AABB interviewed Colleen Maiden, executive director for Clinical Apheresis and Cell and Gene Therapy Solutions at American Red Cross, a participating organization in the Biotherapies Pavilion at the 2024 AABB Annual Meeting. Read the interview below to learn more about the American Red Cross Cell and Gene Therapy Solutions team.
Hello, my name is Colleen Maiden, and I serve as the executive director for clinical apheresis and Cell and Gene Therapy Solutions at the American Red Cross. I oversee business development and strategic planning for our autologous and allogeneic products and services, as well as direct patient care services for our therapeutic apheresis and stem cell operations. My team is dedicated to providing research products and manufacturing services to hospitals, patients and biopharma companies with the goal of improving quality of life.
I've been with the American Red Cross for more than 20 years, holding leadership positions across various business units. I currently reside in southern New Jersey, and when I'm not working, I enjoy spending time with my family, participating in outdoor activities and cheering on the Philadelphia sports teams.
Our Cell and Gene Therapy Solutions team has been supporting the collection and processing of autologous and allogeneic therapies for over a decade, offering both CAR-T and stem cell collections and cell-sourcing starting material from a diverse pool of healthy donors. With a national network of more than 70 collection sites, we've completed more than 50,000 autologous collections and support seven FDA-approved cellular drug therapies available for various blood cancers.
Our allogeneic program supplies fresh and cryopreserved Leukopaks for RUO and GMP applications, supporting clients at all stages. We offer flexibility in processing both inside and outside our cleanrooms to ensure high standards of quality. Products are shipped across five U.S. collection sites (California, Georgia, Ohio, Oregon and Pennsylvania), with expansions into New Jersey and Massachusetts this fall. The Red Cross's products and services support all phases of development, from pre-clinical through commercial development.
Our mission is to provide comprehensive solutions to clients, including apheresis treatments, specialized collections and manufacturing services, by leveraging our physician, nursing and technical expertise. These strengths, coupled with the power of the Red Cross brand and our expansive geographical reach, enable us to deliver tailored, life-saving products and services precisely when and where patients need them.
Most of us have a personal connection to the Red Cross mission in some way. However, many may not realize that the Red Cross is a strong partner in the cell and gene therapy space. For us, the challenge is about letting others know that we’re here to support your research needs. Our platform partnership has grown significantly over the past few years to include scientific and medical resources, a more extensive product line and the ability to customize services.
The work we're doing aligns seamlessly with our mission to alleviate human suffering. With our extensive experience in collections and donor management, we are well-positioned to be a trusted partner in this field.
As a strong partner in the cell and gene therapy space, we will continue to strategically look to expand our collection capabilities to reach more patients and donors. We have begun scheduling leukopak collections in Fairfield, N.J., and pre-screens in Dedham, Mass., taking us to seven collection sites with the ability to leverage more. In the near term, we're focused on strengthening ties with the community to further expand our already robust donor pool. On the product side, we're working to grow our GMP offerings within the allogeneic portfolio, particularly for fresh, cryopreserved, and additional processing to meet leukopak market needs. The new GMP products we'll be introducing over the next 12 months reflect the hard work and dedication of our teams, as well as our commitment to meeting the evolving needs of our hospital and biopharma clients.
The American Red Cross Cell and Gene Therapy Solutions (CGTS) has had a longstanding partnership with AABB through our blood collection services, which dates back many years. This collaboration, rooted in ensuring the highest standards for blood collection and safety, naturally evolved as we expanded into the cell and gene therapy space. Our expertise in blood collections, manufacturing and distribution, coupled with AABB's leadership in setting standards and promoting accreditation, provided a strong foundation for extending our work together into advanced biotherapies. This enduring partnership continues to support innovation and excellence as we jointly work towards advancing the field of biotherapies for improved patient outcomes.
I anticipate that the next breakthrough in biotherapies will be the development of more off-the-shelf, allogeneic therapies. These therapies, which don't rely on a patient's own cells, could revolutionize accessibility by reducing the time and cost associated with personalized treatments. As a provider of high-quality starting materials and cell collections, we are uniquely positioned to support this shift by supplying reliable allogeneic products that meet the stringent requirements for next-generation therapies. Our ability to scale collections and provide the critical components for these therapies will play a key role in helping biopharma companies bring innovative, off-the-shelf treatments to patients faster and more efficiently. Until this occurs, I am passionate to engage in discussions around patient centered apheresis sites, how can we further reach the underserved community with personalized medicine.
What I find most rewarding about working in this field is knowing we're part of something that truly changes lives. Whether it's supporting the development of new therapies through our collection services or products, improving processes or collaborating with partners, everything we do has the potential to offer patients options they didn't have before. Being in a field that's constantly evolving is exciting, and the innovation at its core makes the challenges worthwhile.
For anyone just starting out, my advice is to stay curious - this field is always advancing, so keep learning and stay open to new ideas and technologies. Be patient, as progress can take time, but don't let that discourage you. Collaboration is key in biotherapies, so build strong relationships and work closely with others. And above all, always keep the patient at the center of your focus. At the end of the day, your work is about making a real difference in people's lives, remembering that will keep you grounded and motivated.
Register your interest in biotherapies sponsorship and connection packages at the 2025 Annual Meeting, taking place October 25-28, in San Diego, CA.
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