October 29, 2018

A story about adoption – Pharma 4.0 at the world’s largest insulin manufacturers

Pharma 4.0 is a popular topic in this years ISPE Annual Meeting event in Philly and currently of great interest in the industry as a whole. As with all new ideas and concepts, a certain level of misunderstanding and even skepticism exists. You may be wondering, what are the true benefits of all these technologies and how will they change my daily job? Pharma 4.0 is the ISPE’s attempt to adapt the promise of the digital transformation that is considered part of the 4th industrial revolution. It is a play on the term “Industry 4.0” that was born from a German government initiative – in other words, the 4th Industrial Revolution.

Revolution you ask, why is it a revolution? It promises a true paradigm shift in how we design and manufacture products and it promises an order of magnitude productivity increase. Equivalent to the move from horses to automobiles, from steam power to electricity, the introduction of the assembly line, and then the introduction of automation. Whether you are a skeptic or not, the facts are hard to dispute. I believe most manufacturing executives and our own pharmaceutical executives understand and therefore pushing the digital transformation – they do not want to miss the boat.

ISPE’s Pharma 4.0 working group is working hard to explain and define what the revolution means to us and how we can move our organizations into this brave new world. At Bigfinite, we consider ourselves to be enablers of Pharma 4.0. The Bigfinite platform was born from the new digital technologies with a unique focus on Life Sciences and specifically Pharma and Biotech manufacturing. Our customers are all embarking on their digital transformation journey and we are proud to tell their stories.

One of these companies is Novo Nordisk, who will be presenting with us at the ISPE Annual Meeting in Philadelphia. We will be sharing the story of Novo Nordisk’s adoption of the Bigfinite advanced analytics platform as part of their digital transformation. So please join us to hear about how Novo Nordisk started their journey with the Bigfinite platform. Also, we have been paired with Eli Lilly in this session, who will also share some of their stories on digital transformation and Pharma 4.0. So come and learn from the two largest insulin manufacturers in the world about how pharma can adopt digital technologies and Pharma 4.0!

Where: ISPE Annual Meeting Education Session: Next Generation Manufacturing Control at 11:00 – 12:30 on Monday Nov.5th

PS: you can also visit us at the exhibit hall booth #1040

October 23, 2018

Pharma 4.0 is here – we need to understand the compliance implications of big data and AI

With Pharma 4.0 comes a paradigm shift in many aspects. We in the pharma industry know all too well that every move we make needs to consider compliance with regulation – it’s in everything that we do. Yet we can’t ignore the promise that these new technologies come with while at the same time speculating about the regulatory aspects.

Although it may seem overwhelming right now, we must change the way we think.  New technologies such as big data, artificial intelligence, machine learning, and deep learning offer unprecedented analysis of real-time data and can even predict trends in processes, operations, and quality. You probably have heard this many times before, but it is truer this time than before. The digital transformation technologies are really novel, different, and not something that we have seen before – they are disruptive. They promise manufacturers ways to understand and improve their manufacturing and bring about an order of magnitude productivity improvements, and the good news is that the FDA is also in on it.

So, new technologies, new terminology, maybe even new regulation? So much to take in and understand, so many questions – where is this cloud and why is the data big, and what about GMP? In an attempt to explain some of these concepts, technologies and the regulated perspective we recently published an article in the ISPE PE magazine. The article attempts to give a pragmatic approach to how we can use a cloud-based SaaS solution with an AI algorithm to support our pharma manufacturing operations and quality processes.

Note: ISPE member login required to see the article online. Let us know if you can’t access the article.

October 5, 2018

Welcome to the Bigfinite Blog!

Just like many startups in Silicon Valley, Bigfinite started out as a disruptive idea: solve the current Pharma inefficiencies with the newest AI and cloud technologies. Following this idea, we were imprisoned for 9 months writing patents and creating a Minimum Valuable Product (MVP) that could be validated by the Industry (Pep in the technologies, Pere in the Pharma business knowledge, Toni in the science, and Llorenç in the code).  We started from scratch, an idea full of challenges that turned into a side project inside one of our co-founder’s Silicon Valley garage.

Since then, Bigfinite has turned into two “real” offices and over 50 employees. As we continue our growth, we are very excited to spread the word about our advanced analytics SaaS platform (AI and Big Data) for the life sciences industry. Our platform just released version 1.6 and includes some impressive features that will help bring the life sciences industry (particularly the Pharma and biotech manufacturing industries) into the new area of Pharma 4.0.

In this blog, we will discuss some interesting topics ranging from product features, regulatory advances, best practices, and our thoughts about the industry and related technologies.  We hope to convey this in an open and direct format – this is our perspective on the state of the industry and how Bigfinite helps. We pledge to keep it interesting and exciting and we are looking forward to seeing your comments, opinions, and beginning discussions.

Our Founders (left to right) Toni, Pep and Pere, the day they officially founded Bigfinite Inc. (October 20th 2014).