Associate Principal Scientist, Pharmaceutical Sciences
Andrew Poulton after completing my PhD in organometallic synthesis in 2004 I work as a post doc on asymmetric synthesis until joining AstraZeneca as a senior analytical scientist in 2006.
During my time at AstraZeneca I have contributed and led analytical aspects for numerous drug projects across the portfolio including Tagrisso which achieved progression from FTIH to successful Regulatory approval in 2y 8 months.
In 2015 I moved into Pharmaceutical Sciences supporting projects from preclinical to phase IIb. In this role I have worked across a broad range of therapy areas and modalities including Antisense oligonucleotides and (currently) antibody drug conjugates.
For the last 5 years or so I have been a member of the AZ impurities advisory group (IAG) which oversees and advises AZ globally on all aspects of impurity control including mutagenic impurities. My focus has been on control and specifications of impurities during clinical development and more recently the development of nitrosamine risk assessments in the clinical phase.
DAY 1: NOVEMBER 30th, 2023
SESSION: Nitrosamines, industry perspective
◆ Understanding of the evolution of the issue – Valsartan to NDSRIs.
◆ Current risks – progress against deadlines.
◆ Areas of uncertainty and their impact.
◆ Where will we be in 12 months times.