The medical affairs function undoubtedly plays a pivotal role in the success of a brand, not just during the pre-launch phase, but also throughout the product lifecycle. Medical affairs acts as a conduit between Research & Development (R&D) and commercial, working extremely closely with both internal and external stakeholders to ensure appropriate use of interventions leading to enhanced patient benefit.
Numerous articles in industry journals have captured the importance of the role that medical affairs play within the industry. Traditionally the medical affairs function has been an office-based role, and the past decade or two has seen an exponential growth across the world in field-based medical teams often referred to as medical science liaison (MSL). This article aims to succinctly capture this ever-evolving landscape.
In order to comprehend the evolving landscape, one needs to understand the key drivers of the external environment. Among several key drivers, certain important and notable ones, as outlined in Figure 1, are: Introduction of novel therapies, R&D output, changing regulatory environment and healthcare landscape, digital revolution, stakeholder behavior, and the growing importance of big data analytics. This article examines four of the key drivers and the changes they bring that influence pharma industry’s engagement with their external stakeholders.
1. Regulatory Environment
The regulatory environment has seen significant changes over the past decade, such as the introduction of the Sunshine Act in the United States and pharma disclosure in Europe. These codes on direct and indirect transfer of value have a significant impact on the way the pharma industry engages with healthcare professionals (HCPs) and healthcare organizations (HCOs). Such levels of transparency are certainly making HCPs hesitant about accepting, or altogether turning down invitations to paid attendance or sponsorships to attend international conferences or similar scientific meetings in the fear that the public will interpret such support as prejudicial towards a particular organization or its brand(s)1.
2. Healthcare Environment
Although value definition is not a new phenomenon, this has gained tremendous importance in the recent past, especially with the rising budget constraints and increasing cost of intervention to treat a variety of ailments. Introduction of concepts such as cost per quality adjusted life year (QALY) is driving the pharma industry to demonstrate or define value of their new intervention over existing cheaper or older alternatives.
3. Emerging Decision Makers
Gone are the days where physicians were the only decision makers when it comes to the choice of intervention in the treatment or management of any given disease state. Nowadays there are other stakeholders such as members of the formulary committee comprised of pharmacists and other HCPs, other than physicians, influencing decisions on appropriate interventions, essentially raising the barriers to entry. There is an even greater need to discuss the scientific evidence and value definition of an intervention, especially in the rare diseases area, in which the cost of intervention is significantly higher than the other disease states.
4. The R&D shift
R&D output has significantly and most notably, radically changed over the past decades with introduction of novel therapies into the mix, especially therapies such as RNA interference, therapeutic cancer vaccines, cell therapy, gene therapy, and monoclonal antibodies (mAbs). Monoclonal antibodies, for example, have grown from a humble beginning in the year 1973 with the first production of mAbs with a human-mouse hybrid, to the first approved humanized mAb in the year 1997, to more than 30 approved mAbs in the year 2013 and hundreds more in development2.
Investment in personalized medicine has seen an exponential growth with the industry investment up by 75% between the years 2005 an 2010 and a further 53% increase between 2010 and 20153, with personalized medicines constituting between 12% and 50% of the biopharma pipeline. Over 70% of the global biopharma pipeline is potentially first-in-class. Nearly half of the new drugs and biologics approved by the U.S. Food and Drug Administration (FDA) in the year 2015 were for rare diseases4.
The Field Medical Function
In 1967, Upjohn introduced the first so-called MSL function primarily to provide educational services to healthcare professionals. Fast forward four decades, the MSL function not only thrives but has also grown exponentially doing a multitude of things with the role becoming increasingly complex in a highly regulated and challenging environment. Even with all the complications, the core value of the function remains the same, which is to foster and maintain relationships with key stakeholders and develop advocacy.
The way the industry engages with HCPs has changed over the past decade and is undergoing further transformation with MSLs increasingly at the forefront of scientific exchange with HCPs. Changes in the external environment, including regulatory changes, emerging decision makers, and the need for value demonstration, requires companies to have meaningful, credible, unbiased, truly scientific, and non-promotional discussions with HCPs, rather than just delivering key messages using a promotional team. With more and more complex and novel therapies in the pipeline, the industry is even more compelled to employ clinicians (such as physicians, pharmacists, and nurses) and specialists holding PhDs in the respective therapy areas to engage with HCPs in order to have those in-depth and truly meaningful scientific conversations.
More and more HCPs across the world now prefer to have discussions with field medical (MSL) personnel as they increasingly see the value that these roles bring to their practice. Apart from being credible, unbiased, and highly scientific, one other reason for the exponential growth of the field medical function is their ability and permission (from regulators and industry codes) to engage with HCPs prior to receiving license for their drugs. This ability and permission to engage with HCPs early on in the lifecycle (which their commercial counterparts do not have) acts as an impetus to organizations investing in and expanding their field medical team.
To summarize, specialist medicines require support from medically or scientifically qualified teams. There is an ever-increasing need for a consultative approach between the HCPs and pharma companies. This does not mean to say that employing sales teams and delivering key messages are the thing of the past. They will continue, but the delivery method of messages will change further with the introduction of different types of engagements into the mix. Channels of engagement will further change in the future and, most importantly, the field medical function will play a pivotal role in not only engaging with HCPs and HCOs in a credible, unbiased, and scientific fashion, but also by being at the forefront in demonstrating the value their interventions bring to the management of any given disease state, thereby ensuring appropriate use of interventions leading to enhanced patient benefit.
2. Innovation in the Biopharmaceutical Pipeline: A Multi-Dimensional View.” www.analysisgroup.com/uploadedFiles/Publishing/Articles/2012_Innovation_in_the_Biopharmaceutical_pipeline.pdf.