Former GCP Inspector at MHRA, Executive Director
Poulton Quality Solutions, UK
Mark started his career at Beecham Research Laboratories in anti-infective discovery programs, where he was involved in the development of high-throughput screening systems for drug discovery and in the isolation and identification of naturally produced active components. The discovery research involved antibacterial, antimycoplasmal, antiviral and antiparasite research. After 17 years in the lab, Mark then moved into Clinical Research, where he worked as a global Program Manager. In this role, Mark worked for a number of different pharmaceutical companies (British, French, American and Japanese) and managed different trials in many therapeutic areas on a global basis. In this time Mark was involved in all aspects of research, including drug development planning, management and reporting of trials and submitting trial data to authorities. After 13 years in clinical research, Mark moved to the MHRA, where he was a GCP Inspector and was involved in all aspects of GCP inspection in the UK and overseas. He was involved in the non-Commercial inspection process and also the bioequivalence inspection process. In addition, he was part of the inspectorate training team, and also managed a number of GCP Consultative meetings. After 5 years as an inspector, Mark joined ADAMAS Consulting in October 2011, where he was involved in a number of different audit types in different areas of the world, having performed most aspects of GCP, laboratory aspects of GLP and IMP manufacturing aspects of GMP audits. In 2017, Mark moved back into the pharma industry by taking on the Senior Manager QA role at Clovis Oncology and in 2019 set up his own quality consultancy company Poulton Quality Solutions Ltd to provide global quality expertise and advice to clients to ensure compliance and understanding of clinical requirements. Mark has a degree in Applied Biology, specializing in Microbiology, and is a member of Research Quality Assurance (RQA).
Digital Innovator, Managing Director/Founder
Muehlhausen Consulting, Ireland
Willie started his consulting business in 2018 after spending more than 20 years in the clinical research industry working for CROs and technology companies in Germany, UK, US and Ireland. He served as the inaugural Vice-Director of the C-Path ePRO Consortium shaping the initial work of the founding members and is an active member in DIA and ISPOR research groups. In recent years he initiated and directed research on multiple patient-facing technologies (i.e. ePRO / BYOD, Wearables, Patient Burden, Fraud Detection via Machine Learning) and co-authored more than 40 publications and two books on electronic Patient Reported Outcomes. Willie successfully developed multiple product and service lines in the eCOA space including the first dedicated ePRO Management group within a global CRO. His work has been recognized by his industry peers by including him in the PharmaVoice100 in 2015 and the CenterWatch Top 20 Innovators in 2018.