Interview: on Medical Affairs best practices – Danie du Plessis, SVP, International Medical R&D Chief Medical Office, GSK
Leading up to NextLevel Pharma’s Medical Affairs Leaders Forum Spring 2015, we are conducting email interviews with selected members of our prestigious speaker panel to learn more about their thoughts on this vital issue.
*Opinions below are those only of the individual and do not reflect upon corporate strategy or positioning.
Danie du Plessis, SVP, International Medical R&D Chief Medical Office, GlaxoSmithKline
NextLevel: What do you think makes the current medical affairs environment so challenging for pharmaceutical companies?
Danie du Plessis: The pharmaceutical environment is one of constant change. Over the years we have moved from pure sales and marketing to access challenges and a focus on benefit-risk profiles. During this journey, medical affairs have become more important and the value of patient-focused data discussions slowly but surely became more visible and important. Different views of the available data by different reimbursement bodies remain challenging. What we are also seeing is the progression of emerging markets from out of pocket markets to reimbursement or partial reimbursement. The need for local data by the regulators may in some cases be challenging as well, given immaturity in some markets as it relates to clinical research. And of course we live in a global village these days, so countries talk to each other and therefore most events and challenges have the potential to go global quite quickly. The technological era and social media provide another challenge as we don’t really know how to utilize these channels in a rigid regulated environment of governance and compliance.
NLP: Which trends have you seen on the ways in which the pharma & biotech sector approach KOLS and stakeholders over the past 5 years?
DdP: There has been a slow change in starting to move away from travel grants and sponsorships to international meetings. This is probably driven not only by an environment pointing out possible conflicts of interest, but also due to the cost of travel and pragmatic business sense. The use of technology, e.g. webcasts, webinars, video on demand, etc. all seem to have gained ground and have been used successfully in most parts of the world including Latin America and the Commonwealth of Independent States. The traditional small ‘promotional’ meetings with dinner are being questioned more and more and hence alternative channels are being utilized. Relationships with KOLs remain important and it appears that medical is playing a bigger role in this while they base the relationship more and more on science and data.
NLP: How much do you think the medical affairs & MSL roles in the pharma & device sector are increasing their influence?
DdP: Influence from medical affairs (including MSL roles) should be, and is increasing more and more. This is aligned with expectations from the environment as well, assuming that the interaction is based purely on scientific data and putting the patient first rather than the product. The implication is also that the medical folk need to have the knowledge and ability to be seen as colleagues and peers - this drives a very different level of conversation. One watch-out is the view that some commercial colleagues may have that being in medical gives one carte blanche to say anything in any context and it will be OK. Medical folk remain company employees and therefore need to clearly understand the boundaries in which they need to operate.
NLP: Why are today’s medical affairs departments so important for generating high-quality real-world evidence?
DdP: All data generation activities need to withstand quality challenges otherwise it will have no credibility and will have been a waste of money as well – something shareholders are usually not too happy with! The differences between early phase research (GCP) and phase 4 type of activities is probably relatively small. The expectations regarding robustness of the data and integrity of analyses for real-world evidence have changed over the years – quite rightly so. Our prescribing colleagues are probably more familiar with research methodology as well and robust real-world data has been seen to provide support for ongoing reimbursement. The industry need to have the integrity to give the appropriate perspective on ALL data which should include a balanced view on transferability of data from one health care environment to another for example
NLP: What’s the best thing for you about working in medical affairs right now?
DdP: This is medical’s time, more so than ever! I know we have been saying this for some time, but if we don’t embrace the opportunity (and the challenge) now, we may have missed the boat completely. The profile and deliverables from medical should be changing, even if only in a subtle way in some instances. In other instance it should be a substantial change. We are moving from a support function to co-leaders. Instead of being stuck in offices reviewing promotional material, we need to be outside, talking about science and appropriate patient populations for treatment. This should be on a 1:1 basis with KOLs and also to groups of colleagues. We need to drive different types of meetings and group dialogue which will truly give patient focus and increase knowledge. We always talk about shared learning within a company – why not facilitate shared clinical learning amongst colleagues? It is beginning to feel as if we are getting closer to patients again – probably an underlying reason why most of us started at medical school in the first place!
NLP: Why is this Medical Affairs Leaders Forum Spring 2015 a good idea for people to attend in your eyes?
DdP: These type of meetings will mean different things to different people. For our younger, less experienced colleagues, it is a forum to potentially expedite learning and see that we have industry issues that go across company boundaries. It is a forum to understand what we can do collectively as an industry. For the more experienced audience, it is an opportunity to share what they have learnt over the years – to give back, but also to embrace the notion that we are never too old to learn! The younger generation can teach us about social media and how to best make us of it as one example. And of course the value of informal face to face interaction between colleagues can never be overestimated.