Member Spotlight: Q&A with KCR

Feb 01, 2019

Every month, MassBio spotlights a member company and the great work they’re doing to advance the life sciences industry and support the patients we serve. This month we spoke with Mike Jagielski, President and Chief Executive Officer of KCR, who has over 20 years of experience in the global clinical trials operations industry and provides strategic leadership to a team of experienced project managers. Under his leadership, the company has grown into a full-service CRO, covering a wide range of therapeutic areas, with a multiregional reach allowing for highly optimized delivery of trial execution strategies.

Tell us about your organization and your current initiatives.

KCR is a full-service contract research organization providing clinical development solutions for the biotechnology, pharmaceutical and medical devices industries. Our current focus is on oncology, CNS, immunology, pediatrics, imaging and vaccines. KCR operates across four main regions: North America, Western Europe, Central Europe and Eastern Europe with hubs in Boston, Berlin, Warsaw, and Kiev. These geographical locations allow us for optimized delivery of fully customized trial execution strategies. Our size of about 400+ employees allows us to adapt quickly to biotech company needs, which is the main development priority for our Boston operation. We want to bring European expertise close to Boston biotech companies and advance their clinical development internationally.

We are a 100% private company with PE investments. Our business focus is on achieving organic growth and being a choice partner for biotech companies who appreciate a speedy and customized trial execution. Our trial execution consulting service is a big part of that tailored delivery.

How does your organization’s activities help patients now and into the future? 

Two years ago, KCR launched the Human Behind Every Number (#HBEN) project. Recognizing that the CRO industry would not exist without patient involvement, KCR wanted to advance trial design with patients at the forefront. The project is based on the voices and perspectives of real patients who are past or present participants in clinical trials. We want to understand their incentives, concerns and opinions throughout the study enrollment.

The results are used to engage stakeholders in a new discussion on improved patient experiences and the continued execution of highly optimized clinical trial design. Moreover, the project provides patients with an informative and supportive experience as they navigate the clinical trial space. For that reason, we decided to turn the project into a non-governmental organization (NGO) – Human Behind Every Number, Inc.  

The research results will be shared with trial participants and industry stakeholders including patients, pharmaceutical companies, medical device companies, biotech companies, clinical research organizations and more. We welcome partners who would like to support the NGO and contribute to clinical trial design in the future.

What do you see as the biggest challenge or opportunity facing the life sciences industry today?

This is a big question, which I would like to answer with emphasis on trial execution in clinical development and new trends to watch. I am not sure what to think about AI in that context, so I will say that access to electronic health records on a large scale will have a permanent impact on trial design. Imagine for placebo-controlled studies that draw placebo data from available health records – opening a whole new world of possibilities for clinical trial designs and sample size calculations. Patient centricity is already a driving force, so I am eager to watch it evolve and to see its influence on real research results. Regardless, AI is here to stay, and it will improve patient comfort.

On the more practical operations side, the truly one-system technologies for CTMS/eTMF will have a significant impact on trial efficiency and trial oversight possibilities. We are not talking integration any longer, we are talking about a new generation of systems altogether. But don’t worry, this industry doesn’t have a reputation for early technology adaptation, so it will not be so fast.  

What’s next for your organization / what are you focused on in the coming year?

This year, we are focusing on two main goals. First, delivering great results in our project portfolio. It is the best challenge to have and we owe it to our customers to stay focused. Second, we are focused on further developing our Boston presence. Boston is a key biotech hub and with our north American operation right here, we are fully committed to be a competitive clinical development solution provider in this biotech ecosystem. If we deliver on these goals, we are good for 2020.  

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