(NOTE: ISMPP will send a registration link to members only the day before this web event.)
In this ISMPP U, two HCEI experts, Brian Ung and Peter Fendt, will discuss recent FDA rulings and federal laws that are reshaping the landscape for HCEI content, allowing it to now be published and communicated to specific audiences before FDA approval. This shift will permit bio/pharma to communicate with key stakeholders and provide them with both pertinent economic information and clinical data to help all parties prepare for future product approvals and launches.
This presentation will provide an historic overview on the evolving role of HCEI and illustrate how our industry is at an important point of transition as it pertains to the ability to disseminate HCEI content. It will highlight results from a real-world case study that illustrates the challenges and opportunities facing bio/pharma manufacturers and related healthcare partners when launching valuable new therapies without adequate HCEI preparation.
Our third presenter, Tom Drake, will review how this changing environment impacts the publication planning team. The discussion will include approaches for publication planners to consider when building multidisciplinary teams that include HCEI management and for leveraging HCEI content during pre-launch to build successful stakeholder awareness and interest across external clinical and economic audiences and constituencies.
At the end of this session, participants should be able to:
- Describe historic challenges that impeded HCEI communication between bio/pharma and stakeholders;
- Understand how the 21st Century Cures Act and recent FDA draft guidelines are providing clearer pathways to disseminate HCEI information during pre-approval phases;
- Describe key HCEI stakeholders that can be part of strategic publication plans; and
- Recall practical steps to build multidisciplinary teams to incorporate HCEI management into effective publication planning structures.