In a recent IBTV Spotlight session titled “What We Don’t Know… Keeping Safety a Priority in Uncharted Territory,” industry experts explored the challenges and opportunities in Cell and Gene Therapy (CGT). Heather Purvis, Director of Clinical Operations at Title21 Health Solutions, provided valuable insights on ensuring safety while navigating rapid innovation. Below are key highlights from her contributions:
The Complexity of Novel Therapies
Heather emphasized the layered complexity of CGT, noting that each new therapy introduces unfamiliar processes, equipment, and expectations for frontline workers. She stressed the importance of balancing urgency with caution: “We’re trying to move at the speed of light to create therapies for patients who are literally dying, but we must also pause to ensure we’re doing it right.”
Digital Solutions and Standardization
Advocating for technology’s role in safety, Heather highlighted the need for digital tools with built-in safety protocols. She pointed out the industry’s struggle with standardized outcomes: “We need apples to equal apples so we can pivot or accelerate with clarity.” By embedding safety into digital workflows, teams can focus on critical decision-making rather than manual tasks.
Workforce Augmentation Through Technology
Heather addressed workforce challenges, arguing that technology should automate repetitive tasks to free up skilled professionals for higher-level thinking. “We need to give clinicians and innovators time back to do what they do best,” she said, cautioning against over-reliance on technology without human oversight.
Collaboration with Regulators
Regarding regulatory adaptation, Heather acknowledged the delicate balance regulators must strike. While advocating for evolution, she underscored their vital role in patient protection: “If we ask regulators to adapt too far, they’re not doing their jobs. We must approach this with grace.”
Final Thoughts
Heather closed by calling for humility and recentering on patients: “They’re not numbers or dollar signs—they’re people. That’s what will keep us at the right pace.” Her perspective underscored Title21’s commitment to advancing CGT safely and sustainably.
Watch the full IBTV Spotlight below:
