staff

Malcolm Boyce

BSc MB ChB FRCP FFPM HonFBPhS FRQA FCMI QP MD

Malcolm was the founding Managing and Clinical Director of HMR in 1993. Since then, he’s been principal investigator or co-investigator for over 950 phase 1 and early phase 2 trials. He is accredited by the MHRA as PI for FIH studies, and is a Qualified Person (QP) to release batches of investigational medicinal products (IMP). Also, as Quality Systems Manager, he has responsibility for our quality management system.

Malcolm qualified in physiology and medicine in Bristol, and subsequently became Fellow of the Royal College of Physicians; Fellow of the Faculty of Pharmaceutical Medicine; and Honorary Fellow of the British Pharmacological Society. He’s Honorary Professor of Clinical Pharmacology, Queen Mary University of London, and Visiting Professor of Clinical Pharmacology, King’s College, London. In 2019, Malcolm was awarded the President’s Medal by the Faculty of Pharmaceutical Medicine of the Royal College of Physicians.

Malcolm has held various posts in clinical and academic medicine, and has worked for several major pharmaceutical companies. While in the industry, he coordinated numerous clinical trials in Europe and the USA across all phases of drug development, with a wide variety of new compounds. He’s published over 160 papers in journals and books on drug development and research ethics.

Outside of HMR, Malcolm is a member of the HRA Phase 1 Advisory Group; MHRA GCP Consultative Committee; Founding Committee of the Faculty of Medical Leadership and Management; The National Research and Ethics Advisors’ Panel (NREAP); BIA Science and Innovation Advisory Committee (SIAC); and Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI).

He’s Chairman of the Faculty of Pharmaceutical Medicine DHP/CHP Advisory Committee; and Clinical Pharmacology Special Interests Group of the Faculty of Pharmaceutical Medicine.

Malcolm is also CEO of a pharmaceutical company, Trio Medicines, a subsidiary of HMR, that has a portfolio of novel compounds at various stages of development.

Steve Warrington

MA MD FRCP FFPM

Steve was the founding Medical Director of HMR in 1993. He’s accredited by the MHRA as PI for FIH studies and has been the principal investigator for numerous phase 1 trials. He is a Qualified Person (QP) to release batches of investigational medicinal products (IMP). He holds a licence for administration of radiolabelled medicines to man. In 2012, he was promoted to Chief Medical Adviser.

He qualified in physiology and medicine at Cambridge University. He trained in clinical pharmacology, internal medicine and in cardiology at St Bartholomew’s Hospital and was awarded an MD by Cambridge University, for research into non-invasive methods of testing cardiovascular medicines in healthy subjects. He’s a Fellow of the Royal College of Physicians and a Fellow of the Faculty of Pharmaceutical Medicine. He’s also an Honorary Senior Lecturer in Clinical Pharmacology, St Bartholomew’s Hospital, London.

During 1981–1993, he was Medical Director of a commercial clinical pharmacology unit linked to the Department of Clinical Pharmacology, St Bartholomew’s Hospital.

He’s served as a committee member of the Clinical and Industry Sections of the British Pharmacological Society and as a referee for various clinical pharmacology journals, and has authored more than 150 publications on general and specialist clinical pharmacology.

Click here to see a copy of Steve’s CV.

Denisa Wilkes

MD MSc (Clin Pharm) DPM Pharmed FFPM

Denisa has been the Medical Director of HMR since 2021. She joined HMR as a Research Physician in 2013 and was promoted to Associate Medical Director in 2019. Since joining HMR, Denisa has been a Principal Investigator (PI) or Co-investigator for over 150 phase 1 and early phase 2 trials of small molecules and biologicals. She has worked on a wide range of studies in both healthy and patient research participants, including First in Human (FIH), PET, bridging, bioequivalence, drug-drug interaction, thorough QT studies, and studies involving administration of radioactive compounds. In 2023, Denisa set up a new Clinical Science department at HMR. Denisa is accredited by the MHRA as PI for FIH studies.

She studied Medicine at University of Oxford and Charles University in Prague. Denisa qualified in Medicine in 2007. In 2009, she completed a 2-year postgraduate Foundation Training Programme in Medicine and Surgery in Oxford. Denisa trained in Anaesthesia and Intensive Care Medicine in both London and Oxford and became an Associate Member of the Royal College of Anaesthetists in 2013.

Denisa gained a Master’s degree in Clinical Pharmacology with Distinction from King’s College London in 2019. She was awarded the UK Diploma in Pharmaceutical Medicine by the Faculty of Pharmaceutical Medicine (London) in 2021. She also holds the European Diploma in Pharmaceutical Medicine from Université Libre de Bruxelles. Denisa became a Member of the Faculty of Pharmaceutical Medicine  (MFPM) in 2022 and was elected as a Fellow (FFPM) in 2024. Denisa is on the General Medical Council’s specialist register in Pharmaceutical Medicine.

She is HMR’s Appraisal Lead and Deputy Responsible Officer– Denisa is responsible for promoting excellence in medical appraisal to deliver robust revalidation recommendations and quality improvements in research participants’ care through the professional development of doctors.

Denisa is a Visiting Lecturer in Clinical Pharmacology, Barts Hospital Medical College and Queen Mary University, London, for the MSc course in early drug development.

She has written or co-authored several papers on clinical pharmacology and drug development.

Outside of HMR, Denisa is a member of the HRA Phase 1 Advisory Group, and a Board Member of the Medical Research Council (MRC) Medicines Development Fellowship Scheme Programme.

Kevin O’Brien

BComm FCMA  CGMA

Kevin is another founder member of HMR. In 1995, he became Company Secretary, and in 1996, he became a full-time member of staff. In 2003, Kevin was appointed Financial Director. He’s responsible for our accounting systems, payroll, pension schemes, taxation compliance, monetary assets, statutory books, and information disclosed to the Registrar of Companies.  He sits on our data privacy committee.

Kevin became a Bachelor of Commerce at University College, Cork, in 1985, a member of the Chartered Institute of Management Accountants (CIMA) in 1995, and a fellow of CIMA in 2006.  He became a Chartered Global Management Accountant in 2012.

Stephen Smith

BA MSc Chartered FCIPD FCMI

Stephen has over 25 years’ experience of administration and staff recruitment at HMR. He joined us as a Research Technician in 1996, after working in NHS pathology laboratories for 6 years. In 2000 he became Head of Administration and Human Resource Management, with additional responsibility for housekeeping and health and safety systems. In 2005 he was made Director. He oversaw the design process for our new premises, and managed our relocation. As Director of Corporate Services, Stephen also now manages the company facilities and the content of our websites.  He chairs our data privacy committee.

Stephen obtained a BA in Fine Art, in 1990, at Wimbledon School of Art. After joining HMR, he gained an MSc in International Business, in 1999, at Birkbeck College, London University. He obtained fellowship of both the Chartered Institute of Personnel and Development, and the Chartered Management Institute, in 2006. Stephen was nominated as Fellow of the Royal Society of Arts in 2007.

Karen Chalk

BSc

Karen rejoined HMR as Head of Clinical Project Management & Regulatory Affairs in 2023.  Her first appointment here was as a Research Technician, back in 2001. She undertook secondments with our training department and pharmacy before leaving HMR in 2003, to continue her career in clinical research.  In the 20 years between her appointments here, Karen has worked for both blue-chip pharma companies and small CROs. Karen has written ~70 protocols covering all phases, multiple therapeutic areas and devices, and has acted as a quality consultant to several small biotech companies. She has also run a large multi-centre, multi-country, EU-funded study, and a research project on regulatory requirements in sub-Saharan Africa.

As Head of Clinical Project Management & Regulatory Affairs, Karen now oversees our clinical project management, regulatory affairs and quality functions. She is a Visiting Lecturer in Clinical Pharmacology, Barts Hospital Medical College and Queen Mary University, London, for the MSc course in early drug development.

Temitope Adeloye

BA  MA  MB BChir MRCP DipPharmMed

Tope did a BA in Biological and Biomedical Sciences/Pharmacology in 2008. She qualified in medicine, University of Cambridge, in 2011. She joined HMR in 2015 as a Screening and Research Physician. In 2019 she passed the Diploma in Pharmaceutical Medicine with Distinction. In 2020 we promoted her to Senior Research Physician, Principal Investigator, and Head of Pharmacovigilance. Tope is accredited by the MHRA as PI for FIH studies.

Tope has been investigator or co-investigator for many early-phase clinical studies of small molecules or biological products. Se has worked on a wide range of studies, including FIH, PET, bridging, bioequivalence, drug-drug interaction, thorough QT, and studies involving administration of vaccines or radioactive compounds.

Tope is Visiting Lecturer in Clinical Pharmacology, Barts Hospital Medical College and Queen Mary University, London, for the MSc course in early drug development.

Tope has written or co-authored several papers on clinical pharmacology and drug development.

John Salter

BSc CStat FRSS

John has worked as a statistician in the pharmaceutical industry since 1995, in major pharmaceutical companies and global CROs, across various therapeutic areas and phases.  He’s provided statistical input into many national and international clinical trials, from protocol through to clinical study report, and advised on statistical elements of clinical development programmes.  He has extensive experience in oncology, including adaptive trial design, and in production and validation of CDISC datasets (SDTM/ADaM) including ODM and DEFINE documentation.  He also has a strong background in the management of projects, resources, and people.

John serves on the PhUSE Board of Directors, and is a Chartered Statistician and Fellow of the Royal Statistical Society.

Nick Jackson

BSc

Nick began his career as a SAS programmer in 2001.  He was made SAS Team Leader in 2016, and further promoted to Head of Statistics and Programming in 2018, with line management responsibility for those groups. In 2021 he was promoted to Associate Director of Statistics and Programming.

Nick has over 20 years’ experience as a hands-on programmer who generates statistical analytical output.  He’s played a major role in developing HMR’s in-house SAS tools for CDISC standards SDTM/ADaM and Define.XML. In his current role as Head of Statistics and Programming, he supports and develops a team of programmers, and oversees the statistics team, to ensure that our output meets clients’ specifications and timelines.  Nick also has primary responsibility for production of randomisation codes and pharmacokinetic analyses.

Nick has a BSc in Pharmacology from the University of East London, and worked at HMR for 2 years, first as a Research Technician on our wards, then as a Data Manager, before becoming a SAS programmer.

Stephen Sah

BSc MSc

Stephen joined our Statistics and Data Management Department as Statistician in 2015.  He was promoted to Senior Statistician in 2016 and further promoted to Statistics Team Leader in 2017.  He manages the statistics team and is actively involved in the design and analysis of trials, and reviews protocols, statistical analysis plans and statistical outputs. Stephen also supports the HMR Laboratory in statistical analyses of assay validation data.

Stephen received an MSc in Statistics from University College Dublin in 2011 and has been a Fellow of the Royal Statistical Society since then.  He worked as a Biostatistician in research and development from 2011 until joining HMR in 2015.

Bhavini Ladwa

BSc MSc

Bhavini (Vin) has over 20 years of data management experience at HMR.  After working on our wards for a year, she joined the Data Management team in 1999.  We promoted her to Team Leader in 2004, giving her managerial responsibility for a team of Data Managers. We further promoted her to Head of Data Management in 2016, and to Associate Director of Data Management in 2021. She runs the data group, and coordinates the data management for all our trials. She’s used her expertise and long experience to optimise all aspects of our data management processes – including design and build of CRF/eCRF, database and CDASH-compliant datasets; coding; validation specifications; edit check programming; and query management – with a focus on data quality and efficiency, to ensure that all our clients’ requirement are met.

Vin gained a BSc in Biochemistry in 1997 from Imperial College of Science, Technology and Medicine, London. Before starting at HMR, she spent a year working as a Clinical Data Associate for another Phase 1 CRO. Vin’s a member of the Association of Clinical Data Managers (ACDM), and is a long-distance tutor for the data management module of the Masters in Clinical Trials at the London School of Hygiene & Tropical Medicine.

Kirsten Heukelbach

MRPharmS GPhC

Kirsten Heukelbach is a registered pharmacist with more than 25 years’ experience, and is a member of the General Pharmaceutical Council. She gained an MRPharmS at the University of London in 1998, having spent four years as a Pharmaceutical Technician at the Educational Institute in Bad Godesberg, Bonn, Germany.

Kirsten first worked at HMR as the Head of Pharmacy Production 2006–2018. After a break from HMR, during which time she worked as a clinical supervisor and radiopharmacist, Kirsten returned in 2020 as the Pharmacy Business Development Manager. In 2021, we promoted her to Head of Pharmacy.

Luke Benjamin

MPharm MRPharmS

Luke joined HMR in June 2014 as a Pharmacist, and was promoted to Senior Pharmacist in 2015, and again to Principal Pharmacist in 2017. He’s responsible for the day-to-day management of the pharmacy department. He deals with sponsor enquiries, facilitates production, maintains MHRA registration of the premises, and helps to ensure GMP compliance.

Luke completed a Master of Pharmacy degree at the University of Bath in 2012, and qualified as a Pharmacist in 2013. He’s been registered with the General Pharmaceutical Council since 2013, and is a Member of the Royal Pharmaceutical Society.

Juan Naveda

BSc FIBMS

Juan joined HMR as Head of Laboratory Services in 2001. He has extensive laboratory experience, including nearly 20 years of laboratory development and management in NHS and private pathology units. His expertise includes business planning and development, and resource management. We promoted him to Director of Laboratory Services in 2010.

Lizelle Krige

Bacc Tech

Lizelle joined HMR as a Biomedical Scientist in 2005. She was promoted to Senior Biomedical Scientist in 2010, and again to Chief Biomedical Scientist in 2011.  She manages the day-to-day running of the laboratory service.

Lizelle worked as a medical technologist in South Africa for 4 years before coming to the UK.  She has a National Diploma and a Baccalaureus Technologiae in Biomedical Technology from Cape Technicon.

John Ring

John has nearly 20 years of IT management and support experience – almost 10 of those in the pharmaceutical industry.  He has experience of building up departments, infrastructure planning, change management, disaster recovery, and global IT operations leadership.  John is Prince2 trained and ITIL aware, with a strong knowledge of best practice frameworks and tools.

John joined HMR in 2017, and has overseen a major overhaul of our IT systems. He sits on our data privacy committee, and advises directors and heads of departments on technological solutions to meet their strategic goals.

Paul Bates

Paul completed an HND in Applied Biology at the North East Surrey College of Technology in 1996. He joined HMR that year, as a Research Technician, and has since worked in several departments, including recruitment and screening, training, and IT, before moving into compliance and validation in 2017.  In 2018, we promoted him to CSV and IT Compliance Manager. Paul was PRINCE 2 (project management) certified in 2019.

In 2021, Paul led the project management for our ISO27001 certification (information security).

Afia Khatun Miah

BSc

Afia joined HMR as a Research Technician in 2003, and soon became Quality Coordinator in her ward team. In 2004 she joined our QA department as a Quality Research Associate. We promoted her to Quality Manager in 2008. In 2017, Afia was further promoted to Head of Quality Assurance and Monitoring.  Afia manages the QA department, liaises with external auditors, sponsors, and regulatory authorities, maintains our quality system, and assures the quality of our work and regulatory compliance.

Afia holds a BSc in Pharmacology from University College London. She ‘s an Associate Member of the British Association of Research Quality Assurance, and a Registered Member of the Institute of Clinical Research.

James Gartside

BSc

James joined HMR as a Research Technician in 2011, and was soon given extra responsibility as a ward Quality Coordinator. He was promoted to Senior Research Technician in 2012. In 2013, he joined our training team and became a Principal Research Technician and Staff Trainer. He was further promoted to Senior Staff Trainer in 2014, became Staff Training Manager in 2016, and Head of Training in 2018. He’s the course leader for our training programme in Clinical Pharmacology Practice – an academic partnership with the University of West London. He sits on our health and safety committee, and is our fire safety officer. James has a BSc in Genetics from the University of Liverpool.

Sarah Boulton

BSc MSc

Sarah joined HMR as a Research Technician in 2000 and was promoted to Team Leader in 2002. She has over 20 years’ experience of phase 1 clinical trials in healthy subjects, and has taken a lead role in more than 50 trials, testing a wide variety of new compounds. In 2007 she was promoted to Ward Manager, responsible for the day-to-day running of our wards.  With a wealth of experience of clinical trials, Sarah is the ideal candidate to manage enquiries from sponsors regarding potential new work.  She became our Enquiries Manager in 2021.

Sarah holds a BSc in Psychology and Biology from Liverpool John Moores University. In 2016, Sarah attained an MSc in Clinical Drug Development at Queen Mary’s University, London.

Wendy Calvert

RGN

Wendy joined HMR as a Research Nurse in 1999.  She was promoted to Deputy Team Leader in 2001, and to Team Leader in 2002. In 2017, Wendy had her first stint as acting Ward Manager, and in 2018, she became Clinical Nurse Manager.  As our lead nurse, she was given special responsibility for patient trials.  In 2021, we further promoted Wendy to Ward Manager and Head of Nursing with responsibility for managing our ward teams and our day-to-day clinical work.  Wendy has run over 100 early phase trials.

Wendy qualified as a nurse in 1986, and now has over 35years of nursing experience. Wendy attained a Postgraduate Diploma in Clinical Drug Development at Queen Mary’s University, London in 2017.

Mavi Walther

BSc

Mavi joined HMR as a Recruitment and Screening Technician in 1999 and was promoted to Team Leader in 2002. She has more than 20 years’ experience of recruiting and screening healthy subjects for phase 1 clinical trials. Mavi played an important role in setting up TOPS (www.tops.org.uk), a UK-wide database to prevent subjects from ‘overvolunteering’. In 2011, we promoted Mavi to Recruitment and Screening Manager, and in 2021, to Director of Volunteer Services, recognising her strategic contribution to HMR.

Mavi holds a BSc in Biochemistry from the Complutense University of Madrid.