Maestre and Thompson featured in Pharma’s Almanac

Noel Maestre, Vice President of Life Sciences, and Ryan Thompson, Industry 4.0 Specialist, were recently featured in Pharma’s Almanac giving their insights on pressing industry topics.

How is an increased focus on patient-centric concerns influencing the way that you work?

Noel Maestre, PE, Vice President of Life Sciences

“As an EPC and consulting firm, we are somewhat removed from the direct patient experience, but we find ways to keep patients at the heart of everything we do.

The speed at which this field is evolving is staggering, and it has broad implications for how life science innovators design, build, and operate a new generation of research and commercial facilities focused on personalized medicine. Rather than churning out repeatable formulations to meet the needs of a large population, these facilities will focus on the aseptic production of many very small, personalized batches — sometimes as small as a single dose. To make these facilities work both financially and in terms of GMP standards, project owners and their EPC partners must rethink their process design, equipment selection, cleaning, and decontamination protocols — everything.

Even the question of where to locate these facilities is complex; manufacturers need to consider their access to a transportation network capable of moving small, time-sensitive doses from the life science facility to the patient’s bedside. Add the logistics of finding a qualified workforce, managing waste, establishing adequate utilities, and many other site-specific details, and the challenge of identifying a suitable site becomes immense. All-new design solutions will play a key role in solving this challenge.

Another hurdle to patient-centricity is the availability and affordability of therapies. An important impact that we can have on making therapies available to patients is delivering facilities that are more flexible, consume less energy, and replace repeat manual labor with automated solutions to reduce the risk of human error and lower the cost of goods.”

To read the full roundtable on patient-centric concerns, click here. 

In what areas of pharma/biopharma are you most excited to see increased adoption of artificial intelligence (AI) and machine learning?

Ryan Thompson, Industry 4.0 Senior Specialist

“I’m most excited about the improvements to the manufacturing processes. Biologics, and in particular personalized medicines, are a challenge due to their high degree of variability. But given enough data, advanced analytics will be able to provide incredible insights. Not just on the process control side, but really in how the whole facility operates. By analyzing business data, lab data, process data, and people data, the combination of predictive and generative AI tools will give our industry new ideas on how to organize and operate our facilities.

Of course, drug discovery has been and will continue to be greatly impacted, and this is where the bulk of capital is being allocated right now. This is exciting, too, but I think one of today’s biggest challenges facing biologics manufacturers is scale and cost of goods. AI and machine learning (ML) are much more powerful than people in generating insights from large amounts of unstructured data. With manufacturers continuing to build robust data platforms and building the infrastructure to begin making these insights, I think the progress we will make in the near term will be more than impressive.

I am also very excited for the unknown. AI was always a pillar of Industry 4.0, but even five years ago I’m not sure we could imagine the impact it is having today. If you ask me this question in another few years, my answer may be completely different.”

To read the full roundtable on machine learning and AI, click here.