Highlights 2017

Industry 4.0 or the industrial internet of things in the pharma industry: Is that the future?

Peter Iles-Smith is currently Head of Technical for GlaxoSmithKlines manufacturing IT organisation and has been responsible for the design and development of automation and MES platforms within GSK. He is currently the Design Lead (and Design Authority) for GSK’s serialisation programme, covering implementation from shop-floor to market reporting. Peter has a PhD in Chemical Engineering from the University of Leeds and over the last 32 years has held various positions with automation, MES and consultancy companies before joining GSK in 2006.

Peter's Keynote presentation will reveal the growing role of IT and IIoT in industrial manufacturing. He will go down to the bottom of: How IIoT will redefine the healthcare industry? You in on that?

What’s on the ISPE Agenda: “Plug & Produce Initiative”

Wolfgang Dedden is project leader and internal consultant for MES in the fields of engineering and technologies at Bayer AG in Leverkusen. He is responsible for the conceptual approach on process automation over the entire manufacturing chain in the validated environment. Wolfgang is accountable for realizing complex applications for digitizing production data, which meets his passion of starting up and sucessfully running a smart factory. His goal is to enable Bayer’s production to react to changing customer demands in a more agile and speedy way.

During his professional career, Wolfgang became an expert for automation working for Bayer and Bayer’s external companies, for Thyssen-Krupp Steel in Bochum, for Aventis in Marburg and for TRIPLAN AG in Bad Soden.

Wolfgang was born is 1960 in Leverkusen, with his wife he has two children and and three grand-kids.

Besides being the automation expert at Bayer AG, Wolfgang is also a member of the ISPE initiativ on Plug & Produce. The International Society for Pharmaceutical Engineering has been working on Standards for Plug&Produce implementation in the pharma industry, which will eventually open the doors to drive IoT in the highly regulated environment. At the Pharma MES, Wolfgang will give insights on the current status and near future industry implications during his Industry Study What’s on the ISPE Agenda: “Plug & Produce Initiative” . He will answer questions on why Pharma needs a Plug & Produce concept, what are the goals and expectations of the ISPE Plug & Produce Workgroup and how do they draw their Roadmap to the White Paper.

Later on Day 1, Wolfgang will take our Delegates into a bit of deeper dive into the topic during his Challenge Your Peers session on "Why is Plug & Produce important for pharmaceutical manufacturers and vendors? - Different perspectives and challenges"

Extending ISA-95 by Industrie 4.0

Technical Director/Founder of the OPEN-Serialization Communication Standard (SCS) Working Group.
BSs in Chemical and Material Engineering, MS in Solid State Physics from Univ. of Maryland.
As TQM Facilitator and Process Action Team Leader of over 28 years, Mr. Gifford led and designed MES, operations management, and supply chain system projects to part of planned intelligent manufacturing transformation across 12 industries and 80 plants. As international recognized chair and author of intelligent manufacturing standards for over 25 years such as International Society Automation, OPC Foundation, OPEN-SCS WG, Open Application Group, Supply Chain Council and MESA International. Authored, applied and taught many of today’s applied intelligent manufacturing operations standards (ISA-88, ISA-95, OAGIS, SCOR, others).
An internationally recognized teacher and author of 5 books, over 50 papers, and 20 courses on combining continuous improvement practices with intelligent manufacturing operations management systems.  ISA’s Best Standard Book of Year 2011, 2013.

Beginning of this year, Charlie was leading part of the re-write of ISA-95, extending ISA-95 by Industrie 4.0. In his Industry Study, Charlie will lay out what the new regulations constitute about building an extended framework for interactive operations. Furthermore, he will give an overview of the updates on ISA-95 operations model and talk about key aspects of Industrie 4.0 for End to End process management.

Customizing „off the rack“ MES solutions to meet SME requirements: Best practice from CDMOs in Biopharma.

Kai Ullmann studied business economics in Würzburg and Milton Keynes and holds a Master’s degree in Business Administration.
During the past 17 years, Kai gathered extensive experience in the field of Supply Chain and Sales&Marketing in a variety of positions and industries. Since 2007, Kai is working in the Healthcare Sector in executive positions.
He started his career in Viag Interkom’s marketing department, heald the leading position in the international customer management of Carefusion, and was Manager Sales Strategy and Head of Logistics & Customer Service at Grifols.
Starting April 2014, Kai is Vice President Supply Chain Management at Rentschler and therefore responsible for the overall central planning including the planning forecast, procurement, logistics and further support teams.

Kai will take us on the journey of customizing „off the rack“ MES solutions to meet small & medium size entities requirements. What’s your best practice? Kai will show his from the CDMO‘s point of view in Biopharma. You will learn what difference in requirements your customer segments can make and that upscaling and hyperconverging is not always the way to go. Sometimes succes can be found in downscaling. What’s your key factor for efficient implementation?

MES as an Enabler of Sanofi’s Digital Strategy

Alex Lee is the Sanofi global head of Information Technology and Solutions (ITS) Digital Industrial responsible for leading Sanofi’s Digital Industrial or Manufacturing 4.0 transformation. Alex is also the ITS Industrial Business Partner for Biologics responsible for IT/automation at Sanofi’s Specialty Care US sites. Alex holds a BSEE degree from Syracuse University and an MBA from the University of Massachusetts at Amherst. Alex has over 26 years of experience supporting information technologies and shop floor systems (DCS, BMS, PLC and SCADA, MES, historians, etc.) on capital projects and in commercial manufacturing facilities, including bulk manufacturing facilities, distribution centers and warehouses. He has spent the last 20 years in the life sciences industry in the Northeast US. Alex also has experience in the specification, design, deployment and support of digital-related systems, such as data analytics systems, online/at-line analytical testing systems, energy management systems, data historian and reporting systems in his career.

During his Case Study presentation, Alex will point out, why MES mus be seen as the foundational element of the digital strategy and how to leverage technology to maximize its ROI. It’s all about exploiting data and creating business value from business insights. What do you do with your data?

IT/OT convergence: How to align information from both IT and OT levels in order to provide a common structure for the information flow?

Rudi Thiel is leading the Operational Technology Operating Model – Program for Novartis Technical Operations. This program includes all activities required in both IT and OT space in order to address the progressing IT / OT convergence for all manufacturing sites.

From 2012 – 2017  Rudi Thiel was the IT Project Lead for New Launch Facility (NSLF) at Novartis. He was responsible for all IT components for the new launch facility for solid forms in PharmOps Switzerland including Manufacturing Execution System (MES) as well as IT Infrastructure.
From 2009 until 2012, Rudi was Head of Risk, Compliance & Quality for Global TechOps IT at Novartis, being accountable for all activities related to risk, compliance & quality in Global TechOps IT, including functional reports in all TechOps sites. Before that, Rudi was Quality Manager Global TechOps IT and prior to that, held the position of Program Quality Manager, Pharma ERP Program (PEP) Program Manager for SAP implementation, all for Novartis and Novartis US.

During his professional career, among others, Rudi Thiel also worked Roche Pharma as Quality Manager for Global SAP Competence Center, for CSC Ploenzke Switzerland as Project & Quality Manager and he was IT Consultant  for various projects in the pharmaceutical industry.

In his Challenge Your Peers discussion round, Rudi will take a deep dive in the „IT/OT convergence: How to align information from both IT and OT levels in order to provide a common structure for the information flow?“. Novartis just recently developed an operating model covering their required service catalogues. But how can this model align efficient information flow and overcome obstacles in IT Application Management? Discuss how to structure your model, from the shop floor to the business decision level.

Advisory Board 2017


Our Speakers 2016