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ADVENTRX Announces Establishment of Regulatory Advisory Board
Date:4/9/2012

an 45 novel therapies for serious and rare diseases. Mr. Sasinowski joined FDA in 1983 as regulatory counsel in the Center for Drugs and Biologics, where he had a key role in implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law. He twice received the FDA Award of Merit. In 1987, Mr. Sasinowski left the FDA as Deputy Director of the health policy staff in the Commissioner's office and joined Hyman, Phelps & McNamara, P.C.

NORD, an organization representing patients with orphan diseases, honored Mr. Sasinowski in 2000 with its Humanitarian Award. Later that year he was elected to its Board of Directors where he has served as Chair and as Vice Chair, and where he remains on the Board today.

Cindy Dinella, R.Ph. Pharm. D.

Dr. Dinella currently serves as Founder, President and Managing Partner at Advyzom, LLC, a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for the pharmaceutical and healthcare industry.  

Dr. Dinella was formerly the Vice President of Drug Regulatory Affairs, the Nutley Site Head for Global Development and Member of the CEO's North American Operating Committee at Hoffman La Roche Inc. She brings more than 20 years of Regulatory and Drug Development experience.

Dr. Dinella has provided oversight and filed over one hundred IND filings across various therapeutic areas for both drugs and biologics. She has filed and received approval for over thirty-five New Molecular Entities (NMES) and major efficacy supplements. She has developed and managed thirteen Risk Evaluation Mitigation Strategies (REMS) with Medguides, Communication Plans, and Elements to Assure Safe Use (ETASU). Dr. Dinella has led numerous milestone and critical issue FDA meetings across Divisions, Centers and with FDA Senior Management.  She has led, presented, and managed oversight for thirteen FDA Public Advisory Committees for NME approvals, safe
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