Cambridge Early Phase Clinical Trials
We turn biomedical discoveries to clinical trials, fast and affordably
Protocol development
Our experinced investigators help transform preclinical biomedical discoveries into Investigational Medicinal Products being tested in humans for the first time.
Study conduct
First time in human, food effect, drug-drug interaction studies and experimental medicine studies all conducted in collaboration with sponsors. Both in healthy volunteers and in patients.
Staffing provision
Provision of recruitment, screening, and consenting staff to help with operational delivery of time-critical clinical trials – GCP accredited and with significant research experience.
Meet our Principal Investigators
Dr Edward Banham-Hall, FRCP DHP PhD
Early Phase Clinical Trials Consultant
Ed graduated in 2004 from University College London medical school before later studying for a PhD in cell signalling immunology at Cambridge University. He then completed his clinical training at Cambridge University Hospitals NHS Foundation Trust an was appointed as a consultant physician in 2016.
During his PhD studies he discovered a new disease (APDS), publishing his findings in the journal Science as joint first author and a further manuscript in the journal Nature Communications. He then went on to work as Principal Investigator for a phase 2a study of a potential treatment for APDS.
He subsequently became one of only eight people to ever have passed the Diploma of Human Pharmacology, a qualification run by the Faculty of Pharmaceutical Medicine with a fail rate of approximately 90%.
For the last several years he has continued to work on a range of First Time In Human clinical trials in an MHRA-accredited unit. He is also Principal Investigator for several experimental medicine studies using intravenous LPS as a model of sepsis in humans, conducting gluten challenge in patients with coeliac disease and eliciting blisters using cantharidin to access a source of macrophages for detailed phenotypic characterisation.
Dr Michalis Kostapanos, FRSPH DHP PhD
Early Phase Clinical Trials Consultant
Dr Michalis Kostapanos graduated in 2004 from the University Hospital of Ioannina, Medical School in Greece and then completed his PhD with honours in Metabolic Medicine (Dyslipidaemias). He completed his training in Internal Medicine (CCT) in the University Hospital of Ioannina in 2013 (UK CCT equivalent for General Internal Medicine) and in Dyslipidaemias in the University Hospital of Ioannina, as well as in the Royal Free Hospital in London (after having been awarded a scholarship by the Greek Atherosclerosis Society).
Having completed his specialty training he worked as a post-CCT Senior Clinical Fellow in the Clinical Pharmacology department in Addenbrooke’s Hospital, Cambridge University Hospitals (2014-2016). In 2016 he was appointed as a Consultant Physician and Senior Clinical Research Physician at a substantive post in Addenbrooke’s Hospital, Cambridge University Hospitals.
His clinical work is with the Acute Internal Medicine department, the General Medicine service and the subspecialty Lipids and Hypertension clinics in Addenbrooke’s Hospital. His subspecialty clinical and research interests have been in Dyslipidaemias, Hypertension, Atherosclerotic Cardiovascular Disease prevention and Cardiovascular Pharmacology. His research work is with the GlaxoSmithKline’s Research and Development Phase 1 Clinical Unit Cambridge within the Addenbrooke’s Biomedical Campus (complementary worker through secondment agreement), and with the Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge. Michalis also has a formal teaching role as Undergraduate Specialty Tutor for Acute Internal Medicine within the Faculty of Clinical Medicine, School of Clinical Medicine, University of Cambridge.
Michalis completed his training in becoming a Phase 1 First in Human Principal Investigator by the Faculty of Pharmaceutical Medicine and was awarded the Diploma in Human Pharmacology in 2018, having been one of very few Physicians in the UK to have passed its final exam in the past 10 years. This qualification is accompanied by his dynamically evolving experience as a Principal Investigator in Phase 1 First in Human Clinical Trials in an MHRA-accredited Phase 1 Clinical Unit. Specifically, Michalis has conducted a number of Phase 1 Clinical Trials (First in Human and non-First in Human ones) as a Principal Investigator having been involved in all stages of their development, including but not limited to preclinical clinical pharmacology evaluation (e.g., target evaluation, mode of action, ADME, safety pharmacology and toxicology), study design, first in human dose calculation, risk assessment and management planning, PK modelling, PD biomarker evaluation, study conduct as Principal Investigator, data review and assessment, data analysis and publication. He has similarly conducted and contributed to development of Experimental Medicine studies (e.g., in evaluating new imaging techniques for the assessment of Sjogren disease activity and challenge models for interferon pathway activation).
In parallel with his Early Phase clinical trials activity, Michalis has designed and conducted as Principal Investigator exploratory and mechanistic studies on the effects of novel lipid lowering treatments on vascular biology and inflammation biomarkers/surrogates within the Division of Experimental Medicine and Immunotherapeutics, Department of Medicine, University of Cambridge. His research on the fields of Dyslipidaemias, Cardiovascular disease preventions and Cardiovascular Pharmacology over the years has been well largely published in high impact international peer reviewed journals.