Peter Tattersall

Background

About Peter Tattersall

Peter Tattersall, Ph.D. is a Director of an Analytical group in the Chemical Process Development at BMS. B.Sc. and Ph.D. from the University of Manchester, UK; Post Doc University of Texas at Austin. More than 20 years in analytical development and over 25 publications. He worked at AstraZeneca, Delaware before joining Bristol-Myers Squibb in 2003 where he is an analytical team leader (FIH to NDA >15yrs), project leader (10yrs) for cross functional CMC development teams. Supervises a group of analytical chemists working on separation science in small molecule development, solving challenging problems, developing analytical control strategies, in-process testing, method development, validation and transfer in support of drug substance synthesis. Previously had DP experience (>15yrs) and is an SME on forced degradation studies, specifications, investigations, method development, NDA validation and transfer following cGLP, GMP, ICH and pharmacopeia / directives. Led analytical leader training program (10yrs), validation best practice team (>5yrs) & analytical method risk assessment program (>5yrs). Authored method IND/NDA validation SOP and contributed to the company wide directive. Actively reviewed and commented on draft ICH and health authority guidance, conducting impact assessments on BMS internal practices. Over the last 8 years, he has led analytical teams to perform NDA stage validation and transfer of robust methods to commercial sites. Traveled to ANVISA, Brazil to discuss forced degradation and validation in relation to emerging guidance. He was chair of the small molecule Specification Committee covering FIH to registrational specification setting of API and drug product. Authored specification SOP and led integration processes from BMS and Celgene. Authored CMC analytical sections for worldwide filings with assessments for specific agency requirements and several HA question responses. He has given invited talks on stability indicating method development, method validation, risk assessment, forced degradation, and analytical investigations at various conferences and meetings in US, India, UK, Europe, and Canada. Written articles on various topics including method development, analytical transfers, risk assessments and forced degradation study requirements for American Pharmaceutical Review and LCGC. Co-lead of ETC and IQ consortia teams on data curation for over 5 years. Currently on 1 year Tour of Duty coordinating roll out of product development analytical network community that includes over 450 analytical scientists across BMS.