As cell and gene therapies (CGTs) progress from the laboratory to patient care, clinical centers face unique challenges in adapting to these groundbreaking treatments. A recent IBTV panel discussion brought together industry leaders, including Heather Purvis, Director of Clinical Operations at Title21 Health Solutions, to explore the question: Are clinical centers ready for CGTs?
The conversation delved into several critical bottlenecks facing clinical centers as they prepare to handle CGTs, from infrastructure and workforce readiness to adaptable systems and standardized approaches. Heather Purvis shared valuable insights on how clinical centers can better prepare for the growing wave of gene therapies and improve their operational efficiencies.
Key Challenges in Preparing Clinical Centers
Heather began by emphasizing the challenges clinical partners face in adopting new therapies quickly. While clinical centers are eager to onboard CGTs, many struggle with infrastructure limitations that slow their ability to implement new systems. “A lot of what I’ve been hearing across the industry is that clinical centers have their way of doing things,” Heather said. “They want these therapies. The patients need them so desperately, so they want to onboard them as quickly as possible. But the infrastructure that they currently have doesn’t allow for super quick onboarding.”
She highlighted the importance of creating standardized equipment, training, and documentation approaches to enable the smooth adoption of CGTs. As she put it, “What we do is give them that standardized approach. Any communication that they have to send to new manufacturers or receive back in, we give them the capacity to digitalize that and support some of that.”
Addressing Workforce Challenges
A recurring theme throughout the discussion was the challenge of building a capable workforce. Heather emphasized the need for clinical centers to invest in training programs that provide technical knowledge and foster mentorship to sustain talent in this rapidly evolving field. “The talent turnover is expensive,” she noted, stressing the importance of retaining skilled professionals. “We have to step up and support that. We’ve seen a lot of emerging training and mentoring programs, and that’s encouraging.”
Other panelists echoed the issue of workforce readiness. Carol Houts of Germfree pointed out the difficulties in planning the workforce needs for clinical centers, especially when it comes to specialized roles required for CGT therapies. She also mentioned the challenge of retaining trained staff, as many clinicians leave for higher-paying opportunities in the private sector.
Overcoming Operational Barriers
Another area where clinical centers face obstacles is the operational side of clinical readiness. Priya Baraniak, an expert in Allogeneic Cell Therapy, pointed out that clinical centers must be fully prepared for the “last mile” of therapy delivery. She stressed the importance of understanding the logistics of cold chain management, proper documentation, and the handling of therapies. “If the therapy gets there and someone is not locked in on how you thaw that and administer it, you could end up not treating the patient,” Priya cautioned.
Heather agreed, emphasizing the need for clinical centers to be proactive rather than reactive when preparing for CGTs. She noted that much of the current approach to clinical readiness happens “too quickly, too late” and that the industry has an opportunity to better prepare centers before the therapies arrive.
The Role of Standardization and Flexibility
One of Heather’s key points was the need for clinical centers to adopt versatile solutions to accommodate therapy changes as they evolve. “It’s about adopting versatile solutions within your space that will allow you to pivot if there are differences or changes with the therapies,” she explained. This flexibility, she added, would help clinical centers scale their operations without unnecessary delays or additional costs.
In line with Heather’s insights, other panelists discussed how the industry must move toward a more collaborative model. Josh Ludwig of ScaleReady emphasized the importance of shared knowledge and flexibility in infrastructure, particularly for new clinical centers that are just beginning to implement CGTs. “We can’t have every new hospital system trying to start from scratch,” he said. “We need to learn from each other.”
A Collaborative Future for CGT Adoption
Looking ahead, Heather expressed optimism about the future of CGT adoption in clinical settings. She highlighted the shift from a supply-and-demand-driven model to a more standardized and scalable approach. “It’s time where the supply is no longer an issue,” Heather said. “We have the capacity to collaborate and have these conversations about what the clinics need from the manufacturers to be successful.”
As the CGT industry matures, successful partnerships and knowledge sharing will be essential for overcoming the challenges of clinical readiness. By addressing infrastructure gaps, providing training, and ensuring flexibility in their systems, clinical centers can be better prepared for the successful adoption of these life-saving therapies.
Conclusion
The road to clinical readiness for CGTs is not without its challenges, but Heather Purvis’s and other experts’ insights provide a clear path forward. By focusing on infrastructure, workforce readiness, and standardized processes, clinical centers can meet the demands of this rapidly advancing field. The collaboration between clinical centers, manufacturers, and technology providers will be key to ensuring the successful implementation and delivery of CGTs to patients in need.
Watch the complete session below.
