“Post-BIO Reflections from NewBiologix CEO, Igor Fisch, PhD”
Q1: It's a challenging time in biotech, and for cell and gene therapy (C>) in particular. What do you see as the key to being resilient in these uncertain times?
It’s true, the current environment is challenging for the biotech sector, and cell and gene therapy is feeling that pressure. I believe with challenge comes opportunity. Opportunity for drug developers to reset, refocus and build smarter. For us at NewBiologix, the key to resilience starts with staying grounded in our founding mission, “Making a quantum leap in the field of gene therapy development and product production.”
Many approved and clinical-stage gene therapies still rely on fragile, highly customized manufacturing processes that are difficult to scale. This often results in variability, high production costs and regulatory challenges. In just three short years, we’ve assembled a world-class team, built a robust scientific platform and advanced our Xcell technology from concept to real-world application. While we’re still early in our commercial journey, our collaboration with leading CDMO ReciBioPharm is already validating our approach. It’s a strong signal that our platform is not only innovative, but also directly aligned with the unmet needs of the industry. By enabling more scalable, consistent and cost-effective manufacturing, we’re helping our partners build resilience and ultimately, bring transformative therapies to more patients.
At the heart of our resilience is our team. We have brought together a group of passionate, curious, and incredibly smart individuals. From day one, we shared commitment to solving complex challenges in gene therapy. Our people are not just building technology; they’re building the future of gene therapy.
Q2: Recent high-profile setbacks in CGT bring to light the issue of whether or not the pace of innovation has outstripped the maturity of the supporting infrastructure, especially in manufacturing, regulatory readiness and long-term clinical data.. How do you balance the urgency of innovation with the need for scientific rigor, especially when patient trust and investor confidence are on the line?”
Recent headlines underscore the complex and multifaceted challenges facing the gene therapy field today, from high treatment costs and manufacturing bottlenecks to clinical setbacks, including serious adverse events. We know these therapies hold extraordinary promise, but they also push the boundaries of science, manufacturing, infrastructure and regulation.
As the field matures, it’s becoming increasingly clear that scientific innovation must be matched by rigorous development, scalable and reliable manufacturing, a robust regulatory framework, and an unwavering commitment to patient safety and long-term outcomes.
However, balancing speed and rigor is one of the defining challenges of our field and it’s never been more important. The urgency is real: patients are waiting, and science is advancing rapidly. As we have seen, if we move too quickly without the right foundation, we risk undermining the very trust we’re trying to build with patients and investors alike.
I believe that innovation and scientific rigor are not opposing forces, they’re interdependent. Our Xcell platform is a good example of innovation and rigor coming together representing a new generation of innovation in gene therapy manufacturing, one that doesn’t compromise on scientific rigor. From the outset, we designed Xcell to address the core challenges of consistency, scalability and regulatory readiness. By combining advanced cell line engineering with deep biological insight, we’ve created a platform that not only accelerates development but also strengthens the reliability and reproducibility that our customers, regulators and patients. It’s innovation built on a foundation of discipline, and data.
Q3: At BIO, you delivered a session on “The Future of Gene Therapy” Can you give us a look into your crystal ball?
Looking into my crystal ball… Well, in the near term, I believe we will see a shift in focus across the gene therapy field, from scientific novelty to executional excellence. The industry is recognizing that the next wave of progress won’t come from new vectors alone, but from solving the persistent challenges of manufacturing: scalability, consistency and cost. That’s where NewBiologix is positioned. Our Xcell platform is designed to address these bottlenecks head-on. By improving the tools at the heart of AAV development and production, we’re enabling more predictable, scalable and regulatory-ready manufacturing. In the next few years, I expect platforms like ours to become essential to how gene therapies are developed and delivered, not just in rare disease, but increasingly in larger indications where cost and scale are critical.
Looking further ahead, I see a future where gene and cell therapy becomes a mainstream modality, not a last resort, but a first-line option. That future depends on building a more mature ecosystem, one where manufacturing is robust, regulatory frameworks are harmonized and therapies are accessible to broader patient populations. We’re not there yet, but we’re laying the groundwork now.
At NewBiologix, we’re not just looking into a crystal ball to see the future, we’re building the tools to make it possible.
