Below is a listing of all sessions the speaker is scheduled to present.
Justin Neway
Executive Vice President and Chief Science Officer
Aegis Analytical Corporation
Speaker Bio
Justin O. Neway, Ph.D., Executive Vice President and Chief Science Officer for Aegis Analytical Corporation, has 25 years of experience in pharmaceutical and biotechnology process development and manufacturing, and in the application of software solutions to quality compliance and operational issues in pharmaceutical and biotherapeutic manufacturing. For 15 years prior to joining Aegis in 1996, Dr. Neway was with Wyeth Biosciences, Chiron Corporation, and Baxter Hemoglobin Therapeutics, where he held increasingly responsible positions including Manager, Principal Scientist, Project Leader for the CMC section of the IL-2 PLA, Department Director, and Director of Process Sciences. During this time, Dr. Neway became intimately familiar with the practical difficulties of accessing process development and manufacturing data in separate databases and on paper records, and the substantial paybacks achievable from connecting to that data in real time for investigational analysis to understand and control the causes of process variability and to prepare and support CMC filings for the FDA and other regulatory bodies. Dr. Neway received his B.Sc. (Microbiology, 1975) and M.Sc. (Biochemistry, 1977) from the University of Calgary, and his Ph.D. in Biochemistry from the University of Illinois in 1982. He has published refereed papers in scientific journals, presented technical papers and chaired technical conferences in the field of pharmaceutical manufacturing, quality compliance and data analysis.
Thursday, March 27, 2008
Technology Enablers
T-14: Achieving Manufacturing Process Excellence with Quality by Design, Design Space Development, Design for Manufacturing and PAT 2:00PM - 3:00PM (Thursday, March 27, 2008)
In the past, unacceptable product batches were prevented from entering the market only by laboratory testing of the finished product – posing risk to the public and wasting both time and money for pharmaceutical manufacturers. In the new regulatory environment, the challenge is to assure the appropriate quality outcome in “real time” by implementing appropriate systems into the process itself, assuring product quality while the batch is being manufactured versus relying on final product testing (RTQA). The increased emphasis on manufacturing process excellence through “Quality by Design” (QbD) requires manufacturers to make larger investments earlier in the product life cycle with the goal of developing a sound scientific basis for a “Control Space” that accommodates a range of defined variability in the commercial process materials and operations and still produces the right product quality outcomes. Manufacturers have the opportunity to develop a “Design Space” that takes into account the need for different Control Spaces to accommodate future changes in the scale, economics or other aspects of the commercial manufacturing process in the later stages of the product life cycle (ICH Q8). This, along with the adoption of QbD and a quality system as described in ICH Q10, will enable pharmaceutical manufacturers to achieve the “Desired State” of manufacturing. To realize the benefits of implementing QbD, it is critical that CPP and CQA be identified and understood during process development, so they can be measured and controlled in real-time during the manufacturing process. This requires a corporate culture of continuous improvement without the need for regulatory intervention to approve changes. It also calls for close collaboration between the process development and manufacturing teams to achieve a sufficient level of Process Understanding prior to regulatory approval of the commercial manufacturing process. And, of course, it requires the deployment of appropriate, enabling technologies. Such technologies provide a single point of on-demand access by multi-disciplinary users to all relevant data in multiple, disparate data sources (in the same environment with analytics) to identify and understand cause-and-effect relationships in process data and easily share results. Process improvement and QbD will become practical realities only when the barriers to easily accessing and working with all the process data together are removed, and the team can spend its time more productively on science-based collaboration. This is the best way to undertake the Design Space Development, Design for Manufacturing and PAT efforts needed to achieve manufacturing process excellence using the principles of QbD.
Speaker:
Justin Neway - Executive Vice President and Chief Science Officer, Aegis Analytical Corporation
