Skyland PIMS Use Case Demonstration

Ken Forman, PIMS Specialist, IDBS
David Brick, PIMS Specialist, IDBS
Mallory Turner, PIMS Specialist, IDBS
Sep Mohseni, PIMS Specialist, IDBS

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About the Session:

Experience first-hand the power and ease of using Skyland PIMS to manage your critical process information and accelerate your product’s time to market. During this session, IDBS’ team members will use real-life examples to demonstrate the value of establishing a centralized, persistent, and dynamic data backbone. See how PIMS easily captures your control strategy and transforms tech transfer for first-time clinical trial runs. Realize how quickly and compliantly PIMS captures batch data across a disparate, global manufacturing network of various IT maturity. And watch how PIMS seamlessly produces outputs to meet your monitoring, investigation, process improvement, and regulatory reporting needs.

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Ken has over 28 years of experience and expertise in IT, Operations, and Product & Project Management focused in the software and pharmaceutical space. Prior to joining Skyland Analytics, Ken served as Director, Project Management, NAM at BIOVIA Dassault Systemes 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.

David Brick

David has more than 30 years of experience in consulting, project management, data management and data warehousing for reporting and analytics  applications. He has spent more than 20 of these years focused in pharmaceutical and biotech manufacturing and process development. As part of Skyland Analytics and IDBS, David has been responsible for data management, connectivity and sharing aspects of PIMS as well as technical implementation project delivery. 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 BS in Applied Mathematics with University Honors and a MS in Statistics from Carnegie Mellon.

Mallory Turner

Mallory Turner is a Sr. Manufacturing Intelligence Specialist at IDBS (formerly Skyland Analytics). She has a Masters in Quantitative Research Methods / Research Methods and Statistics from the University of Denver. After graduate school she joined a Colorado startup called Aegis on their analytic consulting team for Discoverant. In her eight years working with various software in bio-pharma manufacturing, she has established customer monitoring systems and company guidelines, delivered best practices training on CPV and Investigations – as well as directly assisting in numerous customer investigations when an extra set of eyes on an issue was needed. A self-described stats geek, Mallory finds great joy in partnering with a company as they grow from their first control chart to using advance techniques to predict their quality attributes and beyond. For the last two years she has been leading PIMS implementation with customers, strategically advising on product development, and delivering demos to prospective customers.

Sep Mohseni

Sep Mohseni, Director, West Coast – PIMS, has over 10 years of experience bringing innovative solutions to the Pharmaceutical, Hospital, CDMO/CMO, Medical Device, and Analytical Testing industries. Her expertise in identifying the right IT solutions to address diverse and complex challenges makes her a respected advisor in maximizing value and creating pathways to realize improved service, product quality, and patient safety. Prior to IDBS, Sep held roles at Spectra and Infinity Laboratories where she aligned with strategic partners and helped clients define a pathway forward to accelerate product launch and decrease risk in the pharmaceutical and biotech manufacturing process.