Agility Clinical

Description

Hale, who has been a key figure in the Southern California life sciences industry for over 25 years, has been involved as a founder, CEO or chairman of several companies, including Hybritech, Inc., Gensia, Inc., Viagene, Inc., Santarus, Inc., Somaxon Pharmaceuticals, SkinMedica, Inc., Neurelis, Inc., and a number of others.

Dr. Johnson, Ph.D. has more than 20 years of experience in the pharmaceutical industry. During his ten years at Allos Therapeutics, Doug held positions of increasing responsibility including Vice President of Manufacturing and Vice President of Pharmaceutical Sciences. Allos was a virtual company focused on oncology indications. In addition to experience in virtual companies Dr. Johnson held a number of positions during eight years at Baxter Healthcare in both the IV and Renal Divisions. He has prepared complete CMC sections for both INDs and NDAs.

Kathryn Rangus has over 30 years experience in regulatory affairs and has consulted in the medical device, biologic, and drug industries for over 20 years. Consulting projects have included strategic planning, project management, preparation and filing of IND, BLA, NDA, ANDA, SPA, IDE, PMA, 510(k), Orphan Drug and Fast Track requests, and training and mentoring. Kathryn has prepared meeting information packages and participated in meetings with the FDA. Therapeutic areas include oncology, metabolic disease, pain, ophthalmic, gastrointestinal, HIV, and medical imaging.

According to Hale, "Agility's mission is to provide services to small and virtual biopharma companies, with a focus on treatments or diagnoses for children and orphan diseases. While Agility will provide traditional CRO services, companies may also choose from a menu of services that addresses their specific needs.

Ali Sadighian has been in R&D and clinical development for over 20 years. He started his career as a researcher at the UCSD School of Medicine, moved into biopharma at The Immune Response Corporation, and then into clinical operations at Quintiles, PRA, and Monitorforhire.com with increasing levels of responsibility. His experience includes the full project life cycle from startup to closeout, and several therapeutic areas including infectious disease, oncology, and respiratory. Most recently he was Vice President of Business Development at Synteract, where he served for 6 years.

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