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Apr 16, 2024

What are the best ways to set up public, private, and academic clinical research partnerships? How do we get these public-private partnerships (PPP) to work most effectively? And who should be in charge of what in multistakeholder research collaborations? We will get those answers in more in this episode of Research in Action with our guests Rob King, President and CEO of FHI Clinical; and Dr. Kristen Lewis, Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.
Episode Transcript:
00;00;00;01 - 00;00;22;22
What are the best ways to set up public-private clinical research projects? Where does and should the money for such research come from and who should be in charge of what? We'll get those answers and more on this episode of Research in Action. Hello and welcome to Research in Action, brought to you by Oracle Life Sciences.
00;00;22;22 - 00;00;50;05
I'm Mike Stiles. And today we're just trying to outdo ourselves by talking to not one, but two very interesting people. First is Rob King, president and CEO of FHI Clinical. FHI uses Oracle's clinical trial software for their clinical operations and partner with public entities like PATH, which brings me to Dr. Kristen Lewis, who is Head of Clinical Operations at the Center for Vaccine Innovation and Access at PATH.
00;00;50;26 - 00;01;29;23
I could go through what each of these organizations do just to hear myself talk, But why do that when I have both of you here? So, Rob, tell us what FHI Clinical does. Yeah, I think Mike, so clinical in a contract, they were actually for profit and hearing of a large nonprofit called F8 had three ethically and while we are for profit empathy, our mission is to address unmet research needs and maximum social impact pouring into development of medical treatment around the world.
00;01;30;04 - 00;01;58;20
While we work globally, we tend to focus on the low and middle income country on the whole pharma and biotech client are also include nonprofits and government. Empathy. Well with biotech receive public funding and path having him be one of our client. Appreciate Kristen being here arguing that four years ago and I'm currently the CEO and I'm happy to be here.
00;01;58;20 - 00;02;22;19
Well great. Kristen what about PATH? Yeah, thanks for the introduction, Mike. It's a pleasure to speak with you and Rob today and have the opportunity to contribute to this discussion. So most people listening to this podcast may not be familiar with PATH. We're a nonprofit global public health organization with approximately 1600 employees worldwide. Our headquarters are in Seattle, Washington, and we have offices across the African and Asian continents and Europe.
00;02;22;19 - 00;02;53;00
Some of the locations we have offices in include Kenya, Ethiopia, Senegal, Uganda, Zambia, India, Vietnam, Ukraine. And I could go on, but I'll I'll hold hold it there. Our mission is to advance health equity through innovation and partnerships. We do this with the help of local and global partners by generating evidence, advancing innovation and strengthening local capacity to improve health in countries and communities that are experiencing disproportionate burdens of disease and barriers to well-being, specifically in low and middle income countries.
00;02;53;11 - 00;03;26;01
This includes working in over 70 countries across the African, Asian, Latin American, European and North American regions. Within Paths Center for Vaccine Innovation and Access, we drive the mission of achieving health equity using a three-pronged approach, including developing, facilitating and implementing global market and policy solutions to ensure sustainable supply and equitable access to vaccines. Supporting country led efforts to advance national health equity priorities, and to strengthen immunization system resilience and driving innovation and technological advances.
00;03;26;01 - 00;03;50;20
To accelerate and optimize access to vaccines. Now, this last point is where my work is focus. Thus, during today's discussion, I'll be speaking with the lens of developing vaccines for disease indications benefiting low and middle income countries, and the importance of public private partnerships in achieving that goal. And just to note, you'll note a common thread there in the introductions from both Rob and myself, and that's the low and middle income country focus.
00;03;50;20 - 00;04;15;17
And I think that you'll start to hear some commonalities come into play as we go further into this session. Great. Well, I think what I want to get into here is kind of what you talked about is the value of public private partnerships in clinical research. Rob, give me the honest first reaction that a lot of private companies have when it is suggested that they partner with a public or a government organization.
00;04;15;17 - 00;04;45;18
Is that something that they jump at with open arms or is there any hesitancy? How does that go down? You know, with recently reading an article about one of the first public private partnerships and it was how mail really hit home, like, you know, for most of our listener, what most people won't be familiar with are the initiative around vaccination for diseases like polio and Spanish flu, MENA and rubella.
00;04;46;00 - 00;05;33;19
And we tend to have short memories. And they and the devastating impact they've had on society prior to vaccination and treatment options or with also that treatment developed over HIV and AIDS and then most recently the COVID pandemic. So with that said, you know, private companies maintain the shy away from what we call the triple P public private partnership in the funding limitations that my, you know, government based funding required a lot of compliance when the whole myriad of regulations and public kind of activity may have restricting how and where or how and when fund your, you know, without experience are now horsepower in the public private partnership.
00;05;34;07 - 00;06;09;21
It creates see private companies to engage and may see growth for example will not serve as a prime contractor on government funding work because when you're in the accounting and you're when the regulatory compliance and you'll only see those of normal commercial contracts, therefore they can turn them and be overly burdensome for those companies to pay. And public private partnerships, you have to have an operational model that meets the unique need of that partnership.
00;06;10;03 - 00;06;36;15
And at the end of the day, you really can't you can't get value for society that public private partnerships have contributed to. And Kristen, from the nonprofit or public side, what what is the benefit of partnering with private companies? Yeah, that's a great question. And I think to answer that, I'd first like to highlight some of the major successes when these partnerships have come together.
00;06;37;04 - 00;07;05;23
PATH has played through public private partnerships. PATH has played a critical role in some of immunizations, created successes over the past 30 years in lmics low and middle income countries. This includes developing the world's first malaria vaccine, which has now reached more than 2 million children, eliminating meningitis epidemics in Africa following introduction of the A4 backed vaccine protecting over 300 million children from Japanese encephalitis, vaccinating millions of girls against HPV.
00;07;06;06 - 00;07;33;20
And I could go on. But those are some some highlights. Path has not achieved these accomplishments in isolation. These successes have been catalyzed via public private partnerships models, and they're examples of which the private sector alone may not have been interested in developing these indications. These vaccine indications for low and middle income country use due to financing or budget considerations or constraints or some of the points that Rob made earlier.
00;07;34;00 - 00;08;03;13
However, with partnerships between PATH and private entities, including finance mechanisms for rollout and use of the vaccines in the regions following development, we've been able to champion development and introduction of vaccines that might not usually have generated sufficient interest for the investment that's required for full development. So in a nutshell, public private partnerships are the bread and butter of our work and integral to the goal of achieving improvements in global public health among populations facing economic challenges worldwide.
00;08;03;24 - 00;08;43;19
Well, so it feels like these partnerships would automatically create multiple stakeholders. So, Rob, how hard is it to make sure that the goals and priorities are aligned amongst all these people and stay aligned? First, I think I have a, you know, expectation and the goals are higher for public private partnership and for commercial initiative. You know, eight you public five, there is an expectation that you're going to achieve the goal or outcome and you're held accountable for how those on her spent.
00;08;44;11 - 00;09;27;10
You're not accountable to a or stockholder, but general public. And you know, public funds are unlimited and there are every dollar may account for whatever goal they're trying to achieve. And we're spending public funds a buying or accounting of how this on her being spent and her limitation on this on and how there may not be extra funds or reserve goes back to if those funds start to run low and usually the public entity defines the impact and the work that has to be completed in ensuring that the funding is in place.
00;09;28;01 - 00;09;53;24
And they then tracking the work that the private company may have contractually in their you mean clear terms on what's being delivered and the restrictions that may or may not be around the funding for that deliverable. So I you agree that saying, though, priorities are paramount because of the fact that we're accountable to the end of the day, to the general public.
00;09;54;09 - 00;10;29;01
And Kristen, is there anything on the public or nonprofit side that's done to kind of make sure that projects aren't subjected to red tape or bureaucracies? I mean, I guess there's always going to be some of that, but to the extent that would might slow things down. Yeah, it's a great question, an interesting and insightful one. So Path we work as a clinical development partner and hold sponsor sponsor roles to implement clinical trials and generate evidence to support vaccine licensure, W.H.O., Prequalification and decision making for vaccine Introduction.
00;10;29;11 - 00;10;51;09
And our work spans the entire vaccine development and delivery lifecycle. And with this broad set of objectives, in order to achieve the aforementioned successes, we have worked with the same urgencies and efficiencies as our private counterparts. From a private lens, there seems to be a perception that the public sector does not come with the same development pressures as the private sector.
00;10;51;19 - 00;11;22;13
In other words, there seems to be a perception that the public sector works slow due to many policies or rules or paperwork, or is generally lacking a sense of urgency, if you will. Now, I don't have that experience working in government, so I can't comment on that side of things. However, in my experience working in vaccine development with a non governmental nonprofit for the majority of my career as well as a few years working for a for profit entity, I can comment that the intensity of work at a nonprofit has been similar to the intensity at a private entity.
00;11;22;26 - 00;11;46;09
While the root of the development pressures may be slightly different. The goal is to develop products as efficiently as possible, while also retaining high quality remain in both sectors. For private entities, I believe the term may be, quote, time as money and quote as a driving consideration. While for my work in the nonprofit space, what drives us is, quote, time is lives, unquote.
00;11;46;14 - 00;12;17;20
And that is really the driving consideration. But regardless of those driving considerations, there's still urgency and sense that we need to be as efficient as possible and ensure that we aren't were removing blockages, red tape, bureaucracy as much as possible. So, Kristen, I'm curious, just from your point of view, when the pandemic came down, that was an entirely different animal in terms and the need to get something done and get something done rapidly.
00;12;17;25 - 00;12;48;23
Just how different a process was that? Yes. So I wouldn't say that the process was necessarily different between the public and private side. I would say that we did things across both sectors in a a new way. So the COVID pandemic really brought home how there are many similarities between the public and the private sectors. Not everything differs according to operating model.
00;12;49;01 - 00;13;14;16
In fact, during the pandemic, the global public health and product development safe spaces, regardless of the type of sector, were going through the same waves of initial shock and uncertainty and how to continue the trials during the very initial stages of the pandemic considerations in terms of the risk benefit tradeoffs of operating non-covid interventional trials during that time, and depending on the type of trial availability of remote technologies and a product's importance to saving lives.
00;13;14;27 - 00;13;38;24
We had to take into consideration different ways and methods for making sure that those Non-covid interventional trials were completed. We also were involved with needing to identify new ways of getting the work done, which included catalyzing a more definitive shift towards identification of local partners that were in close proximity to the trial locations for ease and trial oversight and management.
00;13;38;24 - 00;14;04;12
Implementing remote solution for activities such as source, document verification, remote training, remote site assessments and other types of remote activities, identifying how to get supplies or equipment to the sites ahead of study. Start with supply chains being disrupted and finally determining how to maintain the trials and keep them running once up and going while continuing to deliver with with high quality and ensuring participant safety.
00;14;04;24 - 00;14;30;10
So from Passent, given our work is primarily focused in low and middle income countries, many of the challenges faced in the private sector high income market were further exacerbated due to the relatively slower adoption or uptake of technology surgical clinical trial advances. And this experience was important as it pushed for adoption of technologies that had been previously questioned due to fear of loss of data or other concerns, as with other areas of our lives.
00;14;30;11 - 00;14;56;28
COVID really helped to push the envelope in terms of finding new efficiencies and ways of getting things done. Rob When a partnership like this comes together, I guess this goes along with the expectation setting side that you touched on earlier. How are the roles and responsibilities assigned? I say that in the triple P or public private partnership it really different in that respect as compared to commercial partnership.
00;14;57;25 - 00;15;41;11
You know, the earlier the public finds an objective and a private is to execute that. Now the public entity may only outsource part of the work because they already have the skills and knowledge and the resources themselves. And then they will only outsource the pieces that they can't do themselves. But I think the main thing to keep in mind when a public private partnership is that the public entity, a steward of the public interest and liability and accountability for that public interest lies with them regardless of whether they outsource or not to a private company.
00;15;41;11 - 00;16;05;12
So I feel bad for Kristin and the pressure that they have on them as a public entity compared to myself and her private empathy, where I don't necessarily feel the same pressure we have. Some people might think that the role of public funding is just to get the project more money. You know, we tell you what we need, you go get it for us, and that's your role.
00;16;05;12 - 00;16;28;04
How true or not true is that, Kristin? Yeah. You point out an important consideration for pairing public funding with private resources. There is the potential that private entities may believe that we, the nonprofit, will help bring in key funder resources to augment a development program regardless of their development goals, in alignment with the use of the product in low and middle income countries.
00;16;28;13 - 00;16;54;25
However, in order to mitigate the potential for this misalignment within PATH, we focus on partnering with private entities. When there's clear alignment between Path's mission and the mission of the private entity. Additionally, this alignment has to be in writing agreed to via contract. It includes global access agreements for product availability and use. And so in summary, my experience has been that it's not true that the goal of public funding is to get the project more money.
00;16;54;25 - 00;17;16;10
The goal of public funding is to achieve an outcome that might not otherwise be achievable, given lack of private interest without the public funding to come in and co-fund an objective that benefits low and middle income countries. So we've got public and private represented on this episode with the two of you. What we don't have is someone representing the academic side.
00;17;16;10 - 00;17;45;27
Rob, do you have any thoughts on the role that that third leg of the stool plays or should play? Yeah, you know, there are academic institutions that also have private public anything in and out where I have a lot of admiration for the role of peer academia, Both public and private institutions rely on academia being a catalyst for innovation and providing health very specific areas of research.
00;17;46;24 - 00;18;13;00
There are a lot of academics out there. They're doing very research and I never know when that point of time in in hand. So at every level we rely on our advisory or academic consultant to keep us informed on very specific events or therapeutic topics. And this plays into whether the research into them or not that we intend to do.
00;18;13;10 - 00;18;51;08
And there's a large portion of investigator and key opinion leaders involved in research actually come from academia. On the flip side, academia also relies on public private partnership to bring their ideas into the research environment because they lack the funding to paint the vision or the technical knowledge on how to bring that idea to the next step. You know, I think the example that perhaps a lot of people have heard of are the bar industry days and Loreal, which is the Biomedical Advanced Research and Development Authority.
00;18;51;24 - 00;19;35;13
They host annually this event where people come in for ideas, for collaboration in partnership with US funding, and so they have it. So for them, the novel idea that aligns with the interests of the US government and they get the opportunity to collaborate with other companies that can bring that into fruition as well with funding behind it. So I think there are a lot of opportunities out there for academics to bring the right into fruition, but we have a great job of sort of pulling them in the right direction.
00;19;35;28 - 00;19;58;14
Kristen, I have to tell you, as a as a layperson, I kind of picture this three way partnership, and the first thing that comes to mind is that's a lot of cooks in the kitchen. So it's kind of amazing to me that anything gets done or gets done in kind of a timely manner. What are the essential ingredients of a truly successful collaboration in your mind?
00;19;58;26 - 00;20;34;24
Yeah, it's a very good point. And I will add on to Rob's comments regarding academia that academia is a very important partner in this setup. Academia generally is part of these partnerships. And so there are I would, as you put it, a lot of cooks in the kitchen when we're bringing these projects together. And the short answer and how we make these successful is to never underestimate the value of careful pre-planning and preparation and setting up the partnerships, including mission alignment, alignment in the partners scopes of work and roles and responsibilities.
00;20;34;25 - 00;21;11;19
I think Rob alluded to that earlier. And the Seven Seas of collaborations jump to mind, clarity of purpose, concurrency of mission strategy and values, creation of value, connection with purpose and people, communication between partners, continually learning or a growth mindset and commitment to the partnership. In addition, it's also important to lay a solid foundation underlying all of that of respect, trust and finding a balance between humility and confidence across the partners to make sure that everybody is partnering fairly and with trust and in good faith.
00;21;12;01 - 00;21;37;07
Yeah, you know, I don't want to start a fight, but who is largely responsible for big innovations in clinical health? I think the public gets the impression there are private scientists huddled together in one lab, and then government scientists huddle together in another lab, probably in D.C. That's not really the way it is, is it, Rob? I mean, how are the big, impactful innovations truly getting developed?
00;21;37;17 - 00;22;07;29
Yeah, I'm one I answer that question in the obvious here. I mean, there when we all work together and leverage the strength of all of our partners. I honestly do think that commercial or private things are faster innovation, but they have a feel and reward system. They're always our innovation, a profit making endeavor. I mean, why not? You have a good eye and you want to be recognized and rewarded for it.
00;22;08;12 - 00;22;36;24
But bringing innovation in areas where the opportunity for regular recognition and reward is not so great. And that's where public private partnership come into play. You know, as a global community, it's in our interest to innovate in low reward scenarios because the knock on effect is that the problem is not spread and that it allows a particular community to or region to prosper.
00;22;37;13 - 00;23;00;15
And so therefore, if people prosper, they're less likely to mean in the future and we can maximize their contribution for the greater good. Yeah, but Rob, when it comes to public health, people do seem to put the bulk of that responsibility on government. Like people didn't demand an answer to COVID from Pfizer. They demanded it from the White House.
00;23;00;15 - 00;23;29;27
So is that fair? I think fair and yet a moral issue that we can do a whole nother podcast around. So, yeah, but, you know, human empathy and theoretically the government are there to serve the public and the public good through taxation and donations. We expect the instinct to step up when the need arises. You know, the public can't hold a private company like Pfizer accountable in a crisis.
00;23;30;13 - 00;23;58;14
And then the obvious thing here is they hold the public entity responsible. The only problem is we pan who fund our public entity with a little support if possible, or we lose the funding that's already there with a whole myriad of special interests. We don't leave a whole lot left in crisis. We're also very bad at funding the future, whether it's for crisis or innovation.
00;23;58;27 - 00;24;25;25
We're not people that really think ahead, sometimes have public empathy, have to scramble to reallocate funds, and they usually can't staff up or get resources in place quick enough. And they turn to commercial companies that really have no restriction on growth and simply eat the money and make it happen. Rob What's the most gratifying thing that's come from working with Path from your perspective?
00;24;26;17 - 00;24;57;14
Well, I'll make this short with Sweet. We know toward the beginning of our path and we'll have similar missions now. Path being a public entity, hailing here for the greater good and not really for a reward or profit. Who? I don't know. But I feel I feel better about myself and my company associating and working with Light Path.
00;24;58;00 - 00;25;22;15
And Kristen, what keeps you bought into the whole public private partnership model? Well, it's it's that it's a factor that the model is effective in bringing new life saving interventions to low and middle income countries. So for me, it's the advancement of the public health mission and being able to efficiently facilitate implementation of health interventions for low and middle income income countries that wouldn't otherwise be available.
00;25;22;16 - 00;25;42;26
It's the ability to have a true impact to save lives. And this partnership model is is critical in making that happen. Yeah, but it can't all be gumdrops and rainbows. So what are some of the challenges as or wish list items that you both feel still kind of need to be addressed when it comes to the partnerships around clinical research?
00;25;42;26 - 00;26;18;16
First Rob, then Kristen how I think we can do a better job of building trust and sharing intelligence even in public private partnership. There in Singapore. If trust and holding on the information that can be of mutual benefit. And I personally would like to break down some of the barriers, you know, a key concept in public private partnership in the best value and in most cases that require public entity get like three quotes for some of activity or contract.
00;26;19;02 - 00;26;44;17
And then you have to justify why you can go with it. So we all know that paper is not always better, and I would like to see us define value in more ways than just cost. Also think they're alive and healthy. It can be shared around best practices of Kristin and I belong to a group that's publicly funded that share best practices.
00;26;45;07 - 00;27;25;20
But you know that sharing of best practice has been limited with sort of all that culture of caution. So I'd like to see more sharing and the assumption of positive impact on our party. And I think we held out a lot during the COVID pandemic, and I applaud that. I hadn't felt the call center for a large government project, and we had to do it time and when I reached out to a technology company to help me fill up that call center, the question was, how much are you going to pay me or what kind of, yeah, how quickly you need it.
00;27;26;12 - 00;28;06;15
And then we literally are without contract, without much, especially around term. And they phone up in record time and we work the other stuff out on the back end to mutual benefit. And I know that we can't always do that, but it shows you what possible. And Kristen, what gets your goat? Yeah, I guess there's two points that jump to mind in the first is that we have some more work to do and in terms of sustainable capacity development to ensure that the ground that we gain in facilitating research in low and middle income countries continues to be built without the loss of human or material resources that are built out for trials.
00;28;06;27 - 00;28;26;16
How do we do a better job of sustaining capacity that's been built following the completion of a trial or a set of trials at sites that we've invested in? That's an area that many folks are putting thought into these days, But I think we have yet to identify a solution to that. And I think that's that's something that we can do, do better at.
00;28;26;16 - 00;28;56;00
And I know we will. It's it's a work in progress. And then the second thing is the concept of equitable partnerships that needs additional consideration and support. And I think back to Rob's comment about assuming positive intent and working in good faith, there's a focus now on on transferring leadership and ownership of much of our clinical development work to the regions that are participating in the work so that they're really co-creating and co owning the development work in the development space.
00;28;56;08 - 00;29;17;00
While COVID helped to catalyze that shift, there's still some more push that we need to do within the global public health and development community to make this shift really, really be adopted and occur. And we have a bit of a way to go in terms of fully embracing the models that are led out of the regions that our products serve.
00;29;17;16 - 00;29;38;27
And I believe that the public private model and partnership is an area where we can help to facilitate this in the future. You know, I'd probably be remiss if I didn't ask about the role that you see technology playing and being maybe that fourth partner in clinical trials. Rob, I know you use Oracle's clinical trial Solutions. What does that bring to the table?
00;29;38;27 - 00;30;25;07
So I think, you know, you're in the COVID pandemic. Technology was really a shining star and allowed some things that we probably couldn't done earlier by embracing technology that people were perhaps hesitant to use before. So I think that certainly around Oracle, we were able to use many of the Oracle platform during the COVID pandemic. I think my favorite story, and people probably heard it before, I apologize to anyone hearing me repeat, is that I think how clinical it have at home, even you're a platform without join and so joined right before the pandemic and you're all now on my whiteboard.
00;30;25;16 - 00;30;50;07
My ideal platform for data collection analysis and sharing with other and a former colleague of mine who we recently joined Oracle dropped by the office and we were hanging out my office and he looked at my whiteboard and he said, What's the Oracle Product Development Plan doing on your whiteboard? I said, Well, that's not the Oracle product development plan, that's my plan.
00;30;50;18 - 00;31;21;25
And he said, Well, that exactly met what we're doing right now. And that was in of our use of clinical one. And, you know, just hearing differently, you know, what I had in mind and what the Oracle developer had in mind were the same. I don't think anybody with smart irony when they coming in the gene at that time drove innovation and all the partners on that, and it came at just the right time.
00;31;22;12 - 00;31;53;20
And Kristin, are you surprised by or frustrated by the technology capabilities that are available for your endeavors and what you're trying to get done today? Yeah, I'm excited for trial platforms in low and middle income countries to have the chance to further adopt technologies that have been utilized in other regions. I would say there's been some reluctance in adoption of the technologies that have been commonly utilized in high income country settings for some time, but that COVID has really catalyzed adoption of many of those.
00;31;54;22 - 00;32;16;19
There has also been some backsliding in use of those technologies since COVID. The urgency of the COVID vaccine development cycle more or less ended. And so what I'm excited for is that there was a push during COVID. We've seen it work in the past and that there's the potential for continued adoption of these solutions, such as these saucy diaries Pro ET cetera.
00;32;16;28 - 00;32;44;20
As we work through the challenges with implementation of those technologies outside of high income country settings. So there's there's a little bit of work to do in terms of adoption. But I think we're we're getting there and I'm excited to see the field further embrace those technologies. Well, it's great to hear about partnerships like this and what's increasingly becoming an accepted model for how we can get better results for people faster and for more people.
00;32;45;00 - 00;33;08;13
A lot of our listeners may want to learn more about what you've been talking about and what you do. So do each of you have a way they can do that or even contact you? How about you? Rob Yeah, so feel free to reach out to me quote unquote dot com. And I'm also only in and happy to sort of brainstorm with anybody.
00;33;08;21 - 00;33;39;20
We sort of can move the idea of public private partnership even farther and Kristen yeah our websites available WW w path dawg and it provides additional information on path and what we do and I'm also on LinkedIn then can be reached via that platform Perfect well if you want to see how Oracle is accelerating life sciences research and how it might be able to do that for your work as well, check out
00;33;40;00 - 00;33;58;18
Also be sure to subscribe to this show and we'll be back next time for Research in Action.