As the newly appointed General Manager of KLIFO’s Swedish affiliate, what are your initial impressions of the company?

KLIFO is a unique company that stands out from typical Contract Research Organizations (CROs). It operates as a house of senior consultants who provide comprehensive support to clients, starting from target product profiling to market authorization and beyond. The company is filled with experienced professionals, particularly from the Danish pharma and biotech industries, including individuals with past experience at renowned companies such as Novo Nordisk, Lundbeck, LEO Pharma, and Ferring. While KLIFO is currently a Danish company, it is rapidly expanding into an international entity. The company primarily serves early startups, small companies, and medium-sized companies in the pharmaceutical and biotech sectors. KLIFO handles regulatory strategy, prepares the necessary documents for clinical development, and guides clients all the way to approval. Additionally, KLIFO specializes in clinical planning to expedite market entry, boasting a team of medical advisors and doctors in that field. Notably, KLIFO’s ability to support drug formulation development, such as tablets, creams, and injections, sets it apart from other CROs. The company provides support from CMC (Chemistry, Manufacturing, and Controls) strategy to market in this area.

What prompted you to accept the position of General Manager at KLIFO?

Firstly, I have a longstanding friendship with KLIFO’s owner, Alejandra Mörck, spanning over a decade. Witnessing the company’s success in Denmark, I recognized the unmet needs of small and medium-sized enterprises (SMEs) in Sweden. No CRO in the country can match the comprehensive service offering provided by KLIFO. The company’s unique capabilities and expertise appealed to me, drawing me to join the team. With nearly 30 years of experience in the life science industry, I understand the specific requirements of clients in Sweden.

In the highly competitive Swedish CRO market, what services will KLIFO offer to the pharmaceutical and medical device industries?

KLIFO will provide a complete range of services in Sweden, including Quality Assurance (QA), regulatory support, pharmacovigilance, CMC (formulation and regulatory), medical and scientific advice, clinical operations, and clinical trial supply. The fact that the southern region of Sweden is accustomed to collaborating with Danish consultants works in our favor. Our aim is to grow the company and the market as quickly as possible, and we already have around ten Swedish employees. Initially, our focus will be on the southern region and the Gothenburg area, but we plan to expand to the Stockholm and Uppsala region in the future.

What are your priorities for launching KLIFO in Sweden?

My primary priority is to establish KLIFO’s presence in Sweden and ensure that pharmaceutical and biotech companies understand the unique ways in which we can support them. We differ significantly from typical CROs, and I am leveraging my network to conduct as many customer visits as possible to achieve this goal. We are actively participating in conferences, utilizing internet tools, and arranging face-to-face meetings, as they tend to have a more significant impact. We have visited companies working in areas such as cancer immunotherapy, which is one of KLIFO’s core strengths, as well as neurology, endocrinology, and other fields in which we possess extensive expertise.

How does KLIFO’s business model distinguish itself from other well-established CROs in Sweden?

For small pharmaceutical and biotech companies, two crucial priorities are clinical planning and initial clinical studies. It is essential for these companies to have a well-defined regulatory plan in place to engage with authorities early on. They must decide whether to seek approval from the FDA, EMA, or local agencies such as the Swedish Medical Products Agency (MPA). Detailed formulation development planning is also critical, and KLIFO offers comprehensive support in all these aspects. No other CRO in Sweden can provide the same level of service, except for multinational giants like IQVIA, but with less flexibility. KLIFO possesses the capabilities to support clients with Good Manufacturing Practices (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP). Our strong quality assurance department can establish the necessary standard operating procedures and a quality management system to meet our clients’ needs.

KLIFO’s CEO, Alejandra Mörck, mentioned that one of the advantages of the company, compared to CRO giants like IQVIA, is that smaller clients won’t be relegated to the bottom of the priority list. What would you say to small and medium-sized companies seeking a research and development partner?

Being a priority is a significant concern for SMEs, as they may have previously engaged with global CROs but found themselves low on the priority list. Larger CROs primarily focus on phase III and phase IV trials, which may not align with the needs of smaller clients. Flexibility is crucial for SMEs, and KLIFO excels in providing precisely that.

Why did KLIFO choose Sweden as its new market, making it the second country where the company has opened offices in the past year?

While the Swedish Medical Products Agency (MPA) has stated that the number of clinical studies in the country has remained relatively stable, the Swedish Association of the Pharmaceutical Industry (LIF) suggests that the number of studies has actually decreased. The decrease in studies is primarily due to large pharmaceutical companies under LIF’s purview conducting fewer trials in Sweden. However, according to SwedenBio, the number of trials conducted by small companies is increasing rapidly. There has been a shift in the landscape, and KLIFO is well-positioned to meet the demand in this market.

What has contributed to the rise in clinical studies by SMEs in Sweden?

Many individuals have gained experience and expertise from companies like Astra and Pharmacia over the years, and now they are beginning to see success. The country is witnessing a surge in interesting startups, with Swedish companies like BioArctic and Alzinova developing two of the most promising drugs for Alzheimer’s disease. It is a privilege for KLIFO to support these startups in Sweden and contribute to their success. Notably, SOBI is thriving thanks to the surge in startups emerging from universities. The ecosystem in Sweden is well-suited for these companies to succeed, with excellent universities, incubators, and funding available for translating drugs into clinical settings. The Swedish Governmental Agency for Innovation Systems (Vinnova) plays a significant role in supporting this infrastructure. It is my hope that more pharmaceutical companies will be established, creating a trend of increased pharmaceutical development in Sweden.

Considering that Sweden’s Quality Registries are essential assets, how does KLIFO plan to leverage them to deliver better outcomes for its partners?

In clinical studies where a placebo arm is not feasible, registry data can be used to compare clinical outcomes. This approach is gaining approval from regulatory authorities. The Nordic region, particularly Sweden, is known for its quality registries, making it the go-to location for accessing such data. For instance, during my time at Stryker, the Swedish hip registry was globally recognized as the standard for evaluating hip surgery. The endocrinology registry is also widely used worldwide. The only drawback is the time-consuming process of obtaining the information. However, I am aware that LIF and SwedenBio are collaborating with the government to expedite the data acquisition process.

With your extensive experience in the global and local pharma, medtech, diagnostics, and CRO industries, how do you intend to leverage your knowledge in Sweden to ensure KLIFO’s success?

The key challenge is identifying the right clients who require the services and expertise that KLIFO can provide. Fortunately, there is a high demand for such services, making the future incredibly promising. Looking ahead, I anticipate KLIFO opening offices in Gothenburg, as well as Stockholm or Uppsala, to establish a strong presence in the region. The opportunities for growth are currently very promising.