Technological advances, regulatory pressures, rising litigations and changing consumer needs are forcing pharma leaders to revisit their traditional practices leading to a paradigm shift in various functional roles and responsibilities. With the industry’s focus shifting from products to outcomes, the objectives of medical affairs (MA) function are also undergoing a drastic change. The MA team no longer plays a behind-the-scenes, supportive role. It has emerged as the driver of all external stakeholder engagement.
Important areas of influence under the purview of MA include medical science liaison (MSL) programs, health economics, investigator-initiated trials, thought-leadership development, medical publications, compliance and regulation, medical grants, health economics, and much more. In fact, leading organizations now consider MA at par with R&D and commercial functions, and are involving its staff in more strategic, customer-facing activities.
Why Is Medical Affairs Pharma’s New Epicenter of Stakeholder Engagement?
- Shift from Generics to Discovery of New Molecules – Although India has traditionally been the hub of generics, the past few years have witnessed several domestic and multinational players focusing their R&D efforts on new molecule development, handing over the post-launch activities to MA team. The future is expected to bring more specialized, targeted treatment requiring partial replacement of the current incentive-based engagement model of sales reps by value-added, scientific interactions initiated through the MA staff.
- Changing Key Opinion Leader (KOL) Expectations –Today’s doctors are operating in an increasingly challenging environment characterized by a rise in medico-legal cases and drug-resistant bacteria, increasingly stringent regulations, availability of new channels of information, etc. MA teams are well-equipped to help them navigate through these complexities. Moreover, physicians are increasingly demanding their engagement with pharma to deliver better value through a more intellectual exchange of information. MSL are better placed than sales reps to convey the science behind the product.
- More Complex, Specialized Therapies – Technological innovations are making diagnostic tools more sophisticated. New age drugs are increasingly complex, having multiple indications. Specialized treatment of rare diseases is steadily gaining ground. Research by Bain & Co. reveals that today’s doctors, especially the younger ones, rely more on academic journals, CMEs, KOLs and other scientific sources of information. The ability of the MA team to offer in-depth knowledge on specialty medicine builds pharma’s credibility with physicians.
- Diverse Stakeholders – Apart from physicians, pharma companies now have to convince a new set of stakeholders like patient advocacy groups, payers and healthcare authorities, of the effectiveness of their therapy. The evidence/information demanded by each of these stakeholders is varied. The MA department is capable of meeting diverse informational requirements of various entities. Often, stakeholder engagement goes beyond the product to assume a much broader scope including educational initiatives, disease management programs and other activities that make possible delivery of the best possible care. By engaging well with external stakeholders, MA can tap the best opportunities, gain insights into influencers’ opinions and contribute to the formation of the most effective strategies.
- Emergence of Big Data – MA professionals, with an exhaustive understanding of the disease as well as products, are uniquely positioned to sieve through the vast amounts of data generated from various sources to offer meaningful insights for the development of better therapies. Data Analytics also helps them effectively identify and segment KOLs and devise targeted engagement strategies based on individual interests and inclinations. They can now provide intelligence on the medical market for use in clinical trial programs.
- Rising Focus on Real World Evidence – MA personnel are uniquely positioned to collate and analyze real-world evidence i.e. observational data drawn from patient claims, electronic health records, social media behavior and patient registries. An expert MA team can connect scientific and clinical findings to actual patient outcomes. This adds value to each stage of the drug’s development.
- Health Economics and Outcomes Research (HEOR) – MA participate in research to determine most effective and economical treatment options and present the findings to external stakeholders such as KOLs. HEOR is one of the key focus areas of KOLs as it affects the duration of hospitalization, cost of care and other important parameters.
- Minimal Impact of Regulatory Changes – The proposed UCPMP Act will bring stringent restrictions on sales representatives’ engagement practices. In this challenging environment, conducting convincing, real world discussions with physicians will become more daunting, calling for a more senior, knowledgeable person at the helm of affairs. Moreover, since the interactions between MA and KOLs have always focused on a scientific exchange as the key deliverable, they will stay uncompromised in the event of more restrictive regulations. Additionally, being well-versed with the recent regulatory environment, the MA department is better-positioned to ensure compliance, transparency and trust across stakeholders.
- Need for Better ROI in Tough Operative Environment – The MA team has a large role to play in maximizing returns by conveying vital information about the market feasibility of a new molecule, gathered during its interactions with various external stakeholders, right at the onset of the drug development process. Over time, such feedback, creates a strong competitive advantage as only the most effective clinical programs are undertaken.
The onus of creating an environment that encourages the MA team to successfully execute this new, multi-faceted role, lies on the top leadership. Following are the areas that need immediate evaluation by the C-Suite:
The 5Rs of Deriving Strategic Value from Medical Affairs
- Revisit Communication Channels – Multichannel engagement will enable optimal access to KOLs and other external stakeholders. Digital technology, when effectively harnessed, can help uncover every missed data point and strengthen competitive positioning by providing intelligence on rivals’ moves. A communications strategy that leaves out social media platforms is a missed opportunity. Internally too, MA department needs to be given access to all necessary information so as to avoid a situation where the company pays a heavy price (product recalls, damaged reputation and financial losses) as a result of negative patient outcomes.
- Reskill Workforce – Often, MSLs stress on a specific disease. However, they need to develop a broader perspective of the healthcare system and the impact of that particular disease or therapeutic area on the organization as a whole. In future, a perfect MA professional would possess the right mix of deep scientific understanding, strategic mindset and business acumen. The team should be trained in the best stakeholder engagement practices along with an in-depth knowledge of the regulatory environment as well as the HEOR data. It is crucial to involve the legal and compliance departments in the development of the training program.
- Restaff and Redefine Job Roles – The erstwhile office-based MA teams are now entrusted with additional responsibilities that have them spending more time with their external stakeholders rather than the internal ones. This calls for new job descriptions that cover attending medical conferences, writing in medical publications, and delivering scientific presentations, among others. Adding to the existing staff should also be considered to ensure all responsibilities are successfully executed.
- Reaffirm Benchmarks – Standards of operations and assessment of outcomes lie at the core of an efficient organization. Valid benchmarks need to be established and communicated to all concerned. Continuous and comprehensive measurement of performance indicators like the no. of attendees for medical conferences, no. of medical articles published, no. and stature of KOLs engaged, quality of scientific presentations made, etc. will ensure optimal outcomes.
- Reallocate Budget – Widening of the MA function to include new responsibilities will require more resources. Budgetary revisions and reallocation are imperative if MA has to be effective in its new role.
In future, exchanges between MA and external stakeholders, particularly KOLs, will determine the level of integrity, authenticity and comprehensiveness of scientific information provided by pharma and imprint the company’s image on the outside world. It is imperative that MA is given the attention and strategic positioning it rightly deserves.
Docplexus – Pharma’s Trusted Marketing Partner
