Simon Burns: Jonathan, thank you so much for joining us. Really appreciate you taking the time to chat today.
Jonathan Zung: Simon, great to be here.
Simon Burns: Quick introductions I’m Simon CEO and co-founder of Vial. We’re building a next-generation CRO that will drive faster and higher-quality outcomes for sponsors. Jonathan let the audience know about your background.
Jonathan Zung: Sure. Jonathan Zung. I’ve been in the industry over 30 years, so I’m Chief Development Officer at Evelo Biosciences, and spent about 25 years between Pfizer and Bristol Myers Squibb, and have headed up clinical operations organizations, and really passionate about clinical operations.
Simon Burns: Awesome. You’ve been in this space a long time, you’ve seen it from the large sponsor side and small sponsor side, and I’m curious, we speak to a lot of early stage biotech teams. ClinOps, ClinDev, first time that they added running a clinical trial, everything from designing it, inclusion, exclusion. They’re nervous about picking sites. A whole ton of things stress them out. What advice do you have for some of these early stage teams?
Jonathan Zung: Yeah, I would say for most teams, it is really understanding, what are you trying to do in the trial? What questions are you looking to answer? And then, really understanding is you developed the trial, how do you make that protocol as friendly as possible? And then really understand where you want to place the trial.
Yeah I find most times, organizations get caught up because they decide where they want to place the trial, but they may not really understand what are those best sites, or best countries to use.
Simon Burns: Totally. you’re in an interesting position, not only have you done the sponsor side, you’ve also worked on the CRO side as well as worked with IRBs. We think a lot about infrastructure and what needs to be built to reimagine clinical trials and support sponsors. What key components do you see as most ready for change in part of the clinical trial infrastructure?
Jonathan Zung: Yeah, I think for me, it’s all about how to use technology efficiently, right? If you think about the old days of collecting data, and there still are sites that are using paper. So if I think about when I go out and visit sites, I’m constantly shocked how many still use paper. But there’s lots of technology out there that can be seamlessly integrated, and if you think about how central IRBs work today, it’s all integrated. It’s a very simple process for a sponsor and a site to, you know, submit their materials for approval, and then get their approvals. And likewise, the way data is collected from ePROs, EDC, it should be relatively straightforward to aggregate that, but I think we still struggle a little bit in the industry sometimes getting that aggregated, and using technology to our advantage.
Simon Burns: Totally. We caught up recently, and we’re chatting endpoints, as folks in the space often do. Dermatology endpoints are notoriously subjective, right? Where the cases of failures that people point back to the subjectivity of endpoints. But that’s not that necessarily the the way it needs to be. Lots of folks are trying it, to move this forward. Full body scanning, other imaging technologies, MLAI to drive endpoints. What do you think of the future of objective endpoints in the space?
Jonathan Zung: Yeah, Yeah. I think for at least the next five to ten years, we’re going to be with where we are, we’re going to be leveraging, IGA. We’re going to be looking at EASI and PASI scores, it’s what everybody is comfortable with, it’s also what, regulators have in guidances, and what they expect to see. Many of us are using I would say machine learning. Especially around images, to try and understand how you can predict a responder, whether you can predict it early on. I see that adding more value, but I don’t think it’s here yet today. That’s something that we’re- we’re probably a good five years out still.
Simon Burns: On the topic of using technology I was speaking to the CEO of a dermatology biotech company recently. He said that the way that they track their trials with a plain text email they get from their clinical operations. And it screens enrollment, and it some of the key information. But that’s a night and day difference from some other executives who get dashboards and real time analytics in other industries. What’s holding back biotech teams living in this world of real time, powerful analytics?
Jonathan Zung: Yeah. I’m surprised to hear that folks are not getting real time analytics, I can tell you a decade ago when I was at Bristol Meyers Squibb, I had regular dashboards that, I could look at daily to look at enrollment. I could look at data cleaning, I could look at different leading measures that were important to see how the trial was progressing. If I think about today, at Evelo Biosciences, a biotech, if I wanted to get daily enrollment, and daily metrics it’s really simple. My operations lead she’s looking at that information daily, so she can be in the IRT system, she’s looking at the systems that our CRO uses, today I think the challenge is, for executives like myself, it’s to figure out what do we really need? And not to get in the way of teams and asking for lots of data. Teams who look at enrollment data daily, I’m not sure what decisions they’re going to make daily.
You know early on in a trial, yes you want to look at things probably two, three times a week to understand the trajectory, but as the trial gets going and you see where the momentum is, and you see the trends, having twice a week updates is probably more than enough. But there are Simon, as you mentioned in your question, there are vendors who have very simple platforms and technology than can aggregate the data, and then put the data in- in usable format. So I hope there are not too many [00:05:00] people you know, getting emails that just have, data thrown at them.
Simon Burns: Fair enough. Fair enough. The balance of policy and innovation through new models is something we think a lot about. Certainly policy drives a lot of how people think about what is or isn’t possible in terms of clinical trial innovation. You’ve done your fair amount of work in the policy space. How do you think about the balance of where policy has a role to play in advancing in the field, and where new innovative models and or sponsors taking that home with more risk taking approaches?
Jonathan Zung: Yeah. My sense is health authorities are looking for industry to be more innovative, and to take a little bit more risk. If we think about the guidances the FDA puts out, they’re guidances. When I look back to how ePRO came into place, a decade ago, people were pretty, pretty cautious around where and when they used ePRO. Because the guidances weren’t fully fleshed out. And now if you look at that, you know it’s mainstream. We’re all using ePRO, we’re feeling more and more comfortable how we use it. Having that early dialogue with health authorities if there’s, some uncertainty around a technology that’s going to be used, or approach that’s going to be used, I think will reduce the stress and the anxiety on the sponsor side, so they’re more willing to try some of those technologies.
Simon Burns: On the topic of the agency, this is also an area of stress for early stage biotechs we speak to. They don’t know how to approach their pre-IND meetings, they don’t know whether to take agency feedback. How to balance out the various trade offs with agency feedback. What advice do you have for early stage biotech teams who are nervous about their-
Jonathan Zung: Yeah-
Simon Burns: Their FDA engagement?
Jonathan Zung: Yeah, I would say early engagement is mission critical. Having a good relationship with the agency, understanding what the reviewers are looking at. What they’re concerned about, what their hot topics may be is important. Having a pre-IND meeting really sets that stage, where you can lay out what you’re thinking of doing, how you’re going to do it, asking questions, these days, the agency is pretty busy. There’s a lot of work going on there, there’s been turnover, staffing challenges. Certainly submitting questions, through an open IND is a great way to get quick feedback, but also engaging with them at key interaction time points is a must.
And it’s not just the FDA. It’s interacting with MA, MHRA, if if you’re running studies in Asia with the health authorities in Japan and China, regular interactions are really critical.
Simon Burns: Totally. We do a set of questions in a segment we call overrated, underrated. We’re going to run through rapid fire, and you’re going to tell me whether you think these concepts are overrated or underrated. Are you ready?
Jonathan Zung: Yeah.
Simon Burns: Okay. The last decade or so has been a huge growth of biotech as the driver of innovation. What do you think of the concept of the future being increasingly so biotech led innovation, and increasingly less so for pharma, I mean you’ve seen both sides of this coin. Overrated, underrated. Biotech as the driver of innovation.
Jonathan Zung: I’d say overrated because I think at the end of the day, I grew up in Big Pharma. An there’s a lot of innovation that still occurs in Big Pharma. there’s also a lot of innovation in the biotech space, but I don’t know that Big Pharma and mid sized pharma are given enough credit for the innovation that goes on in those organizations.
Simon Burns: Fair enough.
Jonathan Zung: I waffled a little bit. [laughs]
Simon Burns: [laughs] On commercialization. Lots of attempts at commercializing in different ways. Lots of biotech companies now especially in our space looking to commercialize themselves, the idea that you have to sell post phase because you did whatever- wherever people use to sell, then you have to sell the commercialize, and then biotechs can’t commercialize, or take just one product to market. What’s your sense of that concept, overrated underrated?
Jonathan Zung: That’s, I’m going to waffle again. I think it’s probably overrated a little bit. I mean there’s really needs to be a partnership, if you think about what it takes to commercialize a drug, you know if it’s a niche indication, I think a small biotech can easily do it. If you’re talking about going into a space where you need large commercial presence, and you need to have the access a Big Pharma company has, you’re going to need to partner. So I don’t know that there’s a one size fits all, but I think at times it’s overrated.
Simon Burns: And where we sit in Silicon Valley, we have a lot of folks who speak to us about programming biology, the concept that-
Jonathan Zung: Yeah.
Simon Burns: If only data’s sufficiently structured and compute is sufficiently scaled, that you can take a new approach to drug discovery, and radically improve the throughput. What’s your sense of programming as biology or programming biology?
Jonathan Zung: I love it. It’s underrated. So I think that’s an area that’s going to continue to be really hot, and it’s going to get more and more attention. Both in Big Pharma and emerging biotechs.
Simon Burns: Awesome. I guess we’ll all be machine learning programmers-
Jonathan Zung: Yeah.
Simon Burns: In the future. And lastly, XBI public markets, private markets, it’s been a tough time out there to be a small biotech company. Really any sized biotech company, what’s your advice for those same ClinOps folks that you advised in their protocol, and their regulatory fair strategy. How should they navigate the market today?
Jonathan Zung: Yeah. Being there’s a finite amount of money in companies in the coffers today, I’d say it’s all about focus. And it’s about understanding how and when to make trade offs. I think you’re finding Simon, and you interact with many of these companies, there’s a huge focus on managing with discipline, right now. To understand what investments you need to make today, what investments can you push out a little bit. And, more and more companies I think have become really rigorous in terms of stage gating, understanding when are they going to apply more funds, and how do you run a little bit lean, and then open up the aperture a bit.
Simon Burns: Phenomenal. Jonathan, thank you for the impact you’ve made on the field, and for taking the time today, I appreciate you jumping on.
Jonathan Zung: [00:10:00] Oh great. Thanks Simon.
