Lubomir Nechev

SVP CMC Development
Alnylam Pharmaceuticals, Inc

Dr. Nechev  leads the CMC Development Department at Alnylam Pharmaceuticals. He joined Alnylam in March 2004 and in the last 19 years, he has led the development and implementation of the CMC strategy for siRNA therapeutics, which is now used in five approved products – ONPATTRO®, GIVLAARI®, OXLUMO®, Leqvio®(Novartis), and AMVUTTRA™. ONPATTRO® is the first approved siRNA therapeutic and the first approved lipid nanoparticle (LNP) formulated oligonucleotide. GIVLAARI® is the first approved GalNAc-conjugated siRNA. Before Alnylam, Dr. Nechev worked at Ribozyme Pharmaceuticals (RPI) and the Nucleic Acids Synthesis unit of Transgenomic, Inc. Dr. Nechev received his Ph.D. degree in Organic Chemistry from St. Kl. Ohridski University, Sofia, Bulgaria and completed his post-doctoral training at Vanderbilt University, Nashville, Tennessee. CMC Strategy

Speech title & Synopsis

CMC Strategy for siRNA Therapeutics

Last few years showed a significant increase in the number of approved oligonucleotide products, not only in the liver-targeting rare disease area, but also in CNS and prevalent diseases. This increased the interest in the process of systematic development of CMC strategies in the field. The talk will focus on successful manufacturing and quality control strategy for synthetic siRNA therapeutics, utilizing different delivery solutions.