#KCRAMA — Ask me anything

Doug Bain, KCR Chief Technology Officer

Q: Is the use of AI in clinical trials just a trend or the future?

A: “AI will significantly change how we define and execute clinical trials. The only question is when. I believe the following areas will be directly impacted by the use of AI in the immediate future:

• The preparation of protocol drafts based on a clinical trial synopsis
• Recruitment and screening: with an awareness of a protocol, and access to a pool of potential study participants, AI will be used to identify potential study participants and screen them for eligibility, in seconds.
• Semi-automatic technology setup (EDC configuration)

Looking further, I think we should also expect to see AI impact patient monitoring and data integration. For patient monitoring, machine learning algorithms will be used to analyze patient data (like vital signs, lab results, etc.) to automatically clean, edit check for quality, identify trends and predict outcomes. Within EHR Data integration, we’ll begin to see the ingestion of data from Electronic Medical Records without requirements for site-by-site data mapping to EDC.

Overall, AI is here to stay, and the introduction of AI will significantly enhance the performance and efficacy of clinical research.”

Iwona Kiezun, Head of HR & Administration

Q: How to maintain company culture in a hybrid workplace?

A: “As a team, we’ve always prioritized commercial and cultural growth with equal importance. In our journey through recent industry and cultural changes across the globe, we remained committed to our goal of supporting our employees in all possible aspects. This dedication has allowed us to maintain a robust internal culture that nurtures our team’s growth and well-being irrespective of working models.

Maintaining company culture in a hybrid workplace is a vital concern and there were key strategic elements implemented to ensure that our culture remained strong in a hybrid environment. Across the organization, we carried out frequent leadership communication and friendly virtual team building activities, implemented flexible work arrangements, promoted a “culture of feedback”, and enabled supportive technology.

One significant step in our journey was the launch of the KCR Celebrates, an initiative created to bring teams together to highlight impressive project milestones, individual accomplishments and all the small wins in between.

We have found that celebrating these “behind the scenes” victories energizes us, and gives our teams a moment to appreciate positive momentum.

Every bit of forward progress matters to us, and we want our teams to feel that every day. We believe that fostering positivity and team spirit has been instrumental in maintaining an encouraging working environment in this hybrid era.

We promote cultural and personal development through various channels but place a particular emphasis on face-to-face interactions. We host regional gatherings and encourage in-office celebrations such as birthdays and work anniversaries to strengthen our team’s camaraderie and connection. Additionally, we focus on authentic communication, collaborative team efforts and peer support.

Having a strong sense of community and clearly defined culture has become essential for successfully navigating the digital shift.”

Aneta Szewczyk, Head of Clinical Operations, KCR Placement

Q: What can FSP+ offers customers with limited or no presence in selected countries?

A: “We have successfully been cooperating with our clients for over 26 years, providing them with fully tailored FSP models responding to their needs.

Building on our experience, we have expanded our offer with the FSP+ solution. This model takes service delivery to the next level, providing support to Sponsors with limited or no presence in specific countries or regions.

FSP+ facilitates seamless integration into unfamiliar territories, with experts skilled in navigating regulatory complexities, cultural differences, and logistical challenges.

Below is a list of solutions that the KCR FSP+ model brings in addition to our standard FSP offering:

· KCR legal representation in new countries

· local processes managed by KCR experts

· dedicated, comprehensive KCR central department support

· full outsourcing provision at national level and across numerous functional platforms

· clinical activities covered by KCR integrated with customer infrastructure

FSP+ facilitates seamless integration into unfamiliar territories, with experts skilled in navigating regulatory complexities, cultural differences, and logistical challenges.

FSP+ empowers sponsors to confidently expand their studies, knowing they have a dedicated team to tackle challenges. This support saves time and resources, and improves study execution and data generation.

Integrating our solutions can make a difference!”

Mike Jagielski, KCR President & Chief Executive Officer

Q: You do not like talking about “differentiators,” but can you talk about how KCR works on its advantages?

A: “Clinical trials follow a very strict set of rules and regulatory requirements, so it’s easy to assume that all clinical trial organizations would have similar operational structures. ​

We are always working to streamline our processes, so clients get the direct, personalized support they deserve when they work with us. ​​In times when the average attention span seems to be shortening, it is important make sure our team members stay focused on the core elements of the clinical trial.

We like to say that we are a “content-driven CRO” because we focus on clinical trial delivery before anything else. Our project management approach would be a good example. Our project management teams have very limited involvement in financial discussions and instead, focus on working directly with study teams to discuss trial activities and site needs. ​We are genuinely interested in what we research and want to bring that passion to our trial execution style.​

We want the PM teams to focus on trial progress with their full attention on achieving milestones, recruiting patients, and activating research sites — not on invoices or project margins. Instead, we have a project finance management team cover the operational and financial processes. This divide of responsibilities, where our teams have streamlined focus areas, allows us to give their complete attention to deliverables and not to get distracted by the bottom line. ​If the trial is progressing, the financial success will follow.

I believe it is written in the Merck Rahway Cafeteria. The Merck founder said something like — “We try to remember that medicine is for the patient. . . . It is not for the profits. The profits follow, and if we have remembered that, they have never failed to appear. The better we have remembered it, the larger they have been.” That always spoke to me, we focus on trial progress and the success will follow.”

Aneta Szewczyk, Head of Clinical Operations, KCR Placement

Q: What’s the difference between FSP and FSP+?

A: We are excited to shed light on the distinction between Functional Service Provision (FSP) and its advanced counterpart, FSP+. At KCR, we believe in providing valuable insights to our esteemed LinkedIn community.

FSP, or Functional Service Provision involves outsourcing specific functions or tasks to specialized service providers within clinical research. This approach enables companies to streamline their operations, optimize resource allocation, and benefit from the expertise of external partners. By leveraging KCR FSP solution, organizations can access a range of functional services tailored to their needs, from data management to clinical monitoring.

KCR introduced FSP+, as an enhancement to traditional FSP. FSP+ was developed to provide support to Sponsors with limited or no presence in selected regions and offers a wider scope of services to ensure clinical success and trusted, experienced teams across all functional areas.

It combines the benefits of FSP with additional value-added services and strategic support, amplifying the impact of outsourced functions on overall project success.

With FSP+, we offer clients legal representation, access to KCR clinical teams, patient recruitment services, line management and training support tailored to Sponsors’ needs and full outsourcing provision, and more in addition to traditional FSP amenities. By integrating these value-added components into our service model, KCR ensures that our clients receive the utmost support throughout the lifecycle of their clinical studies.

In today’s fast-paced and dynamic clinical research landscape, the industry demands innovative solutions that drive efficiency, quality, and flexibility. FSP+ reflects our commitment to continuously evolving and staying ahead of the curve. Providing a comprehensive suite of services empowers our clients to navigate challenges effectively, capitalize on opportunities, and achieve their clinical development goals.

At KCR, we are proud to deliver industry-leading solutions and help our clients unlock the full potential of their clinical research trials. Together, let’s advance the future of clinical trials with FSP and FSP+!

Chief Technology Officer, Doug Bain

Q: Why is it necessary to invest in tech like Veeva?

“As the first CRO in Europe to implement Veeva Vault Clinical Documentation solutions in 2014, KCR has since continued to expand its digital research platform based primarily on Veeva products. Investing in technology like Veeva reflects KCR’s strong commitment to quality and customer needs. In addition to driving complete data and documentation visibility, these cutting edge applications allow for an accurate, real-time, and comprehensive view of study status for all study team members. This reduces communication complexity, increases compliance and inspection readiness and improves overall oversight of the end-to-end clinical trial process.

Using Veeva Vault technology solutions, we are able to offer full-service capabilities in clinical data and documentation processing while meeting the highest industry and regulatory standards. The Veeva Vault products brings the same level of quality, data transparency, and process efficiency for small biotech companies up to medium/large scale pharmaceutical companies.

With this scalable business approach, the difference between a company’s size and project budget becomes insignificant for technology choices. That is a crucial change in the clinical research industry from which Sponsors, CROs, sites and patients will benefit with real-time access to global data that safeguards health and lives.”

Senior Director of Medical Operations, Olga Kielczynska-Chrzaszcz, MD

Q: What are they main challenges in Oncology right now?

A: “Throughout the last decade, clinical trials have contributed to the rapid advancement of global oncology, paved the way for cures to many diseases and extend survival time in patient populations with poor prognoses. Additionally, clinical trials have helped introduce many lines of treatment now available for diseases for which there has been no effective treatment. But this does not come without setbacks; modern approaches to oncology research have changed significantly in the last 10 years and bring a variety of new challenges to research teams. Here are just a few:

Recruitment

One of the most serious challenges researchers face is insufficient recruitment, which delays clinical trial timelines significantly. There are many reasons for this situation, including the increasing availability of appealing treatment forms, often exceeding the option proposed in the clinical trial protocol. In such situations, protocols should take current standards of treatment into account. Because treatment standards vary greatly across countries, it is very important to determine which countries we expect high and low recruitment at the feasibility stage.

Invasive Procedures

Another common challenge in oncology trials is the prevalence of protocol-required invasive procedures, which patients and doctors often do not want to agree to. At the study design stage, it should be considered whether such a procedure is necessary, as it significantly affects recruitment.

Oncologist Availability

Oncologist workloads often cause difficulty for study teams, as the number of patients and the multitude of available drug combinations mean that they rarely have time to properly analyze available clinical trials. They commonly seek trials only when there are no other options available for the patient. This is a serious problem and protocols should be very clear and specify the initial target group and the safety of the molecule.

Despite the availability of many new lifesaving and life-extending drugs and standards of treatment, oncology still requires development, improvement of existing treatment procedures and the introduction of completely new solutions, e.g. overcoming resistance to immunotherapy.”

KCR Principal Consultant, Dr. Dave Li

Q: How have gene therapies evolved in recent years?

A: Recent years have seen a translational evolution in gene therapy from state-of-the-art sciences to direct patient care. Now, with the marketing approval of Hemgenix (etranacogene dezaparvovec), an adeno-associated virus (AAV) vector-based gene therapy for the treatment of adults with Hemophilia B, it heralds of a new age of gene therapy.

The history of gene therapy dates back to the 1960s when scientists first realized that DNA could be introduced to live human cells for the treatment of genetic disease. The initial efforts were to introduce a normal copy of the mutated DNA into human genes using a viral vector as a vehicle, but there was limited success in attempting to correct errors in blood forming cells of DNA sequences due to a single gene defect.

Recently, gene therapy is poised for adopting a newer generation of in gene modification platforms which, instead of introducing a complete replacement copy of a functional gene, used a complementary RNA in editing out the erroneous fragment of the mutated DNA sequence in the disease gene. This was a “cut and paste” maneuver using a system called CRISPR/Cas 9.

The newer technological platforms on the horizon include an improved version of gene editing called “base-editing” among the others which could target the mutation with greater precision by changing a single letter of a genetic code to regain or restore a physiological function due to gene mutations. It is expected that base editing could be even more powerful and offer greater precision, efficiency, and safety to gene therapy.

With this, its potential would be enormous. Its clinical applications would also be likely broadened, at least in theory, to include most, if not all, the human congenital and major age-related degenerative diseases with genetic components in pathogenesis if the costs can be contained.

KCR Head of HR & Administration, Iwona Kiezun

Q: Why is it important for organizations to focus on company culture?

A: “By building a strong culture, companies can provide consistency and direction while guiding decisions and fueling the workforce to reach their full potential.

After the pandemic normalized virtual meetings and remote work, company culture and our overall approach to it has changed immensely.

Strong company culture has traditionally been prioritized so organizations can attract and retain high quality candidates and employees and ensure that morale stays high in the workplace; this remains true.

In the past, cultural practices in the workplace tended to revolve around perks like group outings, casual dress days, extra snacks in the break room etc. While these are still important to some, having a strong sense of community and clearly defined culture has become central to navigating the digital shift while ensuring that employees still feel connected, engaged in our mission, and enthusiastic about the organization.”

KCR Chief Medical Officer, Dr. Anna Baran

Q: What are the challenges in implementing bladder cancer studies?

A: “Although bladder cancer (BC) has a poor prognosis and is the 10th most commonly diagnosed cancer and the 7th most diagnosed in the male population worldwide, implementing clinical trials in this indication has proven to be very challenging.

It all starts from the lack of a widely accepted screening program that results in difficulties to recruit patients with low stages of the disease. The diagnostic procedures are generally expensive, invasive and not easily accepted by patients.

Due to the disease heterogenicity driven by many pathways and molecules, its classification on the basis of molecular subtype may be a better predictive biomarker than histologic stratification, although no single definition containing specific subtypes has been adopted into routine use.

Additionally, the response to checkpoint inhibitors is varying - with an overall response rate (ORR) of 15% to 21%. There is also inconsistent correlation between PD-L1 status and response, enhanced by intra- and intertumoral heterogeneity of PD-L1 expression and evolution of PD-L1 status with development of treatment resistance. So this mandates fresh biopsy collection.

Other genetic features like microsatellite instability and mismatch repair deficiency, observed in 5% of urothelial carcinoma, are predictive of high ORR to programmed cell death 1 (PD-1) blockade. Several biomarkers are being evaluated in predicting response to immune checkpoint inhibitors (e.g. FGFR 3 receptor). Additional challenge is finding a balance between intravesical administration (with more localized toxicity but effectiveness being limited to noninvasive bladder cancer, thus high likelihood of not treating multifocal BC) and systemic treatment with all its consequences.

There are a few ongoing clinical trials trying to improve the efficacy of intravesical BCG. They apply both to the combination of BCG with anti-PD1/anti-PDL1 therapy, and anti-PD1/PDL1 in monotherapy. For locally advanced and metastatic bladder cancer, there is still an unmet need for effective treatment and the optimal sequence of novel agents and potential combinations are the subject of many ongoing trials. The future will certainly bring more trials in this indication, particularly with monoclonal antibodies targeting various checkpoint inhibition pathways.”

KCR CEO, Mike Jagielski

Q: Why is KCR so focused on maintaining its organic growth strategy?

A: “Since our beginnings in 1997, our client portfolio and employee base has been growing steadily thanks to our longstanding belief in an organic growth strategy. Year after year, we have expanded our geographical reach and service offerings while delivering high quality and comprehensive solutions to our clients. ​

Despite the clinical research industry being known for its merger and acquisition activity, especially recently, KCR has chosen not to follow this path. Rather, we focus on maintaining steady economic growth and company development. We believe that this is a path that creates a safe, transparent and predictable environment for our clients. It also brings focus to a single goal, growing organically with our customers in mind only.

This is also beneficial for our employees. The CRO business in general is a dynamic environment and quite challenging for the teams. By eliminating the M&A stress and fear we allow again focus on what matters and that is executing clinical trials.

Again KCR offers Biotech and Pharma clients stability and predictability. Because we focus on execution excellence above all, our clients receive direct support from dedicated teams who know they are in the hands of trustworthy experts with proven success. We grow by earning client trust and looking for building long term sustainable client relationships.”