Boosting Medical ’s Role in Early 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, 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 compani...
Source: EyeForPharma - Category: Pharmaceuticals Authors: Source Type: news