The Medical Affairs function is assuming new responsibilities and facing a wider range of expectations. For executives operating in this broader context, traditional medical backgrounds and capabilities are no longer sufficient for success. Medical affairs personnel must adapt to a host of external challenges, among them a sharper focus on risk management, the growing prevalence of chronic diseases alongside an increased industry focus on specialty and niche diseases, the emergence of new types of data, and finally a more difficult market access environment. Tackling these challenges calls for strong relationships with a broad range of stakeholders, including increasingly sophisticated payer, patient and advocacy groups.
The professional Medical Affairs person needs to have an ability to put processes in place as well as knowledge of the business. They need to understand business issues, science, and medicine, and can assimilate a lot of knowledge and skills quickly.
While medical affairs has been described as a bridge between R&D and commercial functions within pharmaceutical companies, it can also be the bridge between the pharma company and its external stakeholders. Medical affairs departments play a vital role in facilitating an information exchange, both in terms of education and in bringing insights back to the company. The bridging role that medical affairs fulfils between the pharmaceutical company and patient organizations will also increase in importance. While the R&D team focuses on the scientific side of medicine development, medical affairs is well-placed to understand how medicines can best be delivered to patients, particularly in terms of what would be useful ‘beyond the pill’ to provide a better experience for patients and improve compliance and adherence. Medical affairs can also help to drive patient involvement at an earlier stage of the development process, so that they can provide input into trial design.