San Diego-based Adventrx Pharmaceuticals has established a regulatory advisory board, which will provide drug development and regulatory affairs guidance on the company’s interactions with the FDA.
Frank J. Sasinowski, M.S., M.P.H., JD, will be advising the regulatory advisory board as a director at Hyman, Phelps & McNamara, P.C., a law firm with one of the most extensive food and drug practices in the U.S. Sasinowski assists sponsors in developing new medicines and has helped secure FDA approval for hundreds of new drugs including more than 45 novel therapies for serious and rare diseases. Sasinowski had a key role in implementing both the 1983 Orphan Drug law and the 1984 Hatch-Waxman law, and has received the FDA Award of Merit twice. In 1987, Sasinowski left the FDA and joined Hyman, Phelps & McNamara. He is also a current at-large member and a former chair of the board of directors of the National Organization for Rare Disorders (NORD).
Cindy Dinella, R.Ph., Pharm. D., is founder, president and managing partner at Advyzom, a boutique consulting company specializing in highly strategic regulatory and development advice and services for the pharmaceutical and healthcare industry. Dinella has over 20 years of experience and formerly served as 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. She has filed over 100 IND filings across various therapeutic, filed and received approval for over 35 New Molecular Entities (NMES) and major efficacy supplements, and developed and managed 13 Risk Evaluation Mitigation Strategies (REMS).
Bonnie Hepburn, M.D., is a rheumatologist with more than 20 years of experience in drug development and was formerly chair of the FDA's Arthritis Advisory Committee. She currently serves as a clinical professor in the department of medicine, division of rheumatology/allergy/immunology at the University of California, San Diego and as a consultant to private and public pharmaceutical and biopharmaceutical companies. Hepburn has been directly involved in planning clinical and regulatory strategy for multiple products including new molecular entities, both xenobiotics and biologic agents, across different platforms and multiple therapeutic areas. Previously, she has served in senior drug and clinical development roles at Novartis, La Jolla Pharmaceutical and Santarus.