Our Engagement Model

RxGen offers several engagement models, from contract research studies and research collaborations to R&D partnering and platform access agreements with dedicated research teams aligned to efficiently advance discovery and development objectives. All engagements are predicated on defining the scientific and development needs of the sponsor and structuring the appropriate relationship to ensure that our unique platform drives discovery and development value, and ultimately, improved clinical outcomes through the advance of safer and more effective therapies.

We have significant experience and competency in applying our assets, capabilities, and resources toward a wide range of discovery and development activities, in support of all classes of therapeutic interventions. The scope of our engagements spans preclinical strategy, protocol design and development, in vivo study execution, data analysis, study reporting and regulatory support, with a focus on in vivo safety and efficacy, pharmacokinetic, pharmacodynamics, and drug delivery.

Efficacy Assessments

Leveraging our portfolio of models and associated preclinical capabilities, RxGen designs and conducts efficacy studies of small molecules, biologics, cell and gene therapies and medical devices.

Pharmacokinetics, Pharmacodynamics and Delivery Optimization

RxGen conducts rapid turnaround PK and PD studies in drug naïve or non-naïve subjects of preferred age, sex, weight and number with performance of bioanalytics through a preferred provider or secure sample shipment to study sponsors.

Multiple routes of administration

Samples

Design and execution

Toxicology and Safety Pharmacology

By employing clinically relevant primate models, RxGen enables accurate characterization of tolerance, speeds candidate selection, decreases late-stage compound attrition, and improves time to market of small molecule therapeutics, biologics, and medical devices.

Toxicity endpoints

Design and execution

• Acute, subchronic, chronic
• Oral, intravenous, intramuscular, subcutaneous, ocular
• Safety pharmacology study designs to define endpoints for incorporation into larger follow-on toxicology, kinetic and clinical studies

Facilities & Infrastructure

RxGen’s research facilities have been designed to optimize animal wellbeing and study outcomes and we are recognized for our commitment to each. The AAALAC accredited and GLP-compliant campus encompasses study-specific vivariums, surgical and procedure suites, physiology labs, ophthalmic exam rooms, tissue culture, MRI and ultrasound imaging, wet labs, necropsy rooms, test article storage, sample storage and shipping, and staff training, administrative and research and visiting scientist workspace.

Ophthalmic Instrumentation

Surgical, Imaging, Cell Culture and Analytic Instrumentation