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P48: Medical Information Product Launch Best Practices During COVID-19: Journey from Emergency Use Authorization to Approval

Poster Presenter

Truc Dinh

Senior Manager, Medical Information
Gilead Sciences, Inc.
United States

Objectives

To share best practices and key learnings for planning and executing a Global Medical Information (GMI) product launch for a novel COVID-19 treatment; and to examine unique considerations to prepare for an Emergency Use Authorization (EUA) and then a subsequent full approval.

Method

GMI best practices to support EUA and full approval launches of a novel COVID-19 treatment during a pandemic include: (1) Planning Global Responses for Content Readiness; (2) Collaborations; (3) Producing Actionable Insights; (4) Expanding GMI Services.

Results

(1) Planning Global Response Documents (GRDs): Launching a novel treatment for COVID-19 amidst a global pandemic is challenging. GMI planned for country level launches with considerations for EUA and approval timing, label differences, language translations and different regulatory requirements for an EUA factsheet and an approved product label. GRD topics were prioritized based on complexity and urgency of the response needed for clinical decisions. In preparation for EUA launch, over 30 GRDs were developed and then within a few months, over 70 GRDs were developed to support full approval. To ensure rapid dissemination of information when there was an unprecedented increase in HCP questions, GMI developed over 200 clinical and non-clinical FAQs that were updated daily. (2) Collaborations: GMI met regularly with key stakeholders including Medical Affairs, Clinical Research, Regulatory Affairs, Legal and Public Affairs to facilitate alignment and ensure accuracy in the external communication of medical responses. This also enabled MI to be agile and flexible to adapt GMI processes, responses and activities to provide full support throughout the product lifecycle from investigational use, to EUA then full approval. (3) Producing Actionable Insights: GMI conducted monthly global and quarterly country-specific metrics and shared actionable GMI insights to inform data gaps for investigator sponsored research, influenced updates to factsheets and labels, and led to prioritized development of educational materials for pharmacists, who were the most common healthcare provider contacting GMI. (4) Expanding GMI Services: to meet the unprecedented volume of requests, GMI launched new communication channels (US MI website with searchable database of responses, live-chat and MSL requests functions, country-specific online submission forms), and expanded front line global contact center support.

Conclusion

GMI has become an important resource during the pandemic for HCPs and patients to access up to date information to make time-sensitive clinical decisions for patient care. GMI support is critical to successful product launches in a pandemic throughout the lifecycle from EUA to approval which requires agility, creativity, scenario and strategic planning. Key learnings from a successful global MI product launch during the COVID-19 pandemic included: (1) developing GMI content to ensure one globally aligned response. This further enables local MI affiliate teams to easily convert content into their preferred format and language and also provides flexibility to adapt to their local label or regulatory requirements appropriately based on the current regulatory status (investigational, EUA or approved) of the product in their country, (2) proactively collaborating with cross-functional teams ensured the timely dissemination of up-to-date, accurate, and compliant GMI responses in a fast-paced pandemic setting where new information was published daily; (3) sharing GMI insights throughout the product lifecycle from EUA to approval helped to inform on-going activities across the organization including educational initiatives and resources; (4) scaling-up global contact centers support and expanding GMI communication channels helped to manage the unprecedented increase in volume of questions from HCPs and patients during the pandemic. Unique challenges included: (1) variable global access by country and initial government distribution made it challenging to respond to access and availability questions; (2) the fast speed of new data publications, abstracts, press releases, EUA Fact sheet, and approved label updates during the pandemic required a new expedited model for data and literature reviews which resulted in additional cross-functional collaborations with Library and Information Services, Medical Affairs and Public Affairs.