Blood Centers Complement Hospitals to Drive Cell and Gene Therapy Access

Hospitals excel at designing services fit for their needs. A pediatric cancer center of excellence, for example, is likely to produce superior outcomes due to its robust, experienced, cross-functional teams that are hyper-focused on all phases of treatment. These healthcare professionals are experts in the critical thinking required to solve/resolve the myriads of dynamic, nuanced issues affecting each patient’s care.

However, departments within hospitals compete for limited resources such as funding, space and staffing, and must periodically re-evaluate their make-versus-buy decision for services. In today’s competitive environment, hospital systems and pharmaceutical companies are increasingly turning to blood centers to leverage their specific skill sets and collaborative networks to expand access to cell and gene therapies (CGTs). This partnership may include potentially developing curative treatments made directly from patient or donor materials, in several ways.

Blood centers have supported biologic treatments for over 80 years. Initially, blood was collected in hospitals – but due to the complexity of GMP compliance and the fact that biologics manufacturing is not usually part of a hospital’s primary mission, most hospitals opted to leverage blood centers’ expertise in blood component collection and manufacturing. Today, blood centers provide nearly all of the U.S. blood supply and partner with hospitals, providing a variety of services including therapeutic apheresis procedures, immunohematology reference testing, human leukocyte antigen (HLA) testing, organ and tissue procurement services, and stem cell collections and processing.

Similar to the aforementioned concentrated and robust experience at the pediatric cancer center, blood centers consistently deliver high- quality services. Uniquely focused on the recruitment, collection, manufacturing, testing and distribution of biologic products, blood centers employ skilled professionals, including nurses, physicians, technologists, and quality and regulatory professionals. Together, they excel in managing complex logistics, delivering the right product to the right patient at the right time. This is especially true from institutions accredited from the Association for the Advancement of Blood & Biotherapies (AABB) or the Foundation for the Accreditation of Cellular Therapy (FACT), which ensure strong quality management systems and familiarity with regulatory requirements.

While hospitals may partner with other hospitals to share services, this can get complicated due to competition, continuity of insurance coverage, and risk. A hospital system may be reluctant to accept the risk of collecting or processing products for patients from other hospitals, unless that patient is transferred to them. In contrast, blood centers are neutral partners, as they do not compete with hospitals for patients. Instead, they complement hospitals by providing a focused array of high-quality, specialized, patient-centric services, allowing hospitals to maintain primary relationships with patients and their families.

Fit for purpose

Each hospital has its own community, mission, vision, strategic objectives, and how they approach access to CGT related services. Some hospitals, especially larger ones, have developed all required services themselves. The remaining hospitals, though, seek support from one or more outside partners like blood centers in the “first mile and last mile” of CGT, such that the blood centers collect and process (including storage and issue) the final product for them.

Experts have warned of the coming tsunami of CGTs and hospitals are beginning to wonder how they will meet this challenge, and how much further they will be able to expand their current capabilities. Some early adopters support CAR T-cell therapy for hematological malignancies but are concerned they will not be able to expand into other indications, such as solid tumor cancers and autoimmune diseases. Pharmacies, while comfortable handling a variety of biologics (such as monoclonal antibodies and interferon), are mostly not prepared to handle living cellular products, whether fresh or frozen. Nor are traditional cell therapy laboratories necessarily resourced to receive, thaw, dose, and issue CGT products.

Most hospitals understand that there is currently a shortage of trained apheresis and laboratory staff and it takes months to years of highly specialized training to be fully functional. Thus, it will be impossible for every institution to build their own CGT service lines. Further exacerbating the challenge is the additional training and mastery of the CGT collection and processing along with the characteristically nuanced requirements for each type of CGT being licensed, not to mention that an investment would be required in additional administrative, quality, regulatory, clinical, and legal staff to support the services internally.

As these issues crystalize, hospitals are acknowledging to us they are currently at capacity and unable to adequately address the hurtles needed to reach a required level of expertise alone. Blood center partnerships can fit hospitals’ unique CGT needs, freeing up resources for hospitals to do what they do best – treating patients.

Evolving partnerships

In the early days of cell therapy, a single clinical program worked with a single collections team and a single cell therapy lab. Today, these relationships are no longer one-to-one, but many-to-many. A patient may be treated in one of several affiliated locations, including the main facility and a closer community clinic, before having their cells collected by one of several potential teams and sent to specific CGT vendor-approved lab for initial processing, and then to another location for CDMO manufacturing, before being sent back to the patient.

Every step of the CGT process can be uncoupled and performed by a different entity. The blood center business model is designed to interface with hospitals as needed. Like a fast-casual restaurant model, blood centers provide customizable, made-to-order, high-quality fixed and à la carte self-service options. This flexible, multi-purpose model can meet a variety of hospital and patient needs, potentially expanding access to therapies that hospitals might not otherwise be able to offer.

The future of access

A current hot topic in the CGT space is about expanding patient access. Theoretically, everyone in the U.S. has access if they can travel to the limited facilities providing this care. Most of these centers of excellence (academic institutions, comprehensive cancer centers, and other large hospitals) are concentrated within a few 100 miles of the coastline, meaning large geographies remain where therapies are effectively inaccessible.

There is an urgent and growing need to treat patients where they are. Centers of excellence are typically part of a hub-and-spoke network, where specialized resources such as apheresis collections are provided at a single, central location. This means the infrastructure is underdeveloped for satellite locations, 4 to 5 hours away (or further) from the main facility. Patients prefer to receive as much of their care in their own communities as possible, as it is not only convenient but also helps them maintain jobs, stay in school, and be surrounded by their support system.

For example, we support a clinical trial for pediatric patients with inborn genetic errors in one of our geographies. Between local hospitals, the main institution who oversees the clinical trial from several states away, and Vitalant’s locations, families can remain local for most if not all of their treatment. In another instance, a cancer treatment center recently decided to expand into a territory we support. By using the resources already available from the blood center community, it was able to start treating patients quickly by outsourcing the collections and processing, without having to expend the resources required to bring up the services lines

Blood centers are already positioned to support hospitals across the U.S. They thrive in locations where donors can easily access them, which has been key for optimizing recallability. Today, you see blood centers ingrained in local communities – in shopping centers and other standalone collection facilities, at community healthcare facilities, and in mobile units that travel where needed. This accessibility will be crucial for patients who live a distance from large medical centers, outside of cities. In the future, it could even be possible to schedule at-home apheresis services or coordinate a collection during an appointment at their local generalist. Especially in an era of hospital consolidation and shrinking rural facilities, hospitals need to utilize tools like this to better serve their communities and underscore their relevance.

Since inception, blood centers have shared resources through a “network of networks” organized by industry-leading organizations such as AABB and Blood Centers of America (BCA) to expand access to life-saving blood wherever needed. Leveraging these relationships for the newer CGT products is a natural next step allowing hospitals to support patients living further from the main treatment facilities.

Blood centers provide apheresis collection services as inpatient and outpatient services, using either the hospital’s space or their own. Hospital inpatient and outpatient beds are expensive and oftentimes scarce. The trend toward outpatient collection in the blood center space is expected to expand over time, especially as CGT products move toward the first or second line of treatment and patients are treated earlier in their disease progression.

It is likely to follow the same trend seen with dialysis treatment: today, it is estimated that approximately 85% of all dialysis treatments in the US are performed in stand-alone outpatient facilities, although in the early 1960s they were initially provided as an inpatient service. Some dialysis can be done in a specialist’s office, and the same is true of apheresis. However, blood centers already have spaces for collecting blood donors, which can be easily modified to collect patients. In fact, many blood centers have already built dedicated patient-use collection spaces.

Exciting new therapies and treatment models are rapidly being developed and brought to market, combined with a healthcare system straining under increasing costs, diminishing resources, and critical talent shortages. Blood centers are strategically well suited, with flexible, complementary, expert services to support hospitals, as they bridge the growing gap between the promise of CGT and patients in communities underserved around the country, which remain in desperate need of its healing potential.

Photo: jxfzsy, Getty Images

This post appears through the MedCity Influencers program. Anyone can publish their perspective on business and innovation in healthcare on MedCity News through MedCity Influencers. Click here to find out how.