2018 PDA Manufacturing Intelligence Workshop

Session Description: The manufacturing world is undergoing its fourth industrial revolution, spurred by the proliferation of digital capabilities and the integration of these capabilities into existing production and supply systems. The Pharmaceutical industry cannot ignore technology’s impact on the way manufacturers conduct business.  Because the information age has created these mountains of data, the aim of this session is to generate a common understanding of the fundamentals of big/modern data.  A “box of chocolate” summary of the collaborative efforts to transpire throughout the workshop will follow via Pecha Kucha format presentations, where we uncover the unexpected. A final session take away will be an example disruption in the way data is made available, processed, and ultimately used to drive outcomes in product development, quality control, process analytics, or beyond.

4:30 p.m. – 4:50 p.m.
Beyond the Buzz – What Big Data, Artificial Intelligence, and the Internet of Things Really Mean to Pharmaceutical Manufacturing
Chris Garvin, Principal Engineer, Digital Integration and Predictive Technologies, Amgen, Inc.

4:50 p.m. – 4:55 p.m. 
Breakout Session 1 Preview
Richard F. Shakour, Director, IT Account Management, Merck & Co., Inc.

4:55 p.m. – 5:00 p.m.
Session P4 Preview
Mark DiMartino, Director, Quality Engineering, Amgen, Inc.

5:00 p.m. – 5:20 p.m.
Next Generation Manufacturing-A Step Towards Industry 4.0
Rob Guenard, PhD, Senior Director, Global Manufacturing Sciences, Biogen

5:20 p.m. – 6:00 p.m.
Poster: Thursday Session Highlights

Session Description: Insights from outside of the pharmaceutical industry will be explored when going from traditional manufacturing to a fully digitized enterprise.  The journey has transformed nearly every part of the business, from supply chain and logistics, to factory planning and utilization, quality assurance and even research and development.   Discussion will occur surrounding the importance of moving past simple metrics and data analytics and how the true benefits come from combining pervasive digitization with proactive modeling and simulation.   Future directions for the digital enterprise will be highlighted and how these same principles might be effectively applied in the pharmaceutical industry.

8:30 a.m. - 9:00 a.m.
The Digital Enterprise Insights from Non-Pharma Branches
Alastair Orchard, Vice President, Digital Enterprise, Siemens

9:00 a.m. – 9:15 a.m.
Questions and Answers/Discussion

Facilitator:
Arne Zilian, Head, MS&T Processes and Standards, Novartis Pharma AG

Session Description: A recent big data PDA ideation session identified a cross-industry, standardized Manufacturing Information Model (MIM) as being a key enabler for a Pharmaceutical industry digital transformation.  This breakout session will first bring to you the voice of the customer and define the Pharmaceutical Manufacturing Information Model. It will also summarize preliminary studies, explore why a cross-industry MIM is important, identify what applications are available commercially and opportunities for their enhancement.  In an interactive session, we will look into MIM use cases offering most benefit, or deficiencies impairing benefit to be overcome. As a result of this workshop, we will have identified opportunities for PDA member companies and potential MIM collaborations.

9:45 a.m. – 10:15 a.m.
Introduction and Manufacturing Information Model Review

10:15 a.m. – 10:35 a.m.
Building the Use Cases-Interactive Discussion

10:35 a.m. – 10:55 a.m.
Identifying the Challenges-Interactive Discussion

10:55 a.m. – 11:15 a.m.
Potential Areas for Collaboration-Interactive Discussion

11:15 a.m. – 11:45 a.m.
Define Next Steps/Team Definition

11:45 a.m. – 12:00 p.m.
Closing Remarks/Questions

Facilitator:
Leo Xu, Director, GlaxoSmithKline

Session Description: The goal of a manufacturing strategy is to consistently deliver high quality and affordable products to customers every time and all the time.  Excellence in manufacturing process robustness is an essential element of a successful manufacturing strategy.
With ever increasing advances in the digital technology, large amounts of process data are available for analysis.  In addition to the traditionally monitored process parameters, many additional sources of data can be captured such as all other process parameters, time-based equipment performance parameters, raw material characterization data, and analytical testing results.  Application of advanced mathematical and statistical methodology will significantly enhance the ability to integrate and analyze manufacturing big data, improve fundamental process understanding, detect problem before it occurs, and ultimately achieve the goal of process robustness.
In the workshop, we will work together to understand the challenges that our industry is facing in process robustness, share the best practice in data analytics, identify areas for process robustness improvement, explore the collaboration among the companies, and establish the milestones for deliverables. 

9:45 a.m. – 10:05 a.m.
Introduction

10:05 a.m. – 10:30 a.m.
Evolution of Large Molecule Process Monitoring Program
Stephen Dorsch, Associate Director, Global Technical Operations, Merck & Co., Inc. 

10:30 a.m. – 10:55 a.m.
Case Study 2

10:55 a.m. – 11:35 a.m.
Roundtable Discussion

11:35 a.m. – 11:45 a.m.
Closing Remarks/Questions

Facilitator:
Richard F. Shakour, Director, IT Account Management, Merck & Co., Inc.

Session Description: The emergence of the Internet has fundamentally transformed many industries; however, it is only since the rise of the Industry 4.0 concept that the digital revolution has reached the core of industrial manufacturing. The PDA Taskforce will consider the applicability of structured and unstructured manufacturing data/information (GxP vs non GxP) as it relates to the new paradigm

9:45 a.m. – 10:00 a.m.
Introduction

10:00 a.m. – 10:20 a.m.
Use Case 1 - Using Industry 4.0 Concepts to Improve Decision-Making by Machines and People
Chris Garvin, Principal Engineer, Digital Integration and Predictive Technologies, Amgen, Inc.

10:20 a.m. - 10:30 a.m.
Roundtable Discussion

10:30 a.m. – 10:50 a.m.
Use Case 2 - Enabling Comprehensive Data Analytics and Process Monitoring in Bio Manufacturing
Robert Dimitri, Associate Director, Manufacturing Systems, Shire

10:50 a.m. - 11:00 a.m.
Roundtable Discussion

11:00 a.m. – 11:20 a.m.
Use Case 3 - Does the Data Lake have to be Validated?
Sonia Banerjee, PMP, Director, IT Architecture,Merck & Co., Inc.
Dan Wasser, Associate Director, Process Intelligence and Technology, Bristol Myers Squibb

11:20 a.m. - 11:30 a.m.
Roundtable Discussion

11:30 a.m. – 11:45 a.m.
Closing Remarks/Questions

Session Description: Attendees will gain cross industry insights from Disney’s innovative decisions sciences team, focused on driving sustainable value capture.  It’s a great opportunity to gain an outside-in perspective on a digital journey applied in another industry, including lessons learned and critical success factors.

1:00 p.m. – 1:30 p.m.
Decision Science: Learnings from the Front Line
Hai D. Chu, Vice President, The Walt Disney Company

1:30 p.m. – 1:45 p.m.
Questions and Answers/Discussion

Facilitators:
Mark DiMartino, Director, Quality Engineering, Amgen, Inc.
Brett Duersch, Director, Engineering, Merck & Company, Inc.

Session Description: Advances in computing power and storage have not only resulted in the ability to collect and store vast amounts of data, it has also led to the development of powerful and innovative data analysis and computing methodologies to extract insights from the data and automate repetitive tasks. These methodologies include artificial intelligence applications such as machine learning, neural networks, natural language processing, and robotic process automation capabilities. The goal of this session is to discuss the application of these techniques in the quality and manufacturing environments, and to solicit ideas for topics that would benefit from joint discussion and collaboration across regulatory, industry and academic groups to improve the quality, cost and reliability for Pharmaceutical Manufacturing. After the workshop key topics will be presented to the PDA for creation of future PDA workstreams. After the workshop key topics will be presented to the PDA for creation of future PDA workstreams.

Session Description: Panel discussion with industry experts on opportunities and challenges of digital strategies in Manufacturing.  Additionally, hear a synthesis of the 1.5-day PDA workshop on Manufacturing Intelligence.

Panel/Q&A:

Hai D. Chu, Vice President, The Walt Disney Company
Rob Guenard, Senior Director, Global Manufacturing Sciences, Biogen
Alastair Orchard, Vice President, Digital Enterprise, Siemens
Jack Prior, Head, Manufacturing Science, Global MSAT, Sanofi