Women in Clinical Trials: An FPM Member’s Perspective Webinar

What will the session cover?

Our expert panel will explore the following:

• Global landscape and unmet need: An overview of global gender demographics, current female representation in clinical trials, and disparities in morbidity and mortality across a range of indications – including female-predominant and female-specific conditions.
• Regulatory environment: A summary of the evolving global regulatory landscape including MHRA, FDA, EMA, MHLW, and other international agencies, alongside key ICH-GCP principles and expected areas of change.
• Data and biological considerations: Current status of management of data in terms of sex-disaggregation, hormonal cycles, pre, peri and post menopausal status.
• Practical guidance on conducting inclusive clinical trials, handling bias, mitigating risks for WOCP and post licensing commitments such as safety studies, reporting and analysis of AEs/SAEs.

Case studies will be used throughout to illustrate how the application of good practice can lead to more inclusive, representative, and effective clinical trials for women.

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Who should attend?

This webinar is designed for a broad audience across the FPM community and beyond, including those who are directly involved in clinical trials, drug development strategy or in the execution of a clinical development plan.

Those who may specifically wish to attend are:

• physicians involved in trial design, conduct, or monitoring of clinical trials
• pharmaceutical physicians who need to understand the impact of a drug development plan on women’s health.

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Where is this webinar taking place?

This webinar will be delivered on Zoom. Once your booking is confirmed, you will receive joining information.

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Meet the speakers

Dr Bu Siakpere FFPM is a Fellow of FPM with a Pharmaceutical Medicine specialisation and is a senior pharmaceutical physician. Bu is the Chair of FPM’s Equality, Diversity and Inclusion Forum and has held GSK UK and global medical affairs roles of increasing seniority, having started her pharmaceutical career at BMS after practising in the UK NHS and training in obstetrics and gynaecology. Bu also practised as a medical officer in rural South Africa and undertook a special assignment at Save the Children as the global pneumonia advisor. She is Global co-lead of the GSK EMBRACE race and ethnicity employee resource group and a STEM Ambassador. Bu has an MBA from Imperial College Business School, University of London, Membership of the Royal College of Obstetricians and Gynaecologists and an MB ChB from the University of Birmingham, Medical School UK.

 

Dr Kirsty Wydenbach FFPM is a regulatory expert and pharmaceutical physician, and since 2022 has been Head of Regulatory Strategy at Weatherden, a global integrated clinical consultancy experienced in de-risking drug development. She also currently chairs the Clinical Trial Science and Regulations Expert Group of the Faculty of Pharmaceutical Medicine (FPM), is a visiting senior lecturer for King’s College London, and sits on the Drug Development Advisory Board at Simbec-Orion. Prior to joining Weatherden she has over 13 years’ experience as an Expert Medical Assessor at the MHRA within the Clinical Trials Unit, having a particular interest in ATMPs and first-in-human studies. Other work has included collaboration with industry groups and global regulators regarding adaptive and novel trial designs, including co-authoring several publications. She led the MHRA work on novel trial design for the Life Sciences Industrial Strategy as well as through the MHRA Innovative Licensing and Access Pathway (ILAP).Kirsty also oversaw the clinical trials work for COVID-19 and provided regulatory expertise on vaccines both within MHRA but also as part of the Government Vaccine Taskforce.

 

Dr Lisa Campbell FFPM leads regulatory and medical writing functions at Richmond Pharmacology. With over 20 years of experience in drug development, clinical medicine, and regulatory science, she has held senior roles at NDA Regulatory Science, SSI Strategy, and the MHRA. She holds an MD in Diabetes in Pregnancy and is widely published in journals such as Nature Medicine, BMJ Open, and JAMA.

 

 

Dr Denisa Wilkes FFPM is Medical Director & Vice-President of Medical Services UK and an MHRA-accredited First-in-Human Principal Investigator at Hammersmith Medicines Research. With over 18 years’ experience in clinical research and pharmaceutical medicine, she provides senior leadership across early clinical development.

She has led more than 100 early-phase studies across diverse therapeutic areas, focusing on translating scientific innovation into safe, ethical, and inclusive clinical trials, with emphasis on trial design, participant selection, and improving relevance for women’s health and under-represented groups.

Dr Wilkes trained in Medicine and Surgery in Oxford and completed specialist training in Anaesthesia and Critical Care in Oxford and London. She holds an MD, an MSc (Distinction) in Clinical Pharmacology, and UK and European Diplomas in Pharmaceutical Medicine, and serves on national advisory and expert groups.

 

Professor Hilary Thomas is a senior clinician with extensive expertise in oncology and medical management. She has served as an acute trust Medical Director and Professor of Oncology at the University of Surrey and was actively involved in clinical trials across all phases throughout her clinical career.

After more than two decades in the NHS, Hilary transitioned to the private sector, where she has spent the past 16 years in life sciences and healthcare consulting, including the last five years as Chief Medical Advisor at PA Consulting. In July 2024, she became a joint Non-Executive Director at Barking, Havering and Redbridge University Trust and Barts Health, where she chairs the Quality Assurance Committee at both organisations.