AstraZeneca is a global pharmaceutical company focused on science and research in the treatment of various diseases. Part of the research also takes place in Slovakia, where they collaborate with local doctors and patients. Apart from their research initiatives, the company also oversees medical conferences which keep the professional community informed about the latest advancements in the field of pharmacy. In a recent interview, Tamara Mily, Market Access Manager at AstraZeneca, gave us an insight into research and introduction of a new drug to the market, and talked about all the activities that accompany these intricate processes.
Could you briefly introduce your company?
AstraZeneca is a global pharmaceutical company dedicated to advancing science and research to develop treatments and diagnostics for a wide range of diseases. We primarily concentrate on prescription drugs. We operate worldwide, with our main research centers located in Sweden, the United Kingdom, and the United States. With a team of over 80,000 experts around the world, we support more than 180 innovative drug projects in our research and development base.
We're all about science, innovation, and new biotechnologies. In Slovakia, we have a smaller, but certainly dynamic team that specializes in clinical trials, drug registration and safety, meeting all the requirements for drug availability on the market, portfolio expertise and medical support, marketing, and sales support in various regions across Slovakia. We're committed to improving the lives of patients, while always adhering to strict ethical principles and legislative rules. Over the past year, we have introduced five brand-new, innovative drugs to the Slovak market, and we plan to introduce more drugs across various therapeutic areas in the near future.
How many people are on your team?
Our team consists of approximately 30 people, and many of us work flexibly from the office, home or online. Therefore, we have mobile workstations in BASE that multiple people can share.
Is BASE your only office?
Representatives from departments that focus on drug safety, drug registration, marketing, and sales are based in BASE. I, personally, focus on market access, which means ensuring that a drug meets all the legal requirements for entering the Slovak market.
A part of our company which is dedicated to clinical trials is based in our official headquarters on Lazaretská Street. It's a relatively large department that also conducts research directly in Slovakia. The doctors we work with, are involved in research of drugs that are intended for the Slovak market, which also supports ethical principles.
What is the process behind research and clinical testing of drugs?
The research itself goes through several phases. Initially, there is the so-called preclinical phase, which involves research conducted in laboratories at an international level. Subsequently, the research moves to phase one, which consists of a very short period of observation of the studied substance in healthy volunteers. In Slovakia, we join the research process in phase two, i.e., clinical trials with patients. Overall, there are four phases in this very complex process. The clinical testing itself, must, first and foremost, meet all the requirements, such as ethical and legal ones, and must also obtain various approvals and permissions.
Who oversees the selection of patients?
The selection is always overseen by a doctor, who is the so-called "investigator" in clinical research. The selection must meet all professional, ethical, formal, and legislative requirements. The patient always participates in the research voluntarily. The doctor is responsible for explaining the course of the research to the patient. They provide the patient with information about the benefits as well as limitations. Based on this information, the patient decides whether or not they wish to participate in the clinical trial.
How does your company decide on a specific research specialization?
Such strategic decisions are, of course, approved at a global level and are always guided by unmet medical needs. However, there are also long-standing or traditional areas of research, such as respiratory medicine and oncological diseases.
How does the drug registration process work?
Drug registration process is unified within the European Union and drugs are approved by the European Medicines Agency. A drug that is approved in the European Union is also registered in Slovakia. The question then arises about its availability, whether there is demand and medical need for this particular drug, and whether conditions can be created for its reimbursement by health insurance in Slovakia. For instance, treatment with oncology medications is a long and (financially) demanding process. In such cases, a very thorough evaluation is carried out to determine whether the specific medicine can be reimbursed by health insurance in Slovakia.
Has it ever happened that a drug was approved in other European countries but not in Slovakia?
Yes, it has. This is related to how our legislation is changing and how strict are the rules and requirements it imposes. It also relates to the length of the drug evaluation process. Following the latest change in legislation, the conditions have slightly changed, but the process still takes around a year from the date when the application was submitted. However, it can take longer, as it often did in the past.
Isn't there a common European legislation which would determine these conditions?
Each country has its own regulatory authorities. For example, in the Czech Republic, it is the State Institute for Drug Control that oversees this. In Slovakia, the State Institute for Drug Control issues permits for clinical trials and essentially registers drugs. However, the drug availability or how it will be reimbursed by health insurance is decided at the level of the Ministry of Health. This means that the organization can be very different in each country. Independent institutions also enter the process. In our case, after the approval of the new legislation, it is NIHO, the National Institute for Value and Technologies in Healthcare, who conducts impact studies, also known as health outcomes, and oversees the evaluation of pharmacoeconomics.
Do you also consider external factors that affect patients, such as diet and geographical location?
Yes. Regrettably, there are prevalent lifestyle diseases such as cardiovascular diseases that continue to be the leading cause of death in Slovakia. Or diabetes, which may be related to certain predispositions, but it can also be a result of a combination of lifestyle and genetic factors. Also, obesity, lipid metabolism disorders ... unfortunately, lifestyle is not exemplary in other Central European countries either.
What medical disciplines do you specialize in?
Our main focus is on oncological, cardiovascular, metabolic, and renal diseases. We also concentrate on immunological and respiratory diseases, vaccines, and rare diseases.
Oncology medications represent the most significant field of interest, where it's crucial that the new drugs reach patient, also in Slovakia, as soon as possible.
We're also making progress in respiratory medicine, where we're currently focusing on the field of biotechnology. A specific example is biological treatment for asthma, which can be administered if bronchial asthma does not respond well to standard treatment. It is, therefore, intended for more severe forms of this disease.
Are there any medical disciplines that are advancing faster than others?
Practically all medical disciplines I mentioned previously are moving forward. Let’s take diabetes as an example. As a diabetologist myself, I remember that at the beginning of my career there were only a few medications and insulin available. Later, there were technological innovations in the field of insulin (and other injectable) treatments, which represented a significant breakthrough. And last but not least, in the area of oral diabetes medication, there has also been tremendous progress in recent years. Other areas, such as heart failure, vaccines, and others, have seen technological progress as well.
In Slovakia, there is strict legislation regarding drug promotion. What marketing activities do you use when launching a new product on the market?
As we introduce prescription drugs to the market, the only drug promotion or advertisement we can do is for registered drugs, and it can be directed exclusively at professionals - doctors and pharmacists. The goal of communication towards the professional public is to ensure the correct use of the drug. The doctor must receive adequate information about the new drug and its proper administration.
Could you explain your individual marketing activities in more detail?
In simplified terms, our marketing activities involve creating informational materials or directly communicating with doctors and healthcare professionals. We also use market research, consultations, and discussions with experts, and support professional educational activities.
Each department has its own target audience, its “stakeholders” with whom they communicate. I, for example, represent the market access department, so I focus on health insurance companies and the Ministry of Health. The registration and drug safety oversight departments primarily communicate with the State Institute for Drug Control, which regulates the field of medicines and oversees legality and proper use of drugs.
Do you participate in medical conferences?
Yes, that's one of our standard marketing activities. We participate in various medical conferences at both, national and international level, we organize seminars for different sized groups of experts. The primary goal of these activities is education, but they also provide space for valuable discussions and practical questions. Aside from pharmaceutical representatives visiting doctors, this is probably our most common method of communication.
We also use digital marketing communication, which takes place online through various platforms. Professional information is provided electronically, and education is also possible in an online format.
Are there any institutions that bring together pharmaceutical companies?
Yes, this responsibility falls on The Association of Innovative Pharmaceutical Industry (AIFP), of which we are a member. It brings together companies specializing in innovation and new drugs. This association is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Therefore, there is a logical continuity and a set of certain ethical and legal rules that are established at the European level and subsequently implemented in individual countries.
Furthermore, there is The Association for Generic and Biosimilar Medicines (GENAS) that specializes in drugs that are manufactured after the expiration of their patent protection, which, according to European legislation, lasts for 20 years after the date when the patent application was filed and begins with the start of research. Research and development of a drug lasts 10 years, on average. By the time the drug enters the market in a particular country, a significant portion of the patent protection period has already passed.
However, Slovakia is usually not the first country to launch a new drug, therefore under our conditions, 5-7 years of the patent protection period remains. Once the patent protection expires, the drug can be manufactured by other manufacturers, provided that strict rules and regulations are adhered to.
Do you collaborate with other pharmaceutical companies?
Yes, at AstraZeneca, we collaborate and form partnerships and alliances with several other research companies, as well as at the academic level, for example with universities and research centers that focus on innovation and biotechnology.
Do you use any form of artificial intelligence to analyze data?
Yes, we do. However, there's always a human element present, without which it wouldn't work. Modern technologies are very helpful nowadays, and in the pharmaceutical industry, they make research safer and faster.
How did you choose your new office space?
Our colleagues from the headquarters were involved in the selection process, as we needed to ensure that the place we chose met certain requirements. The location, parking options, meeting rooms, and of course the office space itself with the services provided were some of the important criteria. It was also crucial for us to be based in the city center and close to our main office, where the rest of our team resides. Additionally, we wanted the space to be representative enough to welcome external visitors and provide our employees with a pleasant and modern working environment.
What do you like about BASE flexible offices?
First and foremost, your team, who took great care of us right from the start and willingly explained everything. Our colleagues have their own designated workspaces, and if needed, we can easily reserve a meeting room where we can work without any interruptions. The entire space is representative, making it perfect for hosting meetings with external partners.