Vital Science

S3, E03: Donors: The Unsung Heroes Advancing Science

 

About this Podcast Episode

The role of human cells and tissues is key to developing next-generation therapies. With just a few samples, donors contribute to scientific advancements in medicine. This is especially true with cell and gene therapy, a field that is projected to grow over the next several years, and with it comes the growing need to find reliable and recallable donors willing to help those in need. Join us to learn more about the critical role these unsung heroes play in advancing the future of therapeutic development.

  • Episode Transcript

    Chris Garcia:
    In recent episodes of Vital Science, we have heard about the incredible work being done to develop new cell and gene therapies for diseases like Huntington's, multiple myeloma, and epilepsy. But in order for a given treatment to make it from the lab to the hands of patients, several raw materials are needed. The most critical being cells sourced from human donors. Where do these donations come from? And will there be enough supply to sustain the expanding pipeline of groundbreaking treatments?

    I'm Chris Garcia. And in this episode of Vital Science, Gina Mullane speaks with Candace Givens of HemaCare about the important work of donor recruitment. We'll discuss the challenges of recruiting cellular product donors during the pandemic, why donors donate, and the increasingly important role of donation in today's pharmaceutical landscape.

    Gina Mullane:
    Candace, I'd love to start by learning about your experience with donors. As we've discussed previously on Vital Science, there are many key players who contribute to bringing a cellular therapy to market and for most it's their profession, but this isn't the case with donors. So what motivates them to come into the centers to donate?

    Candace Givens:
    So donors donate for many different reasons. We have some donors who are more altruistically motivated, meaning these are people who genuinely want to help others. And they may self-identify as being a donor, which means if you were to ask them to describe themselves, they might say, I'm a yoga enthusiast, I am a dog mom, I'm a blood donor. So they would really have made a point to self-identify themselves as a donor.

    Some feel that they are healthy and because they're healthy, they want to help to make others healthy by donating. Some of them might also have a more due unto to others type of attitude, meaning they know that they would benefit. They would happily receive a donation. So they're more willing to donate themselves. And they feel that sense of duty.

    We also have our cause-based donors as I like to call them. Cause-based donors are typically categorized under altruistic donors. Typically, cause-based donors, they have a specific cause that more motivates them, which could be cancer. It could be an autoimmune disease. It could be a degenerative disease. It could be something without a cure or a lack of effective treatments. But either way, they have some type of personal connection to the cause or disease that they're donating for. It could be because a family friend or a family member had a personal connection to it as well. So this is really their way of giving back.

    And COVID-19 plays into this a bit because COVID-19 is a cause that we've all been impacted by globally. And due to the impact of the pandemic, it's made some people more motivated to donate, to help advance research than previously, before. They feel like they're doing their part to contribute and that's really the cause that's motivating them.

    And then we also have our compensation driven donor. We do compensate our donors for their time and effort spent donating. And compensation donors are initially motivated by the compensation and it could be for various different reasons. It could be, they need extra money to pay for books, or they want to add their savings. They need extra cash or gas money. But I think what most interesting about compensation-driven donors is that they might start off with compensation being the driving force. But once our donor recruitment team starts to educate them on the bigger picture and the significance of their donation, they kind of transition into a more cause-based donor or at the very least a more informed and intentional donor. So they can become more invested in the role of being a donor, which really helps. This is the start of the donor nurturing process because when you give them a greater sense of purpose, they're more likely to return and continue to donate with you.

    Chris Garcia:
    This motivation to return and keep donating is a goal for any donation based organization. But when it comes to cell and gene therapy, it can be at a critical component of simply maintaining the supply chain. Human cells and tissues are the raw materials needed to research and develop next generation therapeutic drugs. These materials are challenging to manufacture and depending on a therapy, we know they must be sourced from human donors. Having a pool of recallable donors provides consistent access to well-characterized starting material for advanced therapies. It also gives drug developers a way to control variability in what is essentially a living product. For this reason, donor recruitment isn't a once and done operation. It's recruiting donors, educating them on how to ensure their donations are viable, and fostering a mutually valuable long-term relationship so they keep coming back. Let's hear more from Candace on the donor's journey at HemaCare.

    Candace Givens:
    The donor targeting and recruitment journey can be a lengthy one. So it starts really with our donor recruitment advertisements and we do specialized targeting methods with those. Those ads produce what we call donor leads, which is someone who's interested in donating and wants to be contacted. Our donor recruitment team then contacts the prospective donor and conducts an over the phone pre-screening. If they pass the over the phone pre-screening, we schedule them for an onsite pre-screening, which involves drawing blood samples, a small scale physical, and a health assessment and qualified donors from there are introduced into our donor program and we schedule their first collection. After the first collection is successful, then they're eligible for another collection, which is about five weeks later. So the total process from targeting to first donation, it takes about seven to nine weeks from initial contact.

    Gina Mullane:
    And what makes a good donor?

    Candace Givens:
    In general, a good donor is a healthy donor. Although we do have patient and disease state donors and collections, a healthy donor is someone who eats an iron rich diet, who has proper management of all their medications, has passed all the health screenings and evaluations, and also has a flexible and compatible schedule. Because a lot of times these donations can take a long time and you need to set aside that time to make sure they're able to complete it.

    A patient or disease stay donor might have a specific disease or disorder that we're collecting for, and they have very specific guidelines and medical requirements to meet.

    Chris Garcia:
    What Candace is referring to is allogeneic cell therapy which is a treatment manufactured from the cells of a donor, as opposed to autologous therapy which is treatment originating from the patient's own cells. As she mentioned, allogeneic therapies can have very specific criteria for donation. So once a drug developer has received FDA approval to commercialize their treatment, cellular product donation becomes a very large part of the manufacturing equation. If you want this product to be on the market for 10 to 20 years, then you'll ideally want donors who are willing and able to contribute for the long haul.

    Worldwide, the global donor base is aging and shrinking so many donation centers are focusing their efforts on recruiting a younger donor pool. Not only do younger donors offer higher cell viability, but they also are more likely to donate throughout product's time on the market. This helps to ensure that treatment is ready and waiting on the shelf when patients need it most.

    Gina Mullane:
    As I'm sure you've seen with delayed clinical trials and serious kinks in the supply chain, the pandemic has had a major impact on drug development. What effects have you seen on the donor recruitment side?

    Candace Givens:
    COVID-19 has been a significant challenge in donor recruitment. Donors in general, they're scared, they're concerned over unnecessarily exposing themselves to COVID-19. They have concerns surrounding their white blood cell count and their potential to fight off a COVID-19 infection. Sometimes we have to set up exclusive appointments for the donors to inspect our facility and to review our COVID-19 protocols just to put them at ease. And again, trending topics a lot of times do affect our donor leads and appointments. So for instance, Delta variant was trending for like eight days straight on social media. And during that time we had several canceled appointments and we had a marked decrease in our donor leads.

    Chris Garcia:
    Delayed and canceled donation appointments have the potential to spell disaster for drug developers, especially in the case of dedicated donors. Dedicated donors are assigned to a research program based on specific physiological, demographic, or lifestyle traits matching the program criteria. HemaCare clients can specify the number of donors they would like assigned to their pool based on current or projected program needs. They can also request donations on a certain schedule to support the project development timeline. This is why it is so important for donation centers to maintain a healthy pool of reliable donors and backup donors in the event a scheduled donor cannot proceed with collection.

    Gina Mullane:
    When you're working with clients, how do you address the complexities that may arise from recruiting very specific donors for products that are targeted to a small population?

    Candace Givens:
    Some orders have more criteria than others. So matching the donors, it's just a lengthier process and it's more involved. This starts with the pre-screening process. That's when they start to identify this. We have to remember that we're dealing with humans and they're not always available when we want or need them. So it really comes down to coordinating with the donor schedule. They might have work issues, babysitting issues, everyday life issues. And we also have to coordinate with our customers based on the donors' availability.

    Gina Mullane:
    So I'm hearing that building and nurturing relationships with prospective donors is critical. And not only as an advocate, but as a reliable and recallable donor for future donations. How do you educate donors on the donation process?

    Candace Givens:
    We educate our donors on the donation process by way of constant communication and relationship-building via our team. So we call and text our donors to inform them about the donation process and what to expect. We're constantly reminding them why they're donating, where their donations are going, how they play a part in advancing research. So constant communication is definitely key here. It's not necessarily formal, but more in a friendly and conversational type of way. We also match up our donor recruiters with our donors based on their personality to really help foster that relationship.

    Chris Garcia:
    Another key part of fostering a long-term relationship with donors is optimizing the donor experience. No one wants to go home from a donation appointment with a sore arm from being jabbed too many times, but it's much more than this. After all, donation isn't just a transaction. It's a contribution to a much bigger cause. HemaCare Goes to great lengths to ensure donors feel valued and safe within the walls of their centers and beyond. This means sending friendly reminders to eat an iron-rich diet and hydrate in the days leading up to their appointment, detailing the COVID-19 protocols each center has in place to help prevent exposure, and informing donors of the impact they are making on the lives of patients through ongoing communications.

    Gina Mullane:
    So tell us about the donor relationship management cycle and what that looks like.

    Candace Givens:
    The donor relationship management cycle starts when the donor is still in the bed, donating. The donor receives at least two visits from a donor recruiter to check in with them, to ensure that they're comfortable, and to thank the donor for donating. Every donor receives a follow-up call to check in with them and to ensure they're comfortable and that they had a pleasurable experience. We take all recommendations and suggestions given to us by a donor very seriously.

    Chris Garcia:
    All of these efforts will become even more important in the years ahead as the number of cell and gene therapies is expected to skyrocket. Materials like leukopheresis collections, isolated immune cells, and bone marrow aspirate are a critical and currently unmet need for therapies in all phases of clinical development from discovery research to commercial manufacturing. To meet this demand, Charles River has invested significantly in HemaCare, expanding its one donor center to four across the US. Now comes the challenging work of keeping donors coming through the doors. Pre-pandemic, donors were often found through tabletop marketing at events and signage on public transportation. But given the lifestyle changes resulting from the pandemic and the vast gap between supply and demand, HemaCare has shifted to a more scalable strategy. By focusing their efforts on digital and social media marketing, Candace and her team are hoping to meet more potential donors of a younger age, where they are, on their smartphones.

    Gina Mullane:
    The cell and gene therapy industry forecasts considerable growth in the years ahead. How will the industry meet the growing needs of customers?

    Candace Givens:
    We will continue to grow and expand our donor pool with current and innovative approaches in mind. We want to ensure our donor pool is large and diverse and we're going to continue to nurture our existing donors to increase donor recall.

    Gina Mullane:
    And will this anticipated growth impact donor recruitment?

    Candace Givens:
    Definitely because as the demand increases, so does the supply. That's why we really want to stay current with what's trending and with our forecasting capabilities. Whether it's social media, if that's still trending a few years from now or it's the next big thing, we want the ability to pivot as necessary. We really want to remain flexible in our approaches and continue to meet the demands of our customers.

    Gina Mullane:
    Thank you so much for the time today, Candace. I'm so glad we were able to tell the story of these donors. They're really the unsung heroes behind these breakthrough therapies. I hope those listening are inspired by your words and consider donating themselves if they're able.

    Candace Givens:
    My pleasure. Thank you so much for having me.

    Chris Garcia:
    In our next episode, the first of the new year, we'll catch up with one of our early guests on Vital Science, the team at Amylyx, to hear about their upcoming NDA for a novel ALS treatment. Until next time, thanks for listening and happy holidays from the team here at Vital Science.

Show Notes

 

All Episodes

 

Acknowledgments

Hosted by: Gina Mullane
Narrated by: Chris Garcia

Special thanks to: Candace Givens


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