April 23-26, 2017 - Lansdowne Resort Leesburg, Virginia, USA
| Editors: | Prof. Antonio Moreira (University of Maryland, Baltimore County, USA) |
|---|---|
| Dr. David Robinson (Robinson Vaccines and Biologics LLC, USA) |
The articles for these proceedings are not peer-reviewed.
These papers will ultimately be reviewed and listed in the refereed section of the ECI Symposium site.
Conference Program, Antonio Moreira and David Robinson (Article)
Facilitation of a rapid response by self-amplifying mRNA vaccines, Jeffrey B. Ulmer (Abstract)
Platforms prepare manufacturing for rapid responses, Jeffrey Welch (Abstract)
Rapid vaccine responses to emerging pathogens using a platform technology, Tim Hahn (Abstract)
Rapid response to pandemic influenza using a licensed recombinant seasonal influenza vaccine platform, Penny L. Post (Abstract)
Innovation and continuous improvement in a seemingly accelerated regulatory environment Roger Nosal, Pfizer Inc, Roger Nosal (Abstract)
Managing CMC for global accelerated marketing approvals, Pradip Ghosh-Dastidar (Abstract)
PATH - A global health nonprofit organization in support of international vaccine manufacturing, George Robertson (Abstract)
Accelerating strategies for FIH process development, Margaret Ricci (Abstract)
Systems analysis and design for accelerating process and cell line development, Wei-Shou Hu (Abstract)
Accelerating development and managing risk, Anthony S. Lubiniecki (Abstract)
Managing and Mitigating Risk in Biologics Process Transfer, Charles Goochee and Janssen Pharmaceuticals (Abstract)
Lifecycle approach to validation supports accelerated approvals, Julia O’Neill (Abstract)
An FDA perspective on the implementation of state-of-the-art analytical methods for therapeutic proteins, Marjorie Shapiro (Abstract and Presentation)
Modernizing analytics for improved manufacturing efficiency – regulatory considerations, Steven Rubin (Abstract)
Physicochemical assays and characterization, Yang Wang (Abstract)
Bioassays and Effector Function, T. Shantha Raju (Abstract)
Leveraging Mab cell culture platform to predict product quality, Chris Kwiatkowski, Alan Gilbert, Christina Alves, and Rashmi Kshirsagar (Abstract)
Comparability and similarity protocols for biotechnology products, Francisca F. Gouveia,; Pedro M. Felizardo; and José C. Menezes (Abstract)
Pre-clinical to Phase III upstream process changes to support next generation manufacturing, Sarwat Khattak (Abstract)
Comparability assessment of an antibody-drug conjugate, Alex Lazar (Abstract)
Global implementation of a cell culture change: Strategies, lessons learned and challenges, Marie-Pierre Gentile (Abstract)