A global pharmaceutical company has launched an innovative ophthalmology asset in the US, and has submitted an MAA to the EMA. To further support future growth and uptake, the company sought to develop a broader, earlier, and longer-term cross-functional integrated evidence generation plan (iEGP), considering all anticipated needs of key external stakeholders and the potential evidence generation options to assess those needs. This iEGP served as a reference to support future evidence generation and tactical planning.
Working closely with Global Commercial, Medical Affairs, Development and Market Access Leaders, the Arya team aimed to identify and prioritize holistic evidence and data needs to inform a comprehensive, multi-year strategy and evidence generation plan. To accomplish this, the Arya Consulting team designed and executed an interactive, in-person workshop and developed a robust, cross-functional iEGP by:
Conducting internal cross-functional interviews and gathering all relevant source materials to develop a comprehensive iEGP knowledge baseline
Designing the structure, agenda, and exercises for a four (4) day in-person workshop to engage approximately ~50 global participants
Leading a virtual kick-off session to level-set on existing evidence, preview workshop expectations, and assign pre-work to ensure a successful workshop
Facilitating the in-person workshops, leading the cross-functional team through in-depth discussions of existing evidence and stakeholder-driven evidence needs to assemble the strongest evidence package possible
Prioritizing post-hoc analyses required to support responses to questions raised by the EMA
Consolidating and refining key insights into a single iEGP, outlining all prioritized stakeholder-driven evidence generation needs and corresponding evidence generation plans with associated timings and functional ownership for tactical pull-through
Working closely with Medical Affairs, Global Commercial, Market Access, HEOR, Clinical & Regulatory, and Patient Centricity, the Arya team identified and prioritized new holistic evidence and data needs to inform a comprehensive, multi-year strategy and evidence generation plan. The Arya team designed and executed an interactive, virtual workshop to further develop a robust, cross-functional iEGP by:
Gathering all relevant source materials to develop a comprehensive iEGP knowledge baseline
Leading a virtual kick-off session to level-set on existing evidence, workshop expectations, and assign pre-work to ensure a successful workshop
Designing the structure, agenda, and exercises for a two (2) day virtual workshop to engage ~45 global participants
Facilitating the virtual workshops, leading the cross-functional team through in-depth discussions of stakeholder-driven evidence needs and corresponding evidence generation plans
Consolidating and refining key insights into a iEGP, outlining prioritized stakeholder-driven evidence generation needs and evidence generation plans with timings and functional ownership for tactical pull-through
Conducted an evidence needs gap analysis, mapping the existing research and analysis studies to prior and newly identified evidence needs to address remaining evidence generation gaps
Working closely with leaders from Medical Communications, Medical Affairs, Commercial, Market Access, Development, Regulatory, HEOR, and Pharmacovigilance, the Arya Team identified and developed unified statements for the following six core communication pillars: (1) Geographic Atrophy (GA), (2) Sight Preservation, (3) GA Diagnosis & Management, (4) Mechanism of Action, (5) Efficacy, and (6) Safety, along with secondary & supporting statements. To ensure a collaborative approach, the ARYA team designed and executed an interactive virtual workshop to further develop the Scientific Communications Platform (SCP) by:
Gathering relevant source materials to establish a comprehensive knowledge baseline for the SCP
Leading a virtual kick-off session to align on existing evidence, set expectations for the workshop, and assign pre-work to ensure its success
Designing the structure, agenda, and exercises for a two-day virtual workshop with ~20 global participants
Facilitating the workshop and guiding the cross-functional team through in-depth discussions to refine messages, identify gaps, and gather materials needed for drafting scientific statements
Supporting the final deliverable by facilitating the Medical & Legal Review process via Veeva Vault, ensuring proper documentation and references to support the new statements
Working closely with a cross-functional core team composed of commercial and medical affairs leads, the Arya team developed a data-driven HCP segmentation framework by:
Designing and conducting a virtual, cross-functional workshop to hypothesize and prioritize prescriber characteristics, including attitudes, behaviors, treatment patterns, and site-of-care factors
Developing questionnaire and interview stimuli for 60-minute interviews with prescribers to refine segmentation hypotheses, and validate the relevance and impact of key characteristics influencing adoption
Moderating interviews with prescribers, using probes and clarifying questions to ensure deep insights
Designing and fielding a survey to validate segment definitions, assess prevalence, and prioritize characteristics for market mapping of primary and secondary prescribers
Synthesizing insights from above project phases into a cohesive HCP segmentation, combining qualitative and quantitative findings to define actionable segments and inform targeted engagement strategies
Working closely with cross-functional teams, the Arya team:
Consolidated and cataloged key cross-functional publications
Implemented dynamic filtering and search functions to narrow citations based on selected criteria
Partnered with the Commercial, Market Access, and Publications teams to source, review, and catalog abstracts, posters, presentations, and manuscripts to date
Performed secondary research to identify and catalog any missing or external publications pertinent to the brand
Created a governance process to update and maintain the repository
Created guidance documents for internal cross-functional use
Developed a robust and cross-functionally aligned iEGP for FY25, highlighting key prioritized evidence gaps and associated evidence generation activities with supporting rational and tactical details necessary for execution
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