Consultancy Cell One Partners is helping innovators translate scientific ambition into viable commercial solutions as the cell and gene therapy industry pushes toward its next era of breakthroughs. Through deep domain expertise, strategic insight, and unmatched access to world-class advisors, the company is accelerating the journey from lab bench to bedside.
“We are closing the gap between innovative science and the commercial imperative to make these therapies available and affordable,” George Goldberger, founder and CEO of Cell One Partners, says in an interview with BioTuesdays.
With more than 25 years in the field, Mr. Goldberger has built a global dream team capable of advising clients through every stage of the development lifecycle—from early research through regulatory approval and commercialization. Cell One Partners supports companies with strategic consulting, regulatory navigation, manufacturing planning, and even operational execution, including full contract management for complex, multi-partner projects.
Mr. Goldberger explains that every engagement at Cell One Partners is tailored for success in today’s complex landscape. Whether advising a startup, a contract manufacturer, or a private equity firm, the consultancy applies a custom strategy grounded in real-world experience.
“What differentiates us is our vast global network of experts who’ve actually done the work—they have a rich understanding of both the science and the operational challenges,” he says.
Joining Mr. Goldberger at BioTuesdays is Andrew Moore, Senior Associate at Cell One Partners, who points out that each client engagement is unique—as are the solutions the firm delivers. “Recently, one of our colleagues went back to the bench to make some cells for a client. The client wanted 10 million cells, and he made 30 million because he was having so much fun creating cells—and of course, the client was delighted with the results.”
Mr. Goldberger underscores that while cell and gene therapy is still in the developmental stage, it has the potential to be the next generation of medicine. Designed to train the body’s own immune system to fight off diseases—including cancer, cardiovascular conditions, autoimmune diseases, and HIV—many in the scientific community are looking to cell and gene therapy for solutions that conventional medicine has been unable to provide. “The cell and gene therapy space is totally global, and there are exciting developments happening in just about every part of the world.”
With approximately 2,000 active clinical trials in cell and gene therapy globally—40% in North America, 20% in Europe, and the remainder across Asia—the field is expanding rapidly. But Mr. Goldberger cautions that more than half of these trials may not reach their endpoints, leading to significant losses in investment.
“There has been an up to $10 to $20 billion in annual investment in this space in recent years, but many programs still fail—that’s why strategic guidance and experience are critical,” he contends. Cell One seeks to serve as that global strategic resource—helping stakeholders reduce risk, evaluate opportunities objectively, and align science with sound business strategy.
“Currently we see a notable change in the cell and gene therapy landscape as the financial funding environment has declined since the post-COVID period,” Mr. Goldberger says. “More recently, we are seeing a change from single-asset acquisitions to more platform like technology acquisitions. If we summarize the major platform deals in 2024 and 2025 YTD, we see a total deal value of about US $8 Billion.”
“There is no doubt that continuous innovation will not stop and will create commercial successes within the next five to ten years, dominated by CAR-T & CAR-NK allogenic therapies, followed by more precise CRISPR based platforms for rare diseases and In-Vivo CART therapies,” he adds. “While some contract development and manufacturing organizations (CDMOs) are currently restructuring their manufacturing assets, other CDMOs have used this time to adopt to manufacturing automation and develop innovative scalable process solutions with the aim to reduce error rates and costs per patient and make the medicines of tomorrow available for a broad spectrum of patients worldwide.”
Emphasizing the value of objectivity in a passion-driven industry, Mr. Moore says, “The emotional and financial stakes in cell and gene therapy are high. Scientists, investors, and patient advocates are deeply invested in these projects—but that can cloud judgment.”
“Our value is in bringing an objective voice to the room,” he adds. “We aren’t just another consultancy trying to retain business—we deliver honest, expert advice and guidance backed by firsthand experience.”
This perspective is especially vital during due diligence. The firm regularly supports private equity and venture capital clients by helping them evaluate whether the science truly supports investment. “We are the ones who ask the question: What don’t you know? And then we help find the answer,” Mr. Moore says.
Highlighting the future of AI in cell and gene therapy, Mr. Goldberger notes, “The pandemic changed clinical development, and Cell One is leveraging the lessons learned. We have successfully conducted virtual clinical trials in North America and Europe, coordinating remote teams across continents—managing everything from trial operations to FDA and EMA regulatory filings.”
He adds that AI is transforming the cell and gene therapy space. From drastically speeding up data analysis to optimizing manufacturing and regulatory submissions, AI is becoming a key enabler in streamlining costly, time-intensive processes. The specific challenge for us as consultants is to select the right AI solution from a multitude of offerings to solve the industry’s critical problems.
“What used to take weeks to source, now takes minutes,” Mr. Goldberger says. “From regulatory submissions to early warning systems in manufacturing, AI is changing how we work.”
Mr. Moore adds that AI’s predictive capabilities could revolutionize cell manufacturing, offering early insights to prevent costly failures. “Especially when cells come from very sick patients, AI could help us identify issues early to improve the cell manufacturing process and most importantly, patient safety.”
Considering the future of automation and integration, Mr. Goldberger envisions a time when cell and gene therapy is administered directly at the patient’s bedside using automated, AI-supported devices—eliminating transport and reducing manufacturing risk. “We’re close,” he says. “Companies are building the parts—we just need full integration. When that happens, it will be a quantum leap forward for the cell and gene therapy industry.”
With that future on the horizon, Cell One Partners continues to work at the cutting edge—bringing together science, strategy, and operations to make next-generation cell and gene therapies both real and accessible.
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