G. Susan Srivatsa, PhDPresident at ElixinPharma
Susan is Founder and President of ElixinPharma, a scientific consulting firm dedicated to assisting emerging pharmaceutical companies with their chemical development needs and writing/defense of CMC sections of regulatory applications, for oligonucleotide-based therapeutics (antisense, siRNA, aptamers, etc.) in simple (parenteral) and complex (topical, oral, pulmonary, liposomes, nanoparticles, etc.) dosage forms. Since 1999, Susan has provided strategic regulatory leadership in the CMC area for a number of leading oligonucleotide companies in various stages of clinical development. Susan received a Ph.D. in Analytical Chemistry from the University of California in 1985 followed by post-doctoral research in NMR spectroscopy.
Workshop Leaders’ Introduction and Overview: Regulatory Expectations for the Control of Impurities in Oligonucleotides, 9:00amView Session