Nicholas Pelliccione

WORK HISTORY

EDUCATION

SKILLS

ABOUT NICHOLAS PELLICCIONE

I am a multi-faceted leader in the areas of global Regulatory Affairs and Quality Assurance for close to 30 years. During that time I have been responsible for teams working in the clinical, preclinical and CMC regulatory development of new drugs in the oncology, endocrine/metabolic, anti-infectives, neurology, psychiatry, cytokines, and cardiovascular therapy areas, leading to several approvals. I have long standing experience working with FDA on development programs, conducting meetings at numerous levels from pre-IND through Advisory Committees. Since 2005 I have worked in the biotech, smaller company environment, where I have gotten involved with in- and out-licensing, and due diligence activities as well. Recent experience includes successfully filing an NDA (electronically), obtaining approval from FDA for Special Protocol Assessments, Parallel Scientific Advice (with EMA/FDA), other eCTD filings such as INDs, and filing and obtaining orphan designation for several products. My various roles have taken me through many aspects of regulatory and quality situations, and that experience has helped in developing strategies for our development programs. My management experience has included managing and directing groups from a few people up to 50 people. Over the years my roles have also provided many opportunities to present to senior executive management up to the CEO of a major pharmaceutical company and other executive committees.