Tracy Rockney, J.D. was formerly VP, Regulatory Affairs at AbbVie Inc. from May 2010 to May 2015, leading executive functions related to regulatory policy and intelligence, and from August 1993 to January 2005 she held positions of increasing responsibility with Pfizer (formerly Wyeth). From January 2005 to April 2010, she held positions with Shire Pharmaceuticals (“Shire”), including serving as Senior Director, Regulatory Affairs. This included responsibilities as Therapeutic Area Head for Shire’s Gastrointestinal Business Unit, Regulatory Advertising & Promotion and CMC.
In January 2007, during her tenure with Shire, Ms. Rockney led the regulatory team and negotiations with FDA for LIALDA™. The FDA approved Shire’s LIALDA™ with MMX® technology, which was the first once-daily oral formulation of mesalamines. Mesalamines are part of the drug class of aminosalicylates, now part of the clinical standard-of-care for treating inflammatory bowel disease. LIALDA™ was found to be effective in Phase 3 trials for inducing remission of active mild-to-moderate ulcerative colitis after eight weeks of treatment. LIALDA™ (also now marketed as Mezavant®) had U.S. sales in 2016 of $714 million, which increased by 16% relative to 2015 sales.
Vitality Biopharma has developed a new class of cannabinoid pharmaceuticals, known as cannabosides, which upon ingestion can enable the targeted delivery of THC and cannabidiol (CBD) to the gastrointestinal tract. Cannabosides could provide therapeutic benefits for inflammatory bowel disease while eliminating or reducing drug psychoactivity. Approximately 1.4 million Americans are affected by inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Most patients are diagnosed before age 30 and require life-long treatment.
“We’re very excited to have Tracy join our team, as a regulatory leader with a clear track record of innovation and success with development of new drugs for gastrointestinal disorders,” said Robert Brooke, Chief Executive Officer of Vitality Biopharma.
About Vitality Biopharma ( OTCQB : VBIO )
Vitality Biopharma is dedicated to unlocking the power of cannabinoids for the treatment of serious neurological and inflammatory disorders. For more information, visit: www.vitality.bio. Follow us on Facebook, Twitter and LinkedIn.
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