Insights

Biotech executive Frank Schnieders shares how Allogenetics is advancing gene therapy to improve transplant success, reduce rejection, and enhance patient quality of life.

Ester Weijers explains why CRISPR delivery remains a bottleneck in cell therapy and how scalable editing strategies can shape manufacturing, cost, and patient access.

Future of CGT comes from a simple observation: most conversations in this field stay too high-level to be useful. This piece explores what happens when you shift the focus to real challenges.

Hans Schikan is a leading voice in biotech and rare diseases, known for his patient-first approach and contributions to translating scientific innovation into real-world therapies.

Why do gene therapies struggle to scale beyond the lab? Olga Labovitiadi of Johnson & Johnson explains how formulation, cost of goods, and early development decisions determine whether viral vector therapies can realistically reach patients.

What does it take to move a gene therapy from preclinical research into the clinic? Janneke Meulenberg reflects on manufacturing, dose translation, and the decisions that shape early clinical development.

Ricardo Baptista, CTO at SmartCella, discusses the biggest challenges in scaling cell therapies—from maintaining cell integrity to preparing for GMP manufacturing and explains why early CMC strategy is critical for commercial success in CGT.

Moving Cell Therapy from bench to patient rarely fails because of one big mistake. It stalls because of dozens of small, unspoken assumptions on what it takes to bring a process into a GMP environment. Working with that challenge every day, NecstGen sees where...

How do you build a cell therapy company from an academic idea to clinical development? Rob Meijer shares how Amphera approached dendritic cell therapy, combining early clinical work with a clear focus on regulatory strategy and patient access.

What does it take to move a therapy from academic discovery to patient use? Vincent van der Wel discusses the practical challenges of translating research into cell and gene therapy development.

Hospital-based CAR-T manufacturing is emerging as an alternative to centralized production models. In this interview, Professor Tom van Meerten from UMCG discusses the opportunities and challenges of producing CD19 CAR-T cells within the hospital, and what this approach could mean for the future of cell therapy and patient access.

Sander van Deventer reflects on the realities of bringing gene therapies from the lab to patients. Drawing on experience from antibody discovery to the approval struggles of Glybera and current ALS programs at VectorY, he discusses safety margins, manufacturing economics, and the political dynamics that shape whether therapies reach the clinic.

Rachel Abbott, CEO of Pan Cancer T, shares what it takes to bring a TCR-based T cell therapy from academic discovery to first-in-human trials. From funding constraints to manufacturing strategy and lean team building, she reflects on the practical decisions shaping early clinical development in cell and gene therapy.

Ana Hidalgo Simon shares practical insights on regulatory strategy in cell and gene therapy. Drawing on two decades at the European Medicines Agency and her work at LUMC, she explains why early evidence planning, GMP considerations, and long-term patient access decisions shape the success of advanced therapy development.

Thomas Broekhoff on shaping cell and gene therapy policy through better questions and clearer strategy.

Kees Mensch explains why early digital decisions in cell and gene therapy companies can create long-term GMP, data integrity, and scalability challenges.

Many CGT programmes show strong preclinical biology, but still face major challenges when moving from the lab to the clinic. According to Frank Staal, these translational development challenges often stem from early decisions that underestimate patient variability, rely on models optimised for proof-of-concept rather than long-term clinical function, and postpone regulatory or manufacturing considerations until they become difficult and expensive to change. Drawing on experience across the full CGT translational pathway, he shows how early alignment on models, immune monitoring and post-trial strategy can reduce clinical uncertainty and help gene therapy programmes generate evidence that supports real patient benefit beyond the first trial.

Many CGT programmes look strong in preclinical work, yet still stumble once the first patients are dosed. Margot points to recurring causes: models that miss clinical variability, donor material that behaves unlike patient samples, and key development decisions postponed until they become hard to reverse. Her perspective helps teams design studies that better support benefit-risk early on.

Tol Trimborn describes CAR T development through a company-builder’s lens. His focus is not only the science, but the conditions that determine whether a programme survives: investor fit, clinical proof of concept, and deal structures that protect execution after an acquisition.

Dirk stresses that CGT teams fail when they ignore structure, CMC, and real trial justification. Early choices set the path. Bring in expertise, design for patients, and avoid shortcuts that force rebuilds. Success comes from alignment, not speed alone. Choose cautiously to avoid costly delays ahead.