PLAYBOOK:

Patient Advocacy Group and Biopharmaceutical Company (Industry) Collaboration throughout the Research and Drug Development Process

Best Practices & Tools for an Effective Partnership

All best practices are gathered and driven by consensus from the entire consortium, comprised of over 20 patient advocacy groups and biopharmaceutical companies.

Background

There has been, and remains, an ongoing and dramatic increase in the understanding and adoption of patient-informed medicines development collaborations between patient advocacy groups and industry. However, the increase in collaborations and number of entities initiating patient informed R&D efforts, has highlighted the range of disparities in approaches, variations in understanding of what can be done and a lack of consensus in how groups can work together more effectively. This is largely due to wide variation and inconsistency in collaboration expectations, processes, and practices confounded by a lack of consensus-driven expectations related to these topics (reference DiBiaso, Getz, et al).

The PALADIN Consortium assessed various areas whereby a common alignment on how to collaborate could save time, reuse, and better leverage resources already available. In doing so, the time saved could be applied to increasing the scope and effectiveness of such work.

The objective of this resource is to aggregate examples of best-in-class standards, templates, and recommendations for organizations to consider:

  • Improving understanding of respective operating processes; objectives; restrictions; needs; priorities; and timelines.
  • Establishing standards for contractual arrangements and fair market value language.
  • Increasing transparency around effective organizational and governance structures, training, operational support, monitoring and evaluation/assessment.
  • Improving understanding of funding requests and delivery cycles.
  • Improving early communication to anticipate short- and long-term mutual interests and promote effective planning of resources and timelines.

Note: the recommendations put forth in this section, largely represent the laws and compliance regulations in the US. There may be suggestions transversally adaptable to other countries, however, for the purposes of this document it is intended for US collaborations

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