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 realworld 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 crossfunctional , 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 realworld data analyses to demonstrate a new drug ' s strength as a patientcentric 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 future development strategies .
• Process , systems , and tools : Innovative medical education campaigns are developed and linked to assessments to show improved patient outcomes . These efforts , delivered to the healthcare professional community , are designed to raise awareness of gaps in care that current and future products can close . Digital and multichannel strategies are used to inform but also to collect feedback
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