From The Editor | January 27, 2025

How Biotech Academy In Rome Is Reshaping Workforce Readiness

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By Louis Garguilo, Chief Editor, Outsourced Pharma

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Leonardo Sibilio is an exceptional scientist, accomplished in process characterization and validation, regulatory support, and coordination of international R&D projects.

He’s experienced in GMP manufacturing of drug substances such as recombinant proteins, viral vectors, vaccines, and monoclonal antibodies, and he’s done some designing of GMP facilities.

A few years ago, he decided to leave his last position – at a CDMO in the viral vector area.

He opened a consultancy, but then also found a new calling: he co-founded and became CEO of Biotech Academy In Rome, a training organization for sponsors, CDMOs, academicians and their students.

“There’s a fundamental need to train more professionals and students,” Sibilio says. “That need has arisen for many reasons.”

Why Insufficient Training?

Leonardo Sibilio
First, the biotech industry continues to boom as novel platforms accumulate. “Everyone needs to align with these new technologies,” says Sibilio.

The fast pace at which this is happening diverges from “classical pharma,” as Sibilio calls it, and as example cites the relatively sluggish pace to retrofit operations/facilities from a small-molecule focus to those for biopharmaceuticals.

A major component of the challenge is that the professionals who worked with those chemical processes are not adequately prepared to move to bioprocessing.

Understood, but what about new hires?

Sibilio says universities that should be training those new workers, are also slow to adapt. Institutions don’t “find channels to communicate effectively with industry” to understand what is needed from today’s graduates.  

The challenge, then, is two-fold:

  • Devise a method to graduate students with relevant training in skills and technologies the industry needs now
  • Provide enhanced (and accelerated) retraining opportunities to existing employees for speedier technology transitions.

Ultimately, says Sibilio, needed are people ready to cope with complex projects associated with the production of biopharmaceuticals and the continuing increase in the outsourcing of those programs.

“That,” explains Sibilio, “was the foundational idea for the Biotech Academy in Rome.”

More Relevant Training

Foundational or otherwise, ideas themselves are hard to put into business practice.

The Academy’s first year (starting in mid-June 2023) was difficult, says Sibilio, “but we are harvesting last years’ activities – especially with big CDMOs.”

“These organizations have been quickest to realize they need more and specific training, and their internal mentoring and training programs aren’t sufficient for all the new technologies their customes are interested in.”

That CDMO realization and interest in fixing the situation should be good news for sponsors.

But it’s not only CDMOs on the training mend. The Academy’s client base now in 2025 is divided evenly between biotechs and CDMOs.

“We have clients in monoclonal antibodies, antibody-drug conjugate, viral vectors, plasmid DNA, and other areas,” Sibilio says.

The Academy’s main training facility is in southern Rome – formerly a functioning GMP facility –  comprised of a ~5,400 sq ft “real GMP facility” for practical training, with upstream and downstream equipment (all single-use technology) and a bioreactor that scales to 200 liters.

“It’s still state-of-the-art,” he says. And so is the training.

The Academy has collaborations with two universities in the Rome area, at Università della Tuscia,Viterbo and Università Campus Biomedico in Rome, forming bridges between academia and industry.

These universities are relatively young and proactive in pursuing innovation in the fields of biotechnology and biomedical engineering, says Sibilio. They have well equipped labs, and multimedia classrooms “ideal for theoretical, practical and virtual reality beads training sessions for Biotech Academy in Rome.”

The Academy also leverages its university presence by becoming a part of their biotech-related curriculum.

“We train students. We help review their curriculum for closer positioning with what the biotech industry expects,” he explains.

Which, by the way, is not a certain number of certificates or publications, but actual acquired hands-on experience.

Sibilio adds that the professionals hired as trainers by the Academy utilize their industry contacts to directly introduce students to biotechs with open positions.

“We already have good success stories,” he says.  

Sibilio’s vision, then, is for the Academy to train individuals so CDMOs and biotechs need to do less of it.

Hands-On With The Best Equipment

Let’s get back to the equipment those who attend Academy classes train on.

For starters, Sibilio mentions Thermo Fisher and Cytiva, both equipment suppliers, as his partners.

“We have a win-win situation with these suppliers,” he explains. “We get to install and use some of their state-of-the-art technologies; they get to promote their products.”

Both sides leverage the accumulated knowledge of trainers and technicians (sometimes provided by the equipment suppliers) for creating “high-level, hands-on courses.”  

As an example, Sibilio says the Academy has been working with Repligen and Merck, with whom they organize events, such as the Second Edition of the Summer School 2024 that was held at the Università della Tuscia, Viterbo.

To put these types of partnerships together, Siblio and company usually take the initiative. The Academy reaches each out to technnology providers like Thermo Fisher with ideas, as with a recent example, for a QPCR course featuring Thermo Fisher kits.

“We installed them in our labs, and did the training together,” explains Sibilio. “We’re considering the same for next-generation sequencing.”

“Clients for such training [CDMOs and biopharma organizations] may hesitate to spend money on courses, thinking they can train workers internally,” Sibilio says. “But when they see you partner with well-known technology providers, and you have trainers with experience, they are ready to engage.”

I ask Sibilio for an example of specific training projects he’s performed with and at biotechs. He cites two, both located in Spain.