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January 15, 2019 – The Medical Affairs Professional Society (MAPS), the premier non-profit global society of Medical Affairs professionals, is pleased to announce the launch of the Medical Affairs Launch Excellence Guidance Resource– the second in a series of Standards & Guidance documents developed through collaborative best practice sharing and input by senior Medical Affairs (MA) leaders to further MAPS’ mission of developing industry standards and best practices.
The MAPS Medical Affairs Launch Excellence Guidance Resource, a vital new resource for MAPS members and constituents, is an essential key to understanding the expanded role Medical Affairs now plays within the healthcare landscape.
According to Charlotte Kremer, Executive Vice President and Head of Medical Affairs at Astellas and MAPS President, the impetus behind developing these guidance documents and templates is to “create a state-of-the-art resource for MAPS members, aligned with MAPS’ vision to advance the Medical Affairs profession through promotion of excellence and support of best practices. The value to our more than 5,000 members is our ability to leverage the collective input from senior seasoned MA leaders and work with strategic product launch experts like MedEvoke to produce a practical and workable guidance resource that can be adapted for use within any Medical Affairs organization.”
Ramin Farhood, PharmD, MBA, Vice President, Head of Global Medical Affairs, AveXis, and Anna Walz, CEO & Founder, MedEvoke, have championed the development of this guidance resource, and expressed how significant the need is as a result of today’s rapidly changing therapeutic environment. Says Walz: “Complex scientific communication challenges coupled with unique regulatory and cultural differences between regions can make alignment across a global Medical Affairs organization seem impossible. Yet within this resource are the keys to this evolving process. They detail specifically how Medical Affairs professionals can help make early decisions on the product to lead to future successes.”
Authored by seven global Medical Affairs thought leaders, at the core of this work are its foundational principles, which express the pivotal need for early team building and involvement by Medical Affairs from the very beginning of the launch process to help guide professionals to success. Collaborative perspectives can be found on building an integrated launch team, assessing team competencies, creating a viable strategy development process, building and executing evidence generation and dissemination plans, and optimizing stakeholder engagement. Also discussed as paramount is the significance of ensuring global strategic alignment, rolling out regional launch plans, measuring impact and value through data analytics, and employing the insights gathered to drive and evolve the launch planning process.
Paul Tebbey, PhD, MBA, Therapeutic Area Head, US Oncology Medical Affairs, Abbvie, sums up the value of this resource for industry professionals: “The emerging role for Medical Affairs is to lead the collection of evidence-based medicine with a view to targeted communication for increasingly fragmented healthcare systems. Excellence requires that these factors be built into launch plans as depicted in the MAPS Medical Affairs Launch Guidance Resource.” Greg Keenan, MD, former Vice President, Medical Affairs & US Head Medical Officer, AstraZeneca, concurs, stating: “The need for an expanded role for Medical Affairs has never been more imperative. This resource addresses the key areas in which Medical Affairs can make a real difference, from well before launch through the later stages of life-cycle planning for a mature product.”
At the heart of this document as well is a focus on better patient care, as Meg Heim, RN, MAS, Vice President, Head of North America DCV Scientific Communications, NA DCV Medical Affairs, Sanofi attests. Heim believes: “The MAPS Medical Affairs Launch Guidance Resource not only sets a standard for excellence but provides guidance for Medical Professionals at all levels to provide innovative critical success factors during an unprecedented, fast-moving landscape in the pharma and biotech industries. This guidance will support not only the scientific and business requirements but also the awesome responsibility we have to patients to bring the right drugs to the right patients in the safest and most expedient manner.”
To see how this resource may help to construct a path to launch excellence for your organization, access the Medical Affairs Launch Excellence Best Practices Resource at: https://www.medicalaffairs.org/resources/standards-and-guidance/launch-excellence/