Regulatory Affairs

Iconic Therapeutics has conducted a pre-IND meeting (PIND 102,472) with the FDA to discuss its phase 1/2a clinical trials. Iconic has assembled a world-class team to write, assemble and submit its Investigational New Drug application (IND) with the FDA for these initial clinical studies: this was successfully accomplished in 4Q10.

Dr. Patrick Trown, Iconic’s principal scientific consultant, is responsible for writing the Non-Clinical Pharmacology and Toxicology section of the IND; Dr. Trown has been has been active in the Pharmaceutical/Biopharmaceutical industry for over 45 years. He held positions of increasing responsibility from researcher to Vice President at Lederle Laboratories, Hoffmann La Roche, Xoma Corporation, Onyx Pharmaceuticals and Jennerex Inc. During this time he wrote the Non-Clinical Pharmacology and Toxicology, Chemistry Manufacturing and Control and Investigators’ Brochure sections of a CTX; the Pharmacology and Toxicology sections of a BLA/MAA; the Preclinical Expert’s Report of a drug that received FDA and EU approval. He also wrote, compiled and submitted an IND for a New Chemical Entity oncology drug.

Dr. Adriana Manzi is responsible for writing the Chemistry, Manufacturing and Control section of Iconic’s IND. Dr. Manzi has over 25 years of experience in biomolecules research and development. She has been the President and Principal Consultant of Manzi & Associates since its inception in June 2006. From 2001 to 2006 she served as the Senior Director of Research for Baxter Healthcare Corporation. From 1999 to 2001 she served as the Director of Analytical Development/Quality Control for Nextran, Inc. From 1998 to 1999 she was the Associate Director of Analytical Development at Cytel Corporation. From 1991 to 1998 she was the Director of Glycobiology Core and an Assistant Professor at the Cancer Center in the Department of Medicine at the University of California, San Diego.

Dr. Judy Gordon, Founder and President of ClinReg Consulting Services, Inc. is managing Iconic’s IND submissions process. Dr. Gordon brings almost 20 years of experience in pharmaceuticals, biologics, and medical devices to her consulting practice a clinical and regulatory consultant since 1998. Dr. Gordon was with Chiron Vision, a division of Chiron Corporation, from the company’s founding in 1986 through its successful acquisition by Bausch & Lomb in 1997. At Chiron Vision, Dr. Gordon served most recently as Sr. Vice President of R&D and as V.P. of Scientific Affairs, with responsibility for product development, clinical research, regulatory affairs, and regulatory compliance. Dr. Gordon has taken multiple PMAs and NDAs through the FDA review process, and has directed large-scale clinical trials of both devices and pharmaceutical products. In total, Dr. Gordon has prepared all or part of 16 successful PMA applications for novel devices. She served as the industry representative to FDA’s Ophthalmic Devices Advisory Panel, chaired an industry-FDA working group on guidance documents for clinical trials of refractive surgery lasers, and as the industry representative to the Mediation Dispute Panel of the Center for Devices and Radiologic Health (CDRH).