In vitro you may see high activity, but in vivo it’s a whole different world.
Formulation, biodistribution and dosage are the top challenges for developers of new drugs and biologics, particularly those for highly specific indications.
Your path to clinical trials for new drugs and biologics runs through us
On your path to establishing safety and efficacy for your new drug or biologic therapy, we have the surgical expertise, husbandry experience and specialized knowledge needed to pull through positive results in preclinical testing.
How to solve the top challenges in preclinical testing for drugs and biologics
We have the surgical, veterinary and specialized experience needed to generate positive results in preclinical testing for drugs and biologics.
Surgical Expertise
Our surgical expertise, particularly in large animal models necessary for the regulatory process including IDN, maximizes the efficiency with which our drug and biologic sponsors accomplish their preclinical testing programs. Placement of tiny catheters near the spine for directed drug delivery, infarctions, biologic or stem cells for cardiothoracic repair, sample processing and associated documentation require the high levels of surgical expertise. Our team of 40 preclinical staff members include 9 surgical experts with more than 100 years of surgical expertise are ready to put that experience to work for your new drug or biologic therapy.
Cardiology
Cormatrix relies upon us for preclinical testing for micronization of its device-like patch on the bleeding edge of science where device meets biologic. The company’s patented ECM® material acts as a scaffold into which the patient’s own cells migrate and integrate — stimulating natural wound healing mechanisms which mature to form a strong, permanent tissue repair. CorMatrix devices have been used as a biologic scaffold in many different surgical applications, including cardiac and vascular repairs and reconstruction. It enables surgeons to restore the native anatomy of cardiac and vascular tissues in need of repair, serving as a superior alternative to synthetic or cross-linked materials.
Husbandry / Veterinary
Our preclinical CRO staff includes 5 DVMs with more than 50 years of experience in preclinical. This expertise enables our sponsors to rest assured the proper models and protocols are rigorously known and adhered to. Our veterinary experience enables us to deliver consistency in study design, excellence in execution and innovation in preclinical solutions that make the most out of our sponsors’ investments in preclinical testing for new drugs and biologics.
Neurology
The Neuralstem therapy for spinal cord degeneration used our services to help achieve IND approval and advance to clinical trials. Neuralstem is the first FDA approved neural stem cell trial for the treatment of ALS. Its proprietary Spinal Cord Delivery Platform and Floating Cannula make the first ever intraspinal injections possible.
Specialization
We have highly specific expertise in drug and biologic preclinical testing for cardiology, neurology and regenerative medicine.