Joe Newcome, Minaris Advanced Testing, on why release testing is setting the pace.
Introduction
In advanced therapies, speed is often framed in terms of manufacturing—how quickly a product can be produced, scaled, and delivered. But before any therapy reaches a patient, there is another step that ultimately determines how fast that process can move: release.
That step is defined by analytics.
For Joe Newcome, Senior Director of Analytical Sciences at Minaris Advanced Testing, the shift is clear. After more than two decades working across potency assays and analytical development, he has seen how the role of analytics has evolved from a supporting function into a defining one. “Every product needs to be released,” he said. And increasingly, the structure and performance of that release process are what determine how quickly a therapy can move from development to patient.
Where Time Is Gained—or Lost
In cell and gene therapy, timelines are often measured in days, sometimes even hours. The concept of “vein to vein”—the time from patient sample to treatment—has become a central metric in how programs are evaluated. And within that window, analytics plays a decisive role.
“Having a well thought-out, built release panel is what’s driving turnaround times,” Newcome explained. The design of that panel—what assays are included, how they are run, and how quickly results can be generated—directly impacts how fast a therapy can be released.
That makes analytics more than a checkpoint. It becomes a constraint—or an accelerator—depending on how it is built. The question is no longer just whether testing is accurate. It is whether it is structured to support the timelines advanced therapies demand.
The Complexity of Potency
Among all analytical challenges, potency remains one of the most difficult to define and execute. It is not a single measurement, but a reflection of how a therapy performs—something that can be difficult to capture in complex biological systems.
“Potency is one of our key assay areas,” Newcome said. “It is typically one of the most difficult for people to manage.” At Minaris Advanced Testing, his team works across the full lifecycle—from early method development through commercial lot release—helping translate biological function into measurable, reliable outputs.
That translation is not straightforward. Potency assays must balance scientific relevance with operational practicality, all while meeting regulatory expectations. As therapies become more complex, that balance becomes harder to achieve—and more critical to get right.
A Shift in Regulation—and Responsibility
At the same time, the regulatory environment is evolving. One of the most visible shifts is the move away from animal testing, a change that has been discussed for years but is now becoming more concrete.
“I think the biggest one is the push to move away from animal testing—and what that actually looks like in reality,” Newcome said. That transition is driving increased interest in alternative methods, including sequencing-based approaches for adventitious agent testing and other advanced analytical techniques.
But with that shift comes uncertainty. While the direction is clear, the implementation is still being defined. “People have been thinking about it for a while,” he noted, “but how that happens across the board is what a lot of people are focused on right now.”
As regulatory frameworks become more flexible, the responsibility shifts back to organizations to define, justify, and validate their approaches.
The System Has Changed
Newcome’s perspective reflects a broader transformation across the industry. Analytics is no longer confined to the back end of development. It is integrated into how therapies are designed, evaluated, and ultimately delivered.
That shift connects multiple parts of the system: developers designing therapies, analytical teams building assays, regulators evaluating data, and service providers supporting programs across different stages. What was once a sequence of steps is now an interconnected process, where decisions in one area directly affect outcomes in another.
In that environment, analytics becomes the point where science, operations, and timelines intersect.
The Bottom Line
The next phase of advanced therapies will not be defined by how quickly products can be made. It will be defined by how quickly they can be released. Joe Newcome’s perspective makes that clear. The ability to design analytical systems that are both rigorous and efficient is no longer optional—it is central to delivering therapies at the speed patients require. Because in the end, innovation does not reach the patient until analytics says it can.
