Dr. Neway has over 30 years of experience in biotechnology and pharmaceutical process development and manufacturing, and in the application of software solutions to operational issues and quality compliance in the biotechnology and pharmaceutical industry. He received his B.Sc. (Microbiology, 1975) and M.Sc. (Biochemistry, 1977) from the University of Calgary (Canada) and his Ph.D. in Biochemistry from the University of Illinois (USA) in 1982. After holding various Process Development and Manufacturing leadership positions at Wyeth, Novartis and Baxter, Dr. Neway joined Aegis in 1997 which became a part of Accelrys in 2012 and Dassault Systèmes’ BIOVIA in 2014.
1. What are you looking forward to discussing with the audience?
Although we will be giving an overview of BIOVIA Discoverant, we will also discuss some of the major improvements of the recently released and the latest iteration of BIOVIA Discoverant, version 5.0. This latest release includes new features and functionality that users will really benefit from. These benefits include features like signal monitoring dashboards and interactive graphical process genealogy mapping. The BOIVIA Signal Monitoring Dashboard is a purpose-built validated environment that satisfies requirements for Continued Process Verification (CPV), process robustness and process performance visibility needs across local operations and global manufacturing networks that include Contract Manufacturing Organizations. The BIOVIA Interactive Process Genealogy Mapping solution allows users to visualize all the points where splitting and pooling occur in the process stream during production operations.
2. What are your thoughts on the current state of the drug manufacturing industry, where do you see the industry going and how will Discoverant help organizations along the way?
The drug manufacturing industry has clearly been heading away from small molecule development towards biologics. With this move comes an exponential increase in data that needs to be managed. BIOVIA Discoverant makes it possible to manage this data, while reducing compliance risks and still allows you to get home in time for dinner.
3. There appears to be a disconnection in the industry with drug manufacturers knowing they need product and process understanding, but not investing in the technology tools to make this possible. Why do you feel this is the case, and how does Discoverant fill this gap?
The simple answer here is that many organizations are unaware of a solution to solve their problems of a lack of product and process understanding. There is clearly pain with trying to manage and analyze all of data from disparate systems, but unless you know about a better way, it’s difficult to imagine how to improve the process. We are here to show organizations that there is a better way and we can help them meet their business goals without having to allocate additional resources or allocate resources from other areas.
4. What is Production Process Operations and how does it help your customers? When do customers realize they need a Production Process Optimization solution?
BIOVIA’s Process Production Operations solution, BIOVIA Discoverant, is a validation-ready solution for process and quality data access, aggregation, contextualization, analysis and reporting. This helps users by empowering production operations in process industries including life science or specialty chemicals by shortening time to market and maximizing profitability by enabling the understanding of critical process drivers that affect desired business results. Unfortunately, until people understand what BIOVIA Discoverant can do, they very often don’t realize they need it!
5. What do you hope the audience will learn from this webinar?
By attending this webinar, the audience will learn how improving process control by identifying sources of process variability will result in improving process outcomes. In addition, attendees will see how powerful tools such as role-based signal monitoring dashboards and interactive graphical genealogy mapping can make their lives easier.