An Interview with Karsten Kissel, Head Global Medical Affairs Biosimilars, Boehringer Ingelheim

Interviewed by Louise Rogers  |  Content Marketing Assistant, European Medical Journal

Disclosure: This is a non-commercial feature, although the European Medical Group has been in previous commercial agreements with Boehringer Ingelheim.

Q: You chose to enter the pharma industry after your medical training and residency. What was it about the industry at that time that excited you and made you want to pursue a career in pharma?

A: What attracted me to the pharma industry was the opportunity to shape the development and implementation of treatments on a much broader scale than I otherwise could in clinical practice. Our industry has the purpose of providing clinicians with the essentials to better patient outcomes by developing medicines in collaboration with leading clinical researchers. This is one of my main motivations to work in the industry: the fact that I have the ability to change millions of people’s lives. I think it can be difficult to see where your career will lead you when you start off as a physician. Entering pharma, doctors may wonder: what is it like to be a physician and not treat patients? I am treating patients though, just in a different way, and I find that work intellectually stimulating as I get the chance to discuss scientific topics on a deeper level.

Q: As someone who built a career in Medical Affairs, what insights can you provide into how the department has evolved?

A: Originally, pharma companies established Medical Affairs to address physicians, who at the time were seen as the main customer, in a peer-to-peer fashion. Today, the Medical Affairs function is much more focussed on patient outcomes. The function also continues to have an important internal, strategic role in developing brand strategy together with marketing and sales; for example, through scientific knowledge and customer insights. Therefore, Medical Affairs professionals need to be commercially minded. Medical Affairs activities, particularly outward-facing tactics, such as publication and medical communication activities, are strictly non-promotional and focussed on ensuring that medicines are used in the optimal way to deliver patient outcome. This bigger objective can be hard to achieve in settings where a company’s whole culture is sales focussed. In addition, Medical Affairs is optimally positioned to feed customer-derived medical input into the research and development process and into the Market Access strategy.

Q: The traditional single-customer engagement model has evolved in recent years to incorporate a number of stakeholders, all of whom Medical Affairs must co-operate with to improve patient care. What were the challenges you and your Medical Affairs team faced, suddenly having to listen to input from so many different directions and then effectively communicating that information? How did you overcome these challenges?

A: The pharma customer was always a split customer, which included the patient as the end user, the physician as the main decision maker, the pharmacist and the wholesaler as the purchasers, the health insurance as the payer, and the regulatory agency giving overall approval for a product in a given indication. Today’s reality is even more complex, with stakeholders who were perceived as bystanders in the past now acting as important decision makers. Therefore, all functions in the industry, including Medical Affairs, have had to learn how to engage with newly emerging stakeholder groups. The learning is ongoing and can be a challenge where cross-collaboration is required. It is key to realise that different internal functions may focus on different objectives when engaging with the same external stakeholder. High ethical standards and an excellent understanding of the external regulatory and compliance framework are therefore required. Not working together across commercial and non-commercial functions is not an option. Working together in a non-compliant way is not an option either. Successfully and safely navigating the legal environment requires constructive collaboration between different functions based on excellent compliance knowledge.

Q: Not only do Medical Affairs professionals need to have scientific expertise but they also must possess the ability to effectively communicate the scientific information into a format that brings value to all stakeholders involved. What do you think is the key to successfully marketing a product, while maintaining scientific integrity?

A: It is very simple: scientific integrity is achieved by ensuring that everybody practises integrity. It comes down to company culture and applies to all kinds of integrity, not just at the science level. Integrity needs to be demanded and visibly lived at every management stage, from the corporate board to each line manager in every function. It should be stressed to all employees that the priority of scientific integrity over business potential is expected of them. All functions need to take responsibility for their own actions, and this includes the need to represent scientific data completely and correctly. It is not the role of Medical Affairs to police other functions. Building a bridge between science and marketing requires the promotional and non-promotional teams to fully understand the goals of the other departments.  Medical Affairs have a huge role in delivering their part of brand strategy, which is different from Marketing and Sales, but aligned. It can be surprising for commercial teams to see the two different faces of Medical Affairs. For example, in internal brand strategy discussions we will put our commercial hat on and when discussing a doctor’s question in their practice we will wear the science hat and communicate medical information in the scientifically correct and balanced way.

Q: Patient centricity has been a buzz concept in pharma for several years now and a lot of companies claim to have integrated it into their vision. What does patient centricity look like in Medical Affairs? Can you give me an example that illustrates where your department has implemented a strategy to become more patient centred?

A: The industry still has a way to go until patient centricity is fully described, understood, and implemented. Being traditionally product-centred, pharma would approach the market with a newly developed product asking: in which patient do I best use this product? This is not how a physician, or a patient thinks about a medicine. They never search for a possible use of a given product but rather the solution to a specific clinical issue. For patient centricity to be really implemented, the big step for companies is to move from product-centric marketing to customer-centric marketing, whether this customer is the physician or the patient. Although the patient’s well-being should be the end goal, if companies even begin by just putting the physicians in the centre, then this is a step closer to becoming patient-centric. We just need to move away from being product-centric.

What we do at Boehringer Ingelheim is we listen. We listen much more carefully, openly, and deeply to all our customers, including patients, bearing in mind that listening to patient advocacy groups doesn’t equal listening to patients. We don’t rest until we truly understand an issue and how to address and tackle it, whether this be a product, a support program, etc. We learnt from patients who self-administer medicine via subcutaneous injections how they wanted to be educated on correct self-injection. This led us to design educational materials that were simpler and more user-friendly, and we omitted certain digital features that maybe felt modern and fancy but were actually described by patients as superfluous clutter!

Q: In a department where success is not measured by revenue, how is the value of Medical Affairs measured in a day and age where return on investment is very important to senior stakeholders?

A: Assessing the success of Medical Affairs actions is one of the most difficult tasks in performance measurement. Internal stakeholders must understand that most of our work cannot be expressed in numbers. The quality of input into brand strategy, based on customer insights, is hard to quantify. Similarly, the number of avoided adverse events because clinicians are well educated about the use of a new medicine is impossible to measure. Quality can only be assessed by someone who understands what a good quality activity looks like. A qualified judgment is somewhat subjective by nature, but this limitation must be accepted when assessing certain activities. At Boehringer Ingelheim we have often used customer surveys, but the results received can be of limited value. What do you make out of a 90% customer rating of very good or good for an activity? It still doesn’t tell you anything about whether the objective of the activity was achieved (an educational objective, for example). Comparative ratings and knowledge questions can be useful. We asked the attendees of an educational satellite symposium to what extent they agreed with the statement: “This industry symposium was better than most I attended in the last 12 months.” The absolute percentage of attendees agreeing with such a statement was much lower than for a general “Did you like our symposium?” question, but it gave us more honest feedback about how we were positioned with the quality of our education compared to other companies. The challenge is that some stakeholders like to see simple to understand numbers rather than apply the additional diligence needed to assess the value of Medical Affairs actions. Not everything that can be counted is a useful measure and the really relevant achievements often don’t have numerical metrics.

Q: There is a lot of talk around pharma re-establishing its integrity and credibility among the public, regaining trust through increased transparency of the data available. What role do Medical Affairs as a department play here?

A: Let’s look at two aspects: the lack of transparency about clinical data and the violation of pharma promotion codes and laws. Many of the pharma data scandals we hear about today date back a number of years.  I believe that today the pharma industry, overall, conducts and publishes its studies in a compliant and transparent way. Unfortunately, what we still see happening occasionally is inappropriate or even unlawful promotion, which tends to make it into the news when a company is convicted to pay a high fine. This is one of the reasons our industry still suffers from poor public perception. We can build trust with the public only by being fully transparent and compliant over a long period of time. Trust is quickly lost and takes a long time to regain. Medical Affairs, similar to all other functions, is called upon to keep their shop in order. For scientific publications, this involves working intensively with external and internal authors by fostering an open discussion about the findings of a study. Patients can only benefit from a medicine when all safety risks are well-described so clinicians can manage them proactively. All other functions need to do the same and ensure that their own actions are ethical and lawful. I recommend against using Medical Affairs as internal police to ensure correct marketing and sales practices. Medical Affairs should review the scientific correctness of marketing materials, but the accountability for any promotional activity sits with the function that owns it.

Q: Finally, where do you see the future of Medical Affairs and its place within the pharma industry?

A: Currently, I see different companies taking different approaches in their strategy to building a Medical Affairs function, how they design the interface with other departments, and how deeply they engage the team in clinical development and marketing strategy. Companies that harness the skills and knowledge of Medical Affairs in a modern and intelligent way will have a competitive advantage over those who choose not to utilise the department’s potential. Of course, the size and involvement of the department should be dialled up or down based on the nature of the business (e.g. primary care versus speciality care), the product lifecycle, etc. For me, preserving and protecting the non-promotional nature of Medical Affairs is crucial. Thinking of Medical Affairs as a sales-enhancing function is a big mistake and, to be honest, I don’t see why this is needed, with most companies having excellent Marketing and Sales functions. More importantly, if Medical Affairs would be developed into a promotional function, the company risks losing scientific credibility and, along with that, the attention of customers who prefer non-promotional interactions. A successful pharma company will support all the different channels their customers need, including the promotional and non-promotional channels.