Paula has over 20 years’ experience working in the agrochemical industry (ICI, Zeneca, Syngenta) firstly as a research plant biologist at Jealott’s Hill Research Station before moving into product registration. For the last 13 years Paula has worked opposite the EU and member states as a Regulatory Project Manager delivering active substance and plant protection product dossiers for EU and national registration/re-registration, and managing all aspects of the dossier review with the regulatory agency. Paula has an in-depth and current knowledge of the regulatory processes operated by Rapporteur Member States, the European Food Safety Authority and the EU Commission when reviewing new and existing active substances in accordance with Directive 91/414/EEC. In addition Paula has followed the development of new legislation and is well placed to advise on the technical and process changes associated with the introduction of Regulation (EC) No 1107/2009.

Richard has over 25 years industry experience in the environmental risk assessment (ERA) of general chemicals and human medicines.  Previously Head of AstraZeneca Global Environmental Risk Assessment he is fully conversant with the technical ERA requirements under EU REACH, EMA and US FDA.  He has represented AZ and national and EU pharmaceutical trade associations on ERA issues and been an active member/participant in several ECETOC and OECD taskforces, SETAC Pellston and DIA workshops and seminars on ’pharmaceuticals in the environment’ and ERA of pharmaceuticals.

Richard also supports the operational management of RSA, coordinating responses to new enquiries, pulling together project teams and ensuring that projects are appropriately resourced.  He has an analytical, ‘fit for purpose’ mind-set and is highly customer-focused, with a track record of delivering quality outputs to meet client and regulatory needs.

Sandra has a first degree in Pharmacology, a PhD in Experimental Neurology and 24 years’ experience as an industrial toxicologist at ICI/Zeneca/Syngenta Central Toxicology Laboratory (CTL). Sandra had a number of roles at CTL and was finally Head of Regulatory Toxicology. Sandra has an international reputation as an expert in neurotoxicology and is regularly invited to speak on this topic (most recently at a 1 day course for ECHA). She has extensive expertise in the design, conduct and interpretation of a full range of toxicology studies ranging from acute to lifetime exposures in a variety of species, including method development, novel research and human volunteer studies.

Sandra’s expertise covers industrial chemicals, agrochemicals and pharmaceuticals (including biologicals) and she has designed and project managed the delivery of testing programmes which meet all aspects of safety, efficacy and regulatory requirements as needed for product development. She now provides technical consultancy and advice to a variety of clients in a wide range of business sectors.

Mac has over 30 years’ experience in chemistry, biochemistry and toxicology with major companies (ICI, Zeneca and Syngenta) and was an investigative toxicologist at the world-famous Central Toxicology Laboratory (CTL) from 1979 to 2003. He is a recognised expert in the investigation and understanding of the role of metabolism and kinetics in species-specific responses to xenobiotics and has made numerous contributions in this field of regulatory science.

In addition to these key scientific skills, Mac also has significant experience of project management and information systems management. He was responsible for development of appropriate in-house ‘decision-making’ safety information for potential new products, prior to defining and managing the development of safety data packages and science-based registration strategy for new product registration and/or defence. More recently Mac has been involved in REACh technical dossier compilation and project management, particularly for substances with complex toxicology issues.

Gary is a skilled environmental fate specialist and environmental risk assessor, having formed part of the scientific team at Brixham Environmental Laboratory (BEL) between 1985 and 2014 (ICI, Zeneca and then AstraZeneca). His broad experience encompasses a range of chemical industry sectors, including pesticides, biocides, pharmaceuticals and industrial chemicals.

Gary has served on European scientific committees including the EU Biocidal Products Directive Notes for Technical Guidance. Gary chaired the ECETOC (European Centre for Ecotoxicology and Toxicology of Chemicals) Task Force which developed interim guidance for the inclusion of Non-extractable Residues (NER) in environmental risk assessment. He was also a member of the ECETOC monitoring team overseeing the CEFIC (The European Chemical Industry Council) LRi (Long-range Research initiative) research project ECO 24 (prediction of NER formation using structural alerts and QSARs) and ECO 25 (the development of ecotoxicity tests for assessing the environmental risk of NER in soil).

Since joining RSA in 2016, Gary has contributed to projects on behalf of clients which have used QSARs and read across for predicting toxicology and environmental endpoints. He has also used these approaches to preform projects focused on the establishment of the residue definition for dietary risk assessment. Gary has conducted work packages assessing the validation of analytical methods for EU pesticide registrations and used his chemistry and environmental fate knowledge to contribute to pesticide CLH (Harmonised Classification and Labelling) projects.

Jeanette has over 30 years’ experience in toxicology. She commenced her career with ICI Pharmaceuticals in 1976. She then worked in the world renowned Central Toxicology Laboratory (part of ICI, Zeneca and latterly Syngenta). Her expertise includes the ability to abstract, collate, interpret and summarise data from mammalian and eco-toxicology studies and to present it in a format that meets the requirements of international submission dossiers for submission to regulatory authorities. (e.g. for OECD and REACH IUCLID 5 dossiers).

Jeanette is experienced in drafting summaries of endocrine effects from mammalian and eco-toxicology studies. She also reviews data to provide the basis for rebuttal statements, preparation of competitor reviews and auditing of studies for compliance with GLP. She has worked for clients in chemical, agrochemical and pharmaceutical industries and consortia.

Paul is a versatile toxicologist within the pharmaceutical arena and has all round knowledge of all processes involved in drug research and development.  He is recognised internationally as an expert in the field of inhalation toxicology/aerosol science.  He has 30+ years experience in both CRO and pharmaceutical industries (AstraZeneca) as a study director/study monitor on a range of studies including all delivery routes and species but specialising as an inhalation toxicologist.  For the last 10 years at AstraZeneca Paul globally led the strategic implementation of preclinical outsourcing of inhalation toxicology studies, being accountable for all external work.  Paul has been an active committee member of the “Association of Inhalation Toxicologists” since 1987, organising the annual conference and working with regulators to improve the science of inhalation toxicology.

With over 25 years experience in the agrochemical industry, Lynda is an ecotoxicologist with a proven track record in managing environmental risk projects for agrochemical product registration and is able to provide a high level of holistic technical support for regulatory projects to meet business objectives.  She has extensive experience in project planning, development of regulatory strategies, risk mitigation and the generation of data for regulatory submissions through GLP compliant reports and presentations. Lynda’s most recent experience includes managing active substances through AIR and Product Renewal submission processes.

Louise is a highly skilled scientist with experience in the design, conduct, interpretation and reporting of preclinical safety pharmacology and investigative toxicology studies in the agrochemical and pharmaceutical sectors.

After completing an honours degree in Pharmacology and a PhD in Neuroscience Louise started her career in industry in 2002 at the Syngenta Central Toxicology Laboratory (CTL) Alderley Park playing a key role in the Investigative Toxicology group and becoming Neurobiology Team Leader with responsibility for delivering neuro-toxicology studies to support agrochemicals in development and later in the life cycle. After a spell in Medical Communications following the closure of CTL, Louise joined AstraZeneca Pharmaceuticals in 2009 (Safety Pharmacology) and has extensive experience in the safety assessment of pharmaceuticals, including the design, conduct and reporting of preclinical regulatory safety pharmacology packages and overseeing the inclusion of safety pharmacology endpoints to repeat dose toxicology studies. This has included contributing to the preparation of high-level summaries and submission documents, presenting at external meetings and authoring method development papers and reviews. Latterly she specialised in the outsourcing and study monitoring of preclinical safety pharmacology studies.

Kim has extensive experience of developing an understanding of the fate and effects of small molecules in biological systems. As a biologist with a mathematical leaning, Kim's career in ICI (latterly Syngenta) from 1988 to 2019 started in environmental and human exposure modelling and risk assessment for small molecules, followed by 16 years in mammalian toxicology and metabolism groups. His expertise is in understanding and modelling the mammalian kinetics of small molecules, including study design and interpretation, and the relationship to biological effects (desired or otherwise). He has also worked on new molecule discovery projects. Kim has published and presented extensively, and worked on many panels and committees as a recognised expert (e.g. ECETOC, ECPA, CLI, IVA, BBSRC, NC3Rs, FOCUS).

Claire is a driven and enthusiastic investigative scientist with over 15 years of GLP experience within leading, global life science companies. Recognised for expertise in toxicology, safety pharmacology and study management.

Claire started her career in industry in 2003 at Syngenta Central Toxicology Laboratory (CTL) Alderley Park acting as a Biology Research Specialist and Multidisciplinary Study Director, responsible for designing, conducting, analysing and reporting a range of safety assessment studies to GLP. In 2007, Claire joined the Safety Pharmacology section within AstraZeneca and has extensive experience in the design, conduct and reporting of preclinical regulatory safety pharmacology packages and overseeing the inclusion of safety pharmacology endpoints to repeat dose toxicology studies. The role included the outsourcing and study monitoring of preclinical studies. The role also included contributing to the preparation of high-level summaries and submission documents, presenting at external meetings and authoring method development papers and reviews. In 2014, Claire moved to an investigative toxicology Study Director role, leading a team of over 10 individuals, responsible for designing bespoke toxicology studies to address specific concerns within projects.

Claire joined RSA in 2018 and has spent her time supporting a range of projects providing toxicological advice to support product registrations and regulatory compliance. Claire has mainly focussed on conducting endocrine disruption weight of evidence assessments according to the EFSA/EHA 2018 guidance.

Jen graduated from Strathclyde Business School in 1989 with an honours degree in Law and Marketing and subsequent professional development included specialist finance and strategy courses at both Henley and Ashridge Business Schools. Over the years she has worked in senior positions for blue chip companies in the fields of banking, telecoms and latterly with her own family business. Strategy, finance and multi-site operational and people management have been key to all her positions. Jen rejoined RSA in 2020 to support the next stage in its ongoing development and is delighted to be working once again with its senior management team.

Diane has a diverse background in toxicology that spans over 30 years working in the Central Toxicology Laboratories of Syngenta and within AstraZeneca.  Practical and Senior Investigatory roles and later as a Regulatory Project Manager with recognised specialism in reproductive toxicology and expertise with data interpretation, writing Common Technical Dossier tables, report summaries and auditing protocols and reports from CRO’s.  At AstraZeneca, Diane took the lead in one of the largest divestments’ worth in excess of $1 billion to raise funds for investment in new drugs.

As an experienced toxicologist, Diane is well versed with all aspects of Study Monitoring, with site visits, ongoing site dialogue and the review of study documentation whilst ensuring compliance with the appropriate regulatory guidance all within the framework of GLP. 

Dr Phil Botham is a member of RSA’s leadership team, providing advice on organisational development and skills recruitment. He is currently Principal Science Advisor for Syngenta’s Global Product Safety organisation, based at the company’s international research centre at Jealott’s Hill. From 2013 to 2017, he was the Global Head of Product Safety for Syngenta, managing a team of over 300 experts in human and environmental safety based mainly in the UK, North America and Brazil.

Previously he held a number of senior leadership roles in Syngenta and its legacy companies in the area of human safety and toxicology, from 1980 until 2007 at the Central Toxicology Laboratory in Alderley Park and from 2007 at Jealott’s Hill. He has a broad background in chemical and agrochemical human safety and has specific technical expertise in acute toxicity, sensitisation, immunotoxicology and in vitro alternatives.

He has published more than 140 peer-reviewed papers and was appointed as a Fellow of the Royal College of Pathologists in 2001 in recognition of his publication record in the field of toxicology. In 2017 he joined the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Scientific Committee and he was also appointed as a member of the UK Food Standards Agency Committee on Toxicity (CoT). Phil has been a member of the British Toxicology Society for over 30 years and was appointed as a Fellow of the Society in 2006.

Dr Mark Graham PhD, is an experienced Pharmaceutical Toxicologist (28 years) offering Drug Safety Assessment consultancy services to Pharmaceutical, Biotechnology and other Life Science Companies.  Mark spent 19 years with AstraZeneca where he had several senior scientific roles in Global Safety Assessment.  In addition to a career in Pharmaceutical R&D, Mark maintained activity in research via collaborations with several UK Universities involving the supervision of PhD students resulting in many peer-reviewed publications.  Mark is a Fellow of the British Toxicology Society and a past Member of the Committee On Toxicity (COT) which provides expert advice on chemical toxicity to the UK Government.  Mark is also a member of the editorial board of the journal Xenobiotica.

In addition to working as a preclinical safety consultant to the Pharma and Biotech industry, Mark has also founded a virtual Biotech company focused on creating novel immuno-oncology agents to treat cancer and has developed his own client base.

Kemal is a toxicologist with 20+ years’ experience in the biopharmaceutical sector in both large pharma and small biotech organisations (AstraZeneca, Medimmune, OSI Pharmaceuticals, Karus Therapeutics).  He has supported small molecule and biologics projects from early discovery through clinical development and licensing, authored non-clinical safety sections of submission documents, and supported regulatory interactions.  In addition, Kemal has considerable experience of due diligence and in/out-licensing activities.

Kemal has a first degree in Cellular and Molecular Pathology, a PhD in Carcinogenesis, and is a Fellow of the Royal Society of Biology.

Larry studied biochemistry at Trinity College in Dublin (1996-2001) followed by a PhD at the University of Dundee (2001-2005) studying the role of Nrf2 in adaption to oxidative stress under the tutelage of Professor John Hayes and Dr Cliff Elcombe. After his PhD, he continued his work on Nrf2 and oxidative stress in professor Hayes lab as a post-doctoral research assistant (2005-2008) before switching to study the role of PPARβ/δ in the initiation and promotion of breast cancer with Professor Colin Palmer (2008-20011). To formalise his training, he studied toxicology at the University of Birmingham 2016-17.

Larry has over 14 year’s experience in toxicology and in particular mechanisms of action and human relevance. He started his career as a bench scientist where he then very quickly progressed into Senior Principal Scientist combined with business development and customer facing roles working with CRO’s such as CXR Biosciences (CXR) and Concept Life Sciences (CLS). He has experience in mechanistic study design and interpretation, study management, GLP and non-GLP study directing and providing leadership and support to the technical teams. He has published regularly throughout his scientific career and he has served on scientific advisory boards of CXR and CLS and provided strategy to meet the CRO demands for mechanistic screens for endocrine disruption, most recently on thyroid hormone endpoints.

Kevan is a metabolism scientist with over 30 years’ experience in supporting the safety evaluation and international registration of agrochemical products and industrial chemicals.  With a PhD in organic chemistry and post-doctoral organic chemistry research experience, he has worked for Shell, Cyanamid, BASF and Syngenta in environmental, mammalian and plant metabolism and in analytical methods leading technical development and contributing to study design, data interpretation and registration documentation. He has also contributed to International Research Projects jointly funded by the Health Effects Institute (USA) and CEFIC (Europe) as well as an ECETOC task force on the percutaneous absorption of chemicals. He has authored or co-authored 18 peer reviewed publications.

James is an extremely competent, enthusiastic, and highly experienced toxicologist with over 30 years of experience (Study Monitor and Study Director roles) providing project support, for an extremely broad range of study types, including designing bespoke investigative studies, across both Pharmaceutical and Agrochemical sectors.  Inhalation toxicology specialist.  Extensive GLP competence and provided significant support to many MHRA GLP inspections.

After completing his first degree in Biological Sciences (University of Sussex), James started his career at Life Science Research in Eye, Suffolk, UK (now part of the Covance group) as a trainee Study Director, gaining a vast wealth of hands on experience across multiple study types and industry sectors.  He subsequently moved to the Zeneca Central Toxicology Laboratory (subsequently part of Syngenta) at Alderley Park as a Study Director for an extensive range of studies, from acute to carcinogenicity studies, including bespoke investigative and mechanistic studies.  During his time at CTL, James specialized in inhalation toxicology and latterly also managed the clinical pathology and microbiology laboratories and completed a master’s degree in applied Toxicology (University of Surrey).  After nine years (and the closure of CTL), James moved to AstraZeneca Safety Assessment as a Study Director and Study Monitor supporting a wide range of projects, including several iv infusion administration infection projects.  James also spent three years as a Study Director for in vitro dermal absorption studies at a small specialized CRO (Dermal Technology Laboratory, Keele University), before re-joining AstraZeneca, in Cambridge, as a Study Monitor for a very broad range of novel therapeutic agents (mRNAs, ASOs) as well as small molecules and inhalation toxicology support.

In April 2020 James joined RSA as a consultant toxicologist with a wealth of cross industry experience and is looking forward to working with you on a diverse range of projects, applying his extensive toxicological knowledge and study management expertise.

Formerly a Senior Study Director at both Syngenta and Central Toxicology Laboratory Karen is involved in regulatory study monitoring, regulatory summary and dossier preparation, and literature searching for RSA.    She has a wide breadth of scientific knowledge with particular skills and expertise in the areas of mammalian metabolism and stability, toxico/pharmacokinetics, soil metabolism and stability, nucleic acids, enzyme kinetics and analytical chemistry.

With over 20 years in the Agrochemical Industry Tonya starter her career in 1997 with Syngenta after graduating from the University of Aberdeen with a Degree in Crop and Soil Science. During her career she has worked in Regulatory, Corporate Strategy, Global Marketing and as a Global Regulatory Manager working on Fungicides, Insecticides and Herbicides.

She has extensive experience in Regulatory, Governance, Standards and Processes, Active Substance Management, RMS selection and AIR.

Tonya has worked extensively with major blue-chip companies worldwide in Regulatory Environment looking at Food Chain Focus.

Since joining RSA Tonya has worked on Regulatory and Project Management services for a number of companies.

Graham has a strong background in e-fate, exposure assessment and modelling gained over 30 years in the agrochemical industry. Most recently he has been working as an independent consultant, but he also had many years experience at DowAgroSciences, where he worked on a wide range of active substances and formulations.  His expertise is in environmental modelling (soil, groundwater and surface water) and in the preparation of e-fate dossier sections (Active Substance approval, zonal dRR's and MS addenda), and in addressing feedback from Regulators and preparing responses/waivers.

Graham has also been an e-fate representative on external working groups eg Crop Life Europe and SETAC, as well as earlier experience of being a Study Director for lab and field e-fate studies.  He has enjoyed providing training on all aspects of e-fate, exposure assessment and modelling to cross discipline/functional peers over the years.

Tom has been working in the agrochemical industry for over 10 years, working as a Study Director at well-established contract research organisations in the UK. Following graduation from the University of Birmingham, Tom worked as a Study Director and has technical experience with non-target arthropods, non-target plants and acute aquatic studies. While at CEM Analytical Services Ltd. (CEMAS), Tom moved his focus to agrochemical residue studies which included operator, worker, resident and bystander exposure (OPEX) studies. While acting as the Study Director for the analytical phase on a range of crop residue, field dissipation and validation studies, Tom became an integral part of the OPEX offering at CEMAS. This involved overseeing all related analysis including dislodgeable foliar residue studies, identifying sites, producing reports and acting as the first point of contact for the applicant. His first-hand experience in the field, organisation skills and understanding of the analytical procedures has formed a strong foundation for moving into the regulatory area.

From March 2020 to June 2021, Tom worked for the Environmental Protection Authority (EPA) in New Zealand as a Senior Advisor focussing on the environmental aspect of the risk assessment. This role involved assessing reports submitted by applicants, generating study summaries and identifying key endpoints to use in the risk assessment.

Tom is now focusing on the consumer risk assessment for human safety (dietary and non-dietary), bringing together all of his technical experience in the field and analytical laboratory with the regulatory mindset he developed at the EPA.

Denis has a strong background in environmental fate lab and field studies, exposure modelling studies and mapping gained over 35 years at Dow AgroSciences, where he worked on a wide range of active substances and formulations as well as new molecule discovery projects. His expertise is in environmental exposure modelling (soil, groundwater and surface water), derivation of degradation kinetics from lab and field studies (including time dependant sorption), preparing visual representations of exposure through mapping, all for inclusion into e-fate dossiers, and in addressing feedback from Regulators and preparing responses/waivers. Denis has also been an e-fate representative on many panels and committees as a recognised Industry expert (e.g. ECPA, CLI, FOCUS, OECD and SETAC).

Peter has over 30 years experience as a Clinical Pathologist and Haematology Specialist, largely gained over a long career with AstraZeneca Pharmaceuticals, UK. He has significant experience in data interpretation for pre-clinical toxicology studies as well as specialist knowledge of toxicological Clinical Pathology.

Paul can provide in silico genetic toxicology prediction and analysis coupled with in vitro and in vivo genetic toxicology data analysis, project management, screening strategies, data reviews, literature reviews, mechanistic investigations, cancer data interpretation/modelling and experimental design. Paul joined the UK Committee on Mutagenicity (COM) in September 2019

David is a European Registered Toxicologist and a Fellow of the British Toxicology Society as well as a Chartered Biologist and a Fellow of the Royal Society of Biology, who spent 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry. In 1996 he joined the Medicines Control Agency (MCA), the UK’s Regulatory Agency, which subsequently became the Medicines and Healthcare products Regulatory Agency (MHRA), from which he retired as an Expert Pharmaco-Toxicologist, the most senior nonclinical assessor, at the end of 2021 before joining RSA.

David’s primary role at the MHRA involved assessing nonclinical data for Clinical Trial Authorisation (CTA) Applications and Marketing Authorisation Applications (MAA), both for non-biological and biological products, including advanced therapy medicinal products (ATMPs).  He assessed every CTA application related to Covid 19 and peer reviewed a number of vaccine authorisations.  David also offered regulatory and scientific advice to companies on behalf of the MHRA as well as assessing a large number of drug-device products.

He represented the UK in the European Safety Working Party for almost 15 years before the UK left the EU and was a member of the Nonclinical Working Group that supported the Paediatric Committee.  David also attended several meetings of the Clinical Trials Facilitation Group.

David was the EU Rapporteur in the ICH revision of the M3 Guideline, on the ICH S10 Guideline, on the Q&A document for ICH S3 (Toxicokinetics) guideline and on the ICH S11 (Nonclinical Studies to Support Paediatric Medicine) guideline.

He worked closely with the UK’s National Centre for 3Rs (NC3Rs) and represented the MHRA on a Governmental body dealing with animal welfare.

David has authored and co-authored a number of scientific papers over the years. He is also a guest lecturer at a number of UK and European Universities and a frequent presenter at conferences around the world.

Dick has extensive experience (30 years plus) in industrial and agrochemical toxicology. After a PhD on the effects of inhaled dusts on the lung (Cardiff University), Dick joined ICI’s Central Toxicology laboratory in 1988. Over the next 30 years he held a number of science and people leadership roles with ICI/Zeneca and Syngenta including heading inhalation toxicology, long term toxicology and reproductive and developmental toxicology. Throughout this time, he was heavily involved in the selection and development of new crop protection molecules. From 2010 he was the Global Head of Toxicology and Health Science at Syngenta having responsibility for the human safety of crop protection chemicals and traits and led groups in the UK, USA, Switzerland and Brazil. Dick has presented and published extensively over the last 30 years and has led and contributed to many scientific initiatives and expert committees on hazard assessment and characterisation (working with various organisation including CLE, CLI. ECETOC, EFSA EChA, HESI, NC3Rs)

Cheryl qualified as a vet from Liverpool University in 1988 and while working at the Rowett Research Institute was awarded a PhD in reproductive physiology from Aberdeen University in 1991. She then joined the Royal (Dick) School of Veterinary Science in Edinburgh initially as a postdoctoral fellow becoming a senior lecturer in Veterinary Pathology. She became a Fellow of the UK Royal College of Pathologists in 2001 and was a member of the Specialty Advisory Committee for Veterinary Pathology from 2002-2006, chairing the committee from 2013-2016. She has been an RCPath examiner since 2006. She has been a Royal College of Veterinary Surgeons Recognised Specialist in Veterinary Pathology (laboratory animals) since 2010 and was awarded Fellowship of the RCVS in 2014 for meritorious contributions to learning in the field of experimental pathology.

Cheryl has experience of pathology in a wide range of species with particular expertise in toxicological pathology and the pathology of genetically modified mouse models of disease and ageing mice. She has worked for a range of organisations including GlaxoSmithKline, Covance, Envigo, MRC Harwell Institute, NationWide Laboratories, Royal Veterinary College and R(D)SVS, Edinburgh. She is also currently an elected member of RCVS Council and British Society of Toxicological Pathology Council.

Alison has extensive practical experience of mammalian toxicology studies from a career with ICI Pharmaceuticals Division and the Central Toxicology Laboratory (latterly Syngenta) from 1982 until 2008. She was a highly experienced multi-disciplinary Study Director with a wide range of experience in the design, conduct, interpretation and reporting of a range of toxicology and safety pharmacology studies for both Syngenta and external clients.

During her career with ICI, Alison gained an Honours degree in Applied Biology. She then gained a post-graduate Diploma of the London School of Hygiene and Tropical Medicine and a Masters in Clinical Trials in 2013.

Since joining RSA, Alison has preparedREACH IUCLID robust summaries and endpoint summaries She is a Study Monitor working with a number of contract laboratories to deliver a range of Regulatory toxicology and environmental toxicology tests for clients. She is skilled in interpreting data, presenting facts clearly and in the liaison between the Laboratory and client.

After graduating in Archaeology and History from the University of Glasgow in 2004, Alison initially worked in commercial fieldwork investigations before taking on her first business administration role within a local yachting business. Having worked on other projects with RSA’s founding directors Mac and Charlotte, she now acts as the “hub” of RSA. Alison is the main point of contact for any financial/administrative queries, and acts as Information Manager on literature searches.

Gill started her toxicology career with ICI/Zeneca/Syngenta Central Toxicology Laboratory (CTL) in 1976 working in inhalation toxicology. In 1981 she moved to the reproduction and long term area to manage studies and technical staff. She has acted as a Study Reviewer, Study Director, Facility Manager, and Study Monitor in the regulatory toxicology area advising on the design, conduct and interpretation of a diverse range of mammalian toxicology studies for both Syngenta and external clients. Her work has included regulatory and research studies on agrochemicals, industrial chemicals, pharmaceuticals, medical devices and food stuffs. She has mentored and trained Study Directors and Study Monitors. Gill has an interest in animal welfare and has been a Project Licence holder and Syngenta representative on NC3Rs/LASA Safety Evaluation Working Group. She was also a member of an ECETOC Task Force reviewing and providing expert comments on the original draft OECD reproductive screening protocols (OECD 421 and 422). Since joining RSA Gill has worked on REACH, CLH and endocrine disruption projects and as a Study Monitor. (She has also produced biological evaluation reports for Medical Devices.)

Jenny has 25 years’ experience in toxicology, working for ICI, Zeneca and Syngenta. She has a broad range of expertise within toxicological specialities and has published widely. She is an expert in the field of endocrine disruption and is a member of a number of OECD expert panels on testing for endocrine disruption. She has provided specialist advice on endocrine disruption and written position statements for compound defence.

Jenny has skills in investigative toxicology, regulatory toxicology and project management. She has been responsible for the scientific and technical integrity, design, conduct and interpretation of a wide range of studies for clients involving industrial, agrochemical and pharmaceutical chemicals. She has also led the preparation of REACH dossiers and population of IUCLID 5.

John obtained his first degree in Zoology from the University of Wales in 1975 before undertaking research, on liver pathology, for which he was awarded a PhD in 1978. He then joined the British Industrial Biological Research Association (BIBRA), at Carshalton in the UK, as an experimental pathologist and head of the electron microscopy unit, which he left in 1983 to join the Pathology Department of ICI Central Toxicology Laboratory in Cheshire, United Kingdom. He became a member of the UK Royal College of Pathologists in 1988, was elected a Fellow in 1997, and ran the Specialty Advisory Committee for Toxicology from 2002-2005. He was Chair of the Panel of Examiners for the Toxicology Specialty of the RCPath from 2006-2012 and remains an examiner for the College.

He was a science-reviewing member of ECETOC’s LRI on Carcinogenicity from 2000-2006 and he sat on the UK Food Standard Agency’s Committee on Toxicity from 2006-2012. He was President of the British Society of Toxicological Pathologists from 2002-2004. He was appointed an Honorary Fellow of the British Society of Toxicology in 2008, was made an Emeritus Professor in the Faculty of Health and Medical Sciences at University of Surrey in 2010 and was elected as an Honorary Fellow of the BSTP in the same year. In 2011 he was made an Honorary Fellow of the Latin American Society of Toxicologic Pathologists and became a Fellow of the International Academy of Toxicologic Pathology in September of 2012.

Prof Foster has published over 130 research papers, review articles and book chapters in toxicological pathology, and was the Editor in Chief of the journal, Toxicologic Pathology from 2008-2013.

He worked for AstraZeneca Pharmaceuticals from 2001 until the end of 2013 as a Senior Principal Pathologist and Deputy Director of Pathology, joining RSA in January 2014.

Jo has over 20 years experience in industry and is a recognised expert in specialist field of inhalation toxicology. Jo is a skilled toxicologist whose early experience as Study Director/Study Monitor formed a strong foundation from which to move into toxicology project management. Initially Jo worked as a Project Toxicologist in the agrochemicals/chemicals sectors with Zeneca/Syngenta. More recently, she has worked in the pharmaceutical sector, where she has spent the last 8 years at AstraZeneca focusing on inhaled drug development for a number of respiratory diseases including COPD, Asthma and Cystic Fibrosis.

Her experience covers all aspects of toxicology program design and conduct in drug development from DRF studies and pivotal toxicology studies for FTIM submissions, to life cycle management of registered products. Jo has successfully completed many regulatory submissions (new product and re-registrations) in both sectors, involving regulatory authority interactions and defence in many territories including the EU and US (EPA/FDA).

Jo maintains a respected external profile through her work on various committees, which include holding the current Chair of the Association of Inhalation Toxicologists (AIT). Jo has previously chaired the Education Sub-Committee of the British Toxicology Society (BTS) and has played a pivotal role in a number of external initiatives including the APSGB-HESI emerging issues workshop (and subsequent publication) on alveolar macrophages in inhaled drug development, and the current NC3Rs “Crack-It” Challenge on Inhalation Translation.

Judy has over 25 years’ experience in the agrochemical industry (ICI, Zeneca and Syngenta) mostly in Regulatory Affairs as a European Project Manager, and including a 6-month secondment to the biocides regulatory team. Latterly, she has worked for a contract company providing pharmaceutical regulatory services on contract. She has a strong technical background with early experience as a technician in a university research and teaching unit for tropical diseases, and with ICI / Zeneca; in field trials, lead discovery, and entomology. She is skilled in writing and explaining scientific findings simply, and in liaison between regulators and scientists.