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Srivatsa

 Dr. Susan Srivatsa is the Founder and President of ElixinPharma, a pharmaceutical regulatory consulting firm that provides scientific and technical leadership in the area of Chemistry, Manufacturing and Controls (CMC) for a number of leading companies in various stages of clinical development.  The firm specializes in supporting the development of novel technologies such as DNA and RNA therapeutics for which FDA regulatory guidance is currently unavailable.

Susan received a Ph.D. in Analytical Chemistry from UCR in 1987 under the mentorship of Prof. Donald T. Sawyer. Her graduate research focused on electrochemical and structural studies of transition metal complexes as models for oxygen binding and electron transfer hemoproteins. She pursued her post-doctoral research at UCR under Prof. Dallas L. Rabenstein on the biophysical applications of NMR spectroscopy.

Prior to founding ElixinPharma in 1999, 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 pre-clinical studies to approval and marketing.  Susan also has broad experience in the development of small molecules, proteins and peptides, having held positions of increasing responsibility at the Procter and Gamble Company, Allergan Inc., Abbott Laboratories and Telios Pharmaceuticals.

Over the past twenty years, Susan has been part of many successful “firsts”, paving the way for the regulation of novel therapeutics in the US and Europe, including approval of the first antisense oligonucleotide drug, Vitravene TM, approval of the first aptamer oligonucleotide drug Macugen TM, first DNA decoy duplex to enter Phase 3, first siRNA to enter clinical trials, first combination oligonucleotide by pulmonary delivery; first regulatable antithrombotic aptamer/antidote combination, first siRNA by systemic delivery and the first siRNA to be delivered in nanoparticles.

In 1998, Susan was elected to the PhRMA Analytical R&D Steering Committee and in 1999 served on the Expert Committee along with FDA, European and Japanese regulators for development of the ICH Quality Guideline, Q6A: Specifications for New Drug Substances. Susan 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 continues to publish articles in peer-reviewed journals and recently co-edited a book entitled “Handbook of Analysis of Oligonucleotides and Related Products” published by CRC Press in 2011.

 

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