Developing a Global Clinical Trial Strategy for Emerging Biotechs

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Welcome to Pharma Talk Radio. This podcast is focused on
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developing a global clinical trial strategy from the twenty twenty
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six Chief Medical Officer Summer three sixty. For more information
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on the CMO Summer three sixty and associated content, please
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visit cmosumm at three sixty dot com. Thank you and
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enjoy the podcast.
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Good afternoon, guys. My name's Albert Kim. I'm the Chief
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Medical Officer at Embriya Pharmaceuticals. I'm cardiologist by background, was
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in Big Farmer for fourteen years at no Artists and
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then a pfiser. Then I have been to smaller companies
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for the last seven and this is my third time
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around a CMO. My I guess fit for this particular
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topic is that we ran global clinical draws Andberg Pharma,
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but now I'm part of a small pharma also that
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is in the midst of a Phase two B clinical
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trial in multiple regions around the globe. And I think
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it's a terrific topic, very timely in this uncertain world
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that we live in, and I'm delighted to be joined
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by this panel of experts next to me, and I'm
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going to ask each one you, maybe starting with Oliver
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on the fore end and coming back towards me to
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introduce yourselves, your current role and maybe describe from what
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perspective you are speaking on global clinical trial strategy to
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help inform our audience. So oliver it with you.
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Thank you, Albert out of a Rosen, chief medical officer
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at I come is BYO medical and colleges by training.
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So I come Aspires a very small company. We have
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single digit nine people, and we have to be used
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to be bigger. But I think and it's actually really
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I really appreciate your point because I'm speaking about this
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not just for Phase three trials that I ran as
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a chief medical officer in another company, but also as
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a Phase one or Phase one B studies, because I
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think independent of regulatory or whatever uncertainties that we have.
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We had a panel this morning what diversity for example,
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So already doing an earlier study in different countries or
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different jurisdictions gives you incredibly important insight as opposed to
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just sticking within one jurisdiction and probably a more homogeneous
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medical practice. So I think, really obviously the scale of
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global trials is different when you have a face one
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on Face one B versus a Phase three but the
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princess are the same.
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Y Hi, I'm Judy Nung cash In. I'm the CMO
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of nov Tech, which is a global CRO completely focused
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on serving biotech. I'm an infectious disease physician by training.
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I also trained in hematology. I've been in the industry
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for twenty polunch years and spent time on the sponsor side,
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ten years in big pharma at GSK, but also Boston
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based biotech and small spec pharma. On the CRO side,
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I've been in advisory service is at Quinn Tiles before
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it was IQVIA, and a chief medical and scientific officer
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at Sinios. So today, the perspective I'll bring is having
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played both sides of the field kind of my perspective,
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but especially on operationally, how CROs and sponsors can partner
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to develop global strategy that fits your priorities.
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Thank you.
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I'm Melissa Bomban. I'm president of bio Rassi you. We're
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a global tech enabled CRO that's built in a fit
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for purpose fashion for biotech, particularly for early funded or
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early stage programs, were often involved in both design as
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well as execution of clinical programs. Certainly, the perspective I
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bring here today is from a career in global clinical
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operations of trials very much often in the early and
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mid sized biotech sponsor space, and additionally, the focus in
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the early decision of when to go global is an
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area where I've had quite a bit of an opportunity
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to advise and work with sponsors.
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And I'm Drew Deets. I'm a pediatric hematology, oncology and
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stem cell transplant physician by training. After some time in
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clinical and academic practice, I went to work at Bluebird
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Bio in x vvo gene therapy, then spent a couple
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of years at a startup doing RNA therapeutics in the
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gene therapy space. And I'm now the head of clinical
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development at Insoma, which is a small, very small biotech
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doing in vivo gene therapy and really bringing the perspective
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of that very early company that's just taking a turn
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to the clinics. So we have our first clinical trial
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that just opened and sort of really thinking about what
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the global strategy looks like from way early on Terroic.
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So I think you guys can see that we have
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a really nicely diverse panel appear with very different perspectives. Actually,
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we're going to start with a general question, and what
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we're going to try to do here is really make
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concepts tangible for our audience today. So I'm going to
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ask each one of our panels this general question, how
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do you think about developing your global clinical trial strategy
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from your perspective? And then share a specific anecdote or
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data point from your personal experience that exemplifies this concept
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and why you think it's important.
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So why don't we.
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Start in the middle, How about with maybe Judy and
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then go to Melissa Ladies first.
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Okay, great, So my perspective on this when to what
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was a question?
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When to how do you think about your global clinical
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trial strategy? It can mean lots of different things to
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different people, right, You can mean an operations footprint, It
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can mean country order of entry, It can mean dealing
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with regulatory authorities of a particular flavor, timelines to CTA.
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So how do you think about crafting your strategy? And
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give us one concrete example of why that's important.
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So, from where I sit at the moment, and given
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that we spend a lot of time, like Melissa in
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the early phase, but also in the global late phase,
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and we're also seeing earlier studies being more global. So
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I think, for me from a cro perspective, the more
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we can develop a partnership with our sponsor and not
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just understand the clinical protocol, but understand the priorities of
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the program and even actually the company when we know
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things like our board is pressuring us to have this
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data package by this date for this meeting so that
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we can raise from that data or approach a strategic partner.
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The more you can share with us, and sometimes you
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know our early but you know or maybe less experienced,
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or maybe with a handful of people biotechs you know
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might feel uncomfortable sharing that information. But to the extent
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that you can, that really helps us develop a strategy
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that is congruent with your tolerance for cost, time, value creation,
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and risk. So I think those are really for me,
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the key success factors in interacting with a biotech, regardless
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of phase around developing that strategy according to their priorities.
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I think I can give a good example of when
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we're not a success well, when there isn't that transparency
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around what the company goals are. So if if we
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you know, we didn't know that this company wanted to
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go to China even though it didn't make sense for
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what we thought was operationally appropriate. But you know, just
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sharing we have two board members who feel really strong,
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strongly about it. We haven't been able to convince them
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that perhaps now is not the time to go. You know,
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then we can offer our CEO or myself to go
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and speak maybe with that those those stakeholders to kind
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of hear their perspective. That didn't happen and the timelines
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were slower.
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Great, thank you so much. Well how about how about
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you share your thought process for how you think about
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global clinical trust strategy and a story or two.
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Thank you so.
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One of the things that I often see is that
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speed becomes the first topic of discussion, and there seems
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to be an interest in pursuing countries that have a
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track record of a more expedited startup timeline as the choice.
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And I'd liked us to question why we're going in
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that direction as opposed to looking first at the science
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and the patients and then establishing how best to get
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to the signal for those patients. Oftentimes we see the
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country choice or let's add countries as a way to
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make up perhaps for a protocol that wasn't designed to
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be recruitable or a protocol that wasn't designed with the
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competitive landscape in mind. And while there is plenty of
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unmet need, you're also in a competitive landscape. And so
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the number one thing that I find to be effective
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is to do a much more comprehensive analysis and instead
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of rushing to get a site open in a country,
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ensure that you actually have a development plan that includes
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really clear understanding of the regulatory landscape for where you
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want to go and the operational costs associated with that.
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Because you can't chase and make up time with opening
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more countries, you will just incur more obligation as you
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have more regulatory commitment, more supply chain commitment, and unfortunately,
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much more burden on your likely already overburdened resources, and
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you're burning your capital at a rate that you likely
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weren't expecting. So the lesson in that is stay focused,
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stay small, and stay emphasizing where you can get to
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signal soonest without trying to go global.
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Terfect Oliver.
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So I would give a slightly different perspective to this
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because I think.
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We heard this this morning.
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It's all about partnerships, and so I would first really
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think about stand left k what is the science, what
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is the stand left kay in a given urisdiction, and
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then come from this perspective, and obviously eventually one has
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to merge the different perspectives. But I think if we're
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not able to identify a champion, be the Phase one
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B study.
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That's what we're in right now.
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If we don't have a champion in a country, for example,
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we shouldn't even start the trial. And that is true
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also for a Phase three trial because obviously there's many
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more sites in a country and if that national champion
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is not there, we're toasted. I mean even if then
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the CER hotels, you we have all the company, all
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the contracts and blah blah blah, it will not work.
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So you really have to to I think again it's
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about perspectives.
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I think one still has to follow really medical practice
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and then move from there.
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I also would caution us to say.
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There's sessions about kind of countries that are fast, to
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really do a thorough assessment of each of these countries,
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because sometimes, yeah, you have a modality where the CMC
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standards are extremely high in that country, or there's country
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there's sites that are fast, they're private sides and they
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don't do this, and there's sites that are slow. They
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would do this, but that defeats the purpose of going
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to certain countries.
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So that's a really important point.
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And then to really come up with clear metrics, how
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do I monitor that my choices were right or then
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when you put it together from an operational perspective, also
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how it was right. And the anecdote I would share
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is that isn't a past life. We were really fast
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from first patient dosed ever to beginning of Phase three trial.
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We want to be super fast. We did it in
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twenty seven months. And so but there were all of
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a sudden, this whole thing, we don't have enough sites,
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we don't have enough countries, we need to expand. It
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was a relatively small Phase three trial, and going through
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that process and issue that aligned out, I could always say, guys,
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we've got to focus.
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Now get more.
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Melissa, you said it very well. It's more liability than
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if you now all by a sudden expand to sites
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and countries, So you lose focus. And so we said,
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we know that people are behind this, we know the
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patients are out there, and guess what. We enrolled really
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in a very tough enrollment schedule and we enrolled instead
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of I think in ten months instead of eleven months
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or twelve months or so. But it was really the
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focus and then going back to we know the champions
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are there, and so now we really now need to
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focus our resources on contracting and all these things.
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Yeah, and not get too broad.
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Great, thank you, Oliver, true.
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Thanks.
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So.
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Yeah.
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The perspective I want to bring is is really from
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that early stage company taking the turn to the clinic
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for the very first time, also trying to think about
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kind of future programs and what that looks like, and
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you know, sort of how you might have different strategies
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for different programs depending on really what your goals are.
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And then in the midst of that kind of balance cost,
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speed and quality and which of those levers you want
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to pull at which time, because let's be honest, you
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can't pull them all.
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At the same time. And although people ask for that.
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Well, right exactly, And so you know, as you're evaluating geographies,
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how many geographies do you need and how many sites
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within each geography do you need? And I'm coming from
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a very rare disease perspective, and so things are by
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nature going to be a bit more focused to begin with.
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But you know, to what degree do you need to
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even think about leveraging different geographies in order to risk
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mitigate against potential problems? You know, we're talking about the
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dynamic regulatory environment as part of this meeting, and so
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you know, you think, Okay, I have no idea what's
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going to happen in the US. I need another geography
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to make sure that if we run into stumbling blocks there,
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we're going to be able to still move this clinical
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trial forward regardless of what the FDA has to say
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right now. And you know, my anecdote to all of
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this is we did we evaluated about a half a
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dozen geographies.
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We settled on a couple.
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We settled on a couple with the idea being that,
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you know, we wanted to be able to risk mitigate,
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and we had one geography that we thought was going
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to be really quick and easy, and we had one
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geography we thought was going to have some stumbling blocks
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along the way. It's a good thing we did the
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risk mitigation strategy, but it's interesting because it turned out
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exactly opposite. So the country we thought was going to
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be easy was very hard. The country we thought was
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going to be hard actually turned out to be really
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quite easy, and so you just kind of never know
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what you're going to get yourself into, and you have
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to be a little bit prepared that it could go
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a variety of different directions. And now as we're thinking
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about our second program, our whole strategy is actually very
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different than how we designed the strategy for the very
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first program.
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So terrific anecdote I can give one that's almost the same.
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We recently went through the unified ema CTA feedback process,
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and I've been through Europe a number of times, but
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this process was new, and believe it or not, it
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went faster than we thought and North American sites were
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actually the problem. So another data point along that same
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axis in our proper I'm going to switch a second question.
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I asked all of you, you know, can you give
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me one terrific success in your globalization history from a
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strategic standpoint or one horrible failure? And you know it's
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not necessarily requirement to air dirty laundry here, but you
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know we learned from our mistakes. So I'm going to
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repeat that question to you guys now and please jump in.
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What one thing can you tell this audience that has
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been a spectacular success or a terrible failure in the
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distant past. Of course, about how you've approached globalizing.
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A clinical trial.
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People just jump in when you're ready.
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Well, I guess one thing that we are seeing is,
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you know, as people are trying to mitigate risk and
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accelerate enrollment.
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And save time.
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Right an area that we see a lot of our
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sponsors turning two is Asia, pack and Australia New Zealand.
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And I think what can be us spectacular failure if
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there is when there's not enough understanding of the country
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regional regulatory differences, cultural differences, and not really having a
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way to really understand those environments if you're inexperienced and
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have been kind of grew up kind of how I
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did you go to the US and the FDA and
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the EMA and call it a day and think about
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the rest of the world later. And so there's a
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perception of risk that.
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May or may not be.
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Accurate in going to some of these places. So where
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we've seen failures is not enough understanding of the different
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investigator relationships who may be competing with each other in
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enrolling your studies or sort of dismissing that that's a thing,
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and then that can really slow down your enrollment in
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a country where people who don't like each other shouldn't
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be on the same study. And we've we've seen that
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really spectacularly slow timelines.
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Perfect thank you in videos.
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Well, one thing I would add where I've seen great
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success is when we have really close collaboration and the
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ability to have feedback in both directions. When sponsors are
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open to getting feedback about the design and the journey
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that the asset is taking by the vendors and the
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operating partners and the execution partners that you're investing in,
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that is where you actually end up having more success
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with global strategy. I've unfortunately had to be at the
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point of escalation for project teams who have had sponsors
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who have refused to sign off on what was considered
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to be an appropriate adjustment to an expansion instead of
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enrolling pardon, instead of adding twenty sites to a program
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that really should have been powered under maybe eight or
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six sites or partner six countries maximum, and the the
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expectation was that as the vendor selected by the sponsor,
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we were to deploy and to execute, not to question
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that's not an appropriate way to collaborate, particularly because the
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site relationships have been fostered and developed by those vendors
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that you engage. They understand the competitive landscape, They know
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that your asset is maybe not as desirable to those investigators,
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and they will point you into other geographies where there
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is less competitive pressure. That may have not been your
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first choice, But if you're trying to get to signal
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and speed matters, it's important to have that collaborative engagement.
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So where I've seen failure is in the lack of
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taking on new suggestions or considering those maybe difficult to
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hear recommendations. But where I've seen great success is in
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the opposite, where a sponsor arrives with a very clear plan,
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we know this is where we want to run the study,
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and then the data doesn't bear out, and our ability
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to collaborate together and find alternatives that can get you
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to signal, that can get efficacy data in a much
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more timely fashion.
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Those are the good examples great points.
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Is it possible to infer that cmos are sometimes stubborn?
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That is that one of the data points.
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I'll let us CMO answer that question.
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Drew Oliver yeah, so I spoke already about the global success,
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so I'd rather speak about the almost failure. So I
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think we all have to ask ourselves at a given
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time in our life, hopefully one time only, but maybe
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for a lot of studies, when to really rescue a trial.
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And so I think that's something that is not a
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decision to do lightly. And so we have been once
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in that situation where if I would list all the
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things that happened to us on that trial, you would
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say one of them was inconceivable that this would happen
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to you. But it all happened at the same time
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or different times at different sites.
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So this was really a tricky decision.
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And so what we then did and certain countries were
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named where it's clear that it's a faster pathway.
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But again you need to do your homework instead of.
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Just saying, oh, we now trust everybody marches to whatever
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Asia pack or so this.
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Is where I mentioned at the beginning.
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CMC strategy and requirements is an incredibly important point.
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And sometimes when you have been already in a clinic,
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you think, oh.
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This is all easy, you don't think about that anymore,
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that all by a sudden somebody says, I remember there
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was a one set of situation a human serum album
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in how many pooled samples can be used together to
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manufacture your drug.
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Ian It was unbelievable in a late stage setting.
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But in another setting we really found out relatively late
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that in a particularly restriction it was impossible to have
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these timelines that we were hoping for, And so then
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we had to go back to the existing jurisdictions and
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we managed the trial. But as I said, it's very
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hard because when you in that situation, just getting to
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more and more sides as hard.
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But my recommendation, what really was helpful for us is
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be very candid with the side. Can you activate in
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three months? We would love to work with you. We'll
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come back earlier next time.
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But being so candid about this was extremely helpful and
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helped us really to rescue a trial without doing major
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humps now going to different countries or different jurisdictions.
397
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Perfect dore any comments.
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I was just going to speak a little bit about,
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you know, thinking as a head of clinical development and
400
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really our biggest stakeholders personally, I feel are the patients
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and the investigators who take care of those patients, and
402
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as you think about your global strategy keeping in mind
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what's going to happen to them along the whole way.
404
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I think sometimes people want the speed, people want the
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low cost, but then where are you leaving those patients,
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those investigators as you continue to progress through kind of
407
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the whole arc of the spectrum of a particular product.
408
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So just kind of keeping that in mind.
409
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Terrific. But we have arrived on time at the last
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five minutes of this session, and Andrew Goldski has been
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emailing me furiously reserve the last five minutes for questions,
412
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so that this is your time. Guys, please step up
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to the mic and ask this panel any questions you
414
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might have or any discussion points you won't want to raise.
415
00:24:31.920 --> 00:24:36.400
Everybody's shy. There's a handheld, there's a standing mic there,
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we have a taker.
417
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Thank you, I Mega st Christian Christian woman representing you're
418
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being in a zero. What I see quite often that
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people stick through their experience which they had in the boss.
420
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They'll give you ensemble. I'm trubling to join us several
421
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times a year and it's like hey, euro up a
422
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CDIs It's all working like clockwork, YadA YadA, YadA is
423
00:24:54.319 --> 00:24:56.759
like now we have given up on Europe really bad experience,
424
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and you never want to set up a troy in Italy.
425
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So how much that influences you decision based Are you
426
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sticking to your histories, the personal experience or do you
427
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fresh at some point or so I would love to
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hear you'll be needing it.
429
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I think that's a really great point, a really great question.
430
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I think it's super important for us to constantly challenge
431
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ourselves to not get stuck in sort of the way
432
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things are done, either whether it's how we operate with
433
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CROs or what geography we're going into. I know for myself,
434
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I actually make a point at regular intervals to just
435
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sort of say, Okay, what are the decisions I'm up
436
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against right now, and how do I make sure that
437
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I don't fall into that trap? Because I think it's
438
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a huge trap.
439
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And I'll also add, this is the way you can
440
00:25:45.279 --> 00:25:47.960
leverage your vendor community. We are eager to come to
441
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you with current reflections on what you're considering and ask
442
00:25:51.720 --> 00:25:54.519
around because we all have access to incredibly rich data
443
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now that can look not just at completed protocols, which
444
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is still looking in the back, but actively recruiting protocols
445
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and what's happening in that indication in those patient populations.
446
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Another perspective that I would like to add to add
447
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to this is I think world history is more predictable
448
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than clinical trial history.
449
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So I would caution you also to.
450
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Trust past performance, be positive or negative, because I would say,
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if I went back to people with whom I worked
452
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for twenty years and all by a sudden something changed,
453
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and it's clear the technology of the platform, whatever, the
454
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everything is attractive, it still might be a complete nightmare.
455
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And on the other hand, former nightmares, when you go
456
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back to them, it's incredible sometimes how.
457
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Successful it is. So that's just a word of course.
458
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I think the last thing I'll say about that is
459
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the pace of change that we're experiencing right now in
460
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our industry is so rapid, and I think more data
461
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is better other people's experience. Like Melissa said, leveraging your
462
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different vendors who've had recent experiences and also getting in
463
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there and interacting with the sites and understanding what.
464
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They can and can't do for you great.
465
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We have question sure.
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Joe Staffer, serial CMO and current CMO, PvP Labs, XCDA
467
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Regulator ex military blah blah blah. Whatever you figured me out,
468
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I'm doing a panel tomorrow and figure that out to
469
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the to the CRO folks up on the stage. You
470
00:27:32.119 --> 00:27:36.000
talked about rescuing a trial. So in my situation, I've
471
00:27:36.039 --> 00:27:38.759
hired and fired many CROs. I've been let go myself
472
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as a CMO, so I know what it's like on
473
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both sides too. What you have you ever lost a trial,
474
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whether you thought you deserved to or not, and if so,
475
00:27:46.359 --> 00:27:49.039
what did you do differently, especially if you lost it
476
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to your most evil competitor.
477
00:27:52.559 --> 00:27:53.599
There are no evil.
478
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Who you thought was one.
479
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Who's worked for a CRO knows that we are all
480
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in this together with the sponsors, and it's fun to
481
00:28:00.920 --> 00:28:04.440
joke around about evil competitors. But your competitor tomorrow is
482
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your boss, or your competitor today is your boss tomorrow
483
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or your client the next day. So the question underlying it, though,
484
00:28:10.960 --> 00:28:13.559
which is an important one, is to normalize that trial
485
00:28:13.640 --> 00:28:16.319
rescue represents about twenty five to thirty percent of any
486
00:28:16.400 --> 00:28:20.480
CRO's book of business, so it's happening everywhere. Trials don't
487
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get managed successfully for all sorts of conditions. The way
488
00:28:24.960 --> 00:28:27.119
to prevent that is to open the lines of communication
489
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early and ask for accountability and transparency of achievement against expectations,
490
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because if you can't see it coming, you'll never prevent it.
491
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And I also think that where things break down in
492
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the relationship partnership wherever's a lot of times at the
493
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executive level, you know, it can be all kumbaya and
494
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shaking hands. And we've agreed on a governance structure. We've
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agreed on the metrics and the timelines, and then it's
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up to leadership to really ensure that on both sides
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of the table, if you like, that everyone is aligned
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and that that same you know, campfire feeling is happening
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with the teams that are actually doing the work and
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getting the job.
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I think you guys answered the question, but I'm not
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so sure I heard an answer to what would you
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do differently if it ever happened to you? Or what
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did you do differently when you lost a trial? What
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happened quickly? And what did you do differently to get
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to get either to get that client back or get
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a better client back.
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Maybe, so let's chat at the break.
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Thank you, thank you, thank you, thank you the question.
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We hope you enjoyed the podcast. For more information on
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00:29:46.680 --> 00:29:50.039
the CMO Summer three sixty and associated content, please visit
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CMO Summit three sixty dot com. Thanks for listening.