RxGen is a specialty translational research company devoted to understanding and overcoming human disease through innovative preclinical modeling. We apply significant preclinical and therapeutic domain expertise in ophthalmic, central nervous system, cardiovascular and metabolic disease to develop and apply translational models to meet the scientific needs of the global biomedical research community.
Our MD and/or PhD trained study directors and highly trained technical team engage with leading academic research institutions, venture-backed start-ups, and biotechnology and pharmaceutical companies to advance a diversity of therapeutic discovery and development programs. RxGen’s research facilities are AAALAC accredited and GLP compliant, providing a wide range of preclinical research expertise, from preclinical strategy to disease model validation to IND-enabling study design and execution.
To develop, validate, and apply the most predictive preclinical models to accelerate candidate evaluation, selection and development, and reduce the risks and costs of clinical failure for therapeutic discovery and development organizations around the world.
To become a leading provider of predictive preclinical models and technologies that drive significant gains in research and development productivity across the biomedical research community.
The RxGen Platform
Research Models & Capabilities that Truly Enable Clinical Translation
From discovery to development to post-market repositioning, RxGen has established a powerful preclinical platform to provide critical insight into the safety and efficacy of novel therapies, medical devices and delivery technologies to accelerate and strengthen the path to clinic and associated development decisions.
The RxGen Advantage
Scientific Engagement. Clinically Relevant Modeling. Timely Execution.
RxGen has advanced discovery and development programs for a wide range of sponsors, collaborators and partners, ranging from large pharmaceutical companies and venture-backed biotechnology companies to academic teams seeking to apply the most cutting edge research and development strategies in the most efficient and robust manner.
Our unique portfolio of models, combined with focused therapeutic domain expertise results in engagements that generate high value, clinically relevant data that yields definitive, actionable study outcomes.
We place ultimate value on scientific excellence and innovation and the effectiveness with which our resources and models are applied toward achieving objectives. All programs are pursued to the highest standards with full consideration of clinical objectives and animal welfare. RxGen is recognized for the quality of scientific engagement and capability applied to research and development programs.
We maintain active research and development programs related to the characterization and validation of new translational research models and technologies that can reduce risk and drive further efficiencies in the drug discovery and development process. This is achieved by harnessing significant therapeutic domain expertise, robust study design and data analysis, and state of the art instrumentation and endpoints, coupled with our unique primate research resources. Our translational research is often conducted in collaboration with industry and academic partners to ensure we are leveraging the most innovative thinking and scientific resources available in terms of defining and addressing the most pressing unmet disease modeling needs. Present research and development programs include:
Dry age-related macular degeneration (AMD)
Chronic vascular leakage
Central Nervous System
Congestive heart failure
Biomarkers of aging
Validated Efficacy Models
We maintain a rigorous scientific process related to characterization and validation of new models and associated drug discovery and development applications. Before a model can move from Research status to Screening status, a model must meet the following criteria:
• The clinically relevant disease pathology can be induced reproducibly with sufficient statistical confidence that a drug screening protocol can be designed and executed toward a specific discovery and development objective.
• The induced disease pathology can be modulated by therapeutic intervention using the current clinical standard of care (assuming there is actually an appropriate benchmark on the market), and/or the known drug target is present in healthy and/or induced conditions and can be measured through clinically relevant endpoints and/or scientifically validated assays.
Wet-age-related macular degeneration • Retinal neovascularization • Glaucoma • Uveitis • Surgical Inflammation • Myopia • Cataract • Optic Neuropathy • Ocular Toxicology • Ocular Pharmacokinetics
Central Nervous System (CNS)
Parkinson’s disease • Spinal cord injury • Schizophrenia • Dystonia • Behavior & Cognition
Diet-induced Obesity • Metabolic Syndrome • Hyperlipidemia
Hypertension • Heart failure
Adjuvant and Vaccine Development
Ophthalmic • Neurosurgical • Cardiac • Renal • Orthopedic • Stereotaxic • MRI-guided
Research Collaborations & Co-Development
RxGen routinely works with study sponsors to create and optimize translational models and to define and validate endpoints applicable to both preclinical and clinical study designs. We embrace a collaborative approach to new model development and pursue co-development opportunities that are enabled by our platform. Our ability to study a diverse population of mixed sex and ages, or a phenotypic subpopulation defined with respect to specific study aims, provides a unique and enabling path to developing and applying more clinically relevant models.
If you have a compelling strategy for an inducible disease and/or other screening model that might be amendable to validation and application in a clinically relevant test system, contact us at .
Our Engagement Model
RxGen offers several engagement models, from contract research studies to 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.
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
Oral • Subcutaneous • Intramuscular • Intravenous • Transdermal • Nasal • Intrathecal • Intraparenchymal • Topical Ophthalmic • Punctal • Subconjuntival • Intravitreal • Subretinal
Serum • Plasma • Whole blood • Cerebropinal fluid • Urine • Aqueous • Vitreous • Other biodistribution endpoints
Design and execution
Protocol customization • Single, repeat and chronic dosing • Continuous infusion • PK/PD modeling • Dedicated colonies available
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.
Ocular • CNS • Systemic • Clinical pathology • Histopathology • Imaging • Study-specific 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.
- Fundus photography
- Fluorescein angiography
- Optical coherence tomography (OCT)
- Laser flare photometry
- Ophthalmic laser
- Specular microscopy
- Full-field electroretinography
- Multifocal electroretinography
- Slit lamp ophthalmoscopy
- Indirect retinoscopy
- A scan
- Surgical microscopy
- Microsurgical instrumentation
Surgical, Imaging, Cell Culture and Analytic Instrumentation
- MRI imaging
- MRI-guided surgical navigation
- Surgical microscopes
- Stereotaxic surgical equipment
- Gait kinematics
- Cognitive testing systems
- Video behavioral assessment
- Plantar pressure systems
- Light & fluorescence microscopy
- Computerized image capture
- Microplate/cuvette readers
- Cell culture incubators
- Laminar flow biosafety cabinets
- Microinjection systems
- Tissue dissection systems
For general inquiries, please contact us at the email below.
RxGen is a rapidly growing company seeking creative, experienced and highly motivated individuals with the ability to lead and contribute to multidisciplinary initiatives. RxGen offers an exciting and congenial environment in which your creativity and innovation will be encouraged and rewarded. While we currently do not have any specific open positions for which we are accepting CVs, please feel free to submit your CV for possible future consideration.