In an environment where a focus on trust and transparency in the pharmaceutical industry has driven the transfer of many commercial activities to medically qualified personnel, medical affairs has transformed into a role of strategic leadership. Medical affairs departments have developed a range of specialist knowledge to assume strategic leadership of medical education and communications and partner with medical communications agencies to deliver these programmes.
The need for a more medically focused function to engage in peer-to-peer interaction with the healthcare professional (HCP) community has been further enhanced by a drive towards real-world evidence (RWE) to support reimbursement and the increasing role of patients in clinical decision-making.
Acceleration of change
The continued acceleration of economic and technological change is clearly already impacting the pharmaceutical industry, but is likely to be much more profound over the coming years. There is a drive to accelerate the drug development process by using trial designs that promise greater flexibility and efficiency. Personalised medicine strategies using targeted approaches are being developed to achieve the best outcomes in the management of a patient’s disease or predisposition to disease. There are also huge potential benefits of digital tools to increase efficiency for healthcare providers and improve adherence and engagement of patients, thus improving health outcomes.
Beginning with the end in mind
So when should the medical affairs team get involved? The earlier, the better! To achieve this pace of change, planning needs to start at an early stage of the process; it may require the acquisition of new skills and processes. In-depth disease understanding and clinical knowledge ensure the team can advise on disease area opportunities of the future, even at the early stages of drug evaluation. This ensures that a focus is maintained on the future health outcomes that can be realised from the development of a particular product.
Leading a cross-functional process at an early stage to facilitate the development of a target product profile (TPP) ensures alignment on the product vision, the future competitive environment and the key issues. This document sets the ‘targets’ for the product, including the key clinical, regulatory, promotional, pricing and attributes/claims, based on customer insight, market research and analysis of unmet needs. The TPP is a living document and key to ensuring that focus is maintained and environmental changes are being constantly considered.
Strategic med comms planning and delivery
The strategic medical communications planning process provides a structured framework agreed across the business to deliver the communication goals for the product. The process starts with deep insights into the disease area, product and competitors, and an understanding of HCP and patient behaviours, attitudes and beliefs. From their extensive therapy area, product and customer understanding, medical affairs teams are well positioned to lead the planning process and subsequently guide tactical delivery and evidence generation. Strategic analysis of insights allows the cross-functional team to analyse trends, gaps and hurdles to develop specific medical objectives and communication messages based on behavioural outcomes. From these high-level drivers, the communication story can be activated by developing a multichannel tactical plan tailored to address barriers and personas, using tools to activate the behaviours. Success can be measured quantitatively and qualitatively in terms of changes in attitudes, beliefs and behaviours (Figure 1).
Successful planning improves patient outcomes
Medical affairs teams must be proactive in incorporating insights from a wide range of stakeholders, as well as embracing patient-centric healthcare. By achieving this understanding of current clinical practice and unmet patient needs, the medical affairs professional will be able to develop effective strategic plans. As the expectations of patients and HCPs will evolve with time, so the role will continue to change accordingly and will continue to require the development of new skills, such as analysis of ‘big data’, genomic and proteomic diagnosis and personalised medicine.
The ultimate purpose of medical education is to improve patients’ lives by helping translate evidence to clinical practice (‘activation of evidence’). Leadership of this process allows medical affairs teams to accelerate change and develop effective programmes derived from deep insight. Applying a behavioural mindset to the analysis of insights unveils the drivers and barriers to evidence-based clinical decisions that ensure development of a focused communications plan.
The evolution of medically led, insight-driven communications ensures that a new era of trust, transparency and outcomes is in sight for the industry, HCPs and patients.
Ian Greenway is medical affairs director at Complete HealthVizion
