White Coats: Kevin Land on the Transformative Power of Cell and Gene Therapies

“White Coats” is an AABB News series that interviews the experts that are transforming the fields of transfusion medicine and biotherapies. Join AABB today to read the rest of this month’s issue.

Kevin Land, MD, CABP(H), is executive medical director for biotherapies and vice president of clinical services at Vitalant and an adjunct professor of pathology at UT Health San Antonio. His clinical responsibilities include serving as medical director for HPC-A collections and cellular therapy processing, supporting traditional hematopoietic progenitor cell (HPC) clinical trials and advanced cell and gene therapy for a variety of clinical programs across several states.

His career has been split between academic institutions and blood centers but has always focused on reducing barriers to increase access to the best care for all patients. His early research involved rapid yeast identification, embryological development, innate immunity and glial tumor induction. Today, he is a primary investigator for several clinical trials. He is an author of more than 80 scientific papers, several book chapters and has given countless presentations.

Land is very active in AABB and throughout the blood community. He was instrumental in helping AABB develop the certified advanced biotherapies professional (CABP) credential. In addition, he currently serves as chair of AABB's Accreditation Provision Committee and as a member of the AABB Cellular Therapy Standards committee.

How have your professional and research interests in systems design and improving donor and patient safety shaped your career?

My father and mother both played major roles. I am a second-generation, homozygous laboratorian who has wanted to be in medicine for as long as I can remember. I used to go to work with my mom, a medical technologist in a hematology lab, and my father, a PhD who ran both research and clinical labs. Whether at home or at work, our conversations would cover a range of medical and scientific topics. Through them, I met scientists and researchers from all over the world. Many of them had escaped their original country due to war and persecution. They were so kind and answered all of the questions a young person might ask. I knew I wanted to be a person who helped make the world a better place early on.

How have your professional and research interests in systems design and improving donor and patient safety shaped your career?

Every challenge is just an opportunity to overcome and improve. Perfection should not be the goal, just less imperfection along a path of continuous improvement. This is my focus in both process design and medical informatics. Improving the condition of patients, donors and the staff who care for them has been a powerful driver in my career. In blood banking, they are interrelated. There is often more than one approach to a problem, and my childhood experiences taught me the importance of getting multiple perspectives.

One of my biggest projects early in my career – where this approach was key to success – involved helping to reduce unnecessary deferral in donors and decreasing unit discards, both of which resulted in fewer units, more deferred donors and frustrated staff. Gathering different perspectives early in the process was the single most useful trick I learned. I love listening to the back-and-forth dialogue between staff sharing their different approaches and points of view. For our travel deferral project, we involved the collection, record review and donor notification staff; CDC and regulators to better understand insights and concerns about transfusion-transmitted disease risk; and several donors who were unnecessarily impacted.

In the end, we took two very complex datasets – the CDC Yellow Book and a global map – and developed a simple red light/green light travel risk toolkit that worked well for all stakeholders regardless of educational level. The error rate was reduced by 88% within the first six months and well received by all stakeholders and the blood bank community.

What is the biggest obstacle facing leaders in biotherapies today?

The biotherapy landscape is dynamic and complex, and the infrastructure is expensive. There are mature processes that support traditional hematopoietic stem cell therapies today – such as apheresis collection and cellular therapy processing, which are expensive enough relative to the current reimbursement models around the world. Many hospitals and blood centers have these resources. Supporting advanced cell and gene therapies, however, still requires clean rooms and additional expensive equipment and reagents. Currently, there is insufficient demand across health care to support this level of infrastructure in more than a few highly specialized locations.

Fortunately, biopharma companies are aggressively trying to find less expensive solutions to ensure more patients have access to their product, and some potential solutions are already coming to market.

Looking ahead, what do you see as the most exciting areas of research in biotherapies?

Advanced cell and gene therapies have the potential to transform health care for many patients, not just cancer patients but also patients with a broad range of conditions such as congenital abnormalities, diabetes, burns and autoimmune diseases (among others). I am most excited about expanding access to cell and gene therapies to a broad range of medical conditions and providing care closer to where patients live.

As more blood collection facilities are moving into cell processing, what are some of the key factors that help lead to success?

Meeting the customer where they are and having a toolkit of potential solutions to help with what we call the first and last mile of cell and gene therapy care is key. Most hospitals do not have the infrastructure to support biotherapies, or they have resource constraints that prevent them from providing every potential biotherapy solution to their patients.

Blood centers have a long history of GxP collection and manufacturing under a comprehensive quality management system for biologics, so they are well positioned to meet the requirements of most biotherapeutics. Many are already collecting cellular starting material or providing some level of support in cryopreservation or storage. Collections can occur at either a hospital or blood center or both, depending on resources. Hospitals seem like a natural location to collect patients, whereas blood centers are better resourced to collect unrelated allogeneic donors. As decentralized manufacturing comes to market, blood centers may be seen as ideal environments for primary manufacturing of some advanced cell and gene therapy products such as CAR-T in a hub and spoke model supporting several surrounding hospitals.

What advice do you have for facilities preparing to begin or increase their cell processing efforts?

Don’t be afraid to think out of the box and dream big audacious dreams. Find out who your potential clients will be and begin having transparent conversations with them about potential resources. The more you learn about their needs, the better you will be able to meet them. Think about how your existing staffing and infrastructure can be leveraged to serve your clients now and understand the gaps you need to address to achieve longer-term strategic goals. Put a strategic plan together filled with practical and achievable next steps and reasonable deadlines.

Give your team clear instructions and access to mentors that can help them grow to meet the challenge. Give them the resources and support they need to succeed. Do not be afraid to bring in new talent that has already succeeded at the higher level you are trying to achieve. Listen when staff say, “I think this is confusing or doesn’t work well.” Do not be afraid to ask questions or challenge the status quo. Solutions that have worked well in the past at your organization may not be the ideal solutions moving forward. There are resources at AABB and experts around the cell therapy world who are eager to help.

During last year’s AABB Annual Meeting, you spoke about workforce development for cell processing labs. What are the best strategies for training and retaining colleagues for cell processing labs?

There are four strategies: Actively make sure everyone feels like they belong IN your organization. Map each person’s job to your mission, vision and strategic plan. Cultivate a positive, customer-centric approach to internal and external customers. Listen to your team and learn and evolve your processes constantly.

If you have an exciting plan and a great culture, people will be motivated to be part of a team that makes that plan happen. We recently successfully collected the first apheresis stem cells in the U.S. for a startup trying to help patients get access to CGT clinical trials regardless of where the patients live, which clinical group they are using, or where the manufacturing occurs. It was amazing to watch the staff from all levels—legal, nursing, labs, IT, quality, medical and logistics—come together to make this happen. The staff were so excited to be a part of a solution that had never been done before. Although the client was beyond impressed we successfully met their requests in such a short time, we still came up with several opportunities for improvement.

What do you like to do in your spare time?

When I am not traveling, my wife and I can be seen walking around our neighborhood in the evening, regardless of the weather or amount of daylight. Folks stop us all the time and say ‘Oh wow, you are that walking couple. We have watched you walking for years.’ On the weekends, I love working on DIY projects around the house while listening to audiobooks or podcasts. I also enjoy cooking and traveling with my wife and now grown children.