Michael Naimark. “Serving the Gap: Combining GLP Preclinical Standards with Academic Rigor for FDA Review.“ Summary: Michael discussed the fundamental principles of preclinical program development with an eye towards clinical testing and market approval through the FDA and its branches. He emphasized new regulatory strategies for novel therapeutic approaches in regenerative medicine including the RMAT designation, […]
Tag Archives: 2018
ICI Meeting 2018, Dec 2-4, Tel Aviv, Israel
ICI Meeting 2018 – Dec 2-4, Tel Aviv, Israel
EuroPCR: Local, regional, and systemic factors in BRS thrombosis in small vessels: understanding the sub-2.5mm barrier
Kumaran Kolandaivelu, Josep Maria Balaguer, Maria Tomas Gracia, Jose Manuel Sanes, Enric Estruch, Laura Perkins, Syed Hossainy, Rami Tzafriri, Peter Markham, Elazer Edelman. “Local, regional, and systemic factors in BRS thrombosis in small vessels: understanding the sub-2.5mm barrier.“ Summary: Device thrombosis dominates bioresorbable vascular scaffolds (BVS) safety concerns, particularly in sub-2.5mm vessels. To better understand […]
EuroPCR: Visualizing and quantifying differential distribution of balloon-delivered coating to porcine arteries
Abraham R. Tzafriri; Arben Muraj; Fernando Garcia-Polite; Peter Markham; Brett Zani; Anna-Maria Spognardi; Steve Alston; Elazer R. Edelman. “Visualizing and quantifying differential distribution of balloon-delivered coating to porcine arteries.“ Summary: Drug coated balloons are a promising therapy for peripheral artery disease, but efficacy varies between devices and with lesion complexity. The accepted hypothesis that coating […]
EuroPCR: Visualizing the tissue distribution and retention of Sirolimus and analog delivered from polymer free drug coated stents
Tzafriri AR, Rotllant Daurella L,Keating JH, Garcia Polite F, Li X, Bailey L, Markham PM, Dutta D, Stoll HP, Edelman ER. “Visualizing the tissue distribution and retention of Sirolimus and analog delivered from polymer free drug coated stents” Summary: Biolimus A9 is a highly lipophilic Sirolimus analog (13-fold the lipophilicity of the parent drug) specifically […]
Eurointervention: Renal artery anatomy assessed by quantitative analysis of selective renal artery in 1000 patients with hypertension
Lauder L, Ewen S, Tzafriri AR, Edelman ER, Lüscher TF, Blankenstijn PJ, Dörr O, Schlaich M, Sharif F, Voskuil M, Zeller T, Ukena C, Scheller B, Böhm M, Mahfoud F; Renal artery anatomy in hypertensive patients study collaborators. Renal artery anatomy assessed by quantitative analysis of selective renal artery in 1000 patients with hypertension. Summary: […]
The International Journal of Cardiology Imaging: Vessel centerline reconstruction from non-isocentric and non-orthogonal paired monoplane angiographic images
Mie Kunio, Caroline C. O’Brien, Augusto C. Lopes Jr., Lynn Bailey, Pedro A. Lemos, Guillermo J. Tearney, Elazer R. Edelman. Vessel centerline reconstruction from non-isocentric and non-orthogonal paired monoplane angiographic images. Summary: Three-dimensional reconstruction of a vessel centerline from paired planar coronary angiographic images is critical to reconstruct the complex three-dimensional structure of the coronary artery lumen […]
ACVP Annual Meeting 2018, November 3-7, Washington, DC
Join CBSET at the ACVP Annual Meeting 2018, November 3-7 at the Marriott Wardman Park Hotel, Washington, DC. CBSET’s Director of Pathology, John Keating, DVM, DACVP, will be attending. If you would like to meet up with us at the event, please contact John. Related CBSET Services: CBSET GLP Preclinical Services CBSET Study Design Guide GLP Histopathology and […]
MDG Forum: Combination Products Medical Device Advances and Opportunities, Oct 30, 2018, Boston, MA
Join CBSET at the MDG Forum: Combination Products Medical Device Advances and Opportunities, October 30, 2018, at the Fine Arts Center at Regis College, 235 Wellesley St, Weston, MA. The topic of this forum will be 21st century drug development and unmet needs. Some of Boston’s most innovative companies will describe advances in drug delivery strategies in preclinical […]
Respirology: Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter
Tsukada H, Entcheva-Dimitrov P, Ernst A, Rafeq S, Keating JH, Seward KP, Yarmus L. Pharmacokinetics and safety of paclitaxel delivery into porcine airway walls by a new endobronchial drug delivery catheter. Background and objective: Intratumoral administration of chemotherapeutic agents is a treatment modality that has proven efficacious in reducing the recurrence of tumours and increases specificity […]