G. Susan Srivatsa, Ph.D.
Susan is an internationally recognized expert with more than 25 years of experience in the area of oligonucleotide analysis and control. Since founding ElixinPharma, Susan has provided strategic CMC regulatory leadership for more than 60 oligonucleotide drug candidates in various stages of pre clinical and clinical development to market authorization. She routinely meets with the FDA and international regulatory agencies to present/defend CMC programs on behalf of client companies.
Susan has been part of many successful “firsts”, paving the way for the regulation of novel technologies including the first oligonucleotide drug approval in US and Europe, first DNA decoy duplex to reach Phase 3, first aptamer to enter Phase 3/subsequent market approval, first siRNA IND/subsequent development to Phase 3, first IND for a combination oligonucleotide for pulmonary delivery, first IND for an antidote controlled aptamer up to Phase 3, first IND for an siRNA by systemic delivery and the first INDs for siRNA in nanoparticle and liposomal delivery systems.
Susan served as Senior Director at Isis (now Ionis) Pharmaceuticals (1993-1999) where she was responsible for analytical development and quality control of oligonucleotide drug candidates from preclinical studies to marketing. She also had responsibility for the strategic planning, writing and defense of CMC sections of US and international regulatory submissions including the NDA and MAA for Vitravene, the first oligonucleotide drug approved in the US and Europe.
In 1998, she was elected to the PhRMA Analytical R&D Steering Committee and in 1999 represented PhRMA at the ICH Meetings in Brussels and contributed to the ICH Quality Guideline, Q6A: Specifications for New Drug Substances and Drug Products.
Susan has broad experience in the development of small molecules, proteins, peptides and oligonucleotides having held positions of increasing responsibility at the Procter and Gamble Company, Allergan Inc., Abbott Laboratories, Telios and Isis (Ionis) Pharmaceuticals.
Susan received a Ph.D. in Analytical Chemistry from the University of California, Riverside followed by post-doctoral research in NMR spectroscopy. She has served on the Scientific Advisory Board of the US Tides conference since 2000, the EuroTides conference since 2004 and AsiaTides conference since its inception in 2009. She is also an advisor to the DIA/FDA Oligonucleotide-based Therapeutics Conference.
Susan is co-editor of a recently published book entitled “Handbook of Analysis of Oligonucleotides and Related Products”, an essential reference manual for the application of current and emerging analytical techniques for the analysis of oligonucleotides in support of research and development.