Cell therapy has emerged as one of the most promising frontiers in biopharmaceutical innovation, offering potential cures for diseases once considered untreatable. Yet, developing these personalized therapies presents a unique set of challenges, particularly for early-stage biotech companies navigating complex scientific, manufacturing, and regulatory hurdles. The Cell Therapy Manufacturing Center (CTMC) is pioneering a new approach by integrating development, manufacturing, regulatory, and clinical logistics under one roof — creating a truly end-to-end ecosystem designed to accelerate therapies from the lab bench to patient care.

We spoke with Amy Hay, chief business officer at CTMC to understand how their model addresses the industry’s toughest pain points, fosters efficient development, and supports global access to these groundbreaking therapies.

CTMC’s model integrates everything from patient cells to regulatory strategy under one roof. What problem were you trying to solve by creating this kind of ecosystem, and how has it evolved since launch?

The biotech industry, especially in cell therapy, is inherently complex and fast-moving. There is tremendous uncertainty, and delays in development or regulatory missteps can be costly, both financially and in terms of patient impact. When we launched CTMC, our goal was to build more than just a traditional contract development and manufacturing organization (CDMO). We wanted to create a supportive, integrated ecosystem that offers not only development and manufacturing expertise but also regulatory strategy, clinical trial logistics, and commercial planning — all in one place.

Early-stage biotech companies often face fragmented vendor relationships, having to contract separate partners for manufacturing, regulatory consulting, clinical site selection, and distribution logistics. This leads to inefficiencies, coordination challenges, and capital drain. CTMC’s model was designed to reduce these barriers by providing a comprehensive platform that enables biotechs to accelerate their timelines, reduce risk, and use their resources more efficiently.

Since our launch, the ecosystem has evolved with an expanding network of partnerships, deeper integration of regulatory experts within development teams, and enhancements in supply chain management to support both local and global manufacturing needs.

You’ve achieved eight INDs in just two and a half years. What lessons or key factors have enabled this pace?

Two core factors underpin our rapid progress. First, embedding regulatory expertise early within our development teams has been critical. This ensures a continuous feedback loop where regulatory considerations inform scientific and manufacturing decisions from the outset, avoiding costly late-stage changes.

Second, we emphasize early and ongoing engagement with regulatory agencies such as the FDA. By initiating discussions early in the development process, our partners gain clarity on evolving requirements, and can tailor their programs accordingly. These early interactions build collaborative relationships with regulators, smoothing the path for IND submissions and approvals.

This combination of integrated regulatory strategy and proactive agency engagement has allowed CTMC to accelerate development timelines significantly compared to the industry norm.

How does CTMC’s partnership with MD Anderson Cancer Center accelerate the cell therapy pipeline compared to traditional CDMO models?

CTMC was spun out of MD Anderson Cancer Center’s Therapeutics Discovery Division, blending their world-class cancer research expertise with Resilience’s advanced manufacturing capabilities. This unique partnership gives CTMC a competitive edge in accelerating early-stage cell therapy development.

MD Anderson is one of the leading cancer centers globally, with over 80% of its patients enrolled in clinical trials and more than 60% of FDA-approved cancer treatments having run pivotal trials there. Through this partnership, CTMC offers its partners direct access to this vast clinical and research network, enabling faster trial initiation and patient recruitment.

Additionally, our presence within the Texas Medical Center — the largest medical complex in the world — provides unparalleled access to cutting-edge research infrastructure and a vibrant innovation ecosystem. This proximity helps shorten timelines and lower costs for clinical proof of concept, as biotechs can rapidly move from development to patient delivery in a streamlined, connected environment.

Biotechs often struggle to scale due to fragmented infrastructure. How does CTMC’s “bolt-on” approach reduce risk and improve timelines?

Our fully integrated model supports companies at every stage of their development journey — from early preclinical development through to commercial-scale manufacturing. By embedding strategic, regulatory, and operational support into a single platform, we eliminate the need for biotechs to hire multiple specialized teams or rely on external consultants for every step.

This “bolt-on” co-development approach allows companies to preserve capital and focus on advancing their therapies, while benefiting from CTMC’s deep expertise and infrastructure. For example, many of our partners operate with lean internal teams, sometimes as small as five employees, relying on us to provide the full spectrum of manufacturing, regulatory, and clinical logistics support.

This alignment of incentives fosters true partnership and reduces the risk of delays or costly missteps caused by disconnected vendor relationships. Ultimately, it helps companies move faster and with greater confidence through the “Valley of Death” — the critical phase between discovery and clinical proof of concept.

What role does your circular supply chain model play in ensuring speed, quality, and patient-centricity?

Cell therapy is the epitome of personalized medicine — the patient is part of the supply chain. In therapies such as CAR-T, the time from cell collection (apheresis) to reinfusion (known as “vein-to-vein” time) is a critical metric that directly impacts clinical outcomes.

Manufacturing close to the patient is not just convenient but essential to shortening this window. A shorter vein-to-vein time reduces the risk of disease progression while cells are outside the body, and can improve overall response rates and survival. Delays often force patients to undergo bridging therapies, like chemotherapy, which can increase side effects and complicate treatment.

Our regional manufacturing sites, embedded near clinical centers of excellence, enable rapid, high-quality production with tight chain-of-custody controls. This circular supply chain model ensures that therapies are delivered quickly, safely, and with patient needs at the center.

How does CTMC help early-stage biotech companies avoid the “Valley of Death”?

Early biotech development is often described as a “Valley of Death” because of the high risk, high cost, and high uncertainty companies face before demonstrating clinical proof of concept. Many promising therapies fail due to lack of funding, regulatory challenges, or manufacturing hurdles.

CTMC acts as a trusted co-development partner, guiding companies through this critical phase by providing strategic and operational support tailored to their needs. We help companies select candidates wisely, design development plans aligned with regulatory expectations, and build flexible business models that can adapt as new data emerges.

This reduces costly errors, shortens timelines, and maximizes the efficient use of capital — helping companies cross the Valley of Death and position themselves for successful later-stage funding and commercialization.

What insights emerged from the “Therapies Without Borders” panel at ISCT regarding manufacturing for global delivery?

Global access to cell therapies remains a major challenge. High costs, complex logistics, and varied regulatory frameworks limit availability outside major markets like the US and Europe. This creates inequities in patient access worldwide.

The “Therapies Without Borders” panel highlighted the urgent need for cross-border collaboration, education, and harmonization of regulatory standards to democratize access. Many panelists expressed frustration with agencies unfamiliar with the unique aspects of cell therapy, leading to onerous requirements that delay patient access and add costs.

At CTMC, we are committed to helping build capacity and knowledge globally through our Global Network Alliance. By sharing best practices and providing education, we aim to support the development of efficient, compliant supply chains that enable cell therapies to reach patients wherever they are.

How is CTMC helping clients stay compliant amid evolving regulatory expectations while maintaining speed?

The regulatory landscape for cell therapies is rapidly evolving as agencies strive to keep pace with scientific advances. However, limited funding and staffing at agencies sometimes slow the updating of guidelines, increasing uncertainty for developers.

CTMC’s deep FDA expertise enables us to guide partners through early regulatory engagement and embed compliance considerations from the outset. This proactive approach helps avoid surprises, reduces review cycles, and streamlines approval processes.

By aligning development strategies with regulatory expectations, our partners can move faster and with greater confidence, balancing speed with patient safety and quality.

What types of biotech partners are best suited for CTMC’s platform, and what do you look for in collaborations?

We partner with biotechs who value collaboration and a co-development mindset, aiming to accelerate clinical proof of concept with a comprehensive, expert-driven platform.

Different manufacturers offer different advantages. If capital efficiency is a priority, partnering with CTMC’s integrated platform that combines development, regulatory, and operational support can be transformative. For companies prioritizing speed to clinic and academic collaboration, CTMC’s close relationship with MD Anderson provides unique benefits.

Ultimately, we seek partners who want to leverage a fully integrated ecosystem to advance their therapies rapidly and reliably.

Looking ahead, how will CTMC’s role evolve as cell therapy matures over the next five years?

We anticipate major innovations driven by demand for cost reduction and broader access. Automation and standardization will be key, reducing manual labor and improving consistency in manufacturing.

Artificial intelligence and machine learning will transform multiple aspects of cell therapy development, from patient selection to predictive analytics for outcomes and safety. These technologies will enable developers to demonstrate value more clearly and optimize therapies more effectively.

Digital biomarkers and real-world evidence collection will become increasingly important, allowing earlier interventions and improving long-term patient monitoring. This will move cell therapy closer to preventive and personalized medicine, improving outcomes and reducing costs.

CTMC is positioned to lead these advancements, continuing to provide the integrated, innovative platform that early-stage biotechs need to succeed in this rapidly evolving field.

“As the cell therapy landscape continues to evolve rapidly, CTMC stands at the forefront, combining scientific innovation with strategic partnership to accelerate the journey from discovery to patient impact. By integrating development, manufacturing, regulatory expertise, and clinical collaboration under one roof, CTMC is helping biotech companies overcome traditional barriers, optimize capital, and bring transformative therapies to market faster. Looking ahead, advancements in automation, digital technology, and artificial intelligence promise to further revolutionize cell therapy, and CTMC’s unique ecosystem is well-positioned to lead this progress, driving both innovation and access globally.”