plasma
  • Whole blood
  • Peripheral blood mononuclear cells
  • Cerebrospinal fluid
  • Urine
  • Aqueous humor
  • Vitreous humor
  • Tissue biopsies
  • Comprehensive tissue collection

Routes of Administration

  • Systemic
    • Oral
    • Subcutaneous
    • Intramuscular
    • Intravenous
    • Transdermal
    • Nasal
  • CNS
    • Intraventricular
    • Intrathecal
    • Intraparenchymal
  • Ophthalmic
    • Topical ophthalmic
    • Punctal
    • Subconjunctival
    • Intracameral
    • Intravitreal
    • Subretinal
    • Suprachoroidal

Cell Therapy Evaluations

  • Defined immunosuppression regimens
  • Target tissue delivery
  • Cell survival assessments
  • Functional endpoints
  • GLP safety

Scheduling and Execution

  • Accelerated initiation
  • Phased study designs
  • Single, repeat and chronic dosing
  • Onsite quality assurance

Surgical Modeling

  • Ophthalmic
  • Neurosurgical
  • Cardiac
  • Renal
  • Orthopedic
  • Stereotaxic
  • MRI-guided
  • Telemetry & Device Implantation