For more than four decades, David Bell, Chief Corporate Affairs and Legal Officer for Grifols, has been a leader within the plasma industry. He shares his career journey in this conversation — from his early legal and scientific roles to his leadership position within the Plasma Protein Therapeutics Association (Global Executive Board). David discusses the critical role of plasma-derived medicines, the importance of industry standards in ensuring patient safety, and the future of plasma science. His passion for mentoring the next generation and his deep commitment to the industry shine through as he reflects on the challenges, opportunities, and profound impact of plasma-derived medicines on patients’ lives.
Anita: You have such a long history in this industry. Tell me about it. Just the evolution and what you've seen overtime.
David: I first had involvement with this industry in 1982, and I was asked to do some legal work, for, at that time, it was Alpha Therapeutic. And from there, it just kind of rolled on.
I've got a bit of a scientific background, so I took on some scientific roles. I took some other business roles in the company, always a little bit from a legal side. But I was involved with Abra back in the 80s and 90s and then as it evolved into PPTA. And when Grifols purchased Alpha Therapeutic, acquired the assets of Alpha, then I became the member of the PPTA Global Board on behalf of Grifols.
And since then, it's been a remarkable journey, you know, experiencing a lot of opportunities with patients, stakeholders, understanding the work we do, understanding how it benefits people who have chronic diseases, that frankly, that’s what we're all about. We give people the opportunity to have a normal life, something they wouldn’t otherwise be able to do. And as a result of that, we have, pretty much a requirement, a responsibility, to ensure that what we do maintains their ability to have medicines that are safe, that are effective, that are pure, that are potent, and they can be comfortable in taking and that's our obligation as a company, our obligation as a provider of these medicines. And PPTA is really is the glue that holds us together. The front, the expert voice of the industry. And it really works well for us. And being able to utilize PPTA that has independently, credibility as an expert, and speaking with government regulators, speaking with people who perhaps don't necessarily feel the same way we do about our business. PPTA is able to get up there in front of stakeholders, in front of governments, in front of regulators and really be the voice that we think is a voice of reason. Voice on behalf of patients, voice on behalf of employees, a voice on behalf of the donors that donate plasma. It's all very, very important to us.
Anita: You are very engaged and have been as a member of the Global Executive Board. We do have a broader membership. What is the value of getting engaged with PPTA?
David: PPTA has developed a reputation and credibility as a true expert when it comes to talking about plasma, plasma therapeutics, how it affects patients, how it affects donors, and how it affects business, essentially allowing us to be able to collect plasma in a manner which is safe and a manner which is compassionate. That manner, which allows us to then manufacture, you know, the old thing of ‘vein-to-vein.’ It's a very true thing. It's taking the product, plasma, out of an individual donor and processing it in such a manner that you then put that into a patient. So there's this connection between the donor and the patient, and the company is in the middle there.
In order to kind of participate in that journey, so to speak, companies belonging to the PPTA, have the opportunity to be front and center when it comes to patients, when it comes to donors being able to promote the responsible treatment of donors, to promote the responsible provision of these lifesaving medicines. And that's really the major benefit, I think, that comes from PPTA. It gives industry, that otherwise, sometimes, does not necessarily have the most credible voice. It gives them an opportunity for a credible voice. And being able to be in front of regulators in such a way that they feel they are heard. Because we have a story to tell. We have a very good story to tell.
We provide what I think is truly a very necessary product. And without our products, a lot of people would be suffering needlessly. And as a result of that, we're able to come before the public, come before, whoever, and ensure that we're able to get that voice to be able to provide these medicines for chronically ill patients.
Anita: What do you see as the future of the plasma industry?
David: It's a really tough question, because a lot of people have said that this industry has been around since the early 1940s when albumin was first discovered to be useful on the battlefield. Eighty years of this industry that you would think by now that's mature and it's on, kind of, its downward slope. And I see it very, very differently than that.
I see that the plasma industry is still a developing industry. We are still identifying new proteins, either through proteomic analysis or all sorts of remarkable changes in the way in which drugs are developed. Looking at plasma proteins that are found in plasma that can either be used as augmentation medicine to assist someone who doesn't have enough of a particular protein, and at the same time, looking at things that can inhibit the formation of these proteins for people who have too much of something, and it can modulate disease. There's a lot of things that can come about now. You know, they talk about the revolution in artificial intelligence to be the way to be able to map the body, looking at technical advances that can essentially demonstrate the entire human proteome. And if you think about it, there are very few, truly, very few, ways in which diseases throughout the body or things can be regulated. Cells can be regulated throughout the body because you have your blood, you have water, you have essentially sodium channels. It's a little technical, but, if you think about how proteins can get to various cells, there's only really one way, and that's through plasma. The plasma that circulates through all the body comes into place with all the various cells and can either turn them on to do something, to signal them to take some activity or action that can give rise to disease. It ages us. There's all sorts of signals that come from proteins in the body that signal cells to age, appropriately. But we've only found a handful of what those actual proteins are. There's at least ten, maybe even as many as 20,000 proteins that we don't know what they do and how they do it, and whether or not those can be used as therapies in the future are something that we and other members of the industry are looking at now. And we're finding not just new proteins, but combinations of proteins, combination therapies, new inhibitors to those proteins, a whole series of new things that all arise out of this notion of plasma science and protein science. And that's really an incredible future for this industry and the ability to help people with other diseases. Also finding new indications for the remarkable, you know, multifactorial actions that we have a senior rotates, such as, you know, IG and things of that nature that right now are very difficult, if not impossible under today's technology to replicate, through recombinant manners or other ways. And that's going to be a while before you're able to see something that can be done through chemicals, to take a pill that takes the place of immunoglobulins or Alpha-1 or something like that.
And so we're still, I don't want to say we're at out infancy, because we know a lot about how proteins work. We know a lot about how they affect the body. We know a lot about the pharmacology of these drugs, but frankly, there's still many, many, many more proteins that we can explore, combinations of proteins we can explore in order to truly help and benefit people with diseases. And a lot of these are chronic diseases. It’s very, very important.
Anita: That really exciting to hear. You've been a long-time champion of the standards. We do have a voluntary standards program that we encourage our companies to embrace. What is the importance of these standards in pursuing our mission of helping these patients while safeguarding donors?
Dave: There was a time 30 years ago that this industry's credibility suffered tremendously. And there were a lot of things that have taken place since then to make our products safe. And if you look at labels on our products, all of the packaging used for our products say that these are derived from plasma, human plasma. And as a result of that, they can't be made perfectly safe. But they are as safe as technology allows them to be. And the only reason they say they can't be made completely safe is because we don't know yet what we don't know. There may be something that could conceivably come along. And we found through various testing, all of our viral tape, you know, inactivation technology that when these new things do come along that what we have in place already is capable of destroying or making that product safe from even new and evolving or emerging viruses.
Anita: But that means constant vigilance.
David: Constant vigilance. And the fact of the matter is that that the governments, regulatory agencies and things of that nature, it takes a long time for regulations to catch up to the technology. So it's truly incumbent upon the industry itself, those of us who know how our products work to make sure that we are utilizing the most promising techniques, the most technologically advanced techniques to ensure that our products are safe. And constantly looking at what's coming down the pike, constantly looking at what new viruses, what new bacteria, what new potential safety issues are there that may affect patients that use our products, that we feel very comfortable that we are doing that and doing that well.
And why are we doing it well? We're doing it well because we, as a group, as an industry, have developed standards that go beyond the regulatory requirements, which I would just say are minimum requirements that can be put down in writing. But the fact of the matter is, there's evolving science, and you have to be capable of responding to that evolving science. Only way to do that is the promise to yourself through the industry, through our voluntary standards, that we're going to meet that bar, raise that bar.
I remember, I think it was the 25th anniversary for PPTA. Jay Epstein, who was the Director of the Office of Blood Research and Review (OBRR), CBER, FDA, came up to me and, he hadn't met Víctor Grífols before. And Víctor Grífols asked me to introduce him. I introduce Jay to Víctor and literally, literally Jay, you know, shook Víctor’s hand and said, ‘I want to thank you and the industry for raising the bar.’ And that was probably the most incredible thing I've heard from a regulator in history. I've had a lot of dealings with regulators, but the fact is, having someone who is involved in the industry, involved in regulations, congratulate industry itself for going beyond those basic things that the government, the regulators, basic science require, and raising the bar to ensure that you are as safe as can possibly be. So it's very heartening to hear that.
Anita: It certainly is. What drives your passion and your continued commitment.
David: I love working with people. I've gotten to the point where I feel I have something to teach others, so I love working with some of the younger people on our company and being able to mentor them so that I know that the ideas that I have will go into the future as a little bit of a legacy. I guess it's a little bit selfish, but that's one of the things that motivates me right now.
And I feel very grateful for having the career that I have. I still go into the office every day feeling proud of what I do, and I surround myself with people who likewise love the challenge, love the opportunity, and feel proud of what they do.
Anita: So David, you've talked about your passion. Clearly you mentor others. What advice would you have for someone just entering this industry?
David: Be afraid at least once every day. Enjoy the challenge. Live up to the challenge. Don't be afraid of making mistakes because it means that you've at least made a decision. But always love what you do. It's really emotional to see what it is that we do and what effect it has on patients' lives on families and patients who come into our manufacturing facilities so that they can see what it is they do.
Anita: Our keynote speaker at the beginning of this conference talked about a visit to a fractionation plant. And to see the dedication, the care, the continued adherence to safety, he said it was a spiritual experience to go through that plant and see all the people working to create the medicine that has changed his life.
David: See it's things like that to make you want to continue doing it, because it is a spiritual experience to tell you the truth. This is like a religion because it's something you practice every single day with every ounce of your being, that if you let it get away from you, then you shouldn't be doing it anymore. And it really is something.