Client issue
A group of leading formulation scientists and device developers in pharma and biotech from 15+ organizations sought expertise and guidance in establishing a pre-competitive consortium of experts to influence patient care and improve outcomes, through leading fundamental advancements in subcutaneous (SC) drug development and delivery.
CRA approach
CRA was commissioned to develop a strategic and operational infrastructure to guide the Consortium in addressing pressing challenges facing SC drug development and delivery.
CRA developed a strategic framework to define the vision, mission, and initial focus areas of the Consortium. Subsequently, working groups were assembled to address specific problem statements, desired future states, annual objectives, and key tactics to steer the teams’ efforts in realizing the Consortium’s vision. The initial strategic framework was extended to a 5-year strategic plan to ensure Consortium progress, relevance, and growth in the dynamic landscape of SC drug development and delivery.
An additional core tenet of the Consortium’s strategic framework was identifying stakeholders critical to success. The CRA team performed a comprehensive landscape and environmental assessment, characterizing the desired scope of stakeholder involvement and identifying mutually beneficial value and funding opportunities.
In parallel, the CRA team built an operational infrastructure to guide the Consortium. This included establishing the Consortium as a non-profit organization, supported through a robust governance structure and bylaws enabling the shaping of strategy, managing, and allocating resources across Consortium workstreams, and navigating legal considerations such as IP generation. Additionally, CRA advised on a marketing strategy to promote and disseminate Consortium accomplishments.
Client impact
The strategic and operational infrastructure developed by CRA’s Life Sciences experts established the Consortium as an official institution, building a foundation to lead advances in SC drug development and delivery. Formalization of the Consortium’s vision, mission, and focus areas established strategic intent for the Consortium, laying the groundwork for long-term interest and investment from stakeholders. CRA’s framework has guided Consortium growth in membership, funding, and impact while also adapting to the needs of the SC ecosystem through creation of new working groups and strategic redirection of existing working groups.
Through CRA’s direct involvement since inception, the SC Consortium has been able to:
- Establish itself as the go-to experts for fundamental advancements in SC drug development and delivery;
- Develop and disseminate impactful positions through industry-wide workshops and publications that move the needle across common-facing challenges pertaining to each focus area’
- And engage with key stakeholders, inclusive of regulators, to inform SC development best practices that accelerate development timelines.
