I am a clinical trials consultant providing specialised expertise in {br}regulatory strategy, clinical science, trial design, operational support, and {br}medical writing for early-phase clinical development. Through my company, Lealto {br}Consulting, I offer bespoke consultancy services to pharmaceutical and {br}biotechnology companies, contract research organizations (CROs), and clinical {br}research institutions, ensuring tailored solutions for each client’s unique {br}needs.{br} I have over 20 years of comprehensive clinical trial experience. My previous {br}leadership roles include Head of Clinical Trials at the MHRA (the UK medicines {br}regulator) and Director of Clinical Science and Regulatory Affairs at one of the {br}UK's most respected CROs. Owing to my unique experience and clinical trials {br}expertise, I combine regulatory rigor and scientific scrutiny with trial {br}logistics and problem solving, making me a valuable partner for those wishing to {br}achieve optimal clinical trial outcomes. I am a people-focused leader, and {br}integrate seamlessly with client teams, fostering open communication and {br}providing practical guidance.{br} I specialise in early phase development, having overseen more than 200 phase {br}I and II trials, from first concept to final trial reporting, across a diverse {br}range of therapeutic areas, including: CNS, dermatology, diabetes, endocrine, {br}gastrointestinal, immunology, infectious diseases, pain, psychiatric, {br}respiratory, and oncology. I have contributed to the design, regulatory {br}strategy, management, medical writing and reporting of many trial types, {br}including: adaptive, multipart first-in-human trials, single ascending dose {br}(SAD), multiple ascending dose (MAD), food effect, ethnicity bridging, {br}bioequivalence and bioavailability, interaction studies, ADME (absorption, {br}distribution, metabolism, and excretion), through QT, PET and fMRI, including {br}those involving special populations, trials of genetically modified organisms (GMO).{br} I am Alternate Vice Chair of London–Brent Research Ethics Committee (flagged {br}for review of clinical trials in children, phase 1 healthy volunteers, and gene {br}therapy products), a member of the UK Health Research Authority’s Phase 1 Expert {br}Advisory Group, a member of the MHRA’s phase 1 stakeholder group, and a guest {br}lecturer at King’s College London (Drug Development Science MSc course). I hold {br}a BA in Natural Sciences (specialising in Cellular Pathology and Virology) and a {br}PhD in Molecular Oncology both from Cambridge University, and a Certificate in {br}Human Pharmacology from the Royal College of Physicians.

Former Director of the Institute of Clinical Research. I have extensive experience of clinical research having worked in this area for more than 30 years.