Why Insufficient Training?

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 biotech’s. He cites two, both located in Spain.

Read the complete article at Outsourcing Pharma

A CAR-T Tech Transfer

Biotech Academy In Rome offers such paths – at times with interesting twists of sorts.

For example, Sibilio’s team recently designed a targeted tech-transfer training course for a small, Italy-based biotech in the CAR-T space. This organization wanted to scale up viral-vector production needed to produce its therapies, and provide high quality material for their clinical trials.

“This biotech has a tremendous scientific and technical knowledge of their lentiviral platform, but limited experience on how to practically transfer the process from R&D to GMP,” explains Sibilio.

“Producing viral vectors – or any drug substance or drug product in a cGMP format – takes a multidisciplinary approach. Technical skillsets should be accompanied by a rational application of established international guidelines on tech transfer [such as established in ICH Q8 and ICH Q9]”

Biotech Academy In Rome has in fact designed a detailed training course on technology transfer. It focuses on how to accomplish specific tasks, understand what documentations are essential, what technical tools are best to use, and so on.

The course has been given to key professionals in R&D, quality assurance, and of course to tech transfer-designated individuals and teams.

“For example,” says Sibilio, “the course has been conducted in an organization’s own classrooms during two-hour sessions over about a month and a half.”

These were interactive and practical sessions, with the goal of personnel learning and applying “standard concepts of tech transfer to the organization’s specific needs.”

Feedback from those who attended was positive, he says, and demonstrated a particular enthusiasm for understanding how to “seamlessly program and prioritize the high number of tasks they had to manage for the transition of their process from R&D to cGMP.”

Sibilio believes this course encompassing company- and employee-level modifications is what is needed throughout our outsourcing industry.

What About University Graduates, And Professors?

Without revisiting logistics of the Biotech Academy In Rome particular to its presence on university campuses (see part one), let’s move to what appears to be a growing number of university students looking to enter our industry.  

I have documented previously some biomanufacturing training programs run at universities; Sibilio’s organization is a newer entrant, joining those institutions and organizations introducing students to the idea of working at CDMOs.

“We sincerely believe we can help out here,” Sibilio says of bridging the gap between academia and industry. “This was a key driver for his founding of the Academy after my a long career in the industry.”

“If we are ever going to solve for the shortage of skilled workers, and specifically those with an understanding of biotech project management – then we need to recruit more work-ready graduating students.”

The Academy trains two categories within academia: students, and academic professors and researchers looking to exit academia.

That second category, Sibilio says, is of growing interest.

“In our experience, we see these individuals have quite limited knowledge of what it means to actually work in the biopharma industry.”

That gap is not all their fault.

For example, often the R&D labs they’ve been working in at their respective universities are equipped “completely different from the real-life production labs of industry.”

In part one, we spoke about what the Academy is doing to remedy this equipment divergence, including partnering with equipment companies, such as Merck Milliporeand Repligen to train on their newest technologies.

Students, their professors, biopharma professionals changing positions, CDMOs handling a variety of new platforms; a whole lot of training needs to take place and tech transfer should be a key component.

Quality Professionals Also Need Training

Along with tech transfer and project management, Sibilio says he’s been training (or retraining) professionals currently working on production staffs in the areas of quality control (QC), quality assurance, and related quality and regulatory units.

Overall, he says, “my experience when I worked at various biotechs and CDMOs was you hire new people who you are always in a hurry to have become effective immediately in day-to-day activities.”

“There isn’t time or a program to explain principles behind a particular technique or piece of equipment, or a certain step, let alone an entire process flow.”

The bright spot?

The CDMOs.

Sibilio says they seem most understanding of the value of outsourcing their training, and have become key clients for Sibilio’s organization, now in year two of operations. 

That makes sense, doesn’t it?

As biotechs stay virtual or lean, CDMOs need to be the tech-transfer experts. They need to keep their personnel up-to-speed and as effective as possible to aid their customers.

But it takes two sides to tech transfer.

And doing that more optimally in our fast-paced world may require the outsourcing of training. That should be a natural for us. 

–Read this same article in Outsourcing Pharma