BioProcess International

IDBS will be showcasing its Polar BioProcess and Skyland PIMS platform at booth #537 in this year’s BioProcess International. Hear from Lee Arnold, Senior Director, Process Development from Jazz Pharmaceuticals joined by Ken Forman, Senior Director, Product Strategy here at IDBS during our Scientific Track Presentation on Friday, September 30, at 9:30AM ET. 

Each year, BPI’s scientific agenda includes 200+ of the industry’s top scientists to present the latest updates on how to improve efficiencies across all phases of biopharmaceutical development and production. Part of Biotech Week Boston, BPI is the largest bioprocessing event for learning how to accelerate promising biologics, cell and gene therapies towards commercial success. 

 

Data, Technology, Collaboration: Building a CPV Program in an External Manufacturing Network

Friday, September 30, 9:30AM ET

Manufacturing Strategy & Bioprocessing 4.0 Track, Room 210B 

Streamlining the flow of accurate and timely data across internal and external teams, sites and partners is critical to ensuring your process is in control. In this session, Lee Arnold, Senior Director of Process Development, shares her proven best practices for formulating a strong process control strategy in an external manufacturing network using innovative technology and thoughtful CMO collaboration. You’ll leave this session with a solid foundation on how modern data capture, verification and analysis techniques can drive faster, better specification development, PPQ execution, regulatory approvals, variability management and manufacturing risk assessment.  

Ken Forman, Senior Director, Product Strategy, IDBS 

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.

Lee Arnold, Senior Director, Process Development, Jazz Pharmaceuticals 

Lee Arnold has over 30 years of experience supporting pharmaceutical and medical device manufacturing beginning at Pfizer in 1984. She is currently the Data Analytics lead in the Manufacturing Sciences group at Jazz Pharmaceuticals where she oversees CPV programs for both internally and externally manufactured products. Lee has a BS in Chemical Engineering from Purdue University.

Michael Barnes, Lead Solutions Consultant

As part of the Solutions team, Michael Barnes helps companies develop and coordinate technical solutions to address their various challenges and needs. 

Michael was a multidisciplinary bench scientist and worked in various roles and companies, from isolating rare and underrepresented cancers at the Broad Institute to automating cell-based toxicology assays in a CRO setting. Prior to joining IDBS, Michael spent three years in Pfizer’s BioProcess R&D Cell Line Development group, working to evaluate different vectors/expression systems and investigate phenotypic challenges at a genotypic level. 

Michael holds a BS in Physiology and Kinesiology from the University of Florida and a master’s degree in Biomedical Engineering, Cellular and Molecular Biology from the University of Massachusetts, Lowell. 

Mark Isaacs, Vice President, Sales

Mark has 30 years of experience in senior-level, global business development focused on bringing innovative solutions to the life science industry. His expertise combines a technical understanding of manufacturing challenges with the commercial application of software solutions to maximize value realized from improved product quality and increased process understanding. 

Mark holds a BS in Natural Sciences/Chemical Engineering and a master’s degree in Chemical Engineering from the University of Cambridge. He is also a member of the International Society for Pharmaceutical Engineering and has served on several industry advisory boards. 

Truman Isaacs, PIMS Account Manager

Truman Isaacs manages biotech and life science accounts in the US Northeast and specializes in IDBS’ manufacturing data intelligence platform – Process Information Management System. 

Aligning and coordinating data management projects with his accounts, Truman seeks to solve issues around tech transfer, data integrity and collaboration throughout the supply chain and product life cycle. 

Truman marries a technical degree in biological sciences from the University of Connecticut with his experience in sales in various industries to provide as seamless an experience as possible for companies embarking on their digital data journey. 

Garrett Mullen, Strategic Account Manager

With more than 20 years of experience in the enterprise lab management software business, Garrett has helped a multitude of companies from the pharmaceutical, biopharma, Petro-Chemical, specialty chemical, food, medical device industries and more.  

Garrett began his career as a molecular biologist working on the Human Genome Project at Washing University in St. Louis. Since then, he’s held various roles as a lab manager, systems engineer, professional services manager, enterprise software sales, engineering and product marketing positions. 

Garrett holds a BS in Biological Sciences from Illinois State University.