Jason Bock

FDA's Manufacturing Registration Rule's Impact on Advanced Therapies: Part 2

On July 10, 2026, the FDA proposed a rule that would let distributed "hub-and-spoke" manufacturing networks register as a single establishment rather than site by site, while still requiring centralized quality oversight.

 Jason Bock, founder and CEO of CTMC, a joint venture with MD Anderson, says earning that trust requires the industry to move away from site-by-site manufacturing and toward a fully digital quality system, where every site runs off identical batch records and standard operating procedures. Without that, version control drifts between locations. An integrated system also allows a deviation or corrective and preventive action at one site to be pushed immediately to another site so the same mistake isn't repeated. For advanced therapies, where each batch is an individualized dose for an individualized patient, a lost batch isn't just an inventory hit; it can mean a patient doesn't get treated.

The proposed rule also closes a registration gap for foreign API and intermediate suppliers, but Bock notes this mainly affects small-molecule supply chains. Advanced therapies depend on viral vectors, specialized reagents, and single-use disposables from a concentrated supplier base, and Bock argues that robustness is currently something industry must build itself rather than something the rule directly addresses—though FDA attention may grow as these therapies scale. Bock sees the rule as part of a broader, encouraging trend of the FDA using data to reduce regulatory friction for advanced therapies. These regulatory actions signal genuine alignment between industry and the FDA on accelerating advanced therapies.

“I think we really feel in industry that we now have a partner with FDA about how to develop these amazingly impactful therapies in concert with FDA, to bring them to more patients and to have the full potential that they can have,” Bock states.

Click the video above to watch the interview.

Click here to watch part 1 of the interview.

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In part 2 of this 2-part interview, Jason Bock, founder and CEO of CTMC provides input on how the FDA's proposed manufacturing registration rule may impact personalized therapies.

FDA's Manufacturing Registration Rule's Impact on Advanced Therapies: Part 1

On July 10, 2026, the FDA proposed a rule to streamline registration for distributed manufacturing networks operating under a “hub-and-spoke” model, allowing them to register as a single establishment rather than registering each production unit separately.

 The change would let networks add, relocate, or remove units with less administrative friction. Companies would, however, have to provide the FDA with advanced notice. This rule may be especially relevant to cell and gene therapies, where personalized, patient-specific manufacturing doesn't fit the centralized, linear supply chains built for traditional small molecules and monoclonal antibodies.

Jason Bock, founder and CEO of CTMC—a joint venture with MD Anderson located adjacent to the Texas Medical Center—welcomed the proposal. Because autologous cell therapies start with a patient's own blood or tumor tissue and return a single dose to that same patient, Bock argues the supply chain needs to be built around proximity to patients rather than centralized scale, which is why CTMC located itself inside the world's largest medical center.

Bock noted that unit-by-unit registration hasn't been a major bottleneck so far, because Big Pharma has largely relied on centralized hubs—shipping starting materials to sites like New Jersey, Maryland, or Boston for manufacturing before redistributing globally. But he sees the FDA's move as forward-looking: distributed networks take years to plan and build, and having regulatory clarity now gives manufacturers confidence to design fit-for-purpose networks before demand requires them.

Bock's broader point is that as advanced therapies mature, moving away from independently regulated, autonomous sites toward integrated distributed networks will become increasingly important for making personalized medicine practical and scalable, and the FDA's proposed rule lays important groundwork for that shift.

Click the video above to watch part 1 of the interview.

1. FDA proposes rule to modernize drug manufacturing registration. FDA. Press release. July 10, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration

Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines.


Jason Bock

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