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Manufacture Advanced Medicine, Profession

Mind the Cell and Gene Gap

A 2018 study by Deloitte suggested that more than 2.4 million manufacturing jobs in the US would remain unfilled in 2028 because of the widening – and often generational – skills gap. This approaching pain point may sting particularly badly in the emerging cell and gene therapy sector, where there is already a shortage of skilled people. Put bluntly, without further training and a boost in headcount, we will see a bottleneck in the rollout of advanced medicines that could ultimately cost the lives of patients.

Proposing solutions is easy enough, but doing something is harder. When considering the cell and gene skills gap at home and abroad, we have a favorite online adage at Project Farma that we return to again and again: “Teach me and I may remember, involve me and I’ll learn.”

Most posts online attribute the words to either Benjamin Franklin or Confucius, but the true author is Xunzi, a Confucian scholar writing in the 3rd century BCE. Translating and distilling classical Chinese is a tricky business, but fortunately the US Department of Health handled this task for us back in 1953, when in their Public Health Reports periodical they boiled Xunzi’s esoteric words down to:

When I hear it, I forget it
When I see it, I remember it
When I do it, I know it

We all likely sat through at least a few “hear it and forget it” conferences (you might know the type: hand-waving and sales pitches). And that’s exactly what we don’t do at Project Farma; before and during the pandemic, in conference halls and in cyberspace, we have presented in dialogue and in panels, using real case studies as the basis for our discussions. We believe this sharing of experience is one form of reinvesting because it helps disseminate knowledge that will help us close the skills gap. The key topic we hit on at these conferences is the journey of developing a therapeutic and getting it to market. The listeners we are hoping our words will benefit? The companies and professionals a few rungs below us on the ladder.

Anshul Mangal, President of Project Farma

Saving lives with talent

Moving aside from the ancients, let’s look at the stakes today. Advanced therapies are often a patient’s only or last hope, so the time to market for these drugs is critical. If we make wrong moves, we create bottlenecks or even put drug approval at risk. And it’s not only the health of our patients at stake – it’s also their hope.

Though we don’t have exact data on the talent gap, we can measure the need by the amount of financial investment going into the space and a number of products that will be commercialized over the next decade. To date, 19 therapies have been approved for about a half a dozen diseases. The FDA expects to approve 10–20 new therapies a year starting in 2025. There are over 1200 clinical trials worldwide, with at least half of these trials in the US. In terms of investment, over $20 billion went into the cell and gene space alone in 2020; up $10 billion from 2019. With that amount of investment pouring into the space, the workforce will need to expand.

Even while most of the world was grappling with a pandemic, we saw a record year for investment in cell and gene therapy. Do you need any clearer signal of the confidence that the investment community has in the sector?

But which roles have fallen into this skills gap. Well, manufacturing for one. We are now seeing demand for manufacturing capacity significantly outstripping supply. One of those constraints is talent – manufacturing talent specifically. But really the demand for talent in cell and gene therapy runs across every functional area, including regulation and commercialization. After all, there are relatively few commercially proven products on the market today, so naturally that means few people have experience with commercially launching cell and gene therapy products.

The FDA has commented that there’s a general problem at the moment getting sufficiently trained staff to even review gene therapy applications – not only in the review of manufacturing, but in all aspects of the FDA review process.

But we also need to think about the corporate level too; this is about catching the folks that have the experience, know-how, and credibility to start and run companies as they step out of academia. Many of today’s new medicines are coming out of both academia and private equity, so we need strong talent and experience in dealing with supply chains, technical operations, business strategy, regulatory affairs… And the list goes on.

At Project Farma, we’ve sought to address the skills gap not only through recruitment but also training. We have set up a free, internal “university” for our engineers. The aim is to provide them with a baseline of knowledge for their own benefit and to accelerate the development of the cell gene therapies we work on.

Tony Khoury, Executive Vice President at Project Farma

The other gap…

The gear in advanced therapy is simply not as sophisticated or mature as that of other therapeutic areas, nor has it gone through as much rigorous testing and development over the years. In 2015, our company went through quite a serious struggle, because we were attempting to work with equipment such as bioreactors and modular cleanrooms that had never been used to manufacture advanced therapies. We could not have done it alone. In this industry, the word “collaboration” cannot be stressed enough. Collaboration. Collaboration. Collaboration!

Companies need to evaluate the available technology, find ways to work with their clients, and effectively manage all the materials tied into the supply chain: critical starting materials, raw materials, plasmids, vectors, disposables – every detail becomes a weed. To succeed, you need to strategize.

At Project Farma our way of dealing with this is to run “make versus buy” or facility-build analyses, and form manufacturing strategies with our clients. It is not enough to simply evaluate internal versus outsourced production. Companies need to analyze every step of every process on the pipeline. Foresight and preparation are essential for success.

Looking to role models

Let’s think back to those words from Xunzi. To learn, students need to do. Take a look at NC State University’s BTech; it’s a bio manufacturing, training, and education center, and it’s home to a manufacturing suite that the students have regular access to. When people first start their careers in engineering, they are often terrified of interfering with equipment – mainly through the fear of losing the company half a billion dollars in batch costs! But in environments like BTech, professionals are freed-up to learn by doing because they have an education centre that mimics the environment of a pharma facility, without the expensive batches.

Finally, we should not underestimate the importance of partnerships. In fact, we believe nothing will help fill the skills gap quicker than partnerships between private and public organizations. For example, Ohio State University announced a new collaboration between Nationwide Children’s Hospital and Jobs Ohio on a massive US$1.1 billion cell and gene project in Columbus. Ohio State is committing to producing over 20,000 graduates over the next 15 years in the STEM field, including health science, vital materials, computer science, and other fields as part of this investment.

In the US, we are fortunate to have many success stories like this, and they are something to be proud of. But we need more of them. To take these stories to heart, people need to see them happen. To build the industry, people need to take part in its construction.

Anshul Mangal and Tony Khoury are President and Executive Vice President of Project Farma, respectively

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About the Authors
Anshul Mangal

President, Project Farma

Tony Khoury

Tony Khoury is Executive Vice President, Project Farma

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