Postmarketing studies are becoming more and more common as a means to gather data supporting product effectiveness, health economics and outcomes. Teams seldom collect these data during Phase 3 trials. Consequently, they are turning to late stage studies to gather metrics important to payers. Many teams find observational studies to be a cost-efficient method to gather necessary data. They are however, not without limitations.
MSL (medical science liaison) teams’ responsibilities in pharma strategy can vary drastically based on many factors such as team level, company size and location. Even with these variations, most MSL teams perform a few core activities including identifying and building KOL relationships, delivering scientific presentations, continuing education, attending medical meetings and travel. The role of MSLs has been growing and evolving over the years, yet there is a division in the industry about the best way to meet companies’ MSL needs. While the majority of companies believe building an in-house dedicated MSL team is worth the effort, there are others who think outsourced MSL teams fit better into some companies’ overall pharmaceutical strategy.
Global medical affairs teams come in all shapes and sizes — some comprise a large percentage of pharma staffing, and others a small percentage. In many cases, the size of a medical affairs team will reflect not only the company’s resources but also its product portfolio. For instance, companies with mostly early-stage investigational products may not need a large medical affairs force. Conversely, companies with constant product launches will benefit from a robust team.
Teams have a variety of options when conducting a post-marketing study, and these options only increase as researchers continue to innovate new trial designs beyond the standard randomized controlled trial (RCT). For instance, teams may decide to collect real-world data with observational cohort studies. Others may want to directly compare two competing treatments with crossover studies. Alternatively, study teams may try to collect near real-world data with pragmatic RCTs.
Medical affairs is on the front lines of a product launch. During this crucial launch window, medical information and communication teams are responsible for raising awareness, educating stakeholders and generally laying the groundwork for the product’s success in the healthcare community. These tasks make medical affairs launch planning a cornerstone of product success. However, medical affairs teams are only as effective as their planning and preparation, as poor timing or a sub-par strategy can diminish their impact. Continue reading
The number of products medical affairs teams support varies widely. Some medical affairs teams focus on only one or two products while others support a couple hundred. The difference may depend on the company’s overall portfolio and the way in which they divide their products among different medical affairs teams – like if teams are structured by therapeutic area. Continue reading
Medical science liaisons (MSLs) are often a key ingredient of life science teams’ medical strategy. For some teams, the MSL hiring process can be arduous as companies focus on qualifications that they believe will make prospective MSLs successful at their organization. To help them recruit and retain well-suited MSL candidates, companies may look to individuals that balance expertise with enthusiasm. Continue reading
Medical affairs teams have made great strides in gaining recognition within life sciences companies. But, for some, the battle is not over as proving value to upper management continues to be difficult. There are three main avenues teams can pursue to demonstrate value: Continue reading
Postmarketing studies help companies expand their product knowledge, even after the launch window has passed. For example, dedicated or non-dedicated post-marketing study teams may leverage Phase 4 research to gather additional safety data as a condition of regulatory approval. Or, companies may develop postmarketing studies to evaluate the impact of long-term product use. Still other life science organizations may generate late-stage studies as a way to demonstrate cost-effectiveness. Regardless of their end goal, companies can gather information to fulfill these diverse objectives through prospective interventional or observational studies or through retrospective data collection methods. Continue reading
Compliance can be medical affairs’ worst enemy. In fact, our new medical affairs report found that compliance and perceived overregulation were the most commonly-reported concerning trends among surveyed industry experts. Compliance concerns include managing off-label discussions and fair market value payments to physicians. However, internal firewalls between medical affairs teams and commercial teams can also be a point of contention at many companies. Continue reading