Vitrian Launches End-to-End Solution for Companies Seeking cGMP and Biomanufacturing Capabilities
By Steve Surdez
February 28, 2023
While working at separate companies, life sciences real estate veterans Scott Nudelman and Sam Johnson kept hearing the same thing from frustrated biopharma clients: we need a comprehensive, one-stop-shop solution to simplify and streamline efforts to expand cGMP and biomanufacturing infrastructure projects.
Seizing on an opportunity to solve a major industry pain point, Nudelman and Johnson formally launched Vitrian in the summer of 2022. Headquartered in Bethesda, Maryland with additional offices in New York and Dallas, Vitrian deploys a differentiated business model that offers a full lifecycle, end-to-end solution for cGMP and biomanufacturing projects.
Vitrian’s novel model is ideally suited for an array of life sciences companies that have received positive Phase II or later data readouts or have already received FDA approval for commercialization. Companies at this inflection point often face the question of whether to build out in-house capacity or to partner with a Contract Development and Manufacturing Organization or “CDMO.” They also tend to have funding and/or human capital constraints, particularly in the challenging capital markets environment that companies face today. Vitrian offers CDMOs and life sciences companies planning to manufacture in-house expert services in concept design, process development, equipment procurement, project capitalization and construction, and CQV, all under one roof. Companies seeking to add cGMP and biomanufacturing capacity can partner with Vitrian for all of their needs, including creative capital solutions, facility development, strategic advisory services and, uniquely, civic engagement with an emphasis on developing the bachelor degree and below workforce required to grow.
The spark for Vitrian ignited five years ago when Nudelman and Johnson crossed paths in Boston. Johnson was working for Oxford Properties, the institutional real estate arm of a large Canadian pension plan, at the time and Nudelman was at Carr Properties, a large investor/developer based in Washington; the two overlapped while their respective companies had common equity partners.
“In the summer of 2021, Sam had been white-papering ideas for expanding beyond life science R&D into biomanufacturing and I had been kicking around a similar idea at my company GlenLine that was in the R&D space. I heard about Sam’s work and I reached out to him and in the first few conversations it was clear we had hit on something,” shared Nudelman. “There was clearly a lot of alignment there. Sam later joined Dallas-based Montgomery Street Partners and they were looking to stand up a dedicated cGMP biomanufacturing platform.”
“Scott and I had a personal connection and the idea of pursuing something totally new and novel to solve an unmet market need is in line with Montgomery Street Partners’ business model. There was clearly a meeting of the minds between all of us,” stated Johnson.
Both Nudelman and Johnson recognized that the traditional life sciences real estate model was not working for a lot of companies. Instead of taking a traditional top-down approach, Vitrian inverted the strategy, choosing to work from the bottom up.
“Clinical and pre-clinical stage companies have that great idea but they are also the riskiest part of the ecosystem and that’s where much of the venture and real estate investment dollars were flowing. We observed this gold rush mentality in the middle of COVID. It seemed obvious there was a disconnect between where this money was going- to back the lesser-capitalized companies and R&D real estate to support them- and where the money was actually needed in the form of manufacturing real estate. We knew we needed to be three steps ahead and attack the need,” stated Nudelman.
“So we thought, why don’t we focus on the companies that have come through the ‘Valley of Death’ and have the greatest chance to succeed, as well as CDMOs working in advanced therapeutics? No one was addressing this need. A lot of these companies had small teams that were outsourcing work to stand up biomanufacturing infrastructure on a la carte basis and hundreds of millions of dollars were being invested in a disorganized fashion,” he added.
Johnson and Nudelman knew they had a powerful business model that could truly assuage significant industry pain points around developing biomanufacturing infrastructure. Vitrian’s powerful solution is grounded in deep subject matter expertise across the full spectrum of building cGMP and biomanufacturing capacity.
Once they knew they had something, Nudelman reached out to Jeff Gilmore, the CEO at cGMPnow, a highly regarded consulting firm specializing in concept design, equipment procurement, IT/OT and CQV services, to test the waters. Gilmore’s response: “We’ve been waiting for you guys,” as he and his team had first-hand experience with the barriers to standing up manufacturing capacity. Vitrian and cGMPnow had complementary strengths and subsequently became strategic partners under Vitrian’s end-to-end solutions platform.
Today, Vitrian is set-up as a first-of-its-kind company to help life sciences companies accelerate the creation of biomanufacturing capacity, through a single, fully-managed platform. Instead of companies having to retain separate consultants and investors, Vitrian offers everything in-house between facility procurement and development, investment capital and assistance with site selection and workforce development. The single source nature of Vitrian’s solution takes the mystery out of the process and creates greater time and cost efficiencies, according to Nudelman.
“The pitch we make to companies is to focus on your product and pipeline and leave the rest of it to us. We can help you accelerate bringing therapies to patients; that’s the end game for all of this,” stated Nudelman.
“We want to be the critical execution partner that will help life sciences companies grow. We’re not just a financing engine, which has been the extent of what real estate companies have offered to date in the biomanufacturing space. Our comprehensive services model helps these companies de-risk what is a mission critical but inherently risky process,” stated Johnson.
Vitrian’s model can play a crucial role for life sciences companies across all life cycles, from larger biopharma companies to earlier-stage venture capital and private-equity-owned firms. For example, Vitrian functions well in situations where a private-equity firm has acquired a company and where significant value is embedded in the facility or facilities. The Vitrian team acts as not only a financial investor in the real estate, but also acts as a technical advisor and performs skilled due diligence to determine what equipment can be secured, what needs to be improved, how the workforce can be developed and what incentives might be available. In other situations, Vitrian engaged to perform a build-to-suit development or re-development project for companies, where the team offers an end-to-end solution for a company’s new facility, overseeing everything through turnkey design and commissioning, in partnership with cGMPnow. The combined team’s experience spans modalities from advanced therapeutics to synthetic biology/fermentation to regenerative medicine; Vitrian is engaged with companies across this spectrum.
“We not only work well with the growth-stage biotechs, CDMOs and within the M&A process, but we also can provide highly valuable services to Big Pharma and more mature life sciences companies,” shared Johnson.
Clearly, the end-to-end, comprehensive nature of Vitrian’s approach is novel, but what truly differentiates the company’s business model is its expertise in civic engagement and workforce development. Vitrian understands that the life blood of any industry, including the life sciences, is talent. And for many biopharma companies, securing the required talent to grow is a major challenge.
The company has its roots in Maryland but is playing a significant role in the emerging Houston, Texas biohub, and other younger life sciences clusters. In many cases, these hubs lose out on investment and development because they lack the workforce depth to support growth. Vitrian partners with other organizations, including state trade associations, community colleges and non-profits like Maryland-based Learning Undefeated to stand up and manage workforce training centers.
“We have a background in non-profit board service and working with communities so the workforce development side of things came to us very naturally. We noticed that places that have the infrastructure to support advanced manufacturing often lacked the workforce. That was the missing ingredient for some of these emerging life sciences hubs,” stated Nudelman.
“We are committed to standing up workforce training centers where we operate because when we succeed the ecosystem can expand and it benefits everyone,” he added.
Vitrian recently received a grant from Montgomery County, Maryland to plan for a future biomanufacturing workforce training center in Silver Spring, Maryland. This training center will have a particular focus on developing workforce talent in communities typically underrepresented in STEM careers.
“We want to meet industry and communities where the needs are. There’s clearly an appetite and interest in workforce development. And there needs to be a bridge between the users and the public sector in order to grow ecosystems and that’s where Vitrian can play an important role” Nudelman stated.
The company is in the early innings of introducing and deploying its unique, end-to-end solution for cGMP and biomanufacturing infrastructure projects not only in BioHealth Capital Region, but also in other emerging life sciences markets across the U.S. such as Houston, Dallas/Fort Worth, Atlanta, Denver/Boulder, central Virginia and the Midwest.
“We’re active in many gateway life sciences markets but beyond that we’re really energized by promoting biomanufacturing in regions with the raw materials and ingredients for success. We have a detailed understanding of where the next five or six hubs will emerge and we hope to become the go to partner and market maker in these hubs in the near future,” Nudelman said.
With a rising tide lifts all ships approach, the future is bright for Vitrian and the emerging life sciences ecosystems it is helping to build across the nation.
“We see Vitrian as a long term, perpetual vehicle that serves the needs of biotech and pharma users as they look to grow manufacturing. We want to become the recognized brand with proven execution capabilities that’s the preferred developer and capital partner for industry,” added Johnson.
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Steve brings nearly twenty years of experience in marketing and content creation to the WorkForce Genetics team. He loves writing engaging content and working with partners, companies, and individuals to share their unique stories and showcase their work. Steve holds a BA in English from Providence College and an MA in American Literature from Montclair State University. He lives in Frederick, Maryland with his wife, two sons, and the family dog.