In many ways, the next ten years promise to be the single brightest decade the pharmaceutical world has ever seen, and we are speaking about an industry that has gone from strength to strength for most of its history. Not only are Small Molecule products undergoing a renaissance powered in part by Digital Transformation while Large Molecule products are finally enjoying their first Golden Age as a now established and mature biopharmaceutical sector within the larger whole, but a whole new and novel generation of products is at last reaching the tipping point of commercialization and stands at the cusp of being the Next. Big. Thing.

So why do the senior executives I talk to at our Pharma Manufacturing World Summits and Biomanufacturing World Summits always sound a little nervous?

I am delighted to say the ubiquitous undertone does not seem to be connected in any way to the science. These new products —be they cell and gene therapies or live modalities or any of a host of other emerging and breakthrough approaches that for the purposes of this blog post we will collectively call advanced therapy medicinal products or ATMPs— are proving to be everything we hoped they might be, and as the first of them become commercially available, thousands of experts at hundreds of companies watch and wait, eager to learn from the pioneers’ experiences as they work to shape their own efforts and collectively forge the future of medicine for patients everywhere.

Are people worried about the industry’s capacity to make all these new medicines and therapies? Well, that certainly is a current pain point, and that challenge is compounded by the fact that the industry is still figuring out product by product what ATMP manufacturing will even look like, so it is hard to invest in the future when its very nature is still being decided on fundamental levels. Still, if it was just a matter of facilities and equipment and supplies and logistics, all of that can be sorted out with the right combination of time, attention, and capital. There will be difficulties to overcome, but there is no existential threat on that front.

No. The thing that really keeps the senior leadership up at night is something fundamental, and it stares them in the face whenever they look in the mirror.

There Are Not Enough People to Fill the Big Jobs

The pharmaceutical industry —and especially the biopharmaceutical industry, and especially the nascent ATMP industry— runs on people with a very specific skillset and knowledge base that takes many years of both education and real-world experience to develop. That’s not all, although it is bad enough that we have already discussed it at some length on this blog before, in podcast interviews, and many times at our events.

Thirty years ago, a generation of the pharmaceutical industry’s Top Talent saw the potential of the emerging biopharmaceutical space and geared their careers towards Large Molecule products. While that was happening for a wide range of reasons Big Tech, Finance, and other industries were capturing the imagination of bright young people making decisions about their future, and for something like ten years there was a noticeable shortfall in students enrolling and graduating in programs relevant to technical operations in the Life Sciences.

Today, that young Top Talent from three decades ago are now the most senior people in a booming industry, and many are beginning to contemplate retirement. Demographically speaking there are not enough rising leaders coming up behind them to guarantee an easy transition of power. While the industry worked to address this challenge, ATMPs are now coming onto the scene even more dramatically than the Large Molecule products once appeared, and every company working on an ATMP from startup through commercialization needs at least a few very competent and experienced people at the helm.

While the number is not static enough to pin down with certainty, there are something like 650 or 700 ATMP companies in the United States right now, with probably the same number again elsewhere in the world. Let’s call that 1400 companies, all of whom need at least a Chief Technical Officer and probably several other seasoned and technically competent executives to help them develop and commercialize their products. They can only recruit those people from the senior leadership and Top Talent in the existing industry, an industry that was already conscious of a Talent and Leadership shortage in the age group immediately younger than today’s chief executives.

Just as the biopharmaceutical manufacturing sector has been drawing from the talent pool of the larger pharmaceutical manufacturing sector for the last couple of decades, now a whole new sector of ATMP manufacturers is coming into being that must draw most of its best people from the veterans of biopharma manufacturing; there are not enough people who can be trusted to do the top jobs to go around, and that problem is only going to get worse not better over the next few years.

Let me reiterate that to ensure I have your full attention. There does not seem to be an easy answer to this problem, and I use the word ‘problem’ with careful deliberation. As a copy writer for business readers, I make it a best practice to talk about challenges rather than problems. Challenges can be identified, mitigated, and overcome. Challenges can even become opportunities when they are capitalized on correctly. There is almost always a way to frame challenges in a positive light.

With that context laid out, it feels dishonest and self-defeating to downplay the seriousness of the very real problem the industry is facing by calling it just a challenge. Three different connected sectors are all drawing from the same finite pool of technical operations knowhow and experience working in a highly regulated environment on lifesaving products. This ongoing problem is moving towards a period of ongoing crisis with every possibility of spiraling into a painful crunch or even chaos in the future unless industry-wide measures are taken to address this problem actively and on a continuous basis for many years to come.

Why Can’t They Just Bring In People?

People who work in pharmaceutical manufacturing probably feel it goes without saying, but I write for a broader audience than that, so I am going to articulate this anyway. You can’t take someone with discrete or even batch manufacturing experience in another industry and have them make medicine at a senior level.

You might be able to move someone from Food Safety and Quality over into a Pharmaceutical Safety and Quality role.

You might be able to take someone with Digital Transformation experience on an assembly line or a process manufacturing facility and have them help improve process performance in a Small Molecule environment.

You might even be able to take a petrochemical engineer and have them come to understand Large Molecule bioreactors with some careful training.

There are ways to bring technical experts from one industry over into the Life Science manufacturing space at entry and mid-level positions.

There is no way to bring senior technical operations executives over from other industries and have them be responsible for the development, scale-up up, commercialization, and day-to-day operations of ATMPs and new Large Molecule products. There is too much to learn that can only be picked up by spending a career in that field, in that working environment, building relationships with those colleagues and those service and solution providers, under that regulatory governance, all with the knowledge and inspiration and motivation and responsibility that your product is going to patients who need it. You need to have all of that in you before you are running things, and you especially need it in you if you are going to build upon what already exists and make something new.

Maybe, maybe, maybe a Small Molecule product line already in commercial operation could bring in someone from outside to guide the whole organization by keeping a steady hand on the tiller, but that is not the shortage of Top Talent we have been talking about all this time.

The new Cell and Gene Therapies and other ATMPs coming down the pipeline are not going to be commercialized by people who have spent the bulk of their careers working outside the pharmaceutical technical operations space. Even if by some miracle they could learn everything required to do the jobs, how do you communicate that miracle’s veracity to a third party? A huge part of most of those ATMP companies is attracting investors, and what investor wants to see the C-Suite and other top jobs are being filled by people without a proven track record in the space? Until there is a product to sell, the senior people are the product the company is selling as it seeks capital to keep going and growing.

No. The top ATMP jobs for 1400 companies (and counting) will need to be filled by existing senior leaders and top talent from biopharmaceutical manufacturing organizations, a very limited number of people who are already doing important work, are coming up on retirement age, and who are struggling to replace themselves with the next smaller echelon of rising talent coming up below them.

So What Should be Done?

Having explained just how serious the problem is, I guess it is time to start talking about options to address it. It hasn’t taken anyone by surprise. It’s been a long time coming, and just because we are only now reaching the breaking point does not mean people have not been thinking about what to do. We are talking about some of the brightest people working in medicine today, many of whom have already built a whole new sector if their industry already over the course of their careers. Someone surely is working on this?

We should start by saying what these top jobs actually consist of in terms of skillsets, and then figure out which skillsets can be learned faster.

A Chief Technical Officer for an ATMP company  —to take one very senior and crucial role and use it as a stand-in for a wide range of equally vital positions— is going to need to understand the science and have all the knowhow necessary to combine the technology and the processes and the people required to take something that has been proven to work in a lab and build a manufacturing organization around that lab work that meets and exceeds regulatory requirements while also reliably producing a product that meets patients’ needs and the demands of the market. The CTO also needs to be able to communicate the needs of that manufacturing organization to the rest of the company’s C-Suite and the board, while also being able to report on progress and explain what is happening both when things are going well and when things are going poorly to all relevant stakeholders, partners, and regulators.

A CTO must have both the hard skills for the technical side of the job, and the soft skills of the executive side of the job. We cannot promote a technically competent person who lacks soft skills into the top job without running the unacceptable risk of the Peter Principle occurring,  and we cannot bring in a proven business leader who has all the soft skills but does not know the science behind it all, how these incredibly complicated manufacturing processes —many of which are currently still being invented— can be optimized, how their people work, what the regulators are going to want. That would be merely to hire a spokesperson for an organization rather than a leader who can make informed decisions and be responsible for outcomes.

So which is the easier thing to teach? Find a senior director or vice president with a through understanding of technical operations and give them ten years of senior corporate experience in a short period of intensive training, or finding a proven business leader and giving them a crash course in everything they need to know about biopharmaceutical manufacturing? Given those options, it sounds wiser to accelerate the career of a subject matter expert than to find someone already at the top of a different industry and try to cram a whole other career’s worth of knowledge into them. Safer too, when you remember we are talking about both the future of a fledgling company, and patients’ lives.

There is a catch in taking someone at the mid-point of their career and giving them the support and investment and resources they need to skip a decade of organic development to prepare for senior jobs, though. The senior jobs are almost all in another company, and in many cases that company is only a few years old. Any pharmaceutical company that puts together a leadership boot camp designed to prepare their people for SVP/EVP/C-Suite roles in ATMPs is going to see their best people in the prime of their careers leave to go work somewhere else!

While conversation is still ongoing, it seems the only solution is for the industry to work together and form an alliance where every company is contributing towards a shared pool of corporate mentorship and accelerated learning. All pharmaceutical companies need to be creating a rising tide that will lift all boats. The ROI needs to be evenly spread. The instinct to poach one another’s rising talent needs to be set aside. The future of a whole new sector of an already booming industry is in jeopardy for lack of people able to do the job, so the best candidates who are most of the way there need to be developed further as fast as possible to meet demand, or it will be chaos for everyone. In an industry already comfortable with collaboration, this is going to be an even bigger ask than normal, but it seems to be the only way through.

One can only imagine how complicated it will be to balance the internal needs of a company against the future requirements of an industry. Fortunately, a lot of very intelligent people are already figuring things out.

Stay tuned for more information about what the industry is doing about all of this. We have recorded an interview with some key players working on a solution, and we have also been reliably informed a major announcement will be made this November at Biomanufacturing World Summit 2023 in San Diego.

We will have a lot more to say about this soon.

 

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Geoff Micks
Head of Content & Research
Executive Platforms

Geoff joined the industry events business as a conference producer in 2010 after four years working in print media. He has researched, planned, organized, run, and contributed to more than a hundred events across North America and Europe for senior leaders, with special emphasis on the energy, mining, manufacturing, maintenance, supply chain, human resources, pharmaceutical, food and beverage, finance, and sustainability sectors. As part of his role as Head of Content & Research, Geoff hosts Executive Platforms’ bluEPrint Podcast series as well as a weekly blog focusing on issues relevant to Executive Platforms’ network of business leaders.

Geoff is the author of five works of historical fiction: Inca, Zulu, Beginning, Middle, and End. The New York Times and National Public Radio have interviewed him about his writing, and he wrote and narrated an animated short for Vice Media that appeared on HBO. He has a BA Honours with High Distinction from the University of Toronto specializing in Journalism with a Double Minor in History and Classical Studies, as well as Diploma in Journalism from Centennial College.