Management

Artisan has assembled a core group of senior managers focused on the clinical development of drugs in the field of critical care and hospital-based therapeutics. We intend to announce additional senior and supportive hires in the near future.

Nita U. Patel, PhD
Senior Vice President, Regulatory Affairs & Quality Compliance

Nita U. Patel, PhD, currently is the Senior Vice President Regulatory Affairs and Quality Compliance
at Artisan, where she is responsible for strategic regulatory overview of all of Artisan’s product development programs. She also is developing and establishing an effective Clinical Quality Compliance program and processes within Artisan.

Dr. Patel has extensive experience (over 15 years) with GMP, GLP, GCP compliance, domestic and international license applications, regulatory agency pre-approval inspections and Biennial/Team Biologics inspections. Dr. Patel, in her auditing capacity, has also performed numerous quality assurance audits of both domestic and international CRO’s, clinical drug distribution sites, contract testing and contract manufacturing facilities.

Prior to joining Artisan, from 2004-2007, Dr. Patel served as is the Vice President of Regulatory Affairs at GenVec Inc. where she was responsible for strategic regulatory overview of GenVec’s gene delivery adenovector investigational products in the areas of Oncology, Cardiology, Opthamology, and Vaccines. She also developed and established an effective Clinical Quality Assurance compliance group and processes within GenVec.

From 2003-4, Dr. Patel served as Senior Director, Regulatory Affairs at Baxter Healthcare Corporation where she was responsible for Global Regulatory activities for licensed and investigational vaccines, including Bio-terrorism Products.

In 2002, Dr. Patel was Vice President of Regulatory Affairs and Quality at Novavax, Inc. where she was responsible for global Regulatory and Quality systems at Novavax.

From 1995 – 2002, Dr. Patel served with MedImmune and was responsible for coordinating both domestic and international filings and communications with the respective agencies regarding the various products developed and produced by MedImmune, most notably Synagis®.

Prior to joining MedImmune, Dr. Patel headed the Molecular Biology laboratory at Bio Reliance, a safety testing contracting laboratory.

Dr. Patel received her Bachelor’s degree in biochemistry at Queen Elizabeth College London and her PhD in yeast genetics at University College London. Dr. Patel has over 25 years of academic experience and over 15 years of pharmaceutical industry experience. Dr. Patel also serves as an adjunct professor of Regulatory Affairs and Biotechnology at Montgomery College, Maryland.