Mastering First-In-Human Clinical Trials: The Journey of Dr. Pui Man Leung in Pharmaceutical Medicine Introduction

In the challenging and evolving field of pharmaceutical medicine, professionals who bring a depth of experience and a diverse skill set are invaluable. Dr. Pui Man Leung, serving as an Independent Consultant in Pharmaceutical Medicine, exemplifies a steadfast commitment to this demanding arena.

His pharmaceutical industry career, which began in 2002, is marked by a pursuit of excellence in clinical research and pharmaceutical medicine. Dr. Leung’s journey, characterised by dedication and a breadth of knowledge, showcases the impact of steady and skilled contributions to this specialised field.

Career Highlights

Dr. Leung’s journey began at Aberdeen Medical School, where he received his MBChB degree in 1989. After being awarded the Diploma in Pharmaceutical Medicine in 2008 he was entered onto the Specialist Register for Pharmaceutical Medicine in 2010.  Since then, his career has been a tapestry of significant roles and milestones:

Dr Leung has worked as a First in Human Principal Investigator since September 2010 through working at several UK Phase 1 Clinical Research Organisations, and has played a pivotal role in approximately 20 FIH clinical trials, with a focus on small chemical entities and biologicals, contributing to advancements in various medical conditions such as atopic eczema, diabetes, obesity, Alzheimer’s disease, inflammatory bowel disease, and hypertension.

He held the role of Senior Director of Early Phase Research at MAC Clinical Research (August 2020 – Dec 2022), where he led the early stages of drug development and clinical trials.

In April 2023, he took on the role of First in Human Principal Investigator at BDD Pharma, Glasgow UK, further cementing his status as a leader in the field.

He is now an active Fellow of the Faculty of Pharmaceutical Medicine acting as a GMC appraiser, educational supervisor and specialty adviser for training in pharmaceutical medicine and an examiner for the Diploma of Pharmaceutical Medicine.

Expertise in Therapeutic Areas: With a diverse range of therapeutic areas in your portfolio, which area do you find the most challenging and why?

I would say in general the therapy areas and the patient populations that rely on hospital specialists for recruitment are the most challenging.  Their success depends on the interest and enthusiasm that the specialists have for clinical drug development trials and also their perception of the pharmaceutical industry.

Advancements in Pharmaceutical Medicine: Considering your extensive experience in first-in-human clinical trials, what do you consider to be the most significant advancement in this area over the past decade?

The use of artificial intelligence (AI) in accelerating the process of selecting candidate drugs to proceed into the clinic and in analysing non clinical toxicology data.

Role of Education in Career Development: How has your educational background, particularly the Diploma of Pharmaceutical Medicine, shaped your approach to clinical research?

The training and the journey through the Diploma of Pharmaceutical Medicine and ultimately achieving the Specialist status in Pharmaceutical Medicine has helped me to understand the various different perspectives of clinical research from different stakeholders. It is definitely a team game and not a one man band.

Challenges and Achievements: Throughout your career, what would you say has been your most challenging project, and how did you overcome the obstacles you faced?

I would say the first subject first dose of the trial immediately after the Northwick Park Incident was the most challenging project, due to obvious worries and apprehension from all parties including myself. The approach to overcome these obstacles is to tell people clinical trials are already much safer than before this incident and safer than many activities we are doing in our every day lives e.g. crossing the road.

Future of Pharmaceutical Medicine: Looking forward, what emerging trends or technologies in pharmaceutical medicine excite you the most?

Definitely the potential and use of AI and digital health technology apps in pharmaceutical industry and healthcare.


Dr. Pui Man Leung’s illustrious career and educational background stand as a testament to his dedication to the field of pharmaceutical medicine. He has made valuable contributions to the development of novel therapies across a broad spectrum of disease, and his ongoing work continues to inspire those around him. As he steps into his latest role, BDD eagerly anticipates the innovations and insights that will emerge under his expertise.