PIMS v4.2 Release: Improved Data Access and Easier Insight into Biomanufacturing Process

April 26, 2022 @ 9am MDT /  11am EST / 4pm BST

Skyland PIMS version 4.2 introduces new capabilities to accelerate biopharma development and manufacturing by eliminating barriers to data and expanding statistical analysis to further enhance monitoring of processes across modalities, including cell and gene therapies, small molecule, and other biologics.

PIMS is IDBS’ BPLM offering to manage and contextualize data across the clinical and commercial production phases of the biopharma lifecycle, dramatically accelerating time to insight and advancing IDBS’ mission to reduce the time, cost, and risk of bringing new therapies to market.

Skyland PIMS version 4.2 enables users to automate access to critical data with a comprehensive data aggregation feature and by extending its API with powerful new ways to directly access data from manufacturing systems, including LIMS, EBR, historians, CAPA, and MES systems. This empowers users to schedule the automatic retrieval of batch data and process parameter values to monitor process variability and support timely analysis.

Key Benefits of the New & Enhanced Features:

• Accelerate biopharma development and manufacturing by eliminating the impact of data silos while simplifying and speeding access to the breadth of manufacturing data with the process context.
• Expand statistical analysis to further enhance monitoring of processes across modalities.
• Generate additional insights from biomanufacturing data and product genealogy.

Speakers: 

David Brick, Sr. Director of Data Sciences, IDBS

David has more than 25 years of experience in consulting, project management, data management and data warehousing for reporting and analytics applications. He has spent 16 of these years focused in pharmaceutical and biotech manufacturing and process development. Prior to joining Skyland Analytics, David served as Director, Professional Services for Dassault Systèmes BIOVIA (and its predecessors Accelrys and Aegis Analytical) where he had responsibility for all implementation activities for Discoverant®, the world’s leading informatics software for Life Science manufacturers, and for the Nexus data access and aggregation components of the product. His clients included more than 50 process development and manufacturing facilities worldwide. David has both a BSc in Applied Mathematics with University Honors and a MSc in Statistics from Carnegie Mellon.

Brent Rognlie, Sr. Director of Applications, IDBS

Brent has over 25 years’ industry experience and expertise in the application of statistical methods for use in reporting and improvement of pharmaceutical and biotech manufacturing processes. He also has extensive experience in application design, systems analysis, informatics software design and quality engineering for software products employed in Life Science manufacturing. Before joining Skyland Analytics, Brent served as Applications Group Manager at Aegis Analytical. He was one of the original developers of Discoverant®, the world’s leading informatics software for life science manufacturers. He became a Certified Discoverant Implementer and deployed the solution in more than 50 process development and manufacturing facilities worldwide. Brent has a BSc in Math and Computer Science from Minnesota State University and a MSc in statistics from Kansas State University.

Ken Forman, Sr. Director of Product & Services, IDBS

Ken has over 28 years of experience and expertise in IT, Operations, and Product and Project Management focused in the software and pharmaceutical space. Prior to joining Skyland Analytics, Ken served as Director, Project Management, NAM at Dassault Systèmes BIOVIA and held multiple director positions at Aegis Analytical. Previously, he was Director of IT at Rally Software Development, Director of Commercial Operations at Fischer Imaging and Director of IT at Allos Therapeutics and Genomica. In addition to his work accomplishments, he is a Certified Scrum Master. Ken holds a BSc in Computer Science from Cal Poly and an MBA from the University of Colorado, Denver.