Nicole Assmann is a Medical Assessor at the MHRA. Nicole obtained her medical degree and her PhD from the University of Berlin, Germany. She initially trained in internal medicine in Germany and the UK. Following this, she completed the postgraduate training in Anaesthesia and Intensive Care in the UK and spent a year in Toronto as a research fellow in anaesthesia. After working as a consultant Anaesthetist in London, she moved to the MHRA and obtained a MSc in Drug Development Science. Her special interests are PK and PK/PD of anti-infectives

Susan Cole is an Expert Pharmacokinetics Assessor and Head of the Pharmacokinetics group at the UK Regulatory Agency. She is also a member of the Pharmacokinetics Working Party, the Modelling and Simulation Working Group and the Scientific Advice Working Party at the European Medicines Agency. Prior to joining the MHRA in 2012, Sue worked for 26 years at Pfizer in the UK in the field of Drug Metabolism and Pharmacokinetics. While in Industry she fulfilled a number of roles including: Head of the Preclinical Pharmacokinetics and Modelling group and as a Clinical Pharmacologist.

Paola Coppola is a Pharmacokinetics Assessor at the MHRA. She obtained her MSc in Biological Sciences from the University Federico II of Naples, Italy. Since 2010 she gained professional experience in pharmacokinetics, having worked in pharmaceutical industry in the position of Pharmacokinetics Scientist. She actively collaborated in clinical drug development programmes for small molecules in the therapeutic areas CNS, inflammatory, pain and antibiotics. She has advanced PK expertise in early phase trials and a particular interest in PK modelling. She joined the MHRA in October 2017.

David Brown is an Expert Statistical Assessor at the MHRA where he has worked for 19 years. He is the team Leader of the Statistics group at the Agency, and a member of the Scientific Advice Working Party and the Biostatistics Working Party at the EMA. As part of the former Efficacy Working Party at the EMA, he was the main author on the CPMP guideline on the choice of non-inferiority margin, and as a member of the Pharmacokinetics Working Party, he was one author of the drafting group for the CHMP guideline on the investigation of bioequivalence. As a member of the CHMP Scientific Advice Working Party since 2008 he has served as coordinator for many advices for biosimilar products.

Essam Kerwash is a Pharmacokinetics Assessor at the MHRA. He obtained his PhD degree in Clinical Pharmacology from University of London. He then received post-doctoral training at Barts Cancer Institute (London) where his research was focused on the clinical pharmacokinetic and biomarker studies during early phase clinical trials of new anti-cancer agents. He has also advanced expertise in the pharmacokinetic data analysis using population and physiologically based pharmacokinetic approaches.

Justin Pittaway-Hay is a Pharmacokinetics Assessor at the MHRA. He was conferred his PhD in Medicine (Pharmacology) from the University of Adelaide, Australia. Following this, he was in the position of Senior Clinical Scientist at CHDR (Leiden, the Netherlands), where he investigated how biomarkers of the central nervous system could be used as a screening tool in early drug development, with a particular interest in analgesics and pain models. In 2011 he was awarded his Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and in 2014 was awarded the Graduate Certificate (with distinction) in Clinical Pharmacology from King's College London. In October 2015 he joined the Agency and is a member of the EMA's Modelling and Simulation Working Party (MSWP).

Nicole Assmann is a Medical Assessor at the MHRA. Nicole obtained her medical degree and her PhD from the University of Berlin, Germany. She initially trained in internal medicine in Germany and the UK. Following this, she completed the postgraduate training in Anaesthesia and Intensive Care in the UK and spent a year in Toronto as a research fellow in anaesthesia. After working as a consultant Anaesthetist in London, she moved to the MHRA and obtained a MSc in Drug Development Science. Her special interests are PK and PK/PD of anti-infectives

Susan Cole is an Expert Pharmacokinetics Assessor and Head of the Pharmacokinetics group at the UK Regulatory Agency. She is also a member of the Pharmacokinetics Working Party, the Modelling and Simulation Working Group and the Scientific Advice Working Party at the European Medicines Agency. Prior to joining the MHRA in 2012, Sue worked for 26 years at Pfizer in the UK in the field of Drug Metabolism and Pharmacokinetics. While in Industry she fulfilled a number of roles including: Head of the Preclinical Pharmacokinetics and Modelling group and as a Clinical Pharmacologist.

Paola Coppola is a Pharmacokinetics Assessor at the MHRA. She obtained her MSc in Biological Sciences from the University Federico II of Naples, Italy. Since 2010 she gained professional experience in pharmacokinetics, having worked in pharmaceutical industry in the position of Pharmacokinetics Scientist. She actively collaborated in clinical drug development programmes for small molecules in the therapeutic areas CNS, inflammatory, pain and antibiotics. She has advanced PK expertise in early phase trials and a particular interest in PK modelling. She joined the MHRA in October 2017.

David Brown is an Expert Statistical Assessor at the MHRA where he has worked for 19 years. He is the team Leader of the Statistics group at the Agency, and a member of the Scientific Advice Working Party and the Biostatistics Working Party at the EMA. As part of the former Efficacy Working Party at the EMA, he was the main author on the CPMP guideline on the choice of non-inferiority margin, and as a member of the Pharmacokinetics Working Party, he was one author of the drafting group for the CHMP guideline on the investigation of bioequivalence. As a member of the CHMP Scientific Advice Working Party since 2008 he has served as coordinator for many advices for biosimilar products.

Essam Kerwash is a Pharmacokinetics Assessor at the MHRA. He obtained his PhD degree in Clinical Pharmacology from University of London. He then received post-doctoral training at Barts Cancer Institute (London) where his research was focused on the clinical pharmacokinetic and biomarker studies during early phase clinical trials of new anti-cancer agents. He has also advanced expertise in the pharmacokinetic data analysis using population and physiologically based pharmacokinetic approaches.

Justin Pittaway-Hay is a Pharmacokinetics Assessor at the MHRA. He was conferred his PhD in Medicine (Pharmacology) from the University of Adelaide, Australia. Following this, he was in the position of Senior Clinical Scientist at CHDR (Leiden, the Netherlands), where he investigated how biomarkers of the central nervous system could be used as a screening tool in early drug development, with a particular interest in analgesics and pain models. In 2011 he was awarded his Certificate in Human Pharmacology from the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and in 2014 was awarded the Graduate Certificate (with distinction) in Clinical Pharmacology from King's College London. In October 2015 he joined the Agency and is a member of the EMA's Modelling and Simulation Working Party (MSWP).