Patient advocacy groups have a growing influence on the drug approval process, according to representatives of the biopharmaceutical industry, the US Food and Drug Administration and patient groups themselves. Working with these groups builds positive long-term relationships, since many of their goals are aligned with the pharmaceutical industry’s, speakers at not-for-profit organization New York Pharma Forum’s (NYPF) 21st annual general assembly in New York concluded.
Terri Cooper, principal and leader, National R&D Life Sciences Practice, Deloitte Consulting and panel moderator, noted that advocacy groups provide patients with many kinds of support, including fundraising for R&D organizing patients to expedite clinical trials; lobbying government and payer organizations to create public awareness and build support for research funding, legislation and formulary access; backing research for “orphan” diseases; providing financial and legal support to patients; and developing patient disease state support systems.
“Drug developers face increased cost constraints, a growing need for real-world evidence and heavier regulatory scrutiny,” she concluded, noting that “patient groups can be valuable partners in dealing with these demands.”
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