Multiphase Clinical Research Unit (Phase I–IV)

Dr. Jim Bush, Vice President Medical Services, Clinical Pharmacology and Principal Investigator. Dr. Bush received his medical degree (MD) and philosophy doctorate (PhD) in regenerative medicine from the University of Manchester, UK. He holds diplomas and a certificate of completion of training in pharmaceutical medicine. He is on the UK General Medical Council Specialty Register for Pharmaceutical Medicine and is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians, UK and a member of the Royal College of Surgeons of Edinburgh. He is also an Honorary Fellow of St George’s, University of London.

Dr Som Menakuru, Medical Director and Principal Investigator. Dr Menakuru qualified in Hyderabad, India. He holds the Diploma in Pharmaceutical Medicine and the Certificate of Completion of Training in this discipline. He is on the Specialist Register of the General Medical Council for Pharmaceutical Medicine. Dr Menakuru is a Member of the Faculty of Pharmaceutical Medicine of the Royal College of Physicians and a Member of the Royal College of Surgeons of Edinburgh. He has been working as an investigator in early phase clinical research for over a decade in a variety of therapeutic areas.

Dr Almazedi is a medically qualified physician and Approved Principal Investigator with extensive experience in early‑phase clinical trials, including First‑in‑Human (FIH) studies. Holds a Diploma in Pharmaceutical Medicine from the Faculty of Pharmaceutical Medicine, London, and is a Certified Principal Investigator through the Association of Clinical Research Professionals.

Academic training includes an MSc in Diabetes from Queen Margaret University, Edinburgh, and a Bachelor’s degree in Medicine and Surgery from Al‑Nahrain University, Baghdad.

Has led and contributed to approximately 250 clinical trials, many as Principal Investigator, with hands‑on expertise in the design, conduct, and medical supervision of Phase 1 studies including FIH, SAD/MAD, DDI, TQT, food‑effect, biologics, radiolabeled, bioavailability, and bioequivalence studies.

Dr Jon Ackroyd, Clinical Research Physician, Principal Investigator. Dr. Ackroyd holds 3 degrees; a BSc in zoology (University College London), a PhD in molecular biology (University of Reading) and a medical degree (University of Liverpool School of Medicine). He is also a Certified Principal Investigator (ACRP). He has been with Fortrea for over 8 years.

Dr Monaghan graduated from the University of Nottingham in 2015 (BMBS) and from the School of Pharmacy, University of London, in 2009 (MPharm). He is an affiliate member of the Faculty of Pharmaceutical Medicine and Certified Principal Investigator. Dr Monaghan brings to the team experience across all stages of drug development, from non-clinical pre-formulation, drug delivery, and safety pharmacology studies, through to conduct of both early and late phase clinical studies as principal investigator. He has been a clinical research physician with Fortrea’s Multiphase Clinical Research Unit since 2022.

Catherine Laing is a Senior Scientific Director at Fortrea with over 20 years of experience in Clinical Pharmacology. She brings extensive experience in First-in-Human, AME and Drug–Drug Interaction studies, supported by a strong background in pharmacokinetics and project management. Catherine provides strategic scientific leadership across study design.  She has led numerous dose escalation programs and conducts scientific review across all phases of study delivery, from protocol development to final clinical study reports

Stavchansky is Executive Director and Global Head of Pharmacy Services at Fortrea, based in Dallas, Texas. With over 20 years of experience in pharmacy practice—primarily in research and development—he leads global pharmacy operations across Fortrea’s Clinical Research Units in North America and the UK. As member of the Clinical Pharmacology Services leadership team, he provides strategic and scientific guidance for Phase I/Ib clinical trials, applying his specialist knowledge to drug development, GMP pharmacy services, On-Site Manufacture (OSM) of investigational drug product to clinic dose administration, and the transition from pre-clinical to first-in-human trials. He has therapeutic experience in cardiovascular disease, diabetes, obesity, asthma, and more. A registered pharmacist in Texas, Marcus also serves as adjunct faculty at the University of Texas and Texas Tech University.

Albarah is a registered Pharmacist and Trainee Qualified Person. After graduating from the University of Bradford’s School of Pharmacy in 2013, Albarah pursued and obtained his doctorate in pharmaceutical and formulation sciences from the University of Strathclyde. Since joining Fortrea in 2020, Albarah has overseen the delivery of sterile and non-sterile IMP to early and late-phase studies conducted within the Clinical Research Unit (CRU) and at external sites. Albarah’s primary responsibilities include operational aspects of the GMP pharmacy facility at the Drapers Yard CRU in Leeds, implementing the quality management system, and he is the pharmacy lead for study setup and CMC activities.

Dr. Cheerag Shirodaria is the Vice President and Cardiovascular/Metabolic Therapeutic Area Head at Fortrea. He has over 25 years of clinical experience as an interventional and clinical cardiologist and remains on the Faculty at Oxford University Hospitals. He is an expert in cardiac imaging, having completed his doctoral thesis at the University of Oxford on the role of cardiovascular MRI in the evaluation of vascular function. He is also co-director of the coronary computed tomography angiography (CCTA) service in Oxford. He is also co-founder and Chief Development Officer of Caristo Diagnostics, an AI image analysis company that has developed proprietary AI image analysis technology that quantifies cardiometabolic risk associated with coronary inflammation plaque and adipose tissue characteristics. He has supported multiple companies through regulatory interactions, protocol development and Scientific Advisory Board interactions. 

Dr. Shirodaria received his medical degree from St. Bartholomew’s Hospital Medical College in London, his medical doctorate from the University of Oxford and his MBA from London Business School.

Kamal Saini, MD, executive medical director at Fortrea Inc., is a board-certified medical oncologist based in Cambridge, United Kingdom, where he also practices part-time at the Addenbrooke’s (Cambridge University) Hospital. He contributes to the scientific strategic leadership of the oncology therapeutic area at Fortrea and provides clinical and medical expertise to project teams and other Fortrea departments on clients’ drug development projects. He liaises with key opinion leaders and academic cooperative groups with regard to the design, setup, and execution of cancer trials, especially in the breast cancer subdomain. He manages a team of high-performing medical monitors who are a part of the European oncology team. He leads the Precision Medicine and Emerging Therapies Leadership Center at Fortrea, and is also our global Scientific Publications Lead (Oncology). He brings more than 15 years of experience in clinical research and development to Fortrea. He is the author or co-author of several peer-reviewed journal articles. He joined our company in 2015.

Publications

• The Evolving Landscape in Multiple Myeloma: From Risk Stratification to T Cell-Directed Advanced Therapies
• Unraveling the link between cholesterol and immune system in cancer: From biological mechanistic insights to clinical evidence. A narrative review
• CAMBRIA-1 & CAMBRIA-2 phase III trials: camizestrant versus standard endocrine therapy in ER+/HER2– early breast cancer
• Bladder Cancer, Loss of Y Chromosome, and New Opportunities for Immunotherapy
• The Convergence of Radiology and Genomics: Advancing Breast Cancer Diagnosis with Radiogenomics

Michiel has more than 21 years of drug development and clinical research experience in both pharma and CROs. He joined Fortrea (then Covance) in 2011 as a lead CRA on global trials and moved into project management and delivery leadership positions. He serves as an accountable executive responsible for Fortrea’s liver portfolio (MASH, PSC, PBC), as well as several other metabolic and cardiovascular indications. Michiel has provided oversight across a portfolio of five T2DM studies from start-up through regulatory filing and marketing approval.