Translational Oncology Research
& Drug Development
At Certis, we envision a future where every patient gets the right treatment for their cancer the first time, every time. Regrettably, the right drug isn’t always available—it hasn’t yet been discovered, or perhaps awaits clinical trials. By partnering with drug innovators seeking to develop more effective, more targeted cancer therapies, Certis is creating a future where cancer is powerless against our science.
We help drug innovators optimize lead candidate selection, understand PK/PD properties, and secure clear and compelling evidence of drug product efficacy. Our technology enables the comparison of your novel or combination therapies against current standard of care—a significant hurdle to new drug commercialization or label expansion. In the simplest terms, our translational studies bring certitude to “go-or-no-go” decisions and help de-risk drug development programs.
De-risk Your IND by Replicating the Clinic in Our Lab–with Orthotopic PDX Technology
Certis’s approach is rooted in a technology rapidly gaining prominence in basic cancer research: orthotopic patient derived xenograft (O-PDX) models. By surgically engrafting a small tissue specimen of a human tumor into the anatomically correct place in immunocompromised mice, we create avatars of human cancer that offer important advantages over more commonly used CDX and subcutaneous PDX models.
- Preserve the histological architecture, stroma construction, and gene-expression or mutation status of original tumor tissue,
- Replicate the human tumor microenvironment, which is critical to cancer progression and metastasis, and can
- Predict development of resistance to first-line therapy and response to second-line therapy–before these events are observed in donor patients
Not surprisingly, O-PDX models have proven to be useful patient avatars in co-clinical trials, whereby mouse studies are run in parallel with human clinical trials to assess efficacy.
Getting the Right Information Requires the Right Plan:
in-vivo Pharmacology Study Design and Execution
Whether you seek to understand one endpoint or several, you can be confident that every in-vivo investigation performed at Certis will be designed and executed to exacting standards. Having years of experience performing personalized studies for cancer patients, Certis scientists are experts at calculating dose and dosing schedules and determining optimal route of administration.
In-House MRI Capabilities Deliver a New Level of Precision
Certis owns one of the world’s only commercially available murine-scale MRIs. This technology, when paired with advanced imaging software, delivers objective tumor volume measurements (TVM) of each study cohort with unparalleled precision. Our in-house histology experts add confirmatory microscopy images to each dataset.
Low-Passage, High-Fidelity Tumors
At Certis, we recognize that access to the right implantable tissue is the first hurdle for any in-vivo investigation. But having the right phenotype or genotype is just the start. You want assurance that the tissue on which studies are based has high genomic and histological fidelity with your target patient population.
When you come to Certis, you can be certain of every tumor’s origin and fidelity. All specimens in our growing bank of tumors are cryopreserved at the earliest viable passage and are accompanied by the full spectrum of characterization data. For many specimens, the donor patient’s full treatment history is available.
If your desired phenotype is particularly difficult to find, Certis has the necessary CLIA license to directly source tissue. Our collaborations with a number of hospital systems, cancer centers and private practices facilitate access to a broad array of tumor tissues and malignancies. Of course, time is sometimes the driving factor. Our scientists also stand ready to develop your orthotopic models using commercially available or client-supplied tissue or cell lines.
Infinitely Searchable Database of Highly Characterized Tumors
- Model Kinetics/Growth Curves
- Patient Demographics
- Patient Treatment
- Copy Number Variation
- Expression Level
Certis conducts clinical research at our CLIA-certified, 7,000 square foot lab in Sorrento Valley, California. SCHEDULE A LAB VISIT: Info@certisoncology.com