Suchi Raghunathan, Randolph Abutin, Amanda McSweeney, Misty J. Williams-Fritze, Rami Tzafriri, Cyrille Sage. ‘Large Animal Models for Auditory Research: Guide to the Perplexed.’ Poster presentation at: ARO Midwinter Meeting, Jan 25-29, 2020, San Jose, CA. Summary: Auditory studies, including those evaluating ototoxicity and pharmacokinetics (PK), are typically performed using rodent models. Some studies, however, may require a […]
Tzafriri AR. “Multiyear Tissue Retention of Paclitaxel is Driven by Lesion Complexity: Insights from Experimentally Grounded Computational Modeling“ A recent meta-analysis of randomized controlled trials investigating paclitaxel-coated balloons and stents in femoropopliteal arteries reported increased mortality risk 2-5 years after treatment, with no causal mechanism. We developed an experimentally grounded computational model to identify scenarios […]
Rami Tzafriri, Sahil A. Parikh, Juan Granada, Elazer R. Edelman. “Identifying Conditions for Very Late Tissue Retention of Paclitaxel: Insights from Mechanistic Computational Modeling.” Background: A recent meta-analysis of randomized controlled trials investigating paclitaxel-coated balloons and stents in the femoral and/or popliteal arteries reported an increased risk of death 2-5 years after treatment. Yet, no […]
Rami Tzafriri, Felix Mahfoud, Sahil A. Parikh, Elazer Edelman. “Quantification of Procedural and Anatomical Determinants of Multi-electrode Renal Denervation” Background: The failure of the prospective, randomized, sham-controlled SYMPLICITY HTN-3 trial to show significant difference in reduction of systolic BP (SBP) in patients with resistant hypertension 6 months after RDN compared to controls was attributed in […]
Margaret Lashof-Sullivan, Amanda L. McSweeney, David T. Ting, Michael P. Kim, Ching-Wei D. Tzeng, Laura Indolfi. “Targeted and sustained drug delivery therapy for localized pancreatic cancer: In vivo validation in porcine models“ Poster presentation at AACR Special Conference on Pancreatic Cancer: Advances in Science and Clinical Care; September 6-9, 2019; Boston, MA. Proceedings of the […]
Michael Naimark. “Swine Clot Model for the Evaluation of Mechanical Thrombectomy Devices” Summary: Restoration of d blood flow (TICI>2b) downstream of a proximal cerebral artery has been established as the definitive treatment for acute ischemic stroke (AIS). In recent years mechanical thrombectomy (MT) using stent retrievers has overtaken thrombolysis as the therapy of choice for AIS. […]
Rami Tzafriri. “Quantitative preclinical insights into procedural and anatomical determinants of multi-electrode renal denervation efficacy” Summary: Radiofrequency renal denervation (RDN) is under investigation for treatment of hypertension with variable success. First generation systems used a single, monopolar radiofrequency (RF) electrode to sequentially ablate a series of angularly staggered locations along the endoluminal surface of the renal […]
Cyrille Sage, Aurore Marie, Randolph Abutin, Rami Tzafriri. “Ototoxicity Related to Cisplatin: Does Gender Matter?“ Summary: Cisplatin is a first-line treatment of several cancers. Adverse effects include nephrotoxicity, neurotoxicity, and ototoxicity with no preventative treatment for the latter. Cisplatin treatment often results in a bilateral elevation of hearing threshold resulting in irreversible hearing loss. In the […]
Michael Naimark. “Partnering for FDA Review: Approaches for Preclinical Outsourcing and CRO Evaluation.“ Summary: Whether you are a large established pharma/device group, a small biotech company, a startup, or an academic spinoff, getting your medical technology into the clinic will likely require partnering with experienced contract research groups with regulatory experience and the infrastructure to […]
Michael Naimark. “Partnering for FDA Review: Approaches for Preclinical Outsourcing and CRO Evaluation.“ Summary: Whether you are a large established pharma/device group, a small biotech company, a startup, or an academic spinoff, getting your medical technology into the clinic will likely require partnering with experienced contract research groups with regulatory experience and the infrastructure to support […]