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Krassimira Chemishanska, Country Director of Amgen Bulgaria, on biotechnology's role in modern life and on importance of innovation and transparency

Driverless cars, quantum computers, the Internet of things: we are living in times when sci-fi ideas are becoming reality. Biotechnologies are one of the fields in human knowledge that have been experiencing a rapid development in the past few decades. Now is the time to reap the benefits in the form of a growing portfolio of biotechnology medicines for deadly and previously untreatable diseases, says Krassimira Chemishanska, MD, MBA, Country Director of the Bulgarian branch of Amgen. The person who brought the world's largest independent biotechnology company to Bulgaria in 2009 and a leader with significant experience in pharmaceutical business, Dr Chemishanska is also the chairman of the American Chamber of Commerce in Bulgaria, or AmCham.

Biotechnologies are one of the fastest developing fields in modern medicine. How innovative technologies are changing our future?

Biotechnologies developed in the past 50 years after the break-through discovery of the DNA double spiral, the sequencing of the genetic code and the deeper understanding we now have of the main biological processes on molecular and genetic level. By studying these processes scientists identify what causes a given disease, and how does the process happen. With the use of biotechnology, scientists target these causes and treat them. Unlike traditional drugs, biotechnology medicines resemble the structure of the proteins in human organism which regulate the main life processes. Biotechnology medicines are the products of living cells and organisms, they have high specificity and thus have lesser side effects on the healthy cells. Thanks to the progress in biology and biotechnology some of the deadliest diseases like diabetes, oncological and haematological diseases, and multiple sclerosis are now becoming chronic ones; the patients live longer and have a better life.

The importance of biotechnology medicines is bound to grow in the following years. The 21st century will probably be the age of biotechnology. Today, four out of five drugs in development are biotechnology medicines.

In which fields does Amgen invest?

The company has been focusing its attention in several traditional fields like treatment of oncological diseases, haematological and onco-haematological diseases, kidney diseases, osteoporosis and other bone diseases. Recently, Amgen's focus has been widening over more common but socially important diseases like cardiovascular ones.

With the acquisition of the Iceland based deCODE genetics company, Amgen has now the potential to offer, via sequencing and analysis of an immense genetical data basis, a radically new approach in identifying the link between a certain gene and a particular disease, as well as the potential 'drug target' to treat this disease. This innovative approach is expected to change the essence of pharmaceutical research and to lead to the development of new drugs for treatment of the genetically linked diseases. Moreover, it is expected to lead to shortening of the time and reducing of the investments for the initial phases of the research and development.

Amgen's Bulgaria representation turns seven years in 2016. What did you achieve during this period?

Amgen stepped in Bulgaria 10 years ago with its clinical trial programme, even before the opening of its branch here in 2009. In the past seven years the company invested over $10 million in Bulgarian healthcare for R&D, in the form of drugs, technology, education for physicians, etc. We are proud with what we do, as these are direct investments in Bulgaria and its healthcare system that save a significant amount of money to the National Health Fund for the treatment of patients with serious diseases.

In its seven years of existence, Amgen Bulgaria worked for the establishment of partnerships that are vital for the company's main aim: to make these innovative medicines accessible for Bulgarian patients. We co-operate with the health institutions in the country, with the medical scientific associations and the medical community. We introduce innovative biotechnology medicines, and work with the reimbursement authorities to prove their value and ensure access for the Bulgarian patients. We are also developing educational activities: each of our drugs provides a new approach in treatment and the physicians have to be properly trained in it in order to see how it works and for which patients it will work best. All Amgen medicines that are registered in Europe are now available in Bulgaria and are a part of the clinical practice.

We will stay on this path. Amgen has significant investments in science, spending about 20 percent of its global turnover on development of new molecules. At the moment, we have a broad portfolio of 50+ new molecules – candidates for future drugs – in development. In the following three to five years about ten of these are expected to pass their clinical tests and regulatory procedures and to be approved as medicines for clinical use.

Bulgaria is a part of Amgen's global programme for clinical research, at the moment we are running about 20 active clinical trials for new molecules and indications in the country, which represents about 10 percent of all the current clinical trials run by innovative pharma companies in Bulgaria.

Recently, Amgen Bulgaria was awarded with a certificate by the TOP Employers Institute. How did a Bulgarian company achieve such success?

Unlike similar certificates and awards in this field, the Amsterdam based TOP Employers Institute rates local and international companies based not on employees' feedback, but on objective evidence of the company's HR practices, staff development, education, competitive payment and additional benefits, motivation. The key to success is investment in human capital.

What science and education projects does Amgen have in Bulgaria?

The dynamically changing modern knowledge and the biotechnologies require a never-ending work with physicians who need to stay in touch with the latest developments. That is why two years ago we launched the long-term project Amgen Biotech Academy. Each year, between 300 and 400 physicians attend work meetings on news in the field. Another problem that we target is the under-representation of biotechnologies – a relatively new area, – in the curriculum of the Bulgarian medical universities and pharmacy faculties. To fix this, we work in a close collaboration with the medical universities.

Regarding innovations, we co-operate with the Junior Achievement Foundation in the so-called innovation camps where groups of students are given the task to develop a project on a new biotechnological drug for a socially-important disease. It is all virtual, but it provides a good training that stimulates entrepreneurial spirit. Entrepreneurship is innate to young people and is crucial for the development of new technologies. Amgen, too, started in the late 1970s and the early 1980s as a startup of three scientists who recognised the scientific and business potential of biotechnologies.

We invest in young people and their education with providing scholarships for top students in medicine and pharmacy, and for post-graduates in medicine together with the Bulgarian Medical Association. With the Bulgarian Charity Aid Foundation we have a programme for orphan students. This year for the first time we provided Bulgarian students with the opportunity to apply for the Amgen Foundation scholarships for summer specialisation in leading universities in Europe. Four of them now have the chance to develop scientific projects of their own, to exchange knowledge and experience in universities like Cambridge and Karolinska Institute.

In 2015 you became the President of the American Chamber of Commerce in Bulgaria. What are the main fields in which AmCham works?

AmCham is one of the largest business organisations worldwide and in Bulgaria. Uniting over 320 Bulgarian, American and international companies, it has been in the country for over 20 years now. Since its very beginning, the organisation has focused on the strengthening of the Bulgarian-American economic connections. AmCham members are some of the biggest investors in Bulgaria and with their support we have been working for the improvement of the business climate in order to boost foreign investments. Bulgaria needs and foreign investors look for transparent business environment, clear rules and regulatory framework, good legal basis and rule of law. As we saw during the forums on rule of law that we organised in 2014 and 2015, foreign investors want predictable and transparent environment, and low corruption level. That is why we are working on the creation of suitable platforms that will help the judiciary, the business and foreign experts to share their views and to exchange opinions on the forthcoming judiciary reform. We also work on promoting alternative ways for trade disputes solving.

AmCham helps Bulgaria to meet these challenges with the publication of a White Book of recommendations to the government in regard of the economy, healthcare, social politics and education. From 2009 on, we published three White Books and we introduced them to the leading political parties. In our latest edition we explicitly recommended improvement of the business environment.

We also cooperate on different projects with other bilateral chambers operating in the country as the German-Bulgarian Chamber of Industry and Commerce, the British Bulgarian Business Association, Confindustria Bulgaria and others. We prepare joint positions and recommendations on different policy and legislative issues and submit them to the relevant institutions.

AmCham Bulgaria has put ongoing efforts to promote the benefits of the Transatlantic Trade and Investment Partnership between the EU and the United States. There are high expectations that the agreement will be negotiated by the end of the year and despite opposition from some non-governmental organizations, there is a large number of studies demonstrating the positive impacts of the agreement on both sides of the Atlantic, including Bulgaria.

What is your advice on aspiring young business leaders?

They have to be brave to think and dream, to have grand goals. When you have good arguments and skills, and when you are teamed with talented people, the things will happen. Business has taught me as well that difficult decisions, no matter how scary, have to be taken. Without them success is impossible. Young entrepreneurs should not be afraid of failure – he who doesn't make mistakes, doesn't learn. My last piece of advice is that team is crucial: you cannot achieve anything without people who you can trust and who share your enthusiasm and desire to reach your goal.