David Aviezer, speaking at World Orphan Drug Congress 2011

David Aviezer,
President &CEO
Protalix Biotherapeutics

Dr. Aviezer has served as Chief Executive Officer of Protalix BioTherapeutics (NYSE:PLX) since 2002 and since 2005 he serves also as President and member of the Board of directors. Dr. Aviezer has 15 years of experience in senior biotechnology management, advancing products from early-stage research up to their regulatory approval and commercialization. Prior to joining Protalix, from 1997 to 2002, he served as General Manager of ProChon Biotech Ltd., a biotechnology company focused on orthopedic and growth disorders. Previously, Dr. Aviezer was a visiting scientist at the Medical Research Division of American Cyanamid, a subsidiary of Wyeth, in New York. Dr. Aviezer is the recipient of the Clore Foundation Award and the J.F. Kennedy Scientific Award. He is an adjunct senior lecturer at Bar Ilan University and is a member of the Israeli National Technology Committee. Dr. Aviezer holds a Ph.D. in Molecular Biology and Biochemistry from the Weizmann Institute of Science and an M.B.A. from the Bar Ilan University Business School, in Israel.

Appearing:

World Orphan Drug Congress Day 3 Thursday 1st December 2011

9.40am

Regulatory expectations and clinical strategy for treating Fabry Disease: Development strategy for a modified version of a known orphan enzyme

On what basis do regulators request specific clinical information?
What type and quantity of clinical information is required to meet regulatory standards for the development of a modified version of a known enzyme?
What information is needed pre-approval to gain market access and post-approval to prove efficacy?
How can patients, medical experts and payers contribute here so drug developers, regulatory authorities are satisfied?

David Aviezer,

President &CEO,
Protalix Biotherapeutics

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