Followed by a presentation on:

How digital strategies and data standards can overcome process monitoring challenges and ensure quality across external networks

Janssen Supply Chain is embarking on a journey towards Industry 4.0 through the implementation of a network-wide program to connect real-time process data from Janssen’s external suppliers with Janssen’s digital twins.

This program is a mutually beneficial collaboration in which data sharing enables manufacturing performance monitoring and optimization against the full network-wide process history and performance. Each supplier can track their process performance in real-time on a detailed and actionable level.

Streamlining the flow of accurate and timely data across internal and external teams, sites and partners is critical for successful tech transfer and ensuring your process variability is understood and minimized. This requires more standardized and digitized approaches to collaboration. You’ll leave this session with a solid foundation on

• How cloud-based process information management systems (PIMS) improve data visibility, collaboration, and process performance
• The role of digital data sharing in accelerating tech transfer and business and regulatory reporting including cGMP CPV
• How industry collaborations such as BioPhorum are helping to ensure reliable information sharing to support supply visibility and ensure quality
• Best practices to successfully engage and onboard partners for seamless data capture, verification, and analysis

Speakers: 

Olav Lyngberg, Advanced Analytics, Modeling & Process Analytical Technology Leader, The Janssen Pharmaceutical Companies of Johnson & Johnson

Olav is a Sr. Scientific Fellow and group leader within Technical Operations, Janssen Supply Chain. In the last nine years with Janssen, he has been leading a team delivering mechanistic modeling, process analytical technology and advanced analytics solutions for large and small molecule active pharmaceutical ingredients and drug product processes.

The outcome of these efforts have among many things, been the approval of two real-time release products, the reduction in qualification timeline by four and a half months of a large-scale manufacturing facility, significant improvements in operational excellence for several vaccines and monoclonal antibody products, as well as countless technology transfers impacted positively with reduced timelines and expenses.

Olav holds a PhD in Chemical Engineering from the University of Minnesota, where he studied under Professors Scriven and Flickinger. He holds a Master of Science degree in Chemical Engineering from The Technical University of Denmark where he studied with Prof. Jens Nielsen.

Olav started his industrial career in Chemical Development with Bristol-Myers Squibb in 2000.

Teodor Leahu, Director of European Operations

Teodor has 14 years of expertise as a scientist in biotech process development, design, optimization, and validation. His successful track record building and managing technology roadmaps for GMP manufacturing, including software selection, qualification, and implementation, position him as a respected advisor on maximizing operational efficiency to accelerate scale-up, tech transfer, and commercial release.

Before joining IDBS, Teo served as Process Development Scientist at Emergent BioSolutions, where he led science and technology for a newly developed orphan disease vaccine. Previously at Merck Healthcare, his roles spanned Bioprocess Development Scientist and Compliance Specialist for Downstream Processing.

Teo holds a BS in Biomedical Engineering from Yale University and an MS in Biotechnology and Bioengineering from EPFL (Swiss Federal Institute of Bioengineering).