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Staff
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Managing and Clinical Director
Malcolm Boyce BSc MB ChB FRCP FFPM FBPharmacolS FRQA FCMI QP
Malcolm was the founding Managing and Clinical Director of HMR in 1993. Since then, he has been principal investigator or co-investigator for over 500 phase 1 and early phase 2 trials. His special interest is asthma. He also has responsibility for our ISO 9001 quality management system.
He 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 Fellow of the British Pharmacological Society. He is an Honorary Senior Lecturer in Clinical Pharmacology at St Bartholomew’s Hospital Medical College.
He has held various posts in clinical and academic medicine, and has worked for several of the major pharmaceutical companies. During his time in the industry, he carried out or co-ordinated numerous clinical trials in Europe and the USA across all phases of drug development, with a wide variety of new compounds.
He is a member or chairman of the: Faculty of Pharmaceutical Medicine DHP/CHP Advisory Committee; Association of Human Pharmacologists in the Pharmaceutical Industry; MHRA GCP Consultative Committee; NRES Phase 1 Advisory Group; and London Research Ethics Committee. He has published over 100 papers in journals and books on drug development and research ethics.
Click here to see a copy of Malcolm’s CV.
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Medical Director
Steve Warrington MA MD FRCP FFPM
Steve was the founding Medical Director of HMR in 1993. He has been the principal investigator for numerous phase 1 trials, especially first-administration-to-man trials. He holds a licence for administration of radiolabelled medicines to man.
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 is a Fellow of the Royal College of Physicians and a Fellow of the Faculty of Pharmaceutical Medicine. He is 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 is a committee member of the Clinical Section of the British Pharmacological Society, a referee for various clinical pharmacology journals, and the author of more than 150 publications on general and specialist clinical pharmacology.
Click here to see a copy of Steve’s CV.
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Director of Clinical Science
Kate Darwin BA DPhil MRQA MICR CSci
Kate joined HMR as Medical Writer and Quality System Administrator in 1998, and became Head of Medical Writing and Quality Services in 2000. As Head of Medical Writing, she was responsible for the writing of our trial reports, and for training and providing support to staff in writing reports, protocols, ethics submissions etc. As Head of Quality Services, she managed the Quality Team. In 2005, Kate was promoted to Director of Clinical Science. She manages our team of Clinical Project Managers, and is responsible for medical writing and providing scientific regulatory support.
Kate gained a BA in Biochemistry in 1992 and a DPhil in microbiology in 1996, from Oxford University. She is a Member of the British Association of Research Quality Assurance, a Professional Member of the Institute of Clinical Research, and a Chartered Scientist.
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Director of Human Resources and Administration
Stephen Smith BA MSc Chartered FCIPD FCMI FRSA
Stephen joined HMR as a Research Technician in 1996. He now has over ten years’ experience of administration and staff recruitment here. In 2000 he became Head of Administration and Human Resource Management with additional responsibility for housekeeping and health and safety systems. He has chaired the Health and Safety committee since 1997. In 2005 he was made Director.
Before joining HMR, Stephen worked in NHS pathology laboratories for 6 years.
Stephen obtained a BA in Fine Art, in 1990, at Wimbledon School of Art, and 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.
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Director of Pharmacy
Linda Clark Dip Clin Pharm, BPharm
Linda joined HMR as Director of Pharmacy in 2011. Since 2002, she has been a Qualified Person through the provisions of Directive 2001/83/EC. She advises on pharmaceutical and regulatory matters, participates in audits, and assures GMP compliance.
She has a BPharm in Pharmacy from the University of Nottingham and a Diploma in Clinical Pharmacy from the University of Belfast. She has 14 years’ QA experience covering hospital pharmacy, commercial manufacture and clinical trials within the international pharmaceutical industry.
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Financial Director and Company Secretary
Kevin O’Brien BComm FCMA
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 is responsible for our accounting systems, payroll, pension schemes, taxation compliance, monetary assets, the statutory books, and information disclosed to the Registrar of Companies.
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.
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Projects Director
Yuet Lewis SRN
Yuet was the founding Chief Research Nurse of HMR in 1993, became Projects Manager in 1995, and Projects Director in 2003. She prepares quotations and schedules trials, taking account of needs for staff, beds and other resources.
Yuet is a qualified nurse with 20 years’ experience of clinical pharmacology trials.
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Head of Data Management and Statistics
Toni Mitchell MSc CStatToni joined HMR as Head of Data Management and Statistics in 2010. The Data Management group builds trial databases, generates randomisation codes, and produces tables and listings for the clinical report. In addition to overseeing the group, Toni writes Statistical Analysis Plans, does the statistical analysis of trial data, and provides statistical advice on trials.
Toni received an MSc in Statistics with Applications in Medicine from University of Southampton in 1991. Since then Toni has worked as a clinical statistician for major pharmaceutical companies. She has supported the development of many compounds, mainly during their early clinical development, and has extensive experience of clinical pharmacology studies.
Toni is a Fellow of the Royal Statistical Society, and became a Chartered Statistician in 1996. She is also a member of PSI (Statisticians in the Pharmaceutical Industry).
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Head of Laboratory Services
Johannes Stanta MSc PhD
Johannes joined HMR as Head of Laboratory Services in 2011.
Johannes read a PhD in Biotechnology and Biomedical Science at the University of Cambridge, focusing on the discovery of a diagnostic biomarker for schizophrenia. His PhD project was funded by a fellowship of the Austrian Academy of Science. He joined the Master of Bioscience Enterprise and Management of Technology & Innovation programmes at the Institute of Biotechnology, University of Cambridge.
Previously, Johannes gained an MSc in Chemistry, Biochemistry and Biotechnology with first class honours at the University of Technology in Graz, Austria. As part of that degree, he held a year-long research fellowship at the Department of Molecular Biology and Biotechnology, University of Sheffield.
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Head of Pharmacy Production
Kirsten Heukelbach MRPharmSKirsten joined HMR in August 2005 as a Pharmacist and was promoted to Head of Pharmacy Production in December 2006. She is responsible for the day-to-day management of the pharmacy department, for maintaining MHRA registration of the premises, and for ensuring GMP compliance.
Kirsten qualified as a pharmaceutical technician in 1991, in Germany, and as a pharmacist in 1998 at the London School of Pharmacy, and completed a course in radiopharmacy at King’s College, London in 2008. She has been a Member of the Royal Pharmaceutical Society of Great Britain since 1999.
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External Qualified Person
Brian Kay MSc PhD MRPharmS QP
Brian joined HMR as Head of Pharmacy Quality Control and as a Qualified Person in 2004. He advises on pharmaceutical and regulatory matters, participates in audits, and enforces GMP.
He has a BSc in Pharmacy, an MSc in Medicinal Chemistry, and a PhD, all from the University of Manchester. He is a Qualified Person and is registered with the Royal Pharmaceutical Society of Great Britain.
Brian has lectured in Pharmaceutical Chemistry at University of Manchester, and has 30 years’ industry experience in senior roles, including Senior Manager, Director and CEO. He has been an assessor for Qualified Persons, a member of the Committee on Safety of Medicines, and a member of the British Pharmacopoeia Commission.
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IT Manager
John Kirk BSc MSc MBCS
John joined HMR as IT Manager in 2005. In addition to managing the IT team, he is also responsible for developing software to assist in the management of clinical trials.
John gained a BSc (Hons) in Computer Science from the University of Durham in 1995, and an MSc in Advanced Computing from Kings College London in 2004. He is a Member of the British Computer Society.
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Quality Manager (External Liaison)
Anneke Wijenberg BSc
Anneke joined HMR as a Research Technician in 2006. She moved to our QA department as a Quality Research Associate in 2007, and was promoted to Acting Quality Manager in 2009. In 2010, Anneke took on the permanent role of Quality Manager (External Liaison). She co-manages the QA department, and is the main point of contact, regarding quality issues, for external auditors, sponsors and regulatory authorities. Anneke is also a trial monitor, and conducts subcontractor audits.
Anneke has a BSc in Animal Science from the University of Pretoria, South Africa. She is an Associate Member of the British Association of Research Quality Assurance, and an Affiliate Member of the Institute of Clinical Research.
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Quality Manager (Internal Compliance)
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. As Quality Manager (Internal Compliance), Afia co-manages the QA department, maintains our ISO 9001 quality system, and assures the quality of our work and regulatory compliance.
Afia holds a BSc in Pharmacology from University College London. She is an Associate Member of the British Association of Research Quality Assurance, and a Registered Member of the Institute of Clinical Research.
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Staff Training Manager
Dawn Sherman RGN
Dawn joined HMR as a Research Nurse in 2001, and, as one of our most experienced nurses, was appointed as Staff Training Manager in 2006. Before joining HMR, Dawn worked as a senior sister in the NHS for over 5 years, and as a nurse manager in a phase 2 clinical pharmacology unit for 3 years.
Dawn qualified as a Registered General Nurse in 1987. Her other qualifications include ENB 998 Teaching and Assessing in Clinical Practice (1992), ENB 176 Critical Care Course (1992) and a Diploma in Management Studies (1995).
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Ward Manager
Sarah Boulton BSc
Sarah joined HMR as a Research Technician in 2000 and was promoted to Team Leader in 2002. She has over 10 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.
Sarah holds a BSc in Psychology and Biology from Liverpool John Moores University.
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