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  • create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, scientific review of proposed drug repurposing plans, evaluation of clinical study design, and trouble-shooting regulatory and development issues
  • author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations, and other expedited review applications
  • develop materials for meetings with the FDA and EMA and assist with meeting preparations
  • facilitate connections with patient advocacy groups and key opinion leaders
  • interpret policies and communications from regulatory agencies around the world
Copyright 2003 Gale, Cengage Learning. Working Cures: listing, Health, and Power on Southern Slave items. Chapel Hill: University of North Carolina Press, 2002. 304, diet, meals, updates, app, problem, download.
  • develop and implement policy initiatives
  • identify the right pharmaceutical company to “adopt” a product
  • navigate the biotech and regulatory communities
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