Boosting Medical’s Role in Early Development
Pharma may be missing an opportunity by not involving Medical Affairs in early stage development
There is a consensus within the industry that Medical Affairs (MA) has an opportunity to redefine its role but there are still questions to be answered about the structure and shape of the new optimized MA department. With unique access to continuously updated insight into the changing needs of physicians and patients, MA can and should play a central role as the facilitator that brings the scientific voice to guide the design and execution of clinical studies. But is Medical involved early enough in development to provide downstream impact?
According to Dr Paul Rowe, VP and Global Medical Affairs Head, Respiratory at Sanofi Genzyme, pharma is missing out on involving MA from the outset of development. From a conceptual perspective, the earlier medical becomes involved the better, he contends. “Medical plays a critical role in ensuring the validity of medical and scientific information in later-stage development,” he says. “Typically, we think of Medical as being involved only in late-stage, but it can also serve as a consultative source of scientific and strategic insight in early-stage development.”
From a practical perspective, this concept is fraught with challenges, namely the first and most challenging being the lack of awareness and /or acceptance of medical being perceived in that manner. “Industry experts often don’t include medical as a key function necessary for early lifecycle management which is a mistake.One could argue for a fundamental change in how companies build and develop their preliminary organizational infrastructures especially larger pharma; I think that’s something that’s required. I have been encouraged by the fact that some of these perceptions are evolving and it appears that the role of medical affairs is evolving as well. I’ve seen recent examples of medical being tapped to join very small early development teams and make significant contributions, utilizing their knowledge of external scientific and clinical/treatment landscape and relationships as a quick example”.
There needs to be a change in mindset in how Medical is viewed and the perceived value it can bring to early-stage development. “Often, there’s a need to engage key experts in a consultative manner early on in a project and that external input is critical to assessing whether and how to progress the development process for a given project. I think when early project teams consist only of R&D and commercial, the same “bridge” that is needed later on in development is arguably the exact same bridge that is required early on.In my experience, if it isn’t present, the downstream negative effects are felt later on. Medical is the owner of late-stage cycle initiatives, however, the challenge is that the infrastructures are built up far too late to optimize efforts.”
Mutual collaboration & respect
To truly drive value, Medical Affairs must take the lead in fostering collaboration and open communication between teams in different departments and between internal teams and external stakeholders. This requires that MA be included as a full collaborative partner in the product cycle, says Peter Rutherford, VP QuintilesIMS, “There’s a greater understanding of the value that Medical can bring and companies are realizing that it’s a very long road to launch. If you can gather insight throughout the lifecycle–supplemented and synergized by medical affairs–this will increase the pace of development and, ultimately, the success of a given product or device or combination. It’s unfair to say that Medical simply sits in the gap between R&D and Commercial, it’s way more than that; its involvement is critical to better care for customer needs. To optimize its impact, there needs to be mutual collaboration and respect for the value Medical can bring – and the earlier it is involved, the better.”
Immuno-oncology drugs are a good example where early Medical engagement pays dividends, says Rutherford. “These drugs are game-changing in how cancer is managed but they have unusual and new adverse event profiles. That’s a problem and a risk but with good medical involvement from early stage development onwards, Medical can provide valuable feedback on study design and launch and can help optimize the product’s entire development path through to and beyond launch”.
In defining an optimized relationship between Medical and R&D, Dr Rowe uses the term ‘equal partnership’. “It has to be the case that there’s shared ownership, not one function handing off a compound to another function. In order to optimize that success, the mindset needs to change to one of equal partnership where the two groups (R&D & Medical) recognize they have mutual goals that they can accomplish together. There are tangible ramifications on deliverables when you don’t have that and we’ve all seen examples of medical affairs being brought in to address problems at clinical trial stage which could have been avoided altogether if medical had been involved from the outset”.
Custodians of the patient voice
Medical is uniquely placed to collect and channel information on the patient experience back to the R&D organization, turning patient data into actionable insights.“MA touches so many internal and external partners that we’re in a prime position to get patients around the table and we’re starting to do that.”
Patient-centricity is evolving beyond simple patient engagement in clinical trials.“The big picture includes consideration of patient lifestyle, as well as trends in society and technology. There’s a growing realization from pharma that we need products that address the needs of patients directly, not by proxy. Medical can incorporate this into what we do in a compliant and effective manner, but it’s not something that we can or should do in isolation, but rather by encompassing a shared patient-centric ideology and culture, across all functions within an organization.”
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