When a patient’s story has a happy end, it is all worth itThe pharmaceutical industry has changed the course of human life
Natural scientist at heart, personable, all smiles and full of life. It is immediately apparent that she has found her mission, that she believes in her work and does it with her heart and soul. She spends many of her working hours in an office with a view of the mountains and a large photo of a sailboat on the wall. It reminds her of the sea and waves, she says, a place where she likes to find her peace in her free time. She loves staying in touch with nature, so a massive green plant keeps her company in the office. She is interested in new developments, cutting edge technology, progress and research. When she speaks of her work her eyes light up. If you do what makes you happy in life, great things can happen, says Mojca. In her work she is always focuses on the person, the patient, whose quality of life or even survival depends on the work of dedicated people in healthcare and the pharmaceutical industry. People like Mojca Šelih, Technical Head of the Medical Regulation Department At Roche. The company is the Slovenian office of the Roche global pharmaceutical group. Roche is headquartered in Basel, Switzerland, was established by Fritz Hoffmann La Roche in October of 1896.
Mojca, what is your area of expertise and what is your job?
Our department cares for registration of our medicines, equipping medicines, appropriate storage and release of medicines into the market. We also continuously monitor the safety of our medicines when they are already on the market. Our department is also responsible for medical information about our medicines, professional education for healthcare workers and performance of clinical trials. The department includes responsible personsons for quality in four good practices areas. We are a relatively small team, the company has just over 40 employees with 13 in my department.
How did you arrive at this point in your life?
I have been working for Roche since 2001, 17 years. I started my career as a technical adviser but soon transferred to the medical side of things, to working in clinical trials. Clinical trials always intrigued me because that is the part of our work where we come closest to the patient. Later I focused on quality assurance in clinical trials and education. I also worked at our company headquarters in Basel for a year. While there I took on the position of regional head of clinical operations. As part of the function we worked towards creating conditions in separate countries that would allow clinical trials to be carried out in more countries. After returning to Slovenia I soon took over managing the medical team, later the medical department and now the medical-regulatory department. Many changes happened over the last year.
Do you feel your work contributes to saving lives? How? And what does it feel like?
Yes, I do have that feeling. We become involved in it quite soon during the clinical trials phase where we monitor medicinal products since the very beginning. A lot of hard work is going into bringing trials to Slovenia and allowing our patients access to the newest medicines. Inclusion of each patient into a clinical trial means a lot to us because we know that that means access to the best clinical potential for treatment. Many of our medicines are intended for the treatment of cancer and other life threatening or debilitating diseases. In our work diseases that we do not normally like to think about are a daily occurrence, so we can appreciate health that much more.
When you see patients in a study or in clinical practice doing well, it is a very special feeling. You feel fulfilled. This is why we come to work each day. A great many aspects of our work are regulated and we need to document each step in writing. There is plenty of red tape to go through, but when a story has a happy end, everything we do is worth it. Today our hallway is buzzing - we are celebrating because we managed to provide a patient with a difficult case of a rare illness with medicines from abroad in just 24 hours. The entire company stepped up on our day off and found a way to get the medicine to the hospital for the patient in just 24 hours for rapid relief.
What did you want to become as a child?
I wanted to be chemist. In primary school I had a very good chemistry teacher and she made me love the subject very much. Quite a few of us from the class happily went to additional chemistry lessons. When the subject matter became more complicated during regular lessons, I was the only one to stay with the teacher for additional lessons. We sped up the pace a bit and really got into chemistry. Instead of a general secondary school I decided to go to the Upper Secondary School of Chemistry as I was certain I would continue on the same path to university. In secondary school we got to know many different areas of chemistry, but the program was very much bound to production and I did not find chemistry for chemistry’s sake as useful and important as when it was applied to people. I sought more links to humans, to treatment, so that the knowledge would have a wider importance. I changed my mind before selecting a faculty and enrolled to the Faculty of Pharmacy.
Was your decision to take up this work influenced by any personal experiences? Could you tell us about them?
Pharmacy is a multidisciplinary science that gives you plenty of wide knowledge and many opportunities to focus on different areas of work ranging from work in pharmacies to clinical pharmacy, manufacturing, research. I did my thesis in biotechnology. Research work for my thesis was very interesting but relatively far away from patients. I still wanted my work to be closer to patients. That is why I decided to focus on the end of the medicinal product production chain, to closing clinical trials and introduction into clinical practice. My interest in innovations brought me to an innovative company. At the time we learned about biological medicines as part of my biotechnology course only from books. Roche was the company that introduced the first biological medicines into clinical practice for the treatment of solid and hematological tumors (note: solid tumors include, for example, breast cancer, while hematological include lymphomas), which changed the course of the disease for these patients and continue to be an important treatment milestone. These medicines were the pinnacle of biotechnology at the time, they were what we were learning about at the faculty from books. Although I was not part of the development of these medicines since the beginning, I did become part of their developmental journey later. When you see how these medicines truly changed practice, you are very proud of your work.
What motivates you most in your work and life in general? Do you have a personal motto you adhere to?
I am a natural scientist at heart and I love science. I believe in evidence based medicine. I believe science is what drives progress. Both privately and in my work I am enthusiastic about new developments, new technologies and resourcefulness of individuals. I also believe that it is important to do what makes you happy in life and remain faithful to oneself. If you work like that, you can be successful and great things happen. Work is an important part of our life, but it is also important that we know how to make time for good moments, to be kind to each other, help each other and truly live life. This means to have interests, our private lives and hobbies and to keep a healthy balance between the business and private life. It is nice to be motivated by things at work to such an extent that they transcend mere work, that they become a subject of your off-work discussions and grow as an organic part of you. Privately I love the sea, I love to sail.Sailing is not just a hobby, it’s a way of life.
Which aspect of your work do you wish people knew more about? What is the most common misconception regarding your work?
I wish people knew more about what the pharmaceutical industry is doing. I guess the most common misconception is that our work is only about profit. We are working in one of the most regulated fields of work, each step in development, manufacturing and testing is legislated and pursued in accordance with best practices. Everything is done under the watchful eye of outside institutions that constantly verify and audit our work. Medicines that come to market under such conditions are tested in accordance with strict ethical standards and proven to be effective with a favorable ratio of risk and safety. Yes, medicines of course also create profits, just like every other industry. But I am proud that our industry is at the very top in terms of investing profits back into development of new medicines. The field of medicine requires very high investments due to all the requirements and standards and they do not end when the medicine makes it to market. Investments continue throughout the entire life cycle of the medicine. Unlike other industries, we are also bound by ethical standards. Our industry has changed the course of human life - our great grandfathers died sooner because they did not have access to the medicines we now have. Today life expectancy is longer because of advances in healthcare and medicines at our disposal.
Are you optimistic about the development and future of human health? Why? Which areas do you believe will see the greatest changes?
I am optimistic. The progress of science and technology is amazing. We will have more technologies available that will influence the way we live. I believe we will see the greatest changes in healthcare and ecology. New technologies are already breaking new ground in healthcare. Genetic profiling of tumor already allows us to recommend treatment based on the characteristics of each tumor, so this type of treatment is already highly individualised. Medical knowledge is growing exponentially and the next challenge will be to manage and follow this knowledge. We will need new technologies that will be able to bring this amassed knowledge into an algorithm that will enable us to manage it effectively. Some new technologies already can do that. But it will always be a question just who and how can access these technologies. Another challenge is the connectivity of these systems. We have plenty of information available in electronic form, but we are not yet good about linking it together.
How do you see our society in a few decades and how will your current work contribute to our future society?
The future will be very focused on technology. Healthcare will advance exponentially with new technologies, as will access to healthcare. A single click will bring us to our physician, pharmacist and nurse without ever needing to go to a clinic. We are already wearing different types of measuring devices and in the future applications measuring our health parameters will link directly to a physician that will use them to supervise our condition. They may be able to see the heart rate of each patient, their exercise regimes and the effects a medicine is having. New technologies will become available in diagnostics and many examination results will be interpreted by artificial intelligence using smart algorithms instead of a physician. A computer has already been taught how to separate melanoma from non-melanoma using a certain algorithm and we are seeing similar breakthroughs in the field of opthalmology. But even 30 years from now technology will never replace a human being. Physicians will simply have more options at their disposal for diagnosing and treating disease. They will have access to examination results and smart algorithms based on clinical research and practice in real time on a computer, allowing them to decide based on knowledge, algorithms and their in-depth analysis of how to optimally treat an illness. All relevant data required to make a decision will be available at the click of a button. This is the future of medicine.
We will also be able to know and address the causes of diseases, not only symptoms. Our medicines will be developed for a certain type of disease in relation to genetic and other characteristics as new technologies enable us to define separate diseases better. We can already do this today and the field is getting ever more detailed. With the help of wide spectrum gene profiling we will be able to determine the type of tumor for each patient. Cancer vaccines will be tailor made for each individual. Medicines will treat the causes of diseases. The future is already in our laboratories.