Program Value Delivered.

As scientists, our aim is to guide you through the design and execution of research that will drive value to your program.  As a development partner, our responsibility is to help you efficiently allocate capital to drive stakeholder return - the patients in need, and the investors that are backing your vision and strategy to bring treatments to market. 

To enable investment decision making, we have established a no-risk engagement model where we design studies and programs at no-cost to you, allowing for accurate project and program budgeting to inform investment decision making.

To enable the most efficient and cost effective scientific execution, we have fully combined preclinical and clinical therapeutic area expertise with advanced NHP translational R&D capabilities, and tightly integrated histopathology and molecular research cores to enable turn-key scientific engagement, study execution, sample processing, data analysis, and study reporting for our sponsors. 

This "platform" approach is underpinned by our unique, cost-effective access to nonhuman primates that conveys significant time and cost savings to sponsors while enabling our team to focus on advanced new models, methods, and data that will improve clinical outcomes. 

All models must meet the following critical induction, characterization, and validation criteria before being employed in sponsor-funded screening studies:

• The clinically relevant disease pathology can be reproducibly induced within variability limits that allow candidate screening protocols of sufficient statistical power to permit 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.
  
  
• The disease pathophysiology can be induced and sustained with limited animal welfare impact.

• Target distribution and indication selection
• Tissue distribution of AAVs, lipid nanoparticles, other viral and non-viral vectors, stem cells, therapeutic antibodies, tag proteins (GFP, RFPs, FLAG, V5, HA)
• Rigorous immunohistochemistry assays development using 20+ tissue matrices correlated with single cell RNA-Seq and public omic databases
• Model characterization, validation and efficacy assessment referencing established historical control databases

• Non-GLP and GLP nonclinical safety primary interpretation and peer-reviews in African green monkey, cynomolgus monkey, mouse, rat, dog, pig, human, and other test systems
• Mechanistic toxicology, including companion molecular methods (RNASeq, western blot, qRT-PCR, ELISA)
• Briefing books and IND authoring, representations at type C meetings, and responses to FDA comments

• Bespoke method and test system development and validation to achieve data objectives
• Analysis of all tissue types, including liver, spleen, kidney, brain, eye, and difficult to process tissues

• DNA, RNA and protein isolation from tissue, blood, biofluids and cultured cells
• Isolation and quantification using Agilent 2100, Spectra Max, Qubit, and Nanodrop