Bringing each new pharmaceutical product to market is a complex and somewhat unique process led and executed by a cross-functional team who undertakes a number of activities to ensure the success of the product launch. In the current pharma industry environment, a company’s Medical Affairs department plays a critical role, especially as it relates to the launch of innovative treatments.
Throughout this two-part blog, we will discuss the role of Medical Affairs and its key functions in execution of successful launches, and we will look at, and highlight, the timelines for pre-launch, at launch and post-launch activities. Although there are already several well-established activities that Medical Affairs teams traditionally manage for each product launch, we will examine some newer, more innovative ways in which companies can leverage their Medical Affairs teams to maximize their product potential and reach the “right” patients at launch.
In this first part, we will focus mainly on the key deliverables that Medical Affairs could and should provide to optimize commercial potential, access and value to the patients.
The first step, however, is understanding the background. Medical Affairs teams originally emerged as a reaction to increasing pressures from regulators to separate the medical and commercial functions within big pharma as companies began experiencing an increase in internal demands to focus on generating and developing new products, rather than on managing products after FDA approval. Over the past 25 years, continued regulatory pressure has shifted a number of marketing activities to people with medical expertise – most often to Medical Affairs groups. These individuals are an integral part of launch success.
Typically, a Medical Affairs team is responsible for three critical deliverables, all of which are focused on clinical data analysis and dissemination, when preparing for a successful launch:
- Development of the key medical messages (story)
- Development of the competitive medical strategy for introduction of the product to market
- Development and flawless execution of the comprehensive tactical plan to support the strategy
Key Medical Messages (Story)
What do we mean by that? The key medical message should clearly and concisely communicate unmet medical needs in the given therapeutic area, as well as which patient population would benefit from this product and why; and it should explain the features of the product that physicians need to understand in order to decide whether this product is right for a specific group of patients.
This may seem like something very simple to do, but it’s really not. Current drug development requirements call for companies to invest in a large number of Phase III studies, and oftentimes the endpoints can be quite different from one study to another. As a result, new products typically come to launch with quite a lot of data, and it is not always consistent or easy to understand.
Given how busy physicians are, they simply don’t have time to read every publication and dive deep into all the data. That’s where the Medical Affairs team comes in. It’s very important that the message, or story, is clearly crystallized early in the pre-launch phase so that the Medical Affairs team can educate all internal stakeholders on what the data means and how to communicate it effectively and consistently through all channels to the external stakeholders upon approval.
Competitive Medical Strategy
Understanding the needs of the market is key to product launch success. With the rare exception of a new product that comes to market as a first-in-class, the majority of new launches face some sort of competition. Having clear communication messages and a defined strategic approach is very important. The goal is to differentiate your product from other available treatment options and upcoming competition to reach the right patients at the right time in their patient journey – when they can benefit from this treatment most.
In the past, launch strategy landed solely in the hands of marketing departments, but we tend to see that in the most successful companies, in today’s environment, there’s a joint effort between the medical and marketing teams. After all, medical accuracy; the understanding of unmet medical needs; and a simple and consistent – but still scientifically sound – story are very important elements of a successful launch strategy.
Comprehensive Tactical Plan
From a tactical point of view, Medical Affairs teams can champion and execute a number of tactics targeting their key customers: physicians, allied healthcare professionals, medical directors at the payer’s organizations, etc. Those tactics shall include disease state education highlighting the unmet medical needs in the relevant areas; ensuring consistency of all communications related to the new medicine in publications and other appropriate venues; providing input on where the product could potentially fit in current armamentarium of the treatment options; and discussing the science related to the medicine. Medical Affairs teams, in partnership with R&D, must also ensure the timely publication of results from Phase III studies, provide a quality presentation of the data at medical congresses, and spearhead several other initiatives focused on educating the medical community about challenges and the latest science in the given disease during the pre-launch phase.
In this part of the article let us highlight one very important element of successful launch lead and executed by Medical Affairs – well-organized series of Advisory Board meetings. The importance of advisory board meetings cannot be underestimated during this time. With the right experts attending those meetings, and with the right expertise and knowledge from both scientific and clinical practice points of view, a company can gain very valuable insights. They can tailor their strategy as needed to ensure maximum success and guarantee that the right patients are able to benefit from the newly introduced therapy.
In the second part of this blog, we will dive more deeply into the exact work done by Medical Affairs teams to attain these deliverables. Part II will be posted next week and will provide a breakdown of the vital 12- to 24-month period immediately leading up to a successful launch.
In meantime please share your thoughts!