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Debra BenAvram, CEO of the Association for the Advancement of Blood & Biotherapies (AABB), reflects on how AABB is helping the biotherapies community continue to expand and innovate while ensuring optimal safety, quality and access for patients.
To start, could you please introduce, or reintroduce, the Association for the Advancement of Blood & Biotherapies (AABB) to those who have yet to interact with the organization?
Of course. AABB is an international, not-for-profit association representing individuals and institutions who are instrumental in making biotherapies safe, effective and available worldwide.
Our diverse membership includes professionals and organizations from across the biotherapies product lifecycle and comprises of medical directors, laboratory technologists, CEOs, cell collectors, and more working in research laboratories, hospitals and other organizations who create and provide these therapies for patients.
We advance the field through the development and delivery of AABB standards, accreditation and education programs. Additionally, in collaboration with our membership, we work to address the field’s challenges, drive policies that advance novel biotherapies research, and increase patient access to biotherapies.
As the number of available biotherapies increases through both clinical trials and commercial approvals, AABB wants to ensure our decades of experience and vast membership supports the promotion of quality and sharing of best practices in developing and providing these treatments to patients.
We are honored to attend Advanced Therapies Week again this year and look forward to collaborating with companies eager to bring their products and services to market.
What have been some of the highlights for AABB in biotherapies sector this past year?
Intercompany and interdepartmental agreements and chain of custody remain a big challenge for the industry, so I am pleased to say they have been added to the latest edition of AABB Standards for Cellular Therapy Services. We have published these standards for more than 30 years, and the current 11th edition went into effect in July 2023.
It’s through these standards that AABB offers accreditation of biotherapies services around the world. AABB Accreditation identifies sites operating at the highest level of quality and serves as an endorsement of their processes and procedures, as well as a strong reassurance that patient safety is paramount.
Another accomplishment for us this year was the return of our in-person AABB Annual Meeting – with more than 3,000 attendees convening for the first time since 2019! Our community could write a book on the power of coming together to learn, network and build toward the future. Similar to Advanced Therapies Week, the energy of our Annual Meeting was palpable from the first moment to the very last – including for me when members who I hadn’t yet met approached me in the airport for a quick chat before getting on our return flights home!
It was particularly exciting to see the marked growth in AABB’s focus on creating a space for learning, problem-solving and providing support for each other around the development and delivery of biotherapies. This included an increase in the number of biotherapies educations sessions, a brand-new Biotherapies Pavilion in the Exhibit Hall, and an overall wonderful event honoring AABB’s first cohort of Certified Advanced Biotherapies Professionals (CABPs).
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Could you remind everyone about the CABP program?
Yes! In 2022, AABB developed the CABP program in response to worldwide workforce shortages in the field of biotherapies and the challenges associated with identifying and retaining highly qualified employees. It is the first and only certification for biotherapies professionals and comprises an exam designed to certify candidates that have the necessary knowledge to practice in the biotherapies field. Candidates must meet pre-requisites, obtain a passing grade on an exam covering seven key domains, and agree to the CABP code of conduct to earn the certification.
We believe the CABP benefits the entire biotherapies field by establishing minimum standards of competence, identifying qualified and proficient professionals, and advancing safety and quality. It makes it easier for companies to identify highly qualified candidates with appropriate knowledge and experience by looking for professionals with the post-nominals of CABP. We’re currently counting more than 120 CABPs in over 10 countries worldwide and expect to see many more in 2024!
We are looking forward to discussing the need for establishing a well-qualified workforce within biotherapies and the CABP and at AABB’s upcoming roundtable discussion during Advanced Therapies Week 2024. As an association, we know our strength lies with community and membership. It is by bringing many and varied voices to the table that, together, we can continue to develop the tools, resources, and services in support of our ongoing mission for the advancement of blood and biotherapies.
What advice would you give to individuals interested in pursuing the CABP?
We had a really interesting discussion with our first cohort of CABPs at the AABB Annual Meeting. Particularly, we explored how we can help biotherapies professionals feel excited and confident in taking the exam.
As the certification benefits our entire field, it will be a continued goal for AABB throughout 2024 to get more people to sit for the exam. That’s why we’ve also been working on various ways to make the exam more approachable for those who qualify.
In late 2023, we launched a new online exam pre-approval questionnaire for the CABP. By completing a few short questions applicants can hear back from AABB to find out if they are pre-approved for the exam. You can find the questionnaire and all the information about the CABP here.
We also want to make studying and preparing for the exam more comprehensive. The exam syllabus on the AABB website is a great place to start, and features both suggested reading and the exam blueprint – it’s an essential and entirely complimentary first resource for anyone interested in becoming a CABP. We’re also soon to publish two separate sets of sample exam questions. These will be available on the AABB website and will be a great way for applicants to prepare and gauge if they are ready for the exam.
So, in a nutshell, I would say to anyone interested in the CABP to go for it – it’s the perfect professional goal for 2024!
What advantage does AABB’s long-standing background in transfusion medicine offer when looking to address similar challenges within biotherapies organizations?
Recently AABB led advocacy activities to protect patients’ access to the range of laboratory-developed tests (LDTs) required to ensure safe blood transfusions and biotherapies. Providers often use LDTs when caring for patients being treated with biotherapies, such as stem cell transplants and CAR T-cell therapies. FDA issued a proposed rule that would classify and regulate LDTs as medical devices, resulting in these tests being subject to unnecessary regulatory burdens and user fees. FDA’s proposed rule has the potential to threaten patients’ access to critical medical services, stifle innovation and negatively impact patient care. Therefore, AABB spearheaded efforts to request that FDA specifically exclude or continue enforcement discretion for all tests conducted by blood establishments, transfusion services, and accredited cell and gene therapy services.
In addition, AABB membership comprises the world’s largest network of cell collectors and we accredit more cord blood facilities than any other accrediting organization in the world. Our vast network of biotherapies professionals is ideal to help biotech companies develop resources and share information and tools to address some of the pressing issues they face.
How can individuals or organizations get involved with AABB and join your conversations?
AABB offers a variety of ways to join our community, including individual membership and our corporate partner program.
Membership comes with exclusive, essential resources and benefits, which provide tools to stay ahead of important issues in the field and education to advance within a career path. All memberships, of course, include access to our community and our invaluable network of members from around the world.
For organizations interested in joining AABB, we work with each company and their staff to fully identify and understand their needs, be it quality management system designs and implementation, regulatory questions and guidance, cell collection partnership and qualification, process improvement, workforce training and development and more. As well as our excellent account management staff, AABB’s strength also lies in our ever-growing, international consulting services team that has been a leader in developing innovative strategies and solutions for the field of transfusion medicine and biotherapies.
I encourage any organization interested in learning more to browse our website, or to book in an introductory meeting with us. The AABB team will be attending Advanced Therapies Week 2024 and look forward to meeting with biotech companies seeking to advance their business to discuss areas of collaboration.
CONNECT WITH AABB DURING THE MEETING USING THE PHACILITATE PARTNERING APP OR
Visit AABB’s Virtual Booth to schedule a meeting with the AABB team or to find out more AABB’s biotherapies offerings.
This interview has been produced in partnership with AABB ahead of Advanced Therapies Week 2024.
