Auritec hires a Director of Pre-clinical Development and Regulatory Affairs.
Santa Monica, CA. June 1, 2010
Auritec Pharmaceuticals, Inc. is pleased to announce the hiring of Robyn Willis, BS, GCPharmSc, for the position of Director of Pre-clinical Development and Regulatory Affairs. Robyn A Willis has 14 years’ experience in the drug development industry that includes regulatory toxicology, regulatory submissions, and ensuring adherence to international regulations and guidelines throughout the drug development phases. Most recently and prior to joining Auritec Pharmaceuticals, Ms. Willis managed the preclinical functional area of a non-profit organization dedicated to discovering and developing therapies for Huntington’s Disease, ensuring the company’s preclinical efforts met product development milestones. At Amgen Inc., she monitored IND-enabling and post-IND studies for multiple therapeutic areas to ensure international regulatory compliance, contributed to regulatory filings, designed and implemented processes and procedures that significantly increased regulatory filing, operations, and business efficiencies, and was instrumental in developing effective Sponsor-CRO partnerships. Prior to Amgen, Ms. Willis was a scientific and technical writer-editor at Biotechnical Services Inc. (BSI) where she wrote and produced peer-reviewed toxicity and carcinogenicity reports for NIH’s National Toxicology Program. Prior to BSI, she conducted and managed GLP and non-GLP toxicology studies at a large CRO. Ms. Willis is excited to join the Auritec team and feels she will be able to expedite Auritec’s pre-clinical and regulatory efforts.
About Auritec Pharmaceuticals
Auritec Pharmaceuticals, Inc. based in Santa Monica and Pasadena, CA, is a R&D company specializing in innovative, extended release drug delivery systems. Auritec was founded by Thomas J. Smith, MD, who has been granted 8 INDs and 2 NDAs throughout his pharmaceutical career in sustained release drug delivery. Dr Smith is joined on Auritec's management team by Gary Ransom, a seasoned international business executive, who focuses on strategy, marketing and business development.
Auritec’s Plexis™ technology is an innovative, polymer-based, proprietary platform technology for sustained release of drugs given by injection. Plexis™ combines a membrane based, diffusion-driven release mechanism with drug particle sizing large enough to allow high drug loading, but small enough to be injected. Plexis™ combines the benefits of linearization of release with those of injectability.
Auritec’s Versa™ technology is an implantable drug delivery platform that is responsible for two FDA approved products. It is based on a core of solid drug, coated with a semi-permeable polymer.
Auritec has developed a novel approach to extended release drug delivery with implications so far for indications including schizophrenia, Parkinson’s Disease, arthritis, herpes and HIV/AIDS. Auritec’s primary objective is to develop and test the use of its Plexis and Versa platforms in a wide range of drug classes, and subsequently license the technology to key partners to continue development, trials and eventual commercialization. Auritec has been previously funded by numerous NIH grants and their IP estate includes worldwide granted and pending patents.