Authored by Darren Jones, Kenquavius McCollum and Mercedes Ekono
In response to recent advancements in the medical affairs function and the growing demand for scientific evidence among healthcare providers in rare therapeutic areas, Baker Tilly hosted a webinar about the evolution of the medical affairs profession. The webinar was focused around a discussion with medical affairs and regulatory professionals regarding ways in which the medical affairs role has expanded over the years and the need to adapt to increased regulatory oversight with many key takeaways.
One of the primary drivers for the creation of the medical affairs role was to establish a line of separation between medical and commercial departments and prioritize education rather than commercialization. As the link between academia and industry strengthens, the level of engagement with key opinion leaders (KOLs) has evolved, allowing for more diversified conversations across various therapeutic areas. By having medical sales liaisons (MSLs) share clinical data with KOLs as it becomes available, there is a greater opportunity for active engagement while avoiding any solicited requests or off-label information.
When conducting investigator-sponsored studies, keep in mind what the study aims to accomplish (e.g., expanding indications or strengthening the evidence portfolio). Internal and external groups may have different objectives, and aligning those objectives is key to a successful study design. In addition, having a tightly defined study goal can help control costs, as well as avoid any unnecessary regulatory requirements. Additionally, as the trend towards collaborative research increases, credibility also heightens as experienced researchers are involved with protocol design, data analysis, and publication efforts. By its nature, collaborative research challenges and redefines the concept of investigator independence.
As there are often limitations with information obtained from clinical trials, RWE may serve as a key tool in bridging any knowledge gaps and understanding the effect of a product or device in non-controlled scenarios. RWE also allows researchers to obtain several key endpoints in a cost-effective manner. As organizations begin to utilize RWE in conjunction to clinical trials, MSL professionals should be equipped to speak to the added benefit of RWE data compared to clinical trials in conversations with clinicians in order to effectively communicate the value of a drug or medical device.
The Accreditation Council for Medical Affairs’ (ACMA) Board Certified Medical Affairs Specialist (BCMAS) program is designed to increase performance, mitigate risk and ensure consistency across the medical affairs industry. As the first medical affairs certification program, the BCMAS aims to ensure graduates are up to date with industry standards, have a strong medical literature terminology background, and are well versed in cross-functional areas such as clinical development, regulatory affairs, marketing and compliance. The BCMAS program can also prove useful not only to new MSLs, but seasoned professionals as well.
To learn more about the changes taking place to the medical affairs function and how organizations can effectively address those changes, listen to our on-demand recording of our informative webinar.
For more information on this topic, or to learn how Baker Tilly’s Value Architects™ can help, contact our team.