Mitchel Sivilotti, CEO, OmniaBio Inc.
OmniaBio Inc., a subsidiary of CCRM, is building the largest facility of its kind in Canada, providing specialized manufacturing to the flourishing cell and gene therapy (CGT) industry. The new contract development and manufacturing organization (CDMO) will focus on producing gene-modified cell therapies and viral vectors compliant with Good Manufacturing Practices (GMP), tapping into a global demand for CGT manufacturing that outstrips supply by at least five times.
We caught up with OmniaBio’s CEO, Mitchel Sivilotti, a respected leader in the life sciences industry with 20 years of global experience spanning the U.S., Europe, and Asia. Mitch has spent the last six years serving as Chief Operating Officer at CCRM, where he oversaw the creation and operation of a technology-focused CDMO with over 200 employees. OmniaBio launched with an investment of $100M and will complete CCRM’s continuum of process development, clinical and commercial capabilities. OmniaBio can support therapeutic developers moving from Phase I to commercial-scale manufacturing – a five-fold increase from CCRM’s manufacturing capacity. OmniaBio will employ over 1,000 skilled CGT professionals by 2027.
Which words or phrase do you most overuse?
Now that I think about it, I use the word “ultimately” quite a bit. The reason is likely because it’s a way of cutting to the important, meaningful and actionable elements of complex conversations. It’s a way to keep myself and others focused on the next steps on the road to any given milestone. That, and I also just like the word.
Which qualities do you most value in a best friend?
There are certainly baseline values like trust, loyalty and integrity, but if we could assume for a moment that those are addressed, then I’d say that the three most important things for me are openness and flexibility (in terms of exposure to new ideas and challenges), a clear understanding of self or self-awareness and, finally, being action-oriented.
When it comes to self-awareness, the more a person can have, the more conscious they’re likely to be about where they invest their time and how they focus their efforts. Perhaps there’s an efficiency about that that I appreciate, or a simplicity because they tend to understand as much about what to do as about what not to do.
On being action-oriented, this is a simple one. I think we can all appreciate this about people – when somebody says they’re going to do something and they do it, right? Whether it’s meeting a friend for dinner, planning a project, or a business commitment. Get it done and then move to the next activity or challenge.
What is your motto?
“Everyone’s an engineer.” My motto tends to change with time as I’m exposed to new ideas, but I read a book fairly recently profiling Toyota, a company that essentially invented and continues to excel at key principles of lean manufacturing. In the book a certain executive was asked “how many engineers do you have at the company?” and they responded “well, we have 500 staff, so we have 500 engineers.” I appreciate that philosophy and what it reveals about their approach to company culture as well as a focus on a particular system driving excellence.
When everyone has a clear understanding of their company’s processes and can see how their own personal contribution fits into the organization, then everyone can play a role in problem solving to remove waste, which is essential to providing more value to our customers.
It sounds like you think about inefficiencies a lot
I believe that a culture of scientific problem solving to drive efficiency is fundamental to achieving the goals that the CGT industry must address. Every person at OmniaBio shares this thinking.
Even our social environments have inefficiency in the funniest ways, and I often ask myself: Why are we doing it this way? We’ve recently optimized the diaper changing process at my house; process optimization can save you from a mess in more ways than one!
Is this where you saw your career taking you?
Firstly, our contribution to health care is one that everyone at OmniaBio and CCRM finds incredibly rewarding. I’m drawn to what we do here. Like many others, I have a personal connection to CGT having lost a very close friend to a disease that I believe our industry will successfully address in the coming years.
In addition, I’m quite an operational person. So, it makes sense to me why I’ve gravitated towards this field and this position within it. Leading a CDMO requires an operational mind, an appreciation for the time and effort that goes into every valuable role involved in manufacturing advanced therapies, from regulatory and quality through operations, project management and supply chain. That’s something I’ve cultivated over the years, and also something that I find very rewarding.
What challenges are on the horizon as we move into the future of regenerative medicine, both for technology developers and CDMOs?
Rapid technological advancement is the name of the game. OmniaBio stays ahead of the curve adopting and continually investing in new technologies through our partnership with CCRM, for example. It’s partnerships and collaborations with leaders in the field that drive innovation, so that approach is really built into the culture of the OmniaBio business. It ensures we’re an innovative partner for our clients, best positioned to advance their clinical and commercial programs and add value to them, whether through cost and timeline reductions through our expertise and manufacturing platforms, or in earlier-stage programs where new ideas and intelligent CMC planning come together. The extraordinary is our bread and butter.
Another challenge is with respect to talent. It’s no secret that finding, training and retaining talent is a challenge for the biomanufacturing industry, which is seeing rapid growth. This is another key area where we can provide a lot of value to our partners and clients – by building an exceptional workforce.
One of the ways we do this is through a unique, internal training team that develops curricula for training on different aspects of our business. Some of those are specifically technology focused, like those developed for our manufacturing platforms in iPSC, immunotherapy and viral vectors. Others are more general around GMP, leadership, quality assurance and process engineering. To advance our training programs, we’ve formed a partnership with the Canadian Advanced Therapies Training Institute (CATTI), which provides training online and hands-on at locations shared with OmniaBio. We plan to expand this relationship by providing CATTI with a dedicated training centre within OmniaBio’s new facility, planned to open in 2024.
Find out more about OmniaBio at omniabio.com and sign up to the OmniaBio mailing list to be first to hear of future developments.
Cal Strode
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