Charlotte Kremer is head of medical affairs for Astellas Pharma and serves as the president of the Medical Affairs Professional Society. At eyeforpharma Barcelona by Reuters Events 2020, a virtual conference held between March 31 and April 3, Kremer spoke on the evolving strategic role of medical affairs in driving global pharma value.


Charlotte Kremer MD MBA


Medical affairs is set to become one of the most strategically important and valued functions in a pharmaceutical company

Charlotte Kremer


Kremer launched her presentation with the idea that “Medical affairs is set to become one of the most strategically important and valued functions in a pharmaceutical company.” She went on to elaborate on the reasons why this is the case.


First of all, as Kremer believes, this is a time of unprecedented change in healthcare where the industry is seeing a shift from a primary model to a more specialised model. Several factors are at play in this shift, including scientific advancements like gene therapy, pricing pressures, a shift from strictly utilising data to value arguments, big data and real-world evidence.


Kremer stated that Medical Affairs is pivotal to the success of pharmaceutical companies because it is poised to deliver more value than ever before and acts as an external ambassador, able to fulfil the need for evidence generation as well as deliver scientific knowledge, from development all the way to commercialisation.  


In recent years, stakeholder needs are changing and Medical Affairs has demonstrated itself capable of stepping up to the plate to help companies meet the new realities and adapt to important trends such as complexity of data, real-world evidence, pricing pressures, collaborative partnerships and next-generation therapies.


According to Kremer, a need for information exists, particularly at the levels of scientific exchange and evidence generation. Medical Affairs is uniquely situated at the crossroads between internal and external stakeholders, facilitating the flow of information and driving exchange. It is a role that unites internal and external through strategic partnerships with R&D and commercial departments. 


Data from the pharma industry shows that more approvals are being seen than ever before, with a record of 59 new drugs approved by the FDA in 2018. However, there is increasing use of accelerated approval pathways, which results in lower exposure to patient programs. Furthermore, many of these approvals are based on smaller indications and patient populations with rare diseases. Kremer underscores the continued importance of Medical Affairs in generating important data and post-approval monitoring.


Kremer mentioned that there are four pillars necessary for Medical Affairs to be able to have a seat at the table. First, it is necessary to deeply understand the disease area, including treatment paradigms and patient journeys. Secondly, it’s essential to demonstrate a full understanding of the products, particularly their safety and efficacy. Thirdly, Medical Affairs must know how to generate valuable data efficiently. Finally, it’s important to embrace a global Medical Affairs function uniting all stakeholders involved and providing the right information at the right time.


In Kremer’s opinion, Medical Affairs is more than ready to meet these new realities, stating that the role has already evolved significantly, starting out by establishing credibility, then by giving input, later becoming a supportive pillar, and finally delivering impact through value creation.


However, she cautions that there is still work to do in three areas. Medical Affairs needs to work on building capabilities, knowledge and experience to realize the wealth of possibilities presented by artificial intelligence, real-world evidence, big data and electronic delivery, and that it’s key to hire the right people who are capable of integrating these advanced tools. Second, it’s crucial to deliver qualitative impact by tying performance metrics to strategy, focusing on more than just the metrics, and using multiple metrics to assess performance. Finally, an essential capability to enhance is communication with C-suite executives by speaking with a sense of business acumen to convey ideas and results, clearly communicating value proposition, and being agile.