Roundtable on Personalized Therapy Innovation in Rare Disease: Focus on Public Policy
Track
:
Track 08:Regulatory Affairs and Submissions
Program Code:
133
Date:
Monday, June 24, 2013
Time:
2:30 PM to 4:00 PM
EST
Location:
253A
CHAIR
:
Jeffrey N. Stuart, PhD,RAC (SCHNON), Director, Regulatory Affairs, Novartis Pharmaceuticals Corporation, United States
Stuart is a Regulatory Affairs Certified professional whose current interests include personalized medicine and drug-diagnostic co-development. He co-authored the original RAPS Online Training Course, “Regulation of IVDs” and has authored numerous scientific publications.
SPEAKER
(S):
Federico Manuel Goodsaid, PhD (SPKNON), Vice President, Strategic Regulatory Intelligence, Vertex Pharmaceuticals, United States
B.A. was in Biochemistry and Biophysics from the University of California at Berkeley and his Ph.D from Yale University, New Haven, in Molecular Biophysics and Biochemistry. He was a Postdoctoral Fellow at Cornell University in Ithaca, New York and at Washington University in St. Louis.
Mark Trusheim, (SPKNON), Executive in Residence and Visiting Scientist, Massachusetts Institute of Technology, Sloan School of Management, United States
Mark Trusheim is founder and President of Co-Bio Consulting, LLC and Visiting Scientist at the MIT Sloan School of Management. He is a former Massachusetts Biotechnology Council interim President, Special Government Employee at FDA and industry executive at Monsanto, Cereon Genomics and Searle.
Russell J. Teagarden, (SPKSUP), Senior Vice President, Medical and Scientific Affairs, National Organization For Rare Disorders (NORD), United States
Description
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.