<p style="text-align: justify;">Medical affairs have diverse functions, which has been changing in the past and still is evolving.</p><p style="text-align: justify;">The changes in medical affairs develop at a different pace in the big pharma compared to a biotech environment. Biotech companies have a flexible structure; their size and culture both serve to adapt faster to the changing environment than big pharma companies.</p><p style="text-align: justify;"><strong>Typically, the medical affairs department's functions are:</strong></p><ul style="text-align: justify;"><li>Provision of information and education</li><li>Management of publications</li><li>Clinical trials input, developing field-based relationships</li><li>Providing both clinical and commercial support</li></ul><p style="text-align: justify;"> </p><p style="text-align: justify;">Apart from the above functions, the key responsibilities of medical affairs also depend on the size and location of the company. The activity across the industry varies significantly between companies. These activities are mainly around the key function of the physician assigned to a therapeutic area, a specific indication, or a brand. </p><p style="text-align: justify;"> <strong>The functions that most companies include are:</strong></p><ul><li style="text-align: justify;">Publications</li><li style="text-align: justify;">Medical communication/medical information</li><li style="text-align: justify;">Health economics </li><li style="text-align: justify;">Outcomes research (HEOR)</li></ul><p style="text-align: justify;"> </p><p style="text-align: justify;">In some companies, these groups are functionally led by the physician of the medical affairs department.</p><p style="text-align: justify;">Medical affairs are increasingly playing a central role in coordinating internal company stakeholders (including commercial, market access, regulatory, clinical development, and drug safety teams) with the needs of external stakeholders. Medical teams need to communicate data clearly and consistently and educate internal and external key stakeholders on the value of those data.</p><p style="text-align: justify;"> </p><p style="text-align: justify;"><span style="font-size: 10pt;"><em>This article was contributed by our expert <a href="https://www.linkedin.com/in/manolobeelke/">Manolo Ernesto Beelke</a></em></span></p><p style="text-align: justify;"> </p><h3 style="text-align: justify;"><span style="font-size: 18pt;">Frequently Asked Questions Answered by Manolo Ernesto Beelke</span></h3><h2><span style="font-size: 12pt;">1. What is the role of medical affairs in preclinical research?</span></h2><p>Beyond the classical tasks for medical affairs, this function can also have a relevant role in reorienting preclinical research. For this purpose, a specific medical affairs strategy should be developed to sponsor investigator-initiated trials based on predefined areas of interest. </p><p>This would allow identifying the new target, developing surrogate biomarkers within a therapeutic area, facilitating future clinical development, or increasing knowledge about patient subgroups for which efficacy or safety could be higher than in the initial broad population. Especially, identifying new targets for drug development can represent a relevant activity of medical affairs, reignite the clinical development within the same indication, or extend patent rights.</p><h2><span style="font-size: 12pt;">2. What is the role of medical affairs in the pharma industry?</span></h2><p>Medical affairs within the pharma industry are frequently perceived as a medical service to support marketing. There is a trend in increasing the responsibilities of this function in leading the whole life-span a drug with granted market access. This also covers the selection of research conducted and the use of the data collected. </p><p>All this requires a specific medical affairs strategy, which should guide commercial and sales. As such, we are living during a time frame of paradigm shift from an environment dominated by commercial and marketing interest towards a new dimension, in which medical knowledge and patient centricity become the core purpose, with a positive impact on commercialization as a secondary effect, only.</p><h2><span style="font-size: 12pt;">3. What is the value of medical affairs?</span></h2><p>The value of medical affairs within a classical approach consists in providing a sound medical, scientific basis on what the commercial team is doing. This comes from a perspective in which it has been thought that sales and marketing activities might be the primary trigger for increasing the prescription of the drug produced by a pharma or biotech company. Nowadays, it becomes increasingly evident that the assumptions of this ancient world conflict with reality. </p><p>What drives physicians to choose one product or another is more the medical-scientific knowledge and confidence with the product than specific relationships with sales forces. Thus, the new medical affairs are responsible for providing an increasing package of scientific evidence for the product, which goes far beyond the regulatory requirements to obtain market authorization.</p><h2><span style="font-size: 12pt;">4. What is the future of medical affairs?</span></h2><p>In the future medical affairs might become the core connection point between external experts, prescribers and internal experts within pharma and biotech. At this point, it might also be possible to consider academic and pharma/ biotech research as a partnership of two different worlds to take the best of both these worlds for the patient’s and healthcare system benefits, creating a win-win situation for all parties involved. </p><p>It is even possible that the classical distinction between medical staff working in clinical development and the staff working in a post-marketing position within medical affairs will disappear and that the same team of people will oversee everything from drug discovery up to the end of drug life-cycle.</p><p> </p><p> </p>
KR Expert - Manolo Ernesto Beelke
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