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.
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.
MD MSc (Clin Pharm) CPM
Denisa is an experienced anaesthetist. She has been investigator or co-investigator for many early-phase clinical studies of small molecules or biological products at HMR since 2013. She has worked on a wide range of studies, including FIH, PET, bridging, bioequivalence, drug-drug interaction, and studies involving administration of vaccines or radioactive compounds. She has been a PI since 2016, and is accredited by the MHRA as PI for FIH studies.
Denisa is HMR’s Appraisal Lead – she is responsible for promoting medical appraisal and revalidation, and co-ordinating effective arrangements for medical appraisal.
Denisa is a visiting lecturer at Bart’s and the London School of Medicine, and a member of the HMR Resuscitation Committee.
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.
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.
Sally joined HMR as a Clinical Project Manager in 2006, with responsibility for management of clinical trials, writing trial-related documents, ethics submissions, and preparing Clinical Trial Authorisation applications. In 2008, she became Senior Clinical Project Manager, with responsibility for training and providing support to Clinical Project Managers. We promoted her to Team Leader in 2010, giving her line management responsibility for the group. In 2014, we further promoted Sally to Head of Clinical Science, and in 2019, to Director, with responsibility for clinical project management, medical writing, and regulatory support. In 2021, she became the head of our projects division, with the title of Director of Clinical Science and Regulatory Affairs.
Sally gained an MA in Natural Sciences in 1998, and a PhD in Molecular Oncology in 2002, both from Cambridge University. She held Post-doctoral Research Associate positions at Cambridge University and Cancer Research UK between 2002 and 2006. In 2010 she gained a Certificate in Human Pharmacology from the Royal College of Physicians, Faculty of Pharmaceutical Medicine.
Stacy joined HMR in 2013 as a Clinical Project Manager. She was promoted to Senior Clinical Project Manager in 2015, and to Team Leader in 2016, with responsibility for managing the team. In 2017, she was further promoted to Deputy Head of Clinical Science, with shared responsibility for running the clinical project management department at HMR. Since 2021, she’s helped Sally to run our projects division as Associate Director of Clinical Science.
Stacy gained a BSc in Biochemistry in 2007 from the University of Bath, and a PhD in Neuroscience in 2010 from Queen Mary University, London. She held a Post-doctoral Research Associate position at Oxford University between 2010 and 2013. In 2018 she attained a Certificate in Human Pharmacology from the Royal College of Physicians, Faculty of Pharmaceutical Medicine.
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.
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 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 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 (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 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 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 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 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 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 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
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 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 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 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 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.