Orphan Drug Development Strategy by Big and Medium/Small Pharmaceutical Industries
Track
:
Track 02: Project/Portfolio Management and Strategic Planning
Program Code:
402
Date:
Thursday, June 27, 2013
Time:
9:00 AM to 10:30 AM
EST
Location:
104C
CHAIR
:
Noriaki Murao, MS (SCHNON), Representative, NM Consulting, Japan
Over 35 yrs exp in new drug development with national and global pharmaceutical companies. He has been actively involved with various conferences, including the DIA.
SPEAKER
(S):
Kenneth Hitchner, MA (SPKNON), Vice President, Development Sciences Project Management, BioMarin Pharmaceutical Inc., United States
Ken Hitchner VP, DevSci Project Mgmt, joined BioMarin Pharmaceutical in 4/12. From 1999-2012, he was w/Monogram Biosciences, & Gilead Sciences from 1997-1999. Previous to Gilead, he was w/Genentech for 15 yrs. Ken has his Bachelor’s Degree in Zoology & Master's Degree in Biology from SFSU.
Yoshihiko Ono, RPh (SPKNON), Executive Director, Head of Regulatory Affairs, Japan Development, MSD K.K., Japan
Yoshihiko Ono currently serves as the head of Regulatory Affairs at MSD KK in Japan. He has 20 years of experience in regulatory affairs in Novartis, Amgen and Pfizer and has handled broad range of responsibilities for regulatory strategy and policy in Japan through his career.
Michael Diem, MD (SPKNON), Director and Head of Business Development, GSK Rare Diseases, GlaxoSmithKline, United States
Description
This session will address considerations for planning the development and commercialization strategy of orphan drugs by large as well as small companies.