Nonclinical study monitoring
A well designed and executed toxicology package can make the difference between success and failure. It is essential that these studies are designed appropriately, conducted to the highest standards, and reported with clarity, in the required timelines. An independent Study Monitor helps to select the right CRO, and ensures delivery of a quality end product that meets the needs of the project.
A Study Monitor should ideally be an experienced regulatory toxicologist with many years of expertise gained from running and monitoring GLP-compliant pre-clinical toxicology studies, at a wide range of CROs. They should have highly developed communication skills to allow open and effective dialogue between the Sponsor and CRO.
ApconiX provide the entire study placement and monitoring service. This includes selection of the CRO, advice and input into study design, oversight of the in-life phases, and reviewing draft reports for scientific and regulatory rigour.
I’ve worked with Guy Healing for the last year on CTA/IND enabling toxicology studies for 2 compounds. Guy did a fabulous job as a study monitor and toxicology consultant for the 15 studies in total placed at CROs in UK and Germany. As I am based in the US, Guy was pivotal in bridging both the time-zone difference and cultural differences with the CROs. He traveled to both CROs to conduct thorough audits of the studies and facilities providing timely and superb audit reports. Guy was also very helpful in pulling in needed expertise in other areas either via his colleagues at ApconiX or an external pathologist. Guy has great communication skills and is a real pleasure to work with. He is very knowledgeable and a great resource for toxicology advice.
Our Study Monitors
Dr Guy Healing
PhD, ERT, FBTS
Dr Guy Healing is a Senior Toxicologist with ApconiX Ltd. Until 2016 he was an Associate Director in the Drug Safety and Metabolism department at AstraZeneca, heading up the Regulatory Submissions Group and the Study Monitoring team. He started his career working for the Medical Research Council at the Clinical Research Centre at Northwick Park Hospital in London, followed by a brief spell working at a large pre-clinical CRO. He then spent five years with Schering Agrochemicals, before joining AstraZeneca (formerly Astra) Pharmaceuticals in 1996. Guy has extensive experience in monitoring and directing pre-clinical studies, has sat on Project teams and managed groups of Project Toxicologists and Study Monitors.
Guy is a European and UK Registered Toxicologist, a Fellow of the British Toxicology Society and a member of the Panel for the UK Register of Toxicologists. He sat on the BTS Executive Committee as Treasurer of the Society between 2010 and 2016, and edited the Society Newsletter between 1995 and 2005. He is an Editorial Board member for the Journal of Applied Toxicology and Toxicology Reports and has published widely in peer reviewed journals, as well as editing textbooks on preclinical infusion technology.
Ian Slater has spent many years in the pharmaceutical industry as a toxicology Study Director and Study Monitor. Ian was previously an Associate Principal Toxicologist in the Regulatory Safety group at AstraZeneca and has a wealth of experience in multiple study types and working with Contract Research Organisations.
Ian has both a bachelor’s and master’s degree in Applied Biology. He has worked in a variety of roles at ICI, Zeneca and AstraZeneca. A member of the British Toxicology Society, Ian was Chair of the Study Director Workshop at BTS from 2011-2015, providing a forum of the sharing of good practice and the development of junior toxicologists.
Pauline is an experienced Genetic Toxicologist and Programme Manager, with over 24 years in nonclinical safety at a medium-sized CRO. As a Genetic Toxicology Study Director and latterly the Section Manager of a small team of scientists and technicians, Pauline is extremely knowledgeable in Good Laboratory Practice and all aspects of in vitro and in vivo genetic toxicology study design, conduct and reporting across a diverse range of indications.
During her time specialising in Programme Management over the last 9 years, Pauline has been able to combine a passion for science and pharmaceutical development, with the knowledge of client’s project and commercial needs. Pauline has a strong reputation in communication and an eye for detail. She particularly enjoys building enduring customer relationships to support optimum delivery of non-clinical safety programmes.