Inna Kolesnyk

MD, PhD, Senior Medical Director

Inna has both clinical and research background in Internal Medicine & Nephrology. Located in the Netherlands, Inna is involved in many George Clinical trials in chronic kidney disease, working predominantly in the EMEA region as Regional Scientific Lead. Her clinical research experience ranges from observational / registries studies in the field of end-stage kidney disease and renal replacement therapy, to Phases I-IV clinical trials in different types of chronic kidney disease, including Diabetic Nephropathy and various forms of Glomerulonephritis.

How did you come to choose the medical field as a profession?

In my case it has been a family thing – quite a few of my close relatives are in the medical field, but mainly I was influenced by my father, who is a professor of Nephrology. Because I grew up surrounded by family members and family friends as medical professionals, I was so exposed to the kind of people, the style of communication including (important!) the peculiar medical humor, that the choice was obvious in my case.

What are your workdays like?

It’s very different day to day and very much depends on the studies’ stages. I am typically working on multiple studies. Within the Scientific Leader (SL) projects, my primary role is direct communication with the National Leaders of the countries involved as well as with George Clinical SL project team members. In addition, some interaction with the sponsor and clinical operations teams is usually required. I must know what is going on with all moving parts of the study so that I can offer support or guidance for any issue. There is typically quite a large group of people who need to be on the same page, and this requires regular internal and external calls with the latest updates from the field, etc.

As part of the SL service, we regularly deliver scientific webinars to update investigators on recent study developments and to give them the opportunity to share how the study is progressing at their sites. The personal involvement afforded by these webinars is critical in keeping everyone informed and engaged to study’s end.

How does your nephrology background fit into / enhance your current work?

It is crucial, because I know exactly what the study implies — what is the disease and type of patients we are targeting. This makes it much easier to communicate with clinicians and to bridge the gap between clinicians, the sponsor and the operational team. Very often these are different worlds and require a translation from one form of communication to another to ensure continuity. Classical CRO operational teams are very process and hierarchy oriented, whereas clinicians are pragmatic and patient-focused. Both are integral to the success of a study, but each needs to understand their counterpart clearly. I often see myself as a “translator” between the most important players in the study.

What has been your professional journey before arriving at George Clinical?

I first got involved with the George Institute for Global Health when my family relocated from the Netherlands to Sydney. I had already decided that I wanted to stay on the clinical research side of nephrology, and when I learned about the work that George Institute was doing, I was really attracted to the fact that it was predominantly an academic organization run by research professors who were driven to answer the essential questions that could potentially improve lives of patients worldwide. I was also interested in their international orientation and involvement with global trials, both academic and commercial.

I started working as a nephrology research fellow for the Institute and simultaneously as a medical fellow for George Clinical. Early on I got involved with the SL model in the landmark CREDENCE and SONAR studies, combining cross-functional roles — as medical monitor for the Asia-Pacific region, and supporting and leading the global SL team as APAC regional lead.

George Clinical’s SL model puts investigators (both scientists and clinicians) in the driver’s seat of a clinical study — from protocol development to active study participation. This important communication layer connects all stakeholders, ensuring the best study governance.

You are one of the earliest people on George Clinical team who started to implement the SL Model. Could you talk about the evolution of this model and your experience with it?

After being involved with many SL studies, it has become evident that the approach depends on the kind of trial and on the stage that we enter. For example, it’s very different when Scientific Leaders are brought in at startup and involved in the very early steps, than when the team gets involved in a study that has already been running. Different approaches are needed to deliver the best of the best results.

The ideal situation is having the model in place at the very beginning — involved in senior steering committees and academic boards — getting a very expert look into the protocol and collaborating on protocol development. This is what George Clinical is known for — our relationships with the top scientists in the field. They add to the discussion of the study feasibility and alignment with current guidelines to determine how realistic it is going to be to meet the sponsor’s timelines and objectives. They also enhance the selection of the right sites for each participating country. This is the most crucial part of the SL model, especially in a global study. Without these steps, the recruitment for a study can be quite challenging. Many classic clinical trials that don’t involve the SL model will struggle to meet recruitment timelines and keep investigators engaged.

On-the-ground National Leaders are also crucial for local insight into the current situation in each country — from the hospitals and nephrology departments to study sites. The situations during these studies are very fluid, and having someone locally respected and knowledgeable on the ground can help determine if the study is moving ahead successfully or is a challenge in that location, and why.

What aspects of your work continue to excite you?

For me it is seeing the shift in the standard of care in CKD and all the new agents available. For example, the very important studies in SGLT2Is. It is very fulfilling to see they have led to a new standard of care for so many patients across the world. When you work on a global trial, and a couple of years later you see the results affecting so many, it is very rewarding. It’s the reason you do your job — to be an active participant in improving the quality of life and longevity of patients. That’s the motivation. We know that it still requires many more years to see the real impact of our research. So we move beyond the euphoria of one discovery to keep looking — there is aways room for improvement. As investigators we maintain critical thinking, keep collaborating and look to the future.

What do you do to relax, unwind and refresh your mind?

For this purpose, I have a pure hedonistic approach: a nice meal with a glass of a good wine in great warm company, whether this is just my close family or group of friends. I love to cook, to travel, to talk and to listen. Add to this a nice view on a beautiful day – and I’m fully on board.