Q1. Tell us something about yourself?

Throughout my 15-year journey in clinical drug development, I've been captivated by the human stories behind the science, particularly in addressing the critical needs of patients battling blood cancer and solid tumors.

In my leadership roles within Clinical Operations over the past 6 years, I've cherished the collaborative spirit that fueled our pursuit of innovative cell and gene therapies.

Witnessing the convergence of expertise and empathy, we didn't just develop drugs; we crafted narratives of hope and progress with truly inspiring and cohesive teams.

Q2. Could you share an example of a particularly challenging project you've led and the strategies you employed to ensure its successful execution?

In rare diseases, you often struggle with patient recruitment timelines. We have successfully used a 3-layer site network which was involved in patient engagement activities (Kudos to Admedium and Trials24 who were our collaboration partners).

Q3. Study set-up involves various critical components, such as investigator selection, budgeting, and regulatory submissions. Can you discuss your approach to managing these aspects to ensure a smooth transition from pre-clinical to clinical stages?

If you start early with your planning phase, you have enough time to walk through all details. This process identifies main hurdles and risks which you will still be able to address in your clinical trial design and set-up.

By early and detailed planning, main budget changes and delays can be avoided.

Q4. What strategies do you employ to effectively manage and collaborate with external partners, such as CROs, to achieve project goals?

During collaboration set-up, it is important to transparently communicate your detailed expectations early and prepare for potential hurdles and risks. A governance structure helps you to oversee the collaboration and act early, if required.

Q5. How do you approach the review and development of standard operating procedures to ensure compliance and efficiency in clinical operations?

A regular review is required to address potential changes in the regulatory framework but also real-life experiences how to improve processes. This input can only be given by functional area experts using the process on a daily basis.

Q6. Quality assurance is vital in clinical research. How your expertise contributes to maintaining high standards in clinical trial processes?

Clinical Operations is closely collaborating with Quality Assurance but all other involved functional area experts to ensure everyone is aligned on the quality expectations.

The operational sponsor oversight ensures regular checks on ‘critical to quality’ factors and continuous improvements in the clinical study documentation and processes.

A collaborative clinical study team is a key to success.