G. Susan Srivatsa, Ph.D.

Since founding ElixinPharma in 1999, Susan has provided strategic regulatory leadership in the CMC area for a number of leading companies in various stages of preclinical and clinical development. She routinely meets with the FDA and other international regulatory agencies to present CMC programs on behalf of client companies. Susan has presented many training courses to pharmaceutical companies in the area of drug characterization, quality control, quality assurance and regulatory affairs in the US, Europe and Asia.

Over the past seventeen years Susan has spent on the development of oligonucleotide therapeutics, she 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, first IND for an siRNA by systemic delivery and the first and only INDs for siRNA in nanoparticle and liposomal delivery systems.

Susan served as Senior Director at Isis Pharmaceuticals (1993-1999) where she was responsible for analytical development and quality control of oligonucleotide drug candidates from preclinical studies to marketing. At Isis, Susan 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 TM, 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 for 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 Pharmaceuticals.

Susan received a Ph.D. in Analytical Chemistry from the University of California 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.

Susan lives in Encinitas, CA with her husband of more than 20 years, Ming Fai Chan, a fellow scientist. They have two daughters, Rebecca, a college student and Alyssa, a high school student. When not thinking about oligonucleotides or playing soccer mom, Susan spends her time walking at her favorite spot, Moonlight Beach, practicing Yoga and reading.