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Value and Access for Special Populations: From Access Restriction to Drug Mortgages
Session Chair(s)
Roxanne Tavakkol, MS
Vice President, Regulatory Affairs, Autoimmune and Rare Diseases, Mallinckrodt Pharmaceuticals, United States
Therapies for rare diseases present particular challenges for access, distribution, and coverage. This session will provide insights into the steps required for patient access to approved and unapproved products as well as distribution and current legal framework challenges. Attendees will learn how to overcome barriers today for improved access tomorrow.
Learning Objective : Identify challenges impacting drug availability in rare diseases; Define scope of legal and regulatory framework for market access.
Speaker(s)
Roxanne Tavakkol, MS
Vice President, Regulatory Affairs, Autoimmune and Rare Diseases, Mallinckrodt Pharmaceuticals, United States
Addressing Urgent Access to Therapeutic Treatment Needs: Meeting the Need for Urgent Access to Therapeutic Treatments
William A. Sarraille, JD
Partner, Sidley Austin, LLP, United States
Panelist
John J. Maddox, MBA, RPH
Founder & Managing Director , Infusion Pharma Consulting LLC, United States
Gaining Access to Orphan/Special Drug Therapies
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