Karsten Lollike, Corporate Vice President, QPPV, Novo Nordisk A/S
Interviewed by Louise Rogers | @EMG_Louise_
Karsten Lollike is the Corporate Vice President and the Qualified Person Responsible for Pharmacovigilance (QPPV) of Global Safety at Novo Nordisk, a position he has held for 11 years. Dr. Lollike joined Novo Nordisk in 2000, working in Global Development in Haemostasis, after obtaining his medical degree and subsequently a PhD. We spoke to Dr. Lollike about his medical expertise and experience, his long-standing career at Novo Nordisk, and what working at the company means to him.
Q: What aspects of your education and experience have led to your success in holding a leading position within the life sciences industry?
A: To be a QPPV, by law, you need to either be a medical doctor or have access to one. You are responsible for keeping the patients safe and this means you may need to make the final call in certain situations regarding the safety of your products; therefore, my medical training is very valuable. You could say most of my day-to-day work is managerial: overseeing strategy, and meeting with colleagues to discuss ongoing projects, so having obtained an MBA gives me a solid background with certain leadership skills. And finally, my PhD – when certain issues arise in safety, my team will look to the scientific literature to understand and develop new methods and techniques, so here my PhD proves very useful. That said, I do believe a lot is learnt just by doing, and as you evolve through your career you will inevitably pick up capability from different circumstances. I feel very lucky to use all aspects of my education in my role today and I have gained a lot from each experience.
Q: How have the fields of haemophilia and diabetes changed since you started in the industry?
A: When I started my training, the rise of HIV in the 80s and 90s meant that we were beginning to see a switch from plasma-derived products in haemophilia treatment. There was a shift towards treatment with recombinant factors and bypassing agents, which was a major step forward in terms of patient safety. Now at Novo Nordisk, we have a full portfolio of recombinant factors: our notable NovoSeven and our second generation long-acting factors VIII and IX. The fact that we have now developed products that don’t need to be administered every day, perhaps only once a week, is also very significant. The most recent development would be how the industry has advanced to deliver a treatment subcutaneously – another huge headway for patients.
When it comes to diabetes, I would say it’s the GLP-1 group of products, which is now the frontline treatment for type 2 diabetes. I would also like to highlight the digital health initiatives in this treatment area. Something very exciting is happening within the field of diabetes and digital health. We are seeing numerous collaborations between the industry and tech companies and patients now have the ability to measure their glucose levels very readily, empowering them to take control of their own values and essentially their own health.
Q: What distinguishes Novo Nordisk from other companies specialising in the same areas?
A: I believe it’s our company culture and philosophy. For us it’s about more than just selling the products – we want to be a responsible partner in society, which we exemplify through our haemophilia and diabetes foundations, and being a large company, we have the opportunity and duty to care about the environment globally. Within the company there is a large focus on the people and their development. We work by a set of principles, which we call ‘The Novo Nordisk Way’ – it underpins all of who we are, how we work, and what we are trying to achieve. It also puts a huge emphasis on leadership and leading by example. I recently attended the company’s annual meeting in Rome along with the most senior 300 leaders. On our journey back to Copenhagen, our CEO boarded the same plane as us, stood in the same queues as us, and was conversing with all the employees. What I am saying is that there are no private jets and it’s the closeness of all the employees and the ability to talk to anyone at any level that makes it a special place to work.
Q: How has Novo Nordisk been able to harness big data and incorporate RWE into clinical frameworks?
A: While big data and RWE are current buzz words, we actually used RWE to get a new indication for Glanzmann’s Thrombasthenia for NovoSeven back in 2003. We have also used RWE for safety evaluations. When Victoza, came to market, there was a concern that the diabetes drug was associated with pancreatitis, so we initiated a RWE study in the US, assessing a claims database. Around 3–4 years later, research was published suggesting a potential association between GLP-1 compounds and pancreatitis. So, we took this research and compared it with our database of >25,000 patients receiving our product. Generally speaking, there is a higher frequency of pancreatitis among type 2 diabetic patients, but the data showed that this did not vary between the different treatment groups, thereby indicating that the higher incidence of pancreatitis was a population factor rather than a direct result of the treatment. This was a very strong indication for us to bring the product forward and it subsequently received FDA approval. As a pharma company we must be smart and start generating data early on – once you have a safety issue it’s too late to start generating the data, so it’s vital to initiate this early. So, we have used RWE for a long time and are for sure going to use it more and in a broader context going forward.
Q: What personal attributes are important in a QPPV?
A: You need to be data focussed and remain calm under pressure, because you will no doubt receive a lot of pressure from the organisation if there is a safety issue with one of your major products. In the situation of a drug recall, as QPPV, you must consider what is best to do, taking all stakeholder perspectives into account, so you also need to see situations from different viewpoints. It is also important to have a good network within the company. Issues can arise from any department so having a good rapport with the rest of your colleagues is beneficial. Lastly – you need to have integrity. You must have a firm belief in what is right for the patient, and then be able to communicate that voice through to the company. That is the responsibility of a QPPV, and it can come with a lot of pressure. How do you go against what is best for the company short-term because it is better for the patient? Luckily there has never been an ethical dilemma for me at Novo Nordisk and I would never be the QPPV if I didn’t believe that the company was making the right decisions for the patients.
Q: If you could have dinner with one person, outside of the industry who would it be and why?
A: I would have dinner with Bill Gates. The work he is doing with the Bill & Melinda Gates Foundation is amazing – what he is giving back to society and the way he is convincing other wealthy individuals to do the same. I also really believe in the causes he is helping; it’s about empowering individuals, especially women and girls, fighting infectious diseases, and using the power of technology to combat these issues. He seems to be a very interesting man who has managed to have tremendous success in business, and then has also been able to achieve a lot for society as a whole with the money he has earned.