Naji Gehchan: Hello, leaders of the world. Welcome to “Spread Love in Organizations”, a podcast for purpose-driven healthcare leaders, striving to make life better around the world by leading their teams with genuine care, servant leadership, and love.

I am Naji, your host for this special episode in partnership with Boston Biotechnology Summit, a bridge to collaboration and innovative synergies between healthcare stakeholders. I am joined today by Vanessa Elharrar, Vice President, Vaccines Business Strategy Lead, Clinical Research, at PPD, part of Thermo Fisher Scientific. Vanessa joined PPD in 2016 with more than eleven years of experience at the National Institutes of Health (NIH) where she served as a medical officer, deputy branch chief, and director of HIV therapeutics research at the Office of AIDS Research.  Vanessa holds a Bachelor of Science in Physiology from McGill University, a medical degree from Indiana University School of Medicine, and completed her residency in Preventive Medicine along with a Master’s in Public Health at Johns Hopkins University.  

Vanessa – I’m honored to have you with me today!

Vanessa Elharrar: Thank you Naji for the opportunity, and lovely to see you as well.

Naji Gehchan: Naji Gehchan: Before we go in your workshop’s topic of “Partnering with International Sponsors to Launch Trials in the US and Globally”, I am eager to hear more about your personal story. What brought you to healthcare, NIH and now being an executive in a large CRO?

Vanessa Elharrar: So goodness, where to start. I’ve always, always, always had an interest in science, I think since grade school truly. Um, and that continued through high school and then wrestling with myself on what to major in, in college physiology was what attracted me most. I was always very interested in it. Um, and I always also wanted to help people. Help people with health in particular and help a lot of people with health. And that’s something that I think followed me, not just through my undergrad but through medical school. When I decided, goodness, do I want to do clinical practice? Do I want to do research? If so, what kind of research? Um, and I ended up pursuing a residency in preventive medicine and public health specifically because, Of the millions and millions of people that that could be affected by the type of research, um, done through clinical trials. Um, I ended up at n i h, specifically in h i v prevention research for that same reason, truly because at that stage of the pandemic, it truly was out of control, um, in, in Africa and many other regions, especially as well in the us and I wanted to make a dent in that and, and. Hopefully do some significant work with the team, um, that could help people and a lot of people, not just one-on-one.

Naji Gehchan: Well, thanks for sharing, Vanessa, Vanessa, and it’s really around the impact you’re obviously now having also in your current role. So I’m, I’m interested to double click a little bit on this. So now, now being in clinical research, How, how do you see your impact today? You who really loves bringing this help for patients, as you said?

Vanessa Elharrar: No, that’s, that’s a very good question and I think that brings me to the part of my career where I’m now at P P D. I mean, there have been certainly some successes at N I H, um, in very large h I V prevention trial networks, H P T N trial network studies that have made. Big strides in H I V prevention, non-vaccine prevention. But my time at P P D I switched over from h I V to vaccines, and the first several years of my career at P P D was a medical monitor overseeing vaccine trials. Um, and about three years in, I decided to join the commercial organization, um, and learn a little bit about a different area of clinical research. And then of course, the pandemic hit. And there I go back to vaccines. Um, this time more in the clinical development role, which I used to occupy at n I h quite a lot and also in early customer engagement. So I think the impact, the major impact thus far in my career has been working in vaccine development, um, during the, the Covid pandemic and interacting with dozens, dozens and dozens of biotechs and biopharmas. Trying to develop interventions to combat covid. Um, truly the highlight and I think the part that has helped, um, and made the biggest public health impact really.

Naji Gehchan: So I’m gonna immediately go there and then Sure. We’ll back up to clinical trials. ’cause I know you’ve done remarkable work within the covid vaccine development. Uh, what, what are your biggest takeaways? Learning from this experience as you brought this vaccine to, to humanity?

Vanessa Elharrar: Um, I think, I think you’re referring probably to the Moderna vaccine, which is it’s public knowledge that P p D worked on that vaccine. We’ve been working with Moderna for, gosh, since they’ve gone into clinic, truly. So, um, that vaccine definitely had a big impact. I think the lesson learned is that we think vaccine clinical research, Can be done a certain way or takes a certain amount of time, and I think we broke a lot of barriers in terms of showing that, you know, we can do it faster, we can do it better. We can learn from this experience and take those learnings into everyday life, non pandemic life, and make vaccine trials move more quickly, make them more efficient, make better use of our resources. I think it also drove home the point that partnership with clients is key. Had we not had that absolutely rock solid partnership with Moderna for many years prior to the pandemic, those relationships and, and, and positive working relationships in place, um, I don’t know that we could have gone as fast and as far, quite frankly. So I think number one, challenging processes and timelines, and number two, the real true importance of partnership and how that can make a huge impact on, on success, frankly.

Naji Gehchan: So if you take a step back into clinical trials, so beyond covid, and obviously this. Uh, really the example as you shared about strong partnership and how we can move fast. So now when you look at clinical trials overall, uh, and vaccine where, where you said, but you also touch different therapeutic areas too, and you see it, uh, can you give us a little bit an overview of what are the main opportunities you’re seeing or the main challenges also in clinical trials

Vanessa Elharrar: overall? So, Challenges, what was the first one? Najee. I’m sorry I missed it. Opportunities. Opportunities. So I think we have, I’ll start with the opportunities, like to start with the positive. Um, so just recently, um, Varda came out with amendment to their b a a looking for next generation COVID vaccines. And that is an area frankly, that has been stalled. Due to lack of ability to procure comparator vaccine, so many biotechs that have had innovative technologies, different routes of delivery, intranasal, oral, et cetera, patches, um, have been steamed frankly in this clinical development and regulatory environment in their development because they could not procure comparator, um, funding was tight and now there’s been an. A new avenue of funding opened for next generation Covid vaccines. Um, the vaccines that are currently on the market are going to be commercialized soon, if not in process right now. So hopefully comparator procurement is going to be much easier and hopefully we can learn a lot about what works. For respiratory illnesses. In terms of vaccines, do intranasal vaccines truly work better? Um, what about patch vaccines? What about oral vaccines? I think there’s a whole area, um, of vaccine clinical research that’s gonna be opening up now that we’re in a different environment with Covid and the funding is there and hopefully comparator is now available. So huge opportunity. And I think that speaks to a challenge that we faced just recently in vaccine development. Um, and I guess with challenges come opportunity, right? So I think that as the landscape change changes, um, you will find new opportunities, but also new challenges. Um, and I think that’s the example of next generation Covid vaccine development. A good example of that.

Naji Gehchan: Are you seeing any challenges, uh, in clinical research for vaccine with also what’s happening in the environment? So beyond what we do in, you know, pharma and biotech and the science we have, obviously there’s a lot of myth around vaccines. There’s a lot of challenges from the public view around, around those. Have you seen this impacting, obviously clinical trials and then our ability to keep on innovating in the vaccine area?

Vanessa Elharrar: So I think that it has raised the profile of clinical research. The pandemic has raised the profile and education level on clinical research. To the population. People understand trials now. They understand the different phases. They understand why we’re doing it, the importance of participating, um, the altruism that goes into, um, participating in a trial. Um, and I think they understand the importance. I think the significance of the contribution they’re making is much more obvious given the global health threat that we all recently faced. Um, so I, I feel like participants are more inclined to really be interested and eventually participate in clinical research, um, because of the global education we’ve received from the pandemic. Uh,

Naji Gehchan: I wanna pivot to another, uh, theme that is obviously discussed as part of the summit. It’s discussed all over ai, you know, I, mm-hmm. Many of us now don’t like this word, these two letters anymore, uh, because we’re hearing it so much. But I’m, I’m interested in your view about AI in clinical research. Do you see any rule for it here? Are you looking into it, uh, as an organization and how to think, how do you think about it?

Vanessa Elharrar: So very good question. So we are looking into it as an organization. I am not quite public yet. There are certain areas in which it’s already used, I would say. Um, I, I personally, um, love the idea of using AI earlier than when you hit clinical trials. Meaning in basic discovery, for example. How best to present an epitope to the immune system. Can you model that? Can AI help you hone in on how best to do that? Um, or which types of neutralizing antibodies would be best for prevention? Which one would decrease viremia most quickly? For example, in chronic viral diseases such as H I V, um, it’s, I. I it for whatever reason, I see the benefit of AI a little bit earlier in, in, in the, in the process of, of, um, drug development. But I do also see that, um, it can be used in clinical research, it can be used in in lab type environments that are related to clinical research. Um, and we are actually in the process of, of honing in on that and seeing where we can apply it most, um, most effectively.

Naji Gehchan: I’m gonna give you now a word and I love your reaction to it. Whatever comes through your mind. Okay. So the first one is leadership.

Vanessa Elharrar: Oh goodness. First thing that comes to mind is altruism. Do you wanna share more? Yeah. I think that as a leader, it’s, it’s a huge responsibility and you need to think not just of yourself, but of your team and everybody that your team is impacting. So it requires a level of selflessness. And removal from, you have to lead from a place of, of very little. If no ego be, be altruistic, be selfless, and give of yourself. I love that.

Naji Gehchan: What about innovation?

Vanessa Elharrar: The heartbeat of clinical research. I think that innovation is what gets us new medicines new. New, new forms, new approaches to treating disease and preventing, um, infections. Um, it’s, it’s, it’s what got us all interested in science in the first place. I bet. ’cause it’s just so exciting. Health equity a must. It’s absolutely a must. Um, health equity is something that, In clinical trials, we manifest it as diversity and, and diversity and inclusion. In terms of the subjects we enroll in our studies, we absolutely must gather data, efficacy and safety in all communities such that our results are representative of the population and can be applicable to all communities within the population. Um, it, it’s critical and that’s, A critical way that we contribute to health equity in the clinical research environment. Yeah.

Naji Gehchan: Can you share a little bit more about diversity in clinical trials? Because this is definitely something we’re all striving for. Mm-hmm. And we should, so we’d, we’d love to hear if you have an example or a story around this.

Vanessa Elharrar: So I think the best example, um, was actually the Moderna phase three covid vaccine clinical trial that we ran. We enrolled 30,000 subjects in about three months, in exactly three months as a matter of fact. And, um, about, if I’m not mistaken, about eight to 9,000 of those subjects were minority subjects. Um, a good number were of Hispanic origin, African American. Um, so really we ended up with a a, a subject. Population within that trial that it was an, a true reflection of the United States of America. Um, and I think that helped give comfort to everyone that this vaccine is not only safe for certain communities, but for all communities and effective in all communities. Um, I think that’s the best example of, um, truly enrolling a study quickly. And doing so with the diversity in your study subject population that that inspires confidence in, in, in folks who are actually going to use the product.

Naji Gehchan: The last word is spread love and organizations

Vanessa Elharrar: I think be generous. Be generous with your time. Be generous with your mentorship. Be generous with your expertise and help. Um, I think that all of all, being open and always willing to give of yourself in an organization is a way of not just spreading love, but spreading knowledge and spreading goodwill. Because many times people learn from your example and also want to pass on the help and the time and the mentorship in return, paying it forward, so to speak. So I think that that’s something that’s actually worked well for me. And you never know. Also when, when that generosity is gonna come straight back to you. It usually does in one form or another.

Naji Gehchan: Any final word of wisdom, Vanessa, for healthcare leaders around the world?

Vanessa Elharrar: Well, I would say, Do what you do because you want to do good and help people in whatever capacity that may be. It does not have to be in clinical research. It can be in technology. It can be in mental health support. It could be in any area. Just make sure that what you’re doing is of help and is doing good. Um, I think that’s key because that’s what’s gonna drive you and get you through the hard times and get you through all the obstacles, is the knowledge that, okay, what I’m doing is making a difference. It’s helping people.

Naji Gehchan: Well, thank you so much for being with me today. It’s been a real pleasure to chat with you and to learn from you. Thanks for being here.

Vanessa Elharrar: Thank you. Thank you, Naji very much.

Naji Gehchan: Thank you all for listening to SpreadLove in Organizations podcast. Drop us a review on your preferred podcast platform

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