Genesis’ Insights: Pioneering Personalized Healthcare Infrastructure

Genesis AEC’s Vice President of Construction, Mark Gagnon, talked to Pharma’s Almanac’s Nigel Walker, during their Road to 50 States trip to address:

• What’s the next big thing in pharma?
• What are the ongoing challenges involved in repurposing older facilities?
• What drivers go into determining whether a project will be stick built or modular? And when is that decision made?
• Where is the industry going in the next few years?

Pioneering Personalized Healthcare Infrastructure for the Future

Genesis AEC, headquartered in Greater Philadelphia, Pennsylvania, is a firm at the epicenter of change. Gagnon revealed insights gathered from his 100-odd peers across the country, disclosing that a revolutionary shift is underway. Bioprinting—creating 3D printed human tissue for research—and the rise of personalized gene therapies are transforming the once homogenous pharmaceutical infrastructure into specialized, tailored facilities.

“Most medicine right now is conducted in big pharma, in large batch. It’s a broad spectrum of people, but we’ve seen therapeutics be much more effective if they’re personalized,” Gagnon said. With gene therapies like CAR-T utilizing patients’ genetics to support cures, there is a clear departure from mass-produced medicine.

Cutting-edge advancements also include the adoption of single-use disposable manufacturing, which circumvents cross-contamination risks and streamlines sterilization procedures. It accelerates the journey for small pharma from clinical to commercial stages, providing a faster, more efficient route to market.

However, the transformative journey toward multi-molecule facilities is not without its challenges. As Gagnon explained, the dilemma often lies in choosing between renovating existing facilities or starting anew. Off-site locations lend themselves to modular builds and componentization, limiting on-site labor—crucial during pandemic times. However, renovating existing facilities demands careful consideration of current operations and potential downtime.

Regardless of the path chosen, Gagnon stresses the importance of early integration between design, construction, and qualification. Understanding the client’s needs and goals at the onset enables Genesis AEC to advise the most cost and time effective solutions. The interplay between stick-built and modular approaches often hinges on factors such as labor availability, project location, and time to market.

The conversation also touched on the wider implications of the industry’s direction. The age of Pharma 4.0 brings with it a need for skills in data dynamics, bioinformatics, and data mining. Gagnon believes this is not exclusive to pharma and biotech companies; wearable tech and the resulting data-driven analytics will open a new world of opportunities in pharma for those outside of traditional engineering, construction, and commissioning roles.

“In the journey to Pharma 4.0, data analytics will provide a significant opportunity for individuals who may not have considered careers in pharma,” said Gagnon.

As the future of healthcare continues to evolve toward personalized medicine, gene therapy, and data-driven decision-making, which require different skill sets, manufacturing processes, and even building designs, Genesis AEC continues to serve as a pioneer, helping their clients navigate the next phase in pharmaceutical development.

Glossary:

1. Bioprinting: This is a type of 3D printing that uses living cells, proteins, and other biological material to build three-dimensional structures of biological tissue. Bioprinting is expected to have wide-ranging implications in medicine, including tissue engineering and regenerative medicine.
2. Gene Therapy: This refers to the process of altering the genes inside your body’s cells in an effort to treat or stop disease. Gene therapies can work by several mechanisms including replacing a disease-causing gene with a healthy one, inactivating a disease-causing gene, or introducing a new or modified gene to help treat a disease.
3. CAR-T: Standing for Chimeric Antigen Receptor T-cell therapy, it is a type of treatment in which a patient’s T cells (a type of immune system cell) are changed in the lab so they will bind to cancer cells and kill them.
4. Single-Use Disposable Manufacturing: This is a type of manufacturing process where the equipment used is designed to be disposed of after use rather than being cleaned and sterilized for reuse. It is growing in popularity in the pharmaceutical industry due to its ability to reduce the risk of cross-contamination.
5. Modular Construction: This is a type of construction method where sections of a building (modules) are manufactured in a factory and then transported to the building site for assembly. This method is considered to be more efficient, flexible, and cost-effective than traditional construction.
6. Stick Built: A type of construction method where the building is built piece by piece on-site, as opposed to modular construction. It involves the use of traditional building methods and is often seen as more time-consuming and labor-intensive.
7. Pharma 4.0: An emerging approach in the pharmaceutical industry characterized by digitalization, automation, and data integration. The goal of Pharma 4.0 is to make manufacturing processes more efficient, reduce errors, and increase product quality.
8. Bioinformatics: An interdisciplinary field that develops methods and software tools for understanding biological data, particularly when the data sets are large and complex. It combines computer science, statistics, mathematics, and engineering to interpret and analyze biological data.
9. Data Mining: The process of discovering patterns and knowledge from large amounts of data. In the context of the pharmaceutical industry, data mining can help to understand patterns of diseases, effects of drugs in populations, and genetic factors in diseases, among other things.
10. Wearable Tech: Devices that are worn on the body, either as an accessory or as part of material used in clothing. These devices are particularly useful in health monitoring, data tracking, and providing timely alerts for medical emergencies.

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