What’s Next for Cell and Gene Therapies?
Brian Newsom, CEO, Carrigent
Cell and gene therapies (CGTs) are emerging as a pillar of medicine, alongside small molecules, biologics, and medical devices. However, despite their transformative potential, challenges in manufacturing, cost, regulation, and accessibility hinder mainstream adoption. Technological advances and regulatory harmonization are crucial for CGTs to become widely accessible, reshaping modern therapeutics.
1. Given the current state of CGT manufacturing, what are the most critical technological gaps that must be addressed to improve scalability and cost-effectiveness?
There are many, but to me two key areas stand out: real-time analytics and potency control. Today’s tools still rely on offline testing, delaying decisions and introducing variability. We need in-line systems that monitor process dynamics (cell health, phenotype, product quality), in real time, not just pH or viability. Equally important is defining and measuring functional potency. CAR+ cells, for example, don’t always correlate with therapeutic effect. Without precise enrichment and live potency assays, we risk delivering ineffective or harmful cells. Bridging these gaps - analytics and potency - will drastically improve yield, dosing accuracy, and scalability. It’s not just a tech issue; it’s a shift toward biologically meaningful, real-time control across the manufacturing lifecycle.
2. What innovations in automation and closed-system processing do you see playing a pivotal role in overcoming the bottlenecks of CGT production?
Rather than relying on one-size-fits-all automation, the near-term opportunity lies in modular, closed systems that standardize critical operations while remaining flexible. Automating discrete steps such as activation, transduction, expansion, and linking them through seamless interfaces allows for reduced contamination risk, improved consistency, and greater scalability. As the industry evolves, success will depend on hardware that integrates across processes, automated fill/finish, and truly closed material handling. This modular “assembly line” approach offers the best of both worlds - customization and standardization - until full-stack automation becomes viable across CGT modalities.
3. As the industry moves towards allogeneic therapies, what unique challenges must be tackled in terms of immunogenicity, persistence, and manufacturing consistency?
Allogeneic CGTs unlock scalability but introduce new hurdles: immunogenicity, limited persistence, and batch consistency. Strategies like gene editing (e.g., HLA knockout, PD-L1 expression), engineered pro-survival traits, and master cell banks help, but variability across donors, patients, and immune environments persists. Companies must build platforms that deliver universal performance - across different immune baselines, tumor burdens, and disease environments - not just scalability. Promising innovations include immune decoy cells, synthetic self-markers, and modular chassis cells that can carry swappable therapeutic components. The challenge isn’t just immune evasion, it is also in building predictable, potent therapies that work across patient populations at scale.
4. How do you foresee the regulatory landscape evolving to accommodate the rapid advancements in CGTs, and what steps should companies take to align with emerging global regulatory frameworks?
Regulators are increasingly responsive to CGT’s unique challenges, with tools like RMAT, INTERACT, and accelerated approvals already in play. But true success depends on how developers respond. Companies must shift toward global compliance strategies, design for product-specific risk profiles, and invest early in real-world evidence infrastructure. As regulations mature, success will favor those who integrate science and policy, building flexible platforms, maintaining transparency, and designing trials and follow-up systems that meet global expectations. Regulatory agility is quickly becoming a competitive advantage.
5. The cost of CGTs remains a significant barrier to widespread adoption. What are the most promising strategies for making these therapies more affordable without compromising quality and efficacy?
Affordability starts upstream. Moving to allogeneic platforms, shortening manufacturing timelines, and boosting per-cell potency can significantly reduce cost per dose. Standardizing manufacturing steps and improving vector yield and recovery further compress costs. But it’s not just about reducing expenses, it’s about building scalable, reproducible systems that align pricing with real-world value. The most successful CGT companies will treat cost as a design input, not an afterthought, and focus on modular platforms, intelligent analytics, and automation that scales with demand.
6. Given the complexity of supply chain logistics in CGT, how can the industry ensure timely and reliable delivery of autologous therapies to patients worldwide?
Autologous logistics are improving, thanks to cryopreservation and better cold chain systems, but challenges remain. Companies should invest in real-time monitored shipping, redundant routing, and decentralized storage to de-risk transport. Long-term, regional manufacturing hubs and allogeneic therapies will reduce reliance on personalized production cycles. Broader clinical site onboarding and automation of the thaw/QC step will help scale delivery while maintaining quality. The key is treating logistics not as an afterthought, but as a core operational strategy designed for reliability, scalability, and patient-centered delivery.
7. What role does artificial intelligence and machine learning play in streamlining CGT development, from early-stage discovery to patient monitoring post-administration?
I have been a skeptic, but AI is moving from hype to real utility in CGT and I have finally ‘bought-in.’ In discovery, it accelerates target identification, guides CRISPR design, and predicts off-target effects. In manufacturing, AI models optimize yield, consistency, and real-time control. For patients, AI enables more personalized therapies by integrating genomics and disease data to refine dosing and delivery. It’s also expanding access through remote monitoring and virtual trial platforms. Ultimately, AI’s true power lies in unifying fragmented systems - from R&D to post-market surveillance - into a closed-loop of continuous improvement for therapy quality, safety, and reach.
8. With the increasing intersection of CGTs and genome editing technologies like CRISPR, what ethical and safety considerations should the industry prioritize?
As genome editing tools like CRISPR become more integrated into CGTs, the line between therapeutic intervention and human enhancement must remain clear. Germline editing, which affects future generations, raises profound ethical concerns and should remain off-limits until the science, and global consensus, matures. The industry must prioritize safety, consent, and transparency, ensuring edits are strictly therapeutic, not for “improvement” or enhancement. Also important: off-target effects, immune responses, and long-term surveillance for edited cells. Regulators and developers must work together to establish ethical guardrails, engage the public, and maintain trust while enabling innovation.
9. As personalized medicine gains traction, what are the key challenges in integrating CGTs with companion diagnostics and predictive biomarkers to enhance treatment outcomes?
The challenge in marrying CGTs with companion diagnostics lies in mismatched development timelines, therapies often advance faster than the tools to predict or monitor their effects. Additionally, mechanistic complexity means that a therapy may address the root cause but not the broader disease expression. To integrate successfully, companies need to invest early in biomarker discovery, align diagnostic and therapeutic pipelines, and leverage AI to interpret multi-omic data for patient stratification. Regulatory frameworks must also evolve to support co-development pathways that make CGTs more personalized and predictive.
10. How do you view the role of synthetic biology in advancing CGTs, particularly in designing next-generation cell-based therapies with improved efficacy and control mechanisms?
Synthetic biology is redefining what’s possible in CGT. It allows us to optimize gene sequences for higher expression, build in logic gates and safety switches, and design circuits that respond to cues in real time. These innovations improve efficacy, specificity, and control while also reducing manufacturing variability and cost. For example, synthetic promoters can tailor expression to specific cell states or tissues, and engineered feedback loops can prevent toxicity. As platforms evolve, synthetic biology will be key to scalable, programmable, and smart CGTs that are both safer and more potent.
11. What are the major hurdles in transitioning CGTs from clinical trials to commercialization, and how can companies navigate these to accelerate market entry?
Commercializing CGTs requires overcoming manufacturing scale, logistical complexity, and clinical variability. Most platforms aren’t yet equipped for broad deployment across diverse indications or geographies. There’s also a lack of clinical infrastructure and physician education, especially in community settings. Companies must build scalable, automated processes, create training and support ecosystems, and partner with logistics providers to manage cold chain and delivery. Early engagement with payers and health systems will help align value propositions with reimbursement realities. Ultimately, commercialization isn't just about science, it’s about infrastructure, education, and execution at scale.
12. With multiple stakeholders involved—from biotech firms to hospitals to insurers—what collaborative models could optimize patient access to CGTs while ensuring commercial sustainability?
To ensure access and sustainability, we need new models that reflect the high upfront cost but long-term benefit of CGTs. One promising approach is outcomes-based risk sharing such as annuity-style payments or rebates tied to therapeutic durability. Collaboration is also needed across stakeholders: biotechs for innovation, hospitals for delivery, insurers for reimbursement, and regulators for pathways that support real-world evidence collection. Shared infrastructure, like decentralized manufacturing hubs or data platforms for post-market monitoring, could reduce duplication and improve system efficiency.
13. What lessons can CGT developers learn from the biologics and monoclonal antibody sectors to enhance process robustness and regulatory compliance?
CGT can take a page from the biologics industry by focusing on platforms, moving away from bespoke, one-off processes to standardized, reusable frameworks. Biologics also taught us the value of early failure: kill weak programs quickly and don’t chase marginal science. CGT developers must embrace robust analytical methods, prioritize process control, and work cross-functionally from the start—bringing in regulatory, manufacturing, and commercial perspectives early. Building to scale from the beginning, rather than retrofitting later, is key to long-term success and compliance.
14. Looking ahead, what breakthroughs do you anticipate will redefine CGTs over the next decade, and what should companies be doing now to stay ahead of the curve?
Over the next decade, we expect to see iPSC-derived therapies move mainstream, enabling scalable, off-the-shelf products for broad indications. Allogeneic platforms, automation, and AI-driven manufacturing will drastically lower costs. With this will come a shift from rare diseases to chronic and high-prevalence indications, expanding market impact. To stay ahead, companies must remain agile: monitor scientific breakthroughs, be willing to pivot quickly, and embed emerging tools early. The next generation of CGT leaders will be those who pair bold science with operational readiness and aren’t afraid to move fast and aggressively adopt what works.
Author Bio
Brian Newsom is the Founder and CEO of Carrigent and a seasoned leader in cell and gene therapy, with over three decades of experience in leadership, business development, and technical roles across academia, tools and technologies, services, and cell therapy development companies.
