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Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy
Session Chair(s)
Jeffrey N. Stuart, PhD
Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States
Orphan product developers face unique challenges that multiply when combined with the need for co-registered diagnostic devices. This forum will discuss the latest policy trends impacting personalized orphan products and patient access.
Learning Objective : Identify policy trends associated with development of personalized health care products and companion assays for orphan diseases; Define innovative strategies to speed development and access to orphan drugs and medical devices.
Speaker(s)
Regulatory Landscape for the Acceptance of Novel Clinical Study Designs in Rare Diseases
Federico Manuel Goodsaid, PhD
Ariana Pharma, United States
Senior Vice President, Regulatory Affairs
Economic Disincentives and Incentives of Personalized Therapy and Possible Policy Responses
Mark Trusheim, MS, MSc
Tufts Medical Center, United States
Strategic Director, NEWDIGS
Rare Disease Patient Group Perspective
J. Russell Teagarden, PhD, RPh
Independent Advisor, United States
Senior Health Care Practioner, Researcher and Writer
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