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University of Maryland Center of Excellence in Regulatory Science (M-CERSI) and Innovation Conference on Patient-Focused Drug Development

On March 9, the M-CERSI Conference on Patient-Focused Drug Development, was held in Bethesda, MD. The conference included planning members M-CERSI, Food and Drug Administration, academia, and industry, and was open to patients, caregivers, and advocacy groups. It provided a forum for all patient-focused drug development (PFDD) stakeholders to gather for an open dialogue.

Topics covered included:

  • Definition of PFDD
  • Essential components that need to be included in successful PFDD
  • Current initiatives, such as those of the FDA, patient advocacy groups, and pharmaceutical companies
  • Challenges to achieving PFDD and methods to overcome those challenges
  • Recommendations on a plan of action that includes a description of stakeholders’ roles to move PFDD forward

Individual presenters’ slides can be viewed here.