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Alison Brammer

Alison Brammer BSc MSc

Consultant Toxicologist/Study Reviewer

Alison Brammer

Alison Brammer BSc MSc

Consultant Toxicologist/Study Reviewer

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.

RSA Alison McCondichie

Alison McCondichie MA

Finance and Business

RSA Alison McCondichie

Alison McCondichie MA

Finance and Business

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.

Claire Grant MSc

Consultant Toxicologist

Claire Grant MSc

Consultant Toxicologist

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.

Debra Gaffney

Finance and Business

Debra Gaffney

Finance and Business

Debra is an experienced PA and Administrator providing support at RSA’s Alderley Park office.

Debra’s career spans over 17 years in the Pharmaceutical Sector where she worked at senior level alongside board members, senior leadership teams, scientists and study teams.

Debra works along with Alison and Mac on the day to day running of the company.

Cheryl Scudamore

Dr Cheryl Scudamore BVSc, DigMgmt, PhD, FHEA, FRCVS, FRCPath

Consultant Pathologist

Cheryl Scudamore

Dr Cheryl Scudamore BVSc, DigMgmt, PhD, FHEA, FRCVS, FRCPath

Consultant Pathologist

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.

Gary Roberts

Gary Roberts BSc PhD

Consultant, Environmental Fate and Risk assessment

Gary Roberts

Gary Roberts BSc PhD

Consultant, Environmental Fate and Risk assessment

Gary is a skilled environmental fate specialist and 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 biocides, pesticides, industrial chemicals and pharmaceuticals.

Gary has experience of the use of QSAR models as a screening tool for selection of “greener” molecules. Since the introduction of environmental risk assessment for pharmaceutical ingredients in 2006, Gary has focused on the risk assessment of pharmaceuticals, developing novel approaches for tests, whilst satisfying international regulatory guidelines.

Gary has served on European scientific committees including the EU Biocidal Products Directive Notes for Technical Guidance, working with several large biocide companies to support them with compliance with the directive. Gary also chaired an 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 is currently a member of the ECETOC monitoring team overseeing the CEFIC (The European Chemical Industry Council) LRi (Long-range Research initiative) research project ECO 24, which aims to improve the prediction of NER formation using structural alerts and QSARs.  Gary is also a member of the ECETOC monitoring team for ECO 25, which oversees a research project focused on the development of ecotoxicity tests for assessing the environmental risk of NER in soil.

RSA Gill Milburn

Gill Milburn BSc

Consultant Toxicologist

RSA Gill Milburn

Gill Milburn BSc

Consultant Toxicologist

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.)

Jeanette Barber

Jeanette Barber (HNC (Applied Science), Licensee of the Institute of Biology – Pharmacology)

Dossier Compliance

Jeanette Barber

Jeanette Barber (HNC (Applied Science), Licensee of the Institute of Biology – Pharmacology)

Dossier Compliance

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.

RSA Jenny Odum

Jenny Odum BSc MSc PhD

Consultant Toxicologist

RSA Jenny Odum

Jenny Odum BSc MSc PhD

Consultant Toxicologist

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.

Jo Kilgour BSc MSc PhD ERT

Consultant Toxicologist

Jo Kilgour BSc MSc PhD ERT

Consultant Toxicologist

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.

RSA Judy Knight

Judy Knight BSc (Hons)

Regulatory Affairs Manager

RSA Judy Knight

Judy Knight BSc (Hons)

Regulatory Affairs Manager

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.

Kim Travis BA MSc

Consultant, Safety Science

Kim Travis BA MSc

Consultant, Safety Science

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).

Louise Marks BSc PhD

Consultant Toxicologist

Louise Marks BSc PhD

Consultant Toxicologist

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.

Lynda Farrelly BSc

Consultant, Ecotoxicology

Lynda Farrelly BSc

Consultant, Ecotoxicology

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.

Mac Provan

Mac Provan BSc PhD

Director

Mac Provan

Mac Provan BSc PhD

Director

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.

Paul Carter

Paul Carter

Consultant Toxicologist

Paul Carter

Paul Carter

Consultant Toxicologist

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.

RSA Paula Batten

Paula Batten BSc PGD

Regulatory Affairs Manager

RSA Paula Batten

Paula Batten BSc PGD

Regulatory Affairs Manager

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.

RSA John Foster

Professor John Foster PhD, DipRCPath, FRCPath, Hon FBTS, FIATP

Principle Consultant Pathologist

RSA John Foster

Professor John Foster PhD, DipRCPath, FRCPath, Hon FBTS, FIATP

Principle Consultant Pathologist

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.

Richard Murray Smith

Richard Murray-Smith BSc

Consultant, Environmental Risk Assessment

Richard Murray Smith

Richard Murray-Smith BSc

Consultant, Environmental Risk Assessment

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.

RSA Sandra Allen

Sandra Allen BSc PhD CBiol MRSB

Consultant Toxicologist

RSA Sandra Allen

Sandra Allen BSc PhD CBiol MRSB

Consultant Toxicologist

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.