As we’ve already begun to look into in Part I of this two-part blog, Medical Affairs teams play a critical role in bringing new treatment options to market in the current pharma industry environment.
In the first part, we focused mainly on the key deliverables that Medical Affairs could and should provide to optimize value to the patients, including patient access and, ultimately, commercial potential at launch – specifically a clear medical story/key medical messages, a competitive medical strategy and a comprehensive set of tactics summarized in a tactical plan.
In this second part, we will dive more deeply into some of the specific deliverables championed by Medical Affairs during pre-launch and at launch. We will also provide a breakdown of the timeline for the periods leading up to, during and following the launch.
It’s common practice in the pharma industry to begin launch preparation approximately 12 to 24 months before launch. However, based on our experience, that is simply not enough time for the majority of companies to prepare the market and get maximum value out of their launches. The launch strategy has to be laid out by the time of completion of the POC (Proof of Concept) study and before the start of the Phase III program, and the medical affairs teams must play a very active role at this stage to ensure that development and commercial teams understand the unmet medical needs in the specific therapeutic field and have a solid understanding of how those needs are expected to evolve by the time of anticipated approval and launch. This important first step is critical in ensuring that the appropriate clinical endpoints are selected for the Phase III studies. From that point forward, medical affairs teams serve as a bridge between the medical community (external stakeholders, such as physicians/healthcare professionals, hospital administrators, professional associations, and patient groups) and R&D and commercial/marketing teams (internal stakeholders).
What to Expect from Medical Affairs in Preparation for Product Launch
There are many critical activities that take place well in advance of the actual launch of a new product, and Medical Affairs departments pay a vital role in that process, as the organization prepares for the successful commercialization of the new product. Each of these activities is time bound and should have a very clear objective. From a timeline perspective, these activities are often divided into three categories: pre-launch, at launch and post-launch.
During the pre-launch phase, the Medical Affairs team plays a dual role. Internally, it is responsible for training medical science liaisons (MSLs) and sales representatives; providing medical input to all pre-launch and launch initiatives championed by other departments within the company; and last but not least, reviewing and approving promotional material to be utilized at launch. Externally, it acts as the face of the organization and focuses on educating physicians on clinical and scientific data related to the disease state and unmet medical needs; addressing queries of physicians; and, when and if appropriate, sharing data about the product(s) in development.
During the post-launch phase, the function of the Medical Affairs team is to update physicians on emerging information and answer queries on the drug’s safety and efficacy profile. In addition, Medical Affairs team members play an important role in partnering with physicians on investigator-initiated research and epidemiological studies, which is currently a real need in pharmaceutical and biotech companies.
To maximize the value and effectiveness of Medical Affairs teams, their representatives are typically involved in the strategic product activities beginning with Phase II/early Phase III; and, depending on the length of the anticipated Phase III program, a focused Medical Affairs launch team should be formed about two to three years in advance of the anticipated product launch.
In the earlier stages of this process, Medical Affairs representatives will bring valuable medical expertise and understanding of the current medical practices in the given disease state to the development and commercial teams. Their expertise helps to ensure that the most valuable information is brought forth from the medical community so that key experts in the field may provide input and help the company guide key decision making on the Phase III study design and study execution as needed. During this time, the Medical Affairs team will also become familiar with the product’s mechanism of action and all available data, and it will develop further understanding of the evolving related issues, ultimately becoming true experts within the larger launch team.
Toward the later stages of the pre-launch phase and during the period immediately surrounding the time of launch, medical directors and other professionals are starting to become more and more involved in the educational efforts targeting payer organizations, focusing on unmet medical needs during pre-launch and addressing how the new innovative therapy can help address those needs after the product is approved. Ensuring product access at launch has become one of the most critical elements of product success, and the role of Medical Affairs in those efforts is dramatically increasing.
It’s also important to note that the Medical Affairs department should have current policies and procedures in place to train and support a culture of compliance among its employees. The adoption of these policies is important regardless of what stage any given product is in, but it is especially critical during the pre-launch phase, which addresses the dissemination of off-label literature; responding to unsolicited requests for information regarding off-label usage; grant funding; medical letters; KOLs and related activities; disclosure of payments to healthcare professionals; and any other activity that falls under the purview of the Medical Affairs department. Moreover, as the law changes, policies and procedures should also be updated, and employees affected by such changes should be trained accordingly.
While the role and importance of Medical Affairs departments in product launches are continuously increasing, cross-functional collaboration remains very important. Medical Affairs teams are becoming stronger partners to marketing and clinical development teams across the industry. Within the most successful launch teams, open and effective collaboration is mastered – from broad, company-wide team meetings to detailed, one-on-one conversations. When the team leaders from each department work well together, it sets the tone for the entire launch team to work together, respect each other’s opinions, and seeks expertise and advice – all while ensuring that individual and functional accountabilities are in place.
Medical Affairs professionals have lots of knowledge and expertise to share, and an open line of communication is critical in understanding the therapeutic area trends and challenges, as well as in being able to have a dialog with other physicians and peers.
In summary, the role of Medical Affairs in preparation and execution of successful product launches is driven by a changing healthcare landscape; the development of very complex treatments for devastating conditions; and new internal and external stakeholders who demand more complex scientific information. With their deep clinical expertise, Medical Affairs departments are uniquely positioned to understand and translate complex clinical data into clear and relatively simple pre-launch and launch communications, as they focus on the patients’ needs and create a competitive advantage for their new products and services.