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BULGARIA HEALTHCARE & LIFE SCIENCES REVIEW 2017

Krassimira Chemishanska, country director at Amgen Bulgaria, shows the role that innovative players play in the country, the importance of moving towards a value-based assessment system, and explains how has Amgen performed since its entrance to the Bulgarian market back in 2009.

You opened the Bulgarian affiliate back in 2009. How challenging was it to start from zero?

Opening from scratch Amgen’s operations in Bulgaria was a really challenging but also highly rewarding experience. Nevertheless, my prior experience of more than 20 years in the Bulgarian pharmaceutical industry, especially from the innovators standpoint, certainly helped me to succeed in this entrepreneurial adventure since I already knew the people and the local procedures. Additionally, I strongly believe that the success of any company relies on its team and being here since the beginning gave me the opportunity to build up Amgen’s team from zero ensuring the high level of professionalism, and engagement as well as alignment with the corporate values.

The Top Employers Institute has officially certified Amgen as the best employer in Bulgaria in 2016 and 2017. What is the successful HHRR strategy to attract, retain, and develop the best team in Bulgaria?

I am delighted to confirm that, throughout the years, I have managed to attract and retain a very highly talented team with different levels of experience. My team has been one of my major accomplishments and most part of the affiliate’s success is based on their work as well as effort.

Expanding on the certificate, it is based on a serial of human resources practices and policies. I have to say that being part of Amgen’s global structure has helped us to have great HR policies and processes in place that have supported such recognition from the Top Employer Institute.

Our HR praxis is based on teamwork, professional development, continuous education, and scientific based values. As a result, the turnover in our organization is extremely low and we have several examples of people that started in junior positions with us and they are now in management levels.

What are the main characteristics that define Amgen’s positioning in Bulgaria?

We were somehow newcomers with a quite different business approach in comparison to the other pharmaceutical players in the country due to the pure biotech nature of our products. Nonetheless, we have positively performed over the course of the last eight years and Amgen is currently ranked within the Top 20 players in the Bulgarian pharmaceutical industry.

In terms of product portfolio, the Bulgarian affiliate totally follows Amgen’s global expertise. We are present in some of the most socially important and challenging diseases with unsolved medical problems such as oncology, nephrology, and hematology. However, we are now enlarging our portfolio in cardiology and bone diseases such as osteoporosis, and bone metastasis. Our duty and commitment is to bring our corporate innovative medicines to the Bulgarian patients.

What has been your most important achievement over the past eight years?

As a truly innovative player, getting our medicines listed in the reimbursement system has been crucial to prove the value behind our biotech solutions. I have to say that the Bulgarian affiliate has been really successful in introducing all these innovative molecules in the market; this success will not be able without the collaboration of government institutions and doctors’ community. As a result, I can say that Bulgarian patients can be treated at the same standards as any European market and this has been one of Amgen’s major achievements.

Globally Amgen has become one of the top pharma company, but with only a very limited and very innovative number of products on the market. In a country like Bulgaria, where funds are limited, what is the key to succeed with such business model?

Amgen’s products have solid science behind and they have been globally proved for being highly effective and providing added value to patients. Proving their efficacy and value has been, therefore, crucial in the success of Amgen globally and, specifically, in Bulgaria. Gaining experience from clinical trials and real-world clinical practice experience has helped Bulgarian healthcare professionals see the clinical benefits and improvements in patient outcomes compared to current standards.

What in your point of view is critical when bringing such innovative (and often expensive) treatments to a country like Bulgaria?

There are three key functions in the organization that are critical in this respect.

Firstly, a very well developed medical department that brings the scientific knowledge and value-based data behind our products has been crucial in our success – this department works really closely with the clinical trials department.

Secondly, our market access department plays its role in Bulgaria in order to work with the Bulgarian authorities in terms of bringing the right arguments including provide health economics analysis. This is key to succeed in the reimbursement process.

Thirdly, our sales department is crucial to successfully promote in a highly ethical and compliant way our solutions. Therefore, our sales force is medically educated with either doctor or pharmacies background in order to be able to enter in a professional discussion with our physicians.

How would you evaluate the Bulgarian market access environment and its openness to innovation?

Bulgaria has been quite successful in introducing some of the most innovative molecules in the Positive Drugs List (PDL) - Indeed, since 2012, around 50 new molecules entered in the reimbursement list, which is a lot but Bulgaria is still lagging behind the European average time for access to innovation. The pharma industry through the Association of Research-Based Pharmanceutical Manufacturers (ARPharM) is very active in building up a successful dialog with the government institutions in order to really find the best way to introduce innovative medicines in the countrythrough sharing the financial impact on the NHIF budget - risk sharing agreements, clawback, and others.

Expanding on our role, Amgen as part of the innovative industry in the country, has always been supporting the government in the implementation of the Health Technology Assessment (HTA), which aims to assess the medical value of a medicine versus its cost and its impact to the NHIF budget. It has created a fair base of how new molecules are entering to the market. I believe that, even though it has slowed down the launch of innovative medicines in Bulgaria, it has helped to gain transparency of the overall process with the right framework and better predictability. Looking ahead, this process needs to be further optimized in order to reduce the long lead times - but it is certainly the right direction since it shows the real value of innovation, demonstrates how many patients benefit from it, and the impact on thepublic drug expenditure. .

Bulgaria is a key location for Amgen’s clinical research. Can you expand on the footprint of Amgen in the Bulgarian clinical development arena?

Clinical research is a key area of investment from research-based multinational companies; indeed, the total investment in clinical research last year was around USD 200 million. Concretely, Amgen has a quite unique positioning in this regard and we have invested in Bulgaria more than USD 10 million in clinical research during the last couple of years.In terms of projects, we are currently running 20 clinical development initiatives for both new molecules and new indications.

Medical education plays an important role when showcasing to healthcare professionals the benefits that the innovative products can create for the patients’ life quality. Medical education is, therefore, a key area of investment for Amgen globally, how is the Bulgarian affiliate committed in this regard?

All innovation needs to be supported with medical education and Amgen globally has been really active in this regard targeting those therapeutic areas in which it has strong expertise. In Bulgaria, we have been doing this type of initiatives since we opened the affiliate back 2009.

We combine medical education actions to both senior professionals but also young and future doctors – the latter through collaborating with universities with medical and biological specialties such as Sofia, Plovdiv and Varna universities. Our CSR policy aims to introduce the latest innovations to medical professionals and ensure sustainable knowledge and high standards of treatment.

As a great example of education of senior healthcare professionals, three years ago, we launched the “Amgen biotech academy” for Bulgarian specialists and this initiative is focused on providing education to a selected group of specialists. This initiative is unique by itself and promotes scientific exchange through a broad program of scientific as well as educational activities aimed to familiarize Bulgarian physicians with the latest achievements of medical science and biotechnology to target a number of significant diseases.

As an example of education to young professionals or life science students, we also launched in Bulgaria the global Amgen initiative so-called “Amgen Scholarship program” three years ago. This initiative provides to Bulgarian undergraduates the opportunity to engage in a hands-on research experience at many of the world’s premier educational institutions.

I am really proud to confirm that, on yearly basis, we educate around 600 doctors through our CSR medical education activities.

Despite the healthcare breakthroughs from biotech, such innovative drugs have smaller eligible population. How do you collaborate with health stakeholders in order to ensure that the right patients get access to the right drugs?

Genetic testing based on biomarkers plays a key role in this regard and this is why companies like us are supporting and financing such type of diagnostic practices since it is the only way to define the group of patients that will benefit most from innovative treatments, such as monoclonal antibodies, target therapies or personalized medicine.

Furthermore, this type of tests creates value-based information about innovation and contributes to the creation of a solid database. In this regard, Amgen is collaborating with the medical community creating knowledge, know how and digital capabilities around our medical areas of expertise.

I would like to highlight that the advancements towards an outcome-based system deserves recognition but there is still a long way to go and it requires a strong collaboration amongst all the stakeholders.

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