The life sciences industry has historically been slow to change, although the current shift in healthcare needs is currently causing some dramatic changes. For example, medical affairs (MA) was once a relatively minor aspect of healthcare marketing that has become responsible for disseminating medical knowledge to both internal and external stakeholders. MA has thus become an invaluable strategic function for many decision-makers in healthcare. The most significant trends in medical affairs include the following:
- Drug Development
- Micro-Battle approach
- Small conferences
- Medical value teams
The importance of these trends primarily lies in their pivotal role in increasing the focus of medical affairs specialists on patient care.
The use of data to provide real-world evidence supporting drug development is dramatically increasing. A few Phase 3 trials has traditionally been sufficient to establish a product’s safety and efficacy. However, today’s healthcare professionals expect more long-term studies of diverse populations. The primary focus of Phase 1 to 3 trials is on efficacy, while Phase 4 trials studies study additional factors such as safety, effectiveness and costs. Phase 4 trials are now going beyond the standard randomized controlled trials (RCTs) to take a closer look at these factors on a diverse population within a clinical setting.
Drug launches require a high degree of coordination between functions such as medical affairs, patient services, marketing, sales and regulatory compliance. However, pharmaceutical companies have traditionally relied on a nominal leader and loosely-organized cross-functional teams to coordinate these functions. The primary problem with this approach is that silo leaders still make the decisions regarding budget, power and talent. They typically use a checklist approach, which undermines the launch team’s ability to raise critical issues.
Pharmaceutical companies are now developing a “micro-battle” approach to launching products to obtain continuous feedback from frontline operators. This approach involves creating an internal organization within the company, which provides the launch team with the authority to make the best decisions for the patient. A micro-battle approach also allows the team to focus on strategic factors, rather than completing a checklist. Furthermore, the ability to explore various scenarios lets the team look beyond the launch date.
The size of medical affairs conferences is decreasing, allowing attendees to focus on their areas of specialty. A small conference also provides attendees with a more detailed education on a topic and greater opportunities to effectively network with people.
Executive leaders and chief medical officers provide valuable insights at conferences, helping to ensure the value of MA specialists to the commercial, legal and scientific community. Medical Science Liaison (MSL) professionals also use small conferences to engage Key Opinion Leaders (KOLs) and establish relationships with clinical teams. Panel sessions are particularly effective at promoting interactive group discussions. Workshops at small conferences can also be more easily tailored to developing the role of MA specialists in medical science liaisons and research collaborations.
Medical Value Teams
Pharmaceutical companies have traditionally used MA staff members as technical product advisers by forming a medical value team with the most effective members. The demand for MA teams to prove their value is thus encouraging team members to provide information that can help the company shape its operational strategy for a product.
MA teams typically use three methods to establish their value, including traditional key performance indicators (KPIs), outcome-based KPIs and strategic insights. Traditional KPIs such as the number of calls that a medical information center receives provide an overview of the MA team’s productivity. Outcome-based KPIs describe the result of the interactions indicated by the traditional KPIs. The strategic insight that MA gains through its role as keepers of information is also essential for proving its value to a company.
The most significant trends in MA currently include the need for more information to support drug development, especially Phase 4 trials. More companies are also using a micro-battle strategy for making decisions regarding product launches. Furthermore, the trend toward smaller Medical Affairs conferences should continue for the foreseeable future. Finally, the value of medical value teams to pharmaceutical companies will continue to increase.