Implementation of Quality by Design: Progress, Challenges and Opportunities - Industry Perspective
Track
:
Track 12: Pharmaceutical Quality
Program Code:
354
Date:
Wednesday, June 26, 2013
Time:
1:45 PM to 3:15 PM
EST
Location:
153C
CHAIR
:
Moheb M. Nasr, PhD,MS (SCHNON), Vice President, Regulatory CMC Strategy, GlaxoSmithKline, United States
Dr. Moheb Nasr joined GSK in September 2011, as Vice President for Global Regulatory Strategy. Prior to joining GSK, Dr. Nasr served as the Director of the Office of New Drug Quality Assessment (ONDQA), CDER, FDA. Dr. Nasr is an elected Fellow of the American Association of Pharmaceutical Scientists
SPEAKER
(S):
Michael Thien, DrSc (SPKNON), Senior Vice President, Global Science, Technology and Commercialization, Merck & Co., Inc., United States
Michael is responsible for small molecule late stage development and launch, as well as technical support for all small molecule in-line products and sterile operations. Mike is the lead sponsor for Merck's Quality by Design Efforts.
Patricia N. Hurter, PhD,MS (SPKNON), Senior Vice President, Product Development, Vertex Pharmaceuticals, United States
Patricia N. Hurter, Ph.D SVP Global Pharmaceutical Development, Vertex Pharmaceuticals Inc. Patricia currently leads Global Pharmaceutical Development for Vertex. This encompasses drug substance, drug product and analytical development as well as materials science characterization.
Lynne Krummen, (SPKNON), Vice President, Technical Regulatory, Biologics, Genentech, A Member of the Roche Group, United States
Lynne Krummen is Vice President, and Global Head for Biologics, Technical Regulatory at Roche and Genentech. Lynne has been employed by Genentech for 23 years, working in the Regulatory and Process Development organizations.
Description
Three industry speakers, representing different segments of the pharma industry, will share their perspectives on Quality by Design (QbD) implementation progress. Presentations will outline different implementation approaches supplemented by case studies.