There are many pathways to take in moving discovery data and early drug development data into the clinic. Recognition of the regulatory pathways that will be most efficient, cost-effective, and time-sparing is critical in the choice of partner, consultants and staff as a great idea is brought into the practical world of exploratory and confirmatory patient treatment. This seminar will provide a framework for the types of data-sets that will be of most interest and usefulness to regulators, and will present concrete examples of how sparse data can be leveraged towards success for a provisional small molecule or biologic product.
Dr. Evan B. Siegel founded Ground Zero Pharmaceuticals, Inc. (GZP) in 1999 from his consulting firm, Ground Zero Strategics, Ltd. He currently serves as its President and CEO and is also the Chairman of the Board. Prior to GZP Evan served as Consultant and CEO to OXO Chemie Inc., Vice President, Regulatory Affairs and Bioethics for Medical Science Systems, Inc. (now Interleukin Genetics), and Director of Regulatory Consulting Services and Principal Regulatory Scientist for Quintiles, Inc., North Carolina. Dr. Siegel has also held regulatory affairs and executive positions at Astra and Syntex and was a Toxicology Reviewer at the US Food and Drug Administration, as well as Supervising Toxicologist and Chief of Special Services at the State of California’s Food and Drug Branch, Department of Health Services.