Dr. James Matriano is scientist with over twenty years research and product development experience, and is a subject matter expert in drug delivery and combination drug/device systems with work from early research (proof of concept) to late stage product development (IND to NDA). Dr. Matriano has experience in controlled drug delivery systems including long-acting injectables, implants and transdermal platforms (passive, iontophoretic and microneedle).
He is experienced in multiple therapeutic areas include endocrinology (diabetes, osteoporosis and hormone replacement), oncology, pain management and infectious disease (vaccines). He has served multiple roles at ALZA/JNJ, Zosano Pharma, Amylin Pharmaceuticals and Durect Corporation, including management of preclinical development and bioanalytical departments, in-house analytical assay development, contract research organization oversight, developing and establishing preclinical models for pharmacokinetic / pharmacodynamic, immunogenicity, and toxicology studies. He has authored technical and regulatory documentation from preclinical to NDA and BLA sections. In addition, he has active preclinical and clinical experience in drug/device safety assessments (irritation, contact sensitization, immunogenicity, and biocompatibility testing programs).
Dr. Matriano has B.A. in biology, and an MS and PhD in immunology from Case Western Reserve University. He completed postdoctoral fellowships in transplantation immune tolerance and T-cell biology at the University of Miami. He has published in peer-reviewed journals, book chapters, and patent/patent applications in the areas of controlled drug delivery, immunology, dermatotoxicology and vaccine delivery.