Karen Montgomery-Douglas

Commercial Development Manager, Akesa, Australia

With over two decades of expertise spanning Australia, the UK, and global healthcare markets, Karen brings a unique blend of hands-on clinical experience and strategic business insight to Akesa.  

Karen’s career began in clinical diagnostics, where she worked on the frontline in patient care. Today, Karen leverages her deep understanding of health systems and the clinical sector to help organisations navigate the complexities of clinical trials and drug development.  Karen has worked with some of the world’s leading healthcare and tech companies, building a reputation as the bridge between scientific innovation and commercial success. Her work has directly supported the delivery of hundreds of clinical trials, thanks to her strengths in business development, market strategy, and relationship management.  

Known for her collaborative mindset, Karen partners closely with CROs, sites and sponsors to understand their goals and pain points. Karen is a passionate advocate for education and knowledge-sharing and regularly speaks at conferences and leads workshops across Australia and internationally.  

Karen’s deep knowledge, coupled with her drive to make healthcare better, continues to make her a valued voice in the clinical research ecosystem.  

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Optimising Clinical Trial Medication Access 

In Australia and New Zealand, clinical trial sites are increasingly being asked by sponsors and CROs to source registered pharmaceuticals—such as comparators, standard of care, and rescue medications—directly through hospital pharmacies. This growing demand is placing significant strain on hospital resources. Site pharmacies face increased administrative workloads, disruption to regular pharmaceutical supplies, and limitations within existing PBS systems, which are not designed to manage clinical trial requirements. These challenges lead to inefficient, paper-based workarounds, reconciliation issues, and revenue loss.

This interactive presentation, including live audience polling, will delve into these operational challenges through a real case study at Westmead Hospital Pharmacy. Together with Akesa, the hospital explored practical solutions such as just-in-time access to medicines, improving accountability, reducing waste, and easing administrative pressures. We will also introduce the journey to develop a purpose-built software solution to streamline trial medication sourcing and management.