FROM MECHANISMS TO PERFORMANCE

Novel drug eluting device designs pose novel challenges in their development and regulatory approval. CBSET embraces the full complexity of combination devices, leveraging its expertise in experimental and modeling techniques to study the mechanisms underlying device implantation, elution kinetics, efficacy and safety. We are world leaders in computational modeling of local drug delivery spanning the gamut of processes underlying elution kinetics from coatings, blood flow, tissue absorption and distribution by diffusion, convection, cell uptake and binding. We have harnessed our expertise in coupling computational mass transport models with quantitative bench-top experiments to provide insights on drug delivery by stents, wraps and coated balloons, the influence of physicochemical drug properties and tissue morphology in native and disease states. Building on that deep expertise, our experienced team of professionals will develop an integrated research program of in-vivo, bench-top and computer studies to identify the rate limiting process governing elution from your devices and to predict the spatio-temporal patterns of drug distribution that they achieve in appropriate animal models. Our mechanistic approach provides a powerful paradigm by which to optimize your devices, educate your clinical and regulatory constituencies and streamline the regulatory process.

CBSET's capabilities include:

• Specialized ex-vivo and benchtop models of elution and drug transport
• GLP pharmacokinetics/toxicokinetics
• PK data analysis and reporting
• In-vitro and in-vivo kinetic models for combination products
• Consulting services on the use of mechanistic modeling for educating clinicians and streamlining the regulatory process