World Monitor Magazine April 2017 - Page 121

additional content quo and conventional wisdom. Rather than treating regulators as obstacles, regulatory affairs teams should consider alternative beneficial approaches to regulator requests and policies, working across the company to enable faster access and broader involvement in healthcare delivery and transformation. Subteam: Pricing and market access Pricing and market access teams need to create partnerships with payors to deliver outcomes. • Strategy: Market research and discussions with payors are leveraged to produce payor insight that informs R&D and commercial strategies, as well as a coordinated pricing and reimbursement approach meant to replace the typical reflexive individual reactions to local payor restrictions. • Organizational structure: Silos are eliminated in favor of proactive interaction across organizational teams to enable integration of the input from a critical team. • Process, systems, and tools: Diseases and patient pathways are assessed and analyzed using all available external and internal data to generate evidence for patient-centric drug development programs. Analytical techniques are used to assess revenue leakage and define processes to better manage pricing transparency in the context of increased tenders and pricing pressure. • Skills and culture: The ability to develop trusted partnerships with payor groups leads to creative contracting and pricing agreements focused on outcomes rather than defensive pushbacks and adversarial negotiations. Subteam: Government affairs • Strategy: Government policy changes are assessed and prioritized in real time to determine how they affect business objectives, avoiding the "fire drill" of panicky reaction to policy decisions that are divorced from company goals and programs. Also, forward-looking policies are developed pertaining to transparency in real- world data studies and pricing. • Organizational structure: Capabilities are needed at both corporate and local levels. Policy positions are proactively drawn up at the corporate level and distributed to be tailored to local requirements and help shape the local policy environment. Every part of the organization must be involved in policy shaping so that the message being communicated is consistent. • Process, systems, and tools: Since government affairs teams are cross- functional, strategy execution vis-à-vis government policy decisions is spread across the organization, allowing the company to proactively take advantage of opportunities and better manage risk. Technology is a good facilitator, allowing strong stakeholder management and effectiveness tracking. For example, a tool akin to a customer relationship management program could be used to capture interactions with external organizations so that the pharmaceutical company's in-field resources have access to the information at a moment's notice. Alternatively, dashboards could be tailored to pull information from multiple company-wide sources to measure the success of critical teams in meeting business-aligned objectives. Government affairs capabilities are needed at both the corporate and local levels. • Skills and culture: An ongoing dialogue in a trusted advisor relationship with relevant policymakers is maintained, obviating the typical transactional policymaker engagement that predominates in the industry now and often leads to mistrust. With an ongoing relationship, the pharma industry can be proactive, providing valuable input into policy development, rather than simply reacting to new policies. Subteam: Medical affairs • Strategy: Pre- and post-approval, cross-functional teams compile real- world data analyses to demonstrate a new drug's strength as a patient- centric solution offering positive patient outcomes. Medical affairs in-field resources take over the medical education role that sales reps formerly had with primary care prescribers. But they focus on scientific exchange rather than sales, challenging the standards of care and identifying gaps in disease management and opportunities for pharmaceutical companies to partner in the healthcare system. • Organizational structure: In-field medical professionals from medical affairs teams support sales reps and key account managers while remaining distinct from them. In addition, medical affairs' insight from the field — particularly about gaps in care and opportunities to serve new populations, formulations, and digital solutions — are fed back into R&D to help determine ]\H][Y[]YY\˂(\\[\[΂[ݘ]]HYYX[YX][ۂ[\ZYۜ\H][Y[[Y˜\\Y[[\ݙY]Y[]Y\ˈ\HYܝ[]\YHX[\Hٙ\[ۘ[[][]K\H\YۙYZ\H]\[\ق\[\H]\[[]\BX[KY][[][X[[]YY\\H\Yš[ܛH][XYYXœ\ܝYHUTАRŒLM