T3 Labs | Drugs & Biologics

Generate Positive Preclinical Results

How to solve the top challenges in preclinical testing for drugs and biologics

T3 Labs has the surgical, veterinary and specialized experience needed to generate positive preclinical results for your drugs and biologics programs.

In vitro you may see high activity, but in vivo it’s a whole different world.

Delivery, dosage, biodistribution and toxicity are the top challenges for developers of new drugs and biologics. Particularly so, for those specific indications where current therapies are underwhelming. Heart attacks, critical limb ischemia, wound healing, stroke and ALS (amyotrophic lateral sclerosis) are a few of the unmet medical needs that will require new, innovative approaches for better treatments and eventual cures. T3 Labs has the unique capabilities to accelerate the development of tomorrow’s breakthrough drugs and biologics.

Surgical Expertise

T3’s surgical expertise, particularly in the large animal models necessary for initial proof-of-concept and feasibility, as well as definitive GLP data for IND regulatory approval, enable our sponsors to evaluate drugs and biologics in clinically relevant preclinical models. Creation of models of human disease such as direct delivery of cells or drugs to single organs or targeted treatment sites,  myocardial  infarctions, hind limb ischemia or blood clots, require high levels of surgical and procedural expertise. Our team of 40 preclinical staff members includes 9 surgical experts that are ready to put their experience to work for you and your new drug or biologic therapy.

Husbandry / Veterinary

Our preclinical CRO staff includes 5 DVMs with more than 80 years of combined experience in preclinical operations. This expertise enables our sponsors to rest assured knowing the proper models are selected and protocols are rigorously designed and executed. Our veterinary experience enables T3 to deliver consistency in study design, excellence in execution and innovation in preclinical solutions like; team member and vendor selection and integration, test system selection and preparation, data collection and test article specific training of all study team members, pilot studies, sample processing and associated documentation. These capabilities create the most value for  our sponsors’ preclinical investments for new drugs and biologics.

Specialization

T3 has highly specific expertise in models for drug and biologic preclinical testing in multiple therapeutic areas including cardiology, neurology, wound healing and regenerative medicine as follows:

  • Delivery of spinal cord regeneration treatments
  • Intrathecal injections
  • Intraparenchymal injections
  • Laminectomies to facilitate intrathecal injections
  • Intrathecal delivery catheter placement
  • Subcutaneous drug delivery pump implants
  • Left or right Ventricular  myocardial infarcts for cardiac tissue repair and reconstruction
  • Right heart failure models via PA obstruction for delivery of progenitor cells
  • Tissue response and resorption of placental tissue or amniotic membrane technology
  • CSF taps
  • Blood Draw for PK studies
  • Dose range tolerability studies
  • Gross Necropsy and Sample harvesting
  • Neurological scoring
  • Gait examination
  • Daily observations

Network of Support

We understand that drug and biologics studies don’t just end at in-vivo experiments. In addition to the models and services outlined above,  T3 Labs has partnered with a network of providers to provide a full spectrum of services as follows:

  • Toxicology
  • Histopathology/Toxpathology
  • Pharmacokinetics
  • Biodistribution assays
  • Biomarker assay
  • Hematology and Serum Chemistry

Your path to clinical trials for new drugs and biologics runs through T3 Labs

On your path to establishing safety and efficacy for your new drug or biologic therapy, T3 Labs has the surgical expertise, husbandry experience and specialized knowledge needed to provide clear direction and pull through positive results in your preclinical testing.

Contact D. Andrew Stevenson andrew.stevenson@t3labs.org or call (404) 251-0631