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Making the Conversation Real – What To Expect From The AI Manufacturing Team At Xavier University

Making the Conversation Real – What To Expect From The AI Manufacturing Team At Xavier University


Artificial Intelligence is no longer an entirely foreign concept in our industry and as companies gradually begin experimenting with these technologies (AI, ML, and big data) in their manufacturing operations, a wave of questions start to surface. How much investment is needed and how do we determine the ROI post-investment?  What will be the regulatory compliance hurdles and how can they be addressed? Where do people fit into all of this? In an attempt to help the pharmaceutical and medical device community adapt to this digital transformation, Xavier Health at Xavier University started an Artificial Intelligence Initiative.  The AI Initiative is a small community focused on integrating the implementation of AI in pharmaceutical and medical device manufacturing operations.  This initiative is the framework where different actors are aligned to explore and empower AI implementation in the regulated environment under the life sciences foundation.  There are four working teams: AI Core Team, CPQA Team, CLS Working Team, and the AI In Manufacturing Team.  Each team is made up of FDA and industry professionals, working collaboratively to address various obstacles from increasing the assurance of product quality through the power of AI to setting a vision and strategy for the AI Intelligence Initiative Core Team.         

As a company that understands first hand the journey companies go through when implementing these new technologies, it was important for us at Bigfinite to join the organization and contribute to the dialogue.  Our co-founder and R&D Director Toni Manzano is a team lead for Xavier University AI in Manufacturing Team where, with the help of FDA officials and industry professionals, they address how the power of AI can be used to optimize manufacturing operations.  The goal is to define requirements and explore the knowledge we have of AI and apply it to the ‘real world’. They aim to share existing use cases of AI in manufacturing and also show how to implement these technologies in manufacturing operations.  They are working to define AI in manufacturing, publish examples of use cases on pharma and medical device manufacturing using AI, and develop a white paper to capture the learnings developed from the early AI solutions being deployed in manufacturing.

The capabilities operations can achieve with the use of AI is exponential (reduce costs, improve time to market, and better quality).  Companies are exploding with data and rather than letting it sit, stored away in cabinets and data silos, we see a tremendous amount of power in all of that unused data.  This initiative will elevate all of our understanding of how AI works and advance the life sciences industry.

If you are interested in joining the AI in Manufacturing Team, you can sign up here:

Melissa Villalobos

Sales and Marketing Coordinator

Bigfinite Announces Additions to Executive Team

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that Brian Sweeney, Lawrence Baisch and Glenn Griffin have been added to the leadership team.
Crystal Black VP of Marketing

AI Algorithm Qualification

Pharmaceuticals and Biotech companies have no doubt that Artificial Intelligence (AI) is here to stay. Nonetheless, the opportunities AI technology offers are developing at a slow pace in a rather conservative manufacturing industry, aimed at managing production risks under controls that are subject to strong regulations. Fear of change? Risk aversion? Likely not.
Jordi Guitart VP of Artificial Intelligence

Bigfinite Announces Senior Leadership Additions

Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that John Vitalie has been named Chief Executive Officer (CEO) and has been elected to the Board of Directors. David Merino has been named Chief Financial Officer (CFO) of Bigfinite.

Why Biotech and Pharma Need GxP for their Digital Transformation Projects Now

Technological Enhancements with Principal Component Analysis Combined with Artificial Intelligence

Bigfinite Closes Series B Financing with Atlantic Bridge and Honeywell Ventures to Drive Disruption in Manufacturing Analytics

2019 Xavier University AI Summit Reflections – Two Industries Ready for Change

Now that the dust has settled from the Xavier University AI Summit and our team is back to business, we’ve had time to process some of the highlights and key takeaways from the exciting event.  In the past few years, there has been a significant increase in the implementation of digital technologies into various industries that subsequently impacted the way we live, travel, and do business.  From driverless cars to 24/7 customer support chatbots, innovation and technology continue to spiral upward and as we’ve entered the 4th industrial revolution, and healthcare + biopharma should be no exception.  The Xavier University AI Summit is a great event that brings together a range of relevant stakeholders with common focus on artificial intelligence (AI).

Bigfinite and NNE Partnership

Bigfinite and NNE announced a strategic partner program agreement to collaborate around accelerating digital transformation within manufacturing operations at the world's leading pharmaceutical and biotech manufacturers. 

Where are Pharma Companies in the Age of Artificial Intelligence?

They say good things come to those who wait; we say good things come to those who wait but only the things left by the visionaries before them.  The pharmaceutical industry has long been known to lag in the adoption of new technology due to strong regulations. Even though regulators have recently begun to open up to several new ‘big data’ or pharma 4.0 technologies - the question remains, if pharma companies are doing the same?  In 2016, the European Pharmacopoeia 9.0 in Chapter 5.21 announced that neural networks (NN) and support vector machines (SVM) are valid chemometric techniques for processing analytical data sets. 

Data Scientist 4.0 – Bridging the World of Manufacturing and Data

Since the announcement of the 4th Industrial Revolution in 2011, multitudes of emerging technologies have transpired around “Industry 4.0”. Technologies such as digital twins, Industrial Internet of Things (IIoT), and cyber-physical systems have come into the scene as core elements, providing the necessary ingredients for a paradigm shift in manufacturing. Technologies around predictive analytics and artificial intelligence are pioneering new approaches with many use cases including predictive maintenance, autonomous process optimization, and pattern recognition - used to identify potential failures in real-time. Because of this, data science is becoming an invaluable discipline for our industry in order to transform information into knowledge.